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Background Malaria in the first trimester of pregnancy is associated with adverse pregnancy outcomes. Artemisinin-based combination therapies (ACTs) are a highly effective, first-line treatment for uncomplicated Plasmodium falciparum malaria, except in the first trimester of pregnancy, when quinine with clindamycin is recommended due to concerns about the potential embryotoxicity of artemisinins. We compared adverse pregnancy outcomes after artemisinin-based treatment (ABT) versus non-ABTs in the first trimester of pregnancy. Methods For this systematic review and individual patient data (IPD) meta-analysis, we searched MEDLINE, Embase, and the Malaria in Pregnancy Library for prospective cohort studies published between Nov 1, 2015, and Dec 21, 2021, containing data on outcomes of pregnancies exposed to ABT and non-ABT in the first trimester. The results of this search were added to those of a previous systematic review that included publications published up until November, 2015. We included pregnancies enrolled before the pregnancy outcome was known. We excluded pregnancies with missing estimated gestational age or exposure information, multiple gestation pregnancies, and if the fetus was confirmed to be unviable before antimalarial treatment. The primary endpoint was adverse pregnancy outcome, defined as a composite of either miscarriage, stillbirth, or major congenital anomalies. A one-stage IPD meta-analysis was done by use of shared-frailty Cox models. This study is registered with PROSPERO, number CRD42015032371. Findings We identified seven eligible studies that included 12 cohorts. All 12 cohorts contributed IPD, including 34 178 pregnancies, 737 with confirmed first-trimester exposure to ABTs and 1076 with confirmed first-trimester exposure to non-ABTs. Adverse pregnancy outcomes occurred in 42 (5·7%) of 736 ABT-exposed pregnancies compared with 96 (8·9%) of 1074 non-ABT-exposed pregnancies in the first trimester (adjusted hazard ratio [aHR] 0·71, 95% CI 0·49–1·03). Similar results were seen for the individual components of miscarriage (aHR=0·74, 0·47–1·17), stillbirth (aHR=0·71, 0·32–1·57), and major congenital anomalies (aHR=0·60, 0·13–2·87). The risk of adverse pregnancy outcomes was lower with artemether–lumefantrine than with oral quinine in the first trimester of pregnancy (25 [4·8%] of 524 vs 84 [9·2%] of 915; aHR 0·58, 0·36–0·92). Interpretation We found no evidence of embryotoxicity or teratogenicity based on the risk of miscarriage, stillbirth, or major congenital anomalies associated with ABT during the first trimester of pregnancy. Given that treatment with artemether–lumefantrine was associated with fewer adverse pregnancy outcomes than quinine, and because of the known superior tolerability and antimalarial effectiveness of ACTs, artemether–lumefantrine should be considered the preferred treatment for uncomplicated P falciparum malaria in the first trimester. If artemether–lumefantrine is unavailable, other ACTs (except artesunate–sulfadoxine–pyrimethamine) should be preferred to quinine. Continued active pharmacovigilance is warranted. Funding Medicines for Malaria Venture, WHO, and the Worldwide Antimalarial Resistance Network funded by the Bill & Melinda Gates Foundation.

Blood pressure measurement is a marker of antenatal care quality. In well resourced settings, lower blood pressure cutoffs for hypertension are associated with adverse pregnancy outcomes. We aimed to study the associations between blood pressure thresholds and adverse outcomes and the diagnostic test properties of these blood pressure cutoffs in low-resource settings.We did a secondary analysis of data from 22 intervention clusters in the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials (NCT01911494) in India (n=6), Mozambique (n=6), and Pakistan (n=10). We included pregnant women aged 15-49 years (12-49 years in Mozambique), identified in their community by trained community health workers, who had data on blood pressure measurements and outcomes. The trial was unmasked. Maximum blood pressure was categorised as: normal blood pressure (systolic blood pressure [sBP]120 mm Hg and diastolic blood pressure [dBP]80 mm Hg), elevated blood pressure (sBP 120-129 mm Hg and dBP80 mm Hg), stage 1 hypertension (sBP 130-139 mm Hg or dBP 80-89 mm Hg, or both), non-severe stage 2 hypertension (sBP 140-159 mm Hg or dBP 90-109 mm Hg, or both), or severe stage 2 hypertension (sBP ≥160 mm Hg or dBP ≥110 mm Hg, or both). We classified women according to the maximum blood pressure category reached across all visits for the primary analyses. The primary outcome was a maternal, fetal, or neonatal mortality or morbidity composite. We estimated dose-response relationships between blood pressure category and adverse outcomes, as well as diagnostic test properties.Between Nov 1, 2014, and Feb 28, 2017, 21 069 women (6067 in India, 4163 in Mozambique, and 10 839 in Pakistan) contributed 103 679 blood pressure measurements across the three CLIP trials. Only women with non-severe or severe stage 2 hypertension, as discrete diagnostic categories, experienced more adverse outcomes than women with normal blood pressure (risk ratios 1·29-5·88). Using blood pressure categories as diagnostic thresholds (women with blood pressure within the category or any higher category vs those with blood pressure in any lower category), dose-response relationships were observed between increasing thresholds and adverse outcomes, but likelihood ratios were informative only for severe stage 2 hypertension and maternal CNS events (likelihood ratio 6·36 [95% CI 3·65-11·07]) and perinatal death (5·07 [3·64-7·07]), particularly stillbirth (8·53 [5·63-12·92]).In low-resource settings, neither elevated blood pressure nor stage 1 hypertension were associated with maternal, fetal, or neonatal mortality or morbidity adverse composite outcomes. Only the threshold for severe stage 2 hypertension met diagnostic test performance standards. Current diagnostic thresholds for hypertension in pregnancy should be retained.University of British Columbia, the BillMelinda Gates Foundation.

Encouraging local transport programs and transport infrastructure in poorly-resourced communities can help improve community access and strengthen engagement with health systems. Mobilizing community resources and leadership to implement a community-based transport scheme in rural Mozambique to support referrals to health facilities can help improve maternal and child health outcomes., Key Findings It was feasible to implement a community-based transport program in rural areas with no external input of vehicles, fuel, personnel, or maintenance. However, lack of available transporters, barriers to fulfill requirements to opening and managing bank accounts, inequities in affordability of the scheme, and tensions regarding views on how to manage funds were implementation challenges identified that require further support. Positive impacts of program implementation included streamlining the process of identifying transport options and collaborators in the community, pre-negotiating travel prices to increase affordability, raising community attention to the role of transport in reducing delays in health care seeking, and raising awareness on the importance of early recognition of warning signs and prompt care seeking. Key Implications Our community-based transport program uniquely emphasized community ownership and leadership at all stages. Decisions were built by consensus within each community, which allowed for flexibility to local conditions and supported local skill and capacity building for financial management. Transport schemes cannot be implemented in isolation from the wider health system strengthening efforts. This scheme used existing referral pathways rather than creating entirely new processes to help sustainability., Introduction: Delays due to long distances to health facilities, poor road infrastructure, and lack of affordable transport options contribute to the burden of maternal deaths in Mozambique. This study aimed to assess the implementation and uptake of an innovative community-based transport program to improve access to emergency obstetric care in southern Mozambique. Methods: From April 2016 to February 2017, a community transport strategy was implemented as part of the Community Level Interventions for Pre-eclampsia Trial. The study aimed to reduce maternal and perinatal mortality and morbidity by 20% in intervention clusters in Maputo and Gaza Provinces, Mozambique, by involving community health workers in the identification and referral of pregnant and puerperal women at risk. Based on a community-based participatory needs assessment, the transport program was implemented with the trial. Demographics, conditions requiring transportation, means of transport used, route, and outcomes were collected during implementation. Data were entered into a REDCap database. Results: Fifty-seven neighborhoods contributed to the needs assessment; of those, 13 (23%) implemented the transport program. Neighborhoods were selected based on their expression of interest and ability to contribute financially to the program (US$0.33 per family per month). In each selected neighborhood, a community management committee was created, training in small-scale financial management was conducted, and monitoring tools were provided. Twenty people from 9 neighborhoods benefited from the transport program, 70% were pregnant and postpartum women. Conclusion: These results demonstrate that it was feasible to implement a community-based transport program with no external input of vehicles, fuel, personnel, and maintenance. However, high cost and a lack of acceptable transport options in some communities continue to impede access to obstetric health care services and the ability for timely follow-up. When strengthening capacities of community health workers to promptly assist and refer emergency cases, it is crucial to encourage local transport programs and transportation infrastructure among minimally resourced communities to support access and engagement with health systems.

To estimate the prevalence and prognosis of proteinuria at enrolment in the 27 intervention clusters of the Community-Level Interventions for Pre-eclampsia cluster randomized trials.We identified pregnant women eligible for inclusion in the trials in their communities in four countries (2013-2017). We included women who delivered by trial end and received an intervention antenatal care visit. The intervention was a community health worker providing supplementary hypertension-oriented care, including proteinuria assessment by visual assessment of urinary dipstick at the first visit and all subsequent visits when hypertension was detected. In a multilevel regression model, we compared baseline prevalence of proteinuria (≥ 1+ or ≥ 2+) across countries. We compared the incidence of subsequent complications by baseline proteinuria.Baseline proteinuria was detected in less than 5% of eligible pregnancies in each country (India: 234/6120; Mozambique: 94/4234; Nigeria: 286/7004; Pakistan: 315/10 885), almost always with normotension (India: 225/234; Mozambique: 93/94; Nigeria: 241/286; Pakistan: 264/315). There was no consistent relationship between baseline proteinuria (either ≥ 1+ or ≥ 2+) and progression to hypertension, maternal mortality or morbidity, birth at 37 weeks, caesarean section delivery or perinatal mortality or morbidity. If proteinuria testing were restricted to women with hypertension, we projected annual cost savings of 153 223 981 United States dollars (US$) in India, US$ 9 055 286 in Mozambique, US$ 53 181 933 in Nigeria and US$ 38 828 746 in Pakistan.Our findings question the recommendations to routinely evaluate proteinuria at first assessment in pregnancy. Restricting proteinuria testing to pregnant women with hypertension has the potential to save resources.Estimer la prévalence et le pronostic de la protéinurie au moment de l'inscription dans l'un des 27 groupes repris dans les essais randomisés en grappes sur les interventions communautaires liées à la prééclampsie.Nous avons sélectionné des femmes enceintes remplissant les conditions requises pour les essais menés au sein de leur communauté dans quatre pays (2013–2017). Nous avons inclus des femmes ayant accouché au terme de l'essai et ayant fait l'objet d'une consultation prénatale avec intervention. L'intervention était menée par un professionnel de santé communautaire prodiguant des soins complémentaires en lien avec l'hypertension, dont un contrôle de la protéinurie par examen visuel d'une bandelette réactive trempée dans les urines lors de la première visite, ainsi que lors des visites qui suivent tout diagnostic d'hypertension. Nous avons employé un modèle de régression multiniveaux pour analyser la prévalence initiale de la protéinurie (≥ 1+ ou ≥ 2+) dans les différents pays. Enfin, nous avons comparé l'incidence des complications ultérieures en fonction de la protéinurie initiale.La protéinurie initiale a été détectée chez moins de 5% des grossesses étudiées dans chaque pays (Inde: 234/6120; Mozambique: 94/4234; Nigeria: 286/7004, Pakistan: 315/10 885), et allait presque toujours de pair avec une tension artérielle normale (Inde: 225/234; Mozambique: 93/94; Nigeria: 241/286; Pakistan: 264/315). Nous n'avons identifié aucun lien concluant entre la protéinurie initiale (qu'elle soit ≥ 1+ ou ≥ 2+) et une progression vers de l'hypertension, une mortalité ou morbidité maternelle, une naissance avant 37 semaines, un accouchement par césarienne, ou encore une mortalité ou morbidité périnatale. Si les tests de dépistage de protéinurie étaient réservés aux femmes souffrant d'hypertension, les économies réalisées chaque année représenteraient 153 223 981 dollars américains en Inde, 9 055 286 dollars américains au Mozambique, 53 181 933 dollars américains au Nigeria et 38 828 746 dollars américains au Pakistan.Nos résultats remettent en question les recommandations selon lesquelles il convient de contrôler régulièrement la protéinurie dès le premier bilan de grossesse. Limiter les tests aux femmes enceintes souffrant d'hypertension pourrait potentiellement permettre de ménager les ressources.Estimar la prevalencia y el pronóstico de la proteinuria al momento de la inscripción en los 27 grupos de intervención de los ensayos aleatorizados del grupo de intervenciones a nivel comunitario para la preeclampsia.Se identificaron mujeres embarazadas que cumplían los requisitos para participar en los ensayos en sus comunidades en cuatro países (2013-2017). Se incluyeron las mujeres que tuvieron un parto al final del ensayo y recibieron una visita de atención prenatal de intervención. Esta intervención consistió en un profesional sanitario de la comunidad quien prestó atención suplementaria centrada en la hipertensión, incluida la evaluación de la proteinuria a través del análisis visual de la tira reactiva de orina en la primera visita y en todas las visitas posteriores si se presentaba hipertensión. En un modelo de regresión multinivel, se comparó la prevalencia del valor basal de la proteinuria (≥ 1+ o ≥ 2+) en todos los países. Luego, se comparó la incidencia de las complicaciones posteriores en función del valor basal de la proteinuria.El valor basal de la proteinuria se detectó en menos del 5 % de los embarazos que cumplían los requisitos en cada país (India: 234/6120; Mozambique: 94/4234; Nigeria: 286/7004, Pakistán: 315/10 885), la mayoría de las veces con una tensión arterial normal (India: 225/234; Mozambique: 93/94; Nigeria: 241/286; Pakistán: 264/315). No se observó una relación coherente entre el valor basal de la proteinuria (ya sea ≥ 1+ o ≥ 2+) y la progresión a la hipertensión, la mortalidad o morbilidad materna, el nacimiento a las 37 semanas, el parto por cesárea o la mortalidad o morbilidad perinatal. Si la prueba de proteinuria se limitara a las mujeres con hipertensión, se calcularían ahorros anuales de 153 223 981 dólares estadounidenses (USD) en la India, 9 055 286 USD en Mozambique, 53 181 933 USD en Nigeria y 38 828 746 USD en Pakistán.Los resultados cuestionan las recomendaciones de evaluar la proteinuria de forma rutinaria en la primera evaluación durante el embarazo. Limitar la prueba de proteinuria a las mujeres embarazadas con hipertensión podría suponer un ahorro de recursos.الغرض تقدير مدى انتشار البيلة البروتينية والتنبؤ بها عند الالتحاق بمجموعات التدخل الـ 27 للتدخلات على مستوى المجتمع للتجارب العشوائية العنقودية لمقدمات الارتعاج. الطريقة قمنا بتحديد النساء الحوامل المؤهلات للمشاركة في التجارب في مجتمعاتهن في أربعة بلدان (الفترة من 2013 إلى 2017). قمنا بتضمين النساء اللواتي ولدن بنهاية التجربة، واستقبلن زيارة رعاية للتدخل سابقة للولادة. كان التدخل بواسطة عامل للرعاية الصحية المجتمعية يقدم رعاية تكميلية موجهة لارتفاع ضغط الدم، بما في ذلك تقييم البيلة البروتينية عن طريق التقييم البصري لمقياس البول في الزيارة الأولى وجميع الزيارات اللاحقة بعد الكشف عن ارتفاع ضغط الدم. في نموذج للتحوف متعدد المستويات، قمنا بمقارنة الانتشار الأساسي للبيلة البروتينية (≥ +1 أو ≥ +2) عبر البلدان. كما قمنا بمقارنة تكرار حدوث المضاعفات اللاحقة بواسطة البيلة البروتينية الأساسية. النتائج تم اكتشاف بيلة بروتينية أساسية في أقل من 5% من حالات الحمل المؤهلة في كل بلد (الهند: 234/6120؛ موزامبيق: 94/4234؛ نيجيريا: 286/7004، باكستان: 315/10885)، دائمًا تقريبًا مع ضغط طبيعي (الهند: 225/234؛ موزامبيق: 93/94؛ نيجيريا: 241/286، باكستان: 264/315). لم تكن هناك علاقة متسقة بين البيلة البروتينية الأساسية (إما ≥ +1 أو ≥ 2+)، والتدهور إلى ارتفاع ضغط الدم، أو وفيات الأمهات، أو الإصابة بالمرض، أو الولادة عند أقل من 37 أسبوعًا، أو الولادة القيصرية، أو وفيات الفترة المحيطة بالولادة أو الإصابة بالمرض. إذا كان اختبار البيلة البروتينية مقصورًا على النساء اللاتي تعانين من ارتفاع ضغط الدم، فقد توقعنا أحجام توفير في التكلفة السنوية تبلغ 153223981 دولارًا أمريكيًا (بالدولار الأمريكي) في الهند، و9055286 دولارًا أمريكيًا في موزامبيق، و53181933 دولارًا أمريكيًا في نيجيريا، و38828746 دولارًا أمريكيًا في باكستان. الاستنتاج لا تثق النتائج التي توصلنا إليها في التوصيات بتقييم البيلة البروتينية بشكل روتيني عند التقييم الأول في الحمل. إن اقتصار اختبار البيلة البروتينية على النساء الحوامل اللاتي تعانين من ارتفاع ضغط الدم، من شأنه أن يوفر في الموارد.评估先兆子痫群体随机试验中，社区干预的 27 个干预群体中蛋白尿的患病率和预后。.我们在这四个国家中选取了符合其社区试验条件的孕妇（2013-2017 年）。其中包括试验结束前分娩且接受了干预产前检查的女性。由社区卫生工作人员提供侧重高血压的补充检查，包括第一次就诊以及在后续就诊期间均检测出高血压时，通过目测评估尿试纸，对蛋白尿进行评估。在多层回归模型中，我们比较了各国蛋白尿（1+ 或 2+）的患病率基线。我们通过基线蛋白尿水平比较了后续并发症的病发率。.每个国家只有不到 5％ 的符合试验条件的孕妇检测了基线蛋白尿水平（巴基斯坦：315/10885、莫桑比克：94/4234、尼日利亚：286/7004、印度：234/6120），其中血压几乎都正常（巴基斯坦：264/315、莫桑比克：93/94、尼日利亚：241/286、印度：225/234）。基线蛋白尿水平（1+ 或 2+）与发展为高血压、孕产妇死亡率或发病率、不足 37 周出生、剖腹产或围产期死亡率或发病率之间，不存在一致的正向关系。据估计，如果蛋白尿检测仅限于高血压孕妇，巴基斯坦每年可节省 38828746 美元，莫桑比克节省 9055286 美元，尼日利亚节省 53181933 美元，印度 153223981 美元。.根据我们的研究结果，我们不建议首次妊娠检查时进行常规蛋白尿评估。我们认为，仅限对高血压孕妇进行蛋白尿检测可能会节省财力。.Оценить распространенность и прогноз протеинурии на момент включения в исследование у пациенток, вошедших по 27 кластерам вмешательств в рандомизированные исследования по кластеру преэклампсии «Меры вмешательства на уровне сообществ».Авторы определили беременных женщин, подходящих для включения в исследования в их сообществах в четырех странах (2013–2017 гг.). Рассматривались женщины, которые родили к концу исследования и к которым применялись определенные вмешательства в ходе визита с целью получения дородовой помощи. Меры вмешательства заключались в том, что местный медицинский работник оказывал дополнительную помощь, ориентированную на гипертензию, включая оценку протеинурии, с помощью визуальной оценки полоски для анализа мочи при первом посещении и во время всех последующих посещений при обнаружении гипертензии. В многоуровневой регрессионной модели авторы сравнили исходную распространенность протеинурии (≥1+ или ≥2+) в четырех странах. Авторы также сравнили частоту последующих осложнений с базовым уровнем протеинурии.Исходная протеинурия была обнаружена менее чем у 5% подходящих беременностей в каждой стране (Индия: 234/6120; Мозамбик: 94/4234; Нигерия: 286/7004, Пакистан: 315/10 885) и почти всегда сопровождалась нормотензией (Индия: 225/234; Мозамбик: 93/94; Нигерия: 241/286; Пакистан: 264/315). Отсутствовала устойчивая взаимосвязь между исходной протеинурией (≥1+ или ≥2+) и переходом в гипертензию, материнской смертностью или заболеваемостью, рождением на сроке37 недель, родоразрешением путем кесарева сечения, перинатальной смертностью или заболеваемостью. Если бы тестирование протеинурии ограничивалось женщинами с гипертензией, то возможно было бы спрогнозировать ежегодную экономию затрат в размере 153 223 981 доллара США (US $) в Индии, 9 055 286 долларов США в Мозамбике, 53 181 933 долларов США в Нигерии и 38 828 746 долларов США в Пакистане.Полученные результаты ставят под сомнение рекомендации по регулярной оценке протеинурии при первой оценке беременности. Исследование на протеинурию только тех беременных женщин, у которых наблюдается гипертензия, может сэкономить ресурсы.

Summary Background To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries. Methods In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014–17. Consenting pregnant women, aged 12–49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564. Findings Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22–30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90–1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility. Interpretation The CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening. Funding University of British Columbia, a grantee of the Bill & Melinda Gates Foundation.

Background Obstetric fistula is still common in low- and middle-income countries (LMIC) despite the on-going shift to increased facility deliveries in the same settings. The social behavioural circumstances in which fistula, as well as its consequences, still occur are poorly documented, particularly from the perspective of the experiences of women with obstetric fistula. This study sought to describe women’s experiences of antenatal, partum and post-partum care in southern Mozambique, and to pinpoint those experiences that are unique to women with fistula in order to understand the care-seeking and care provision circumstances which could have been modified to avoid or mitigate the onset or consequences of fistula. Methods This study took place in Maputo and Gaza provinces, southern Mozambique, in 2016–2017. Qualitative data were collected through in-depth interviews conducted with 14 women with positive diagnoses of fistula and an equal number of women without fistula. All interviews were audio-recorded and transcribed verbatim prior to thematic analysis using NVivo11. Results Study participants had all attended antenatal care (ANC) visits and had prepared for a facility birth. Prolonged or obstructed labour, multiple referrals, and delays in receiving secondary and tertiary health care were common among the discourses of women with fistula. The term “fistula” was rarely known among participants, but the condition (referred to as “loss of water” or “illness of spillage”) was recognised after being prompted on its signs and symptoms. Women with fistula were invariably aware of the links between fistula and poor birth assistance, in contrast with those without fistula, who blamed the condition on women’s physiological and behavioural characteristics. Conclusion Although women do seek antenatal and peri-partum care in health facilities, deficiencies and delays in birth assistance, referral and life-saving interventions were commonly reported by women with fistula. Furthermore, weaknesses in quality of care, not only in relation to prevention, but also the resolution of the damage, were evident. Quality improvement of birth care is necessary, both at primary and referral level. There is a need to increase awareness and develop guidelines for prevention, early detection and management of obstetric fistula, including early postpartum treatment, availability of fistula repair for complex cases, and rehabilitation, coupled with the promotion of community consciousness of the problem.

Background Maternal mortality is an important public health problem in low-income countries. Delays in reaching health facilities and insufficient health care professionals call for innovative community-level solutions. There is limited evidence on the role of community health workers in the management of pregnancy complications. This study aimed to describe the feasibility of task-sharing the initial screening and initiation of obstetric emergency care for pre-eclampsia/eclampsia from the primary healthcare providers to community health workers in Mozambique and document healthcare facility preparedness to respond to referrals. Method The study took place in Maputo and Gaza Provinces in southern Mozambique and aimed to inform the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial. This was a mixed-methods study. The quantitative data was collected through self-administered questionnaires completed by community health workers and a health facility survey; this data was analysed using Stata v13. The qualitative data was collected through focus group discussions and in-depth interviews with various community groups, health care providers, and policymakers. All discussions were audio-recorded and transcribed verbatim prior to thematic analysis using QSR NVivo 10. Data collection was complemented by reviewing existing documents regarding maternal health and community health worker policies, guidelines, reports and manuals. Results Community health workers in Mozambique were trained to identify the basic danger signs of pregnancy; however, they have not been trained to manage obstetric emergencies. Furthermore, barriers at health facilities were identified, including lack of equipment, shortage of supervisors, and irregular drug availability. All primary and the majority of secondary-level facilities (57%) do not provide blood transfusions or have surgical capacity, and thus such cases must be referred to the tertiary-level. Although most healthcare facilities (96%) had access to an ambulance for referrals, no transport was available from the community to the healthcare facility. Conclusions This study showed that task-sharing for screening and pre-referral management of pre-eclampsia and eclampsia were deemed feasible and acceptable at the community-level, but an effort should be in place to address challenges at the health system level., Plain Language Summary Maternal mortality is an important public health problem in Mozambique. Delays in reaching health facilities and insufficient health care professionals call for innovative community-level solutions. We conducted a study to describe the feasibility of task-sharing the screening and initiation of management for pre-eclampsia/eclampsia from the primary healthcare providers to community health workers in Mozambique and to document healthcare facility preparedness to respond to referrals. The study was done to inform a future intervention trial known as the Community-Level Interventions for Pre-eclampsia (CLIP) study. We interviewed community health workers, women, various community groups, health care providers, and policymakers and assessed health facilities in Maputo and Gaza provinces, Mozambique. Our results showed that community health workers in Mozambique were trained to identify the basic danger signs of pregnancy; however, they were not trained or equipped to provide obstetric emergencies care prior to referral. Nurses at primary health facilities were supportive of task-sharing with community health workers; however, some barriers mentioned include a lack of equipment, shortage of supervisors, and irregular drug availability. Local stakeholders emphasized the need for comprehensive training and supervision of community health workers to take on new tasks. Task-sharing for screening and pre-referral management of pre-eclampsia and eclampsia was deemed feasible at the community level in southern Mozambique, but still, to be addressed some health system level barriers to the management of pregnancies complications.

Sub-Saharan Africa concentrates the burden of HIV and the highest adolescent fertility rates. However, there is limited information about the impact of the interaction between adolescence and HIV infection on maternal health in the region. Data collected prospectively from three clinical trials conducted between 2003 and 2014 were analysed to evaluate the association between age, HIV infection, and their interaction, with the risk of maternal morbidity and adverse pregnancy and perinatal outcomes in women from southern Mozambique. Logistic regression and negative binomial models were used. A total of 2352 women were included in the analyses, 31% were adolescents (≤19 years) and 29% HIV-infected women. The effect of age on maternal morbidity and pregnancy and perinatal adverse outcomes was not modified by HIV status. Adolescence was associated with an increased incidence of hospital admissions (IRR 0.55, 95%CI 0.37–0.80 for women 20–24 years, IRR 0.60, 95%CI 0.42–0.85 for women &gt, 25 years compared to adolescents, p-value &lt, 0.01) and outpatient visits (IRR 0.86, 95%CI 0.71–1.04, IRR 0.76, 95%CI 0.63–0.92, p-value = 0.02), and an increased likelihood of having a small-for-gestational age newborn (OR 0.50, 95%CI 0.38–0.65, OR 0.43, 95%CI 0.34–0.56, 0.001), a low birthweight (OR 0.40, 95%CI 0.27–0.59, OR 0.37, 95%CI 0.26–0.53, 0.001) and a premature birth (OR 0.42, 95%CI 0.24–0.72, OR 0.51, 95%CI 0.32–0.82, 0.01). Adolescence was associated with an increased risk of poor morbidity, pregnancy and perinatal outcomes, irrespective of HIV infection. In addition to provision of a specific maternity care package for this vulnerable group interventions are imperative to prevent adolescent pregnancy.

Objectives: Maternal Plasmodium falciparum-specific antibodies may contribute to protect infants against severe malaria. Our main objective was to evaluate the impact of maternal HIV infection and placental malaria on the cord blood levels and efficiency of placental transfer of IgG and IgG subclasses. Methods: In a cohort of 341 delivering HIV-negative and HIV-positive mothers from southern Mozambique, we measured total IgG and IgG subclasses in maternal and cord blood pairs by quantitative suspension array technology against eight P. falciparum antigens: Duffy-binding like domains 3-4 of VAR2CSA from the erythrocyte membrane protein 1, erythrocyte-binding antigen 140, exported protein 1 (EXP1), merozoite surface proteins 1, 2 and 5, and reticulocyte-binding-homologue-4.2 (Rh4.2). We performed univariable and multivariable regression models to assess the association of maternal HIV infection, placental malaria, maternal variables and pregnancy outcomes on cord antibody levels and antibody transplacental transfer. Results: Maternal antibody levels were the main determinants of cord antibody levels. HIV infection and placental malaria reduced the transfer and cord levels of IgG and IgG1, and this was antigen-dependent. Low birth weight was associated with an increase of IgG2 in cord against EXP1 and Rh4.2. Conclusions: We found lower maternally transferred antibodies in HIV-exposed infants and those born from mothers with placental malaria, which may underlie increased susceptibility to malaria in these children. (C) 2021 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Transplacental transfer of antibodies is essential for conferring protection in newborns against infectious diseases. We assessed the impact of different factors, including gestational age and maternal infections such as HIV and malaria, on the efficiency of cord blood levels and placental transfer of IgG subclasses. We measured total IgG and IgG subclasses by quantitative suspension array technology against 14 pathogens and vaccine antigens, including targets of maternal immunization, in 341 delivering HIV-uninfected and HIV-infected mother-infant pairs from southern Mozambique. We analyzed the association of maternal HIV infection, Plasmodium falciparum exposure, maternal variables and pregnancy outcomes on cord antibody levels and transplacental transfer. Our results show that maternal antibody levels were the main determinant of cord antibody levels. Univariable and multivariable analysis showed that HIV reduced the placental transfer and cord levels of IgG and IgG1 principally, but also IgG2 to half of the antigens tested. P. falciparum exposure and prematurity were negatively associated with cord antibody levels and placental transfer, but this was antigen-subclass dependent. Our findings suggest that lower maternally transferred antibodies may underlie increased susceptibility to infections of HIV-exposed infants. This could affect efficacy of maternal vaccination, especially in sub-Saharan Africa, where there is a high prevalence of HIV, malaria and unfavorable environmental factors.

Antibody transplacental transfer is essential for conferring protection in newborns against infectious diseases. This transfer may be affected by gestational age and maternal infections, although the effects are not consistent across studies. We measured total IgG and IgG subclasses by quantitative suspension array technology against fourteen pathogens and vaccine antigens, including target of maternal immunization, in 341 delivering HIV− and HIV+ mother-infant pairs from southern Mozambique. Maternal antibody levels were the main determinant of cord antibody levels. HIV broadly reduced the placental transfer and cord levels of IgG and IgG1, but also IgG2 to half of the antigens. Plasmodium falciparum exposure and prematurity were negatively associated with cord antibody levels and placental transfer but this was antigen-subclass dependent. These findings suggest maternal infections may impact the efficacy of maternal immunization and confirm the lower transfer of antibodies as one of the causes underlying increased susceptibility to infections in HIV-exposed infants.

Background While there is increasing evidence on the safety of artemisinin-based combination therapy (ACT) for the case management of malaria in early pregnancy, little is known about the association between exposure to ACT during the first trimester and the effect on fetal growth. Methods Data were analysed from prospective studies of pregnant women enrolled in Mozambique, Burkina Faso and Kenya designed to determine the association between anti-malarial drug exposure in the first trimester and pregnancy outcomes, including low birth weight (LBW) and small for gestational age (SGA). Exposure to anti-malarial drugs was ascertained retrospectively by record linkage using a combination of data collected from antenatal and adult outpatient clinic registries, prescription records and self-reported medication usage by the women. Site-level data synthesis (fixed effects and random effects) was conducted as well as individual-level analysis (fixed effects by site). Results Overall, 1915 newborns were included with 92 and 26 exposed to ACT (artemether–lumefantrine) and quinine, respectively. In Burkina Faso, Mozambique and Kenya at recruitment, the mean age (standard deviation) was 27.1 (6.6), 24.2 (6.2) and 25.7 (6.5) years, and the mean gestational age was 24.0 (6.2), 21.2 (5.7) and 17.9 (10.2) weeks, respectively. The LBW prevalence among newborns born to women exposed to ACT and quinine (QNN) during the first trimester was 10/92 (10.9%) and 7/26 (26.9%), respectively, compared to 9.5% (171/1797) among women unexposed to any anti-malarials during pregnancy. Compared to those unexposed to anti-malarials, ACT and QNN exposed women had the pooled LBW prevalence ratio (PR) of 1.13 (95% confidence interval (CI) 0.62–2.05, p-value 0.700) and 2.03 (95% CI 1.09–3.78, p-value 0.027), respectively. Compared to those unexposed to anti-malarials ACT and QNN-exposed women had the pooled SGA PR of 0.85 (95% CI 0.50–1.44, p-value 0.543) and 1.41 (95% CI 0.71–2.77, p-value 0.322), respectively. Whereas compared to ACT-exposed, the QNN-exposed had a PR of 2.14 (95% CI 0.78–5.89, p-value 0.142) for LBW and 8.60 (95% CI 1.29–57.6, p-value 0.027) for SGA. The level of between sites heterogeneity was moderate to high. Conclusion ACT exposure during the first trimester was not associated with an increased occurrence of LBW or SGA. However, the data suggest a higher prevalence of LBW and SGA for children born to QNN-exposed pregnancies. The findings support the use of ACT (artemether–lumefantrine) for the treatment of uncomplicated malaria during the first trimester of pregnancy.

Highlights • Task-sharing activities to detect and manage pregnancy hypertension can be achieved by CHWs. • Community engagement activities can achieve a community-driven transport plan. • Intervention effects may have been masked by incomplete implementation or weak in-facility care. • Contact intensity analyses support the WHO eight contact antenatal care model. • Condition-focused community-based interventions without facility strengthening are inadequate., Objectives Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. Study design The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (

Maternal factors and exposure to pathogens have an impact on infant health. For instance, HIV exposed but uninfected infants have higher morbidity and mortality than HIV unexposed infants. Innate responses are the first line of defense and orchestrate the subsequent adaptive immune response and are especially relevant in newborns. To determine the association of maternal HIV infection with maternal and newborn innate immunity we analyzed the cytokine responses upon pattern recognition receptor (PRR) stimulations in the triad of maternal peripheral and placental blood as well as in cord blood in a cohort of mother-infant pairs from southern Mozambique. A total of 48 women (35 HIV-uninfected and 13 HIV-infected) were included. Women and infant innate responses positively correlated with each other. Age, gravidity and sex of the fetus had some associations with spontaneous production of cytokines in the maternal peripheral blood. HIV-infected women not receiving antiretroviral therapy (ART) before pregnancy showed decreased IL-8 and IL-6 PRR responses in peripheral blood compared to those HIV-uninfected, and PRR hyporesponsiveness for IL-8 was also found in the corresponding infant's cord blood. HIV infection had a greater impact on placental blood responses, with significantly increased pro-inflammatory, T H 1 and T H 17 PRR responses in HIV-infected women not receiving ART before pregnancy compared to HIV-uninfected women. In conclusion, innate response of the mother and her newborn was altered by HIV infection in the women who did not receive ART before pregnancy. As these responses could be related to birth outcomes, targeted innate immune modulation could improve maternal and newborn health.

BACKGROUND: Few data on HIV resistance in pregnancy are available from Mozambique, one of the countries with the highest HIV toll worldwide. Understanding the patterns of HIV drug resistance in pregnant women might help in tailoring optimal regimens for prevention of mother to child transmission of HIV (pMTCT) and antenatal care. OBJECTIVES: To describe the frequency and characteristics of HIV drug resistance mutations (HIVDRM) in pregnant women with virological failure at delivery, despite pMTCT or antiretroviral therapy (ART). METHODS: Samples from HIV-infected pregnant women from a rural area in southern Mozambique were analysed. Only women with HIV-1 RNA >400c/mL at delivery were included in the analysis. HIVDRM were determined using MiSeq(R) (detection threshold 1%) at the first antenatal care (ANC) visit and at the time of delivery. RESULTS: Ninety and 60 samples were available at the first ANC visit and delivery, respectively. At first ANC, 97% of the women had HIV-1 RNA>400c/mL, 39% had CD4+ counts

Background: Most estimates of pregnancy hypertension in lessdeveloped countries are from hospital-based cross-sectional surveys and are probably over-estimates. We aimed to estimate population-based rates by standardised methods in intervention clusters of the Community-Level Interventions in Pre-eclampsia (CLIP) cluster randomised trials (NCT01911494). Methods: In study regions, all pregnant women were CLIP-eligible and identified in their homes or local primary health centres (2013-17). This analysis includes women in intervention clusters who both received at least one community health worker (CHW) visit and had delivered by trial end. Trained CHWs provided supplementary hypertension-oriented care that included standardised blood pressure (BP) measurement using a semiautomated device validated in pregnancy. Based on gestational age at presentation, hypertension (BP ≥140/90mmHg) was 'chronic' (

Background At times, ultrasound is not readily available in low resource countries in Africa for accurate determination of gestational age, so using alternative methods is pivotal during pregnancy. These assessments are used to aid the risk analysis for an infant and management strategies for premature delivery, if necessary. Currently, date of last menstrual period, fundal height measurements, and the New Ballard Score are commonly used in resource-limited settings. However, concordance of these measures is unknown for sub-Saharan Africa. We obtained data from an open-label randomized controlled trial, to assess the concordance of these alternative assessment methods. The purpose of our study was to determine the agreement between these alternative methods when used in sub-Saharan African populations. Methods A total of 4,390 pregnant women from Benin, Gabon, Mozambique and Tanzania were included in our analysis. The assessment methods compared were: 1) reported last menstrual period, 2) symphysis-fundal height measurement, and 3) the New Ballard Score. The Bland-Altman method and intraclass correlation coefficient (ICC) were used to test the degree of agreement. Survival range gestational age, used as an inclusion criterion for further analysis, was from 22 to 44 weeks. Findings Plots showed a lack of agreement between methods and the 95% limits of agreement too wide to be clinically useful. ICC = 0.25 indicated poor agreement. A post-hoc analysis, restricted from 32 to 42 weeks, was done to check for better agreement in this near-term population. The plots and ICC = 0.16 still confirmed poor agreement. Conclusion The alternative assessments do not result in comparable outcomes and discrepancies are far beyond the clinically acceptable range. Last menstrual period should not be used as the only estimator of gestational age. In the absence of reliable early ultrasound, symphysis-fundal height measurements may be most useful during pregnancy for fetal risk assessment and the New Ballard Score after delivery as a confirmation of these estimations and for further neonatal management. However, promotion of portable ultrasound devices is required for accurate assessment of gestational age in sub-Sahara Africa.

Background Pregnant women exposed to Plasmodium falciparum generate antibodies against VAR2CSA, the parasite protein that mediates adhesion of infected erythrocytes to the placenta. There is a need of high-throughput tools to determine the fine specificity of these antibodies that can be used to identify immune correlates of protection and exposure. Here we aimed at developing a multiplex-immunoassay to detect antibodies against VAR2CSA antigens. Methods and findings We constructed two multiplex-bead arrays, one composed of 3 VAR2CSA recombinant-domains (DBL3X, DBL5Ɛ and DBL6Ɛ) and another composed of 46 new peptides covering VAR2CSA conserved and semi-conserved regions. IgG reactivity was similar in multiplexed and singleplexed determinations (Pearson correlation, protein array: R2 = 0.99 and peptide array: R2 = 0.87). IgG recognition of 25 out of 46 peptides and all recombinant-domains was higher in pregnant Mozambican women (n = 106) than in Mozambican men (n = 102) and Spanish individuals (n = 101; p

INTRODUCTION: The HIV epidemic is concentrated in sub-Saharan Africa. However, limited information exists on its impact on women and infant's health since the introduction of antiretroviral drugs in this region, where health resources are often scarce. METHODS: The effect of HIV infection on maternal health, birth outcomes and infant health was analysed in two contemporary cohorts of HIV-uninfected and HIV-infected pregnant women from southern Mozambique. Pregnant women attending the first antenatal care visit were followed until one month after delivery. Antiretroviral therapy was administered based on CD4+T cell count and clinical stage. Maternal and neonatal morbidity and mortality, as well as pregnancy outcomes were assessed by mother's HIV status. RESULTS: A total of 1183 HIV-uninfected and 561 HIV-infected pregnant women were enrolled. HIV-infected women were more likely to have anaemia both at the first antenatal care visit and at delivery than HIV-uninfected women (71.5% versus 54.8% and 49.4% versus 40.6%, respectively, p

Introduction Travel time and distance to health facilities are known barriers for accessing maternal health care, particularly in Mozambique. Community health workers (CHWs) are responsible for extending the reach of antenatal care to isolated communities. Less is known about the geographical barriers faced by CHWs that may hamper their access to these isolated communities. Objective This study aimed to evaluate the extent to which related to dose of CHW-led PIERS On the Move (POM) study visit, delivered as an intervention in the Community Level Intervention for Pre-eclampsia trial (NCT01911494) in six clusters in Maputo and Gaza provinces. Methods Access to care was measured by calculating the walking time from each community to the nearest PHC using ArcGIS software. Dose of the intervention was measured by the average number of POM visits during pregnancy. A spatial autocorrelation analysis using the Moran I statistic was used to identify regional clusters of communities with both high and low doses of POM visits and how this compared with access to PHCs. Results Regional clusters (Moran I p 0.001) of communities with poor access to PHCs had significantly lower doses of POM. The high dose areas had POM visits that were almost sevenfold higher than the POM visits in the low POM dose areas. The low dose areas required more that an additional hour of walking time to PHCs. Discussion Inequities in access to pregnancy related care persist, even when the reach of care through community health workers are implemented. Further strategies in addition to assigning community health workers are needed to counter the role of geography in mediating community interventions.

BACKGROUND: A major unresolved safety concern for malaria case management is the use of artemisinin combination therapies (ACTs) in the first trimester of pregnancy. There is a need for human data to inform policy makers and treatment guidelines on the safety of artemisinin combination therapies (ACT) when used during early pregnancy. METHODS: The overall goal of this paper is to describe the methods and implementation of a study aimed at developing surveillance systems for identifying exposures to antimalarials during early pregnancy and for monitoring pregnancy outcomes using health and demographic surveillance platforms. This was a multi-center prospective observational cohort study involving women at health and demographic surveillance sites in three countries in Africa: Burkina Faso, Kenya and Mozambique [(ClinicalTrials.gov Identifier: NCT01232530)]. The study was designed to identify pregnant women with artemisinin exposure in the first trimester and compare them to: 1) pregnant women without malaria, 2) pregnant women treated for malaria, but exposed to other antimalarials, and 3) pregnant women with malaria and treated with artemisinins in the 2nd or 3rd trimesters from the same settings. Pregnant women were recruited through community-based surveys and attendance at health facilities, including antenatal care clinics and followed until delivery. Data from the three sites will be pooled for analysis at the end of the study. Results are forthcoming. DISCUSSION: Despite few limitations, the methods described here are relevant to the development of sustainable pharmacovigilance systems for drugs used by pregnant women in the tropics using health and demographic surveillance sites to prospectively ascertain drug safety in early pregnancy. TRIAL REGISTRATION: NCT01232530.

Background Prevention of reinfection and resurgence is an integral component of the goal to eradicate malaria. However, the adverse effects of malaria resurgences are not known. Methods We assessed the prevalence of Plasmodium falciparum infection among 1819 Mozambican women who delivered infants between 2003 and 2012. We used microscopic and histologic examination and a quantitative polymerase-chain-reaction (qPCR) assay, as well as flow-cytometric analysis of IgG antibody responses against two parasite lines. Results Positive qPCR tests for P. falciparum decreased from 33% in 2003 to 2% in 2010 and increased to 6% in 2012, with antimalarial IgG antibody responses mirroring these trends. Parasite densities in peripheral blood on qPCR assay were higher in 2010-2012 (geometric mean [+/-SD], 409+/-1569 genomes per microliter) than in 2003-2005 (44+/-169 genomes per microliter, P=0.02), as were parasite densities in placental blood on histologic assessment (50+/-39% of infected erythrocytes vs. 4+/-6%, P

BACKGROUND: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ) in women receiving CTXp and long-lasting insecticide treated nets (LLITNs). METHODS AND FINDINGS: A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg) or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27-0.82]; p=0.008), placental malaria (RR, 0.52 [95% CI 0.29-0.90]; p=0.021), and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37-0.95]; p=0.031) in the intention to treat (ITT) analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration). HIV viral load at delivery was higher in the MQ group compared to the control group (p=0.048) in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14-3.33]; p=0.015). The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. CONCLUSIONS: An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with better tolerability to reduce malaria in this particularly vulnerable group. MQ was associated with an increased risk of mother to child transmission of HIV, which warrants a better understanding of the pharmacological interactions between antimalarials and antiretroviral drugs. TRIAL REGISTRATION: ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001813440 Please see later in the article for the Editors' Summary.

Background Intermittent Preventive Treatment (IPTp) and insecticide treated nets (ITNs) are recommended malaria in pregnancy preventive interventions in sub-Saharan Africa. Despite their cost-effectiveness and seemingly straight-forward delivery mechanism, their uptake remains low. We aimed at describing perceptions of pregnant women regarding malaria and the recommended prevention interventions to understand barriers to uptake and help to improve their effectiveness. Methods and findings We used mixed methods to collect data among 85 pregnant women from a rural area of Southern Mozambique. Information was obtained through observations, in-depth interviews, and focused ethnographic exercises (Free-listing and Pairwise comparisons). Thematic analysis was performed on qualitative data. Data from focused ethnographic exercises were summarized into frequency distribution tables and matrices. Malaria was not viewed as a threat to pregnancy. Participants were not fully aware of malaria- associated adverse maternal and birth outcomes. ITNs were the most preferred and used malaria preventive intervention, while IPTp fell between second and third. Indoor Residual Spraying (IRS) was the least preferred intervention. Conclusions Low awareness of the risks and adverse consequences of malaria in pregnancy did not seem to affect acceptability or uptake to the different malaria preventive interventions in the same manner. Perceived convenience, the delivery approach, and type of provider were the key factors. Pregnant women, through antenatal care (ANC) services, can be the vehicles of ITN distribution in the communities to maximise overall ITN coverage. There is a need to improve knowledge about neonatal health and malaria to improve uptake of interventions delivered through channels other than the health facility.

Objectives One of Africa's most important challenges is to improve maternal and neonatal health. The identification of groups at highest risk for adverse pregnancy outcomes is important for developing and implementing targeted prevention programmes. This study assessed whether young adolescent girls constitute a group at increased risk for adverse birth outcomes among pregnant women in sub-Saharan Africa. Setting Data were collected prospectively as part of a large randomised controlled clinical trial evaluating intermittent preventive treatment of malaria in pregnancy ([NCT00811421][1]—Clinical Trials.gov), conducted between September 2009 and December 2013 in Benin, Gabon, Mozambique and Tanzania. Participants Of 4749 participants, pregnancy outcomes were collected for 4388 deliveries with 4183 live births including 83 multiple gestations. Of 4100 mothers with a singleton live birth delivery, 24% (975/4100) were adolescents (≤19 years of age) and 6% (248/4100) were aged ≤16 years. Primary and secondary outcome measures Primary outcomes of this predefined analysis were preterm delivery and low birth weight. Results The overall prevalence of low birthweight infants and preterm delivery was 10% (371/3851) and 4% (159/3862), respectively. Mothers aged ≤16 years showed higher risk for the delivery of a low birthweight infant (OR: 1.96; 95% CI 1.35 to 2.83). Similarly, preterm delivery was associated with young maternal age (≤16 years; OR: 2.62; 95% CI 1.59 to 4.30). In a subanalysis restricted to primiparous women: preterm delivery, OR 4.28; 95% CI 2.05 to 8.93; low birth weight, OR: 1.29; 95% CI 0.82 to 2.01. Conclusions Young maternal age increases the risk for adverse pregnancy outcomes and it is a stronger predictor for low birth weight and preterm delivery than other established risk factors in sub-Saharan Africa. This finding highlights the need to improve adolescent reproductive health in sub-Saharan Africa. Trial registration number NCT00811421; Post-results. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00811421&atom=%2Fbmjopen%2F6%2F6%2Fe011783.atom