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Background: Acyclovir (ACV) given to HSV-2 positive women after 36 weeks reduces adverse outcomes but its benefit at lower gestation was undocumented. We determined the effect of oral acyclovir administered from 28 to 36 weeks on premature rupture of membranes (PROM) primarily and preterm delivery risk. Methods: This was a randomized, double-blind placebo-controlled trial among 200 HSV-2 positive pregnant women at 28 weeks of gestation at Mulago Hospital, Uganda. Participants were assigned randomly (1:1) to take either acyclovir 400 mg orally twice daily (intervention) or placebo (control) from 28 to 36 weeks. Both arms received acyclovir after 36 weeks until delivery. Development of Pre-PROM by 36 weeks and preterm delivery were outcomes. Results: One hundred women were randomised to acyclovir and 100 to placebo arms between January 2014 and February 2015. There was tendency towards reduction of incidence of PROM at 36 weeks but this was not statistically significant (4.0% versus 10.0%; RR 0.35; 95% 0.11-1.10) in the acyclovir and placebo arms respectively. However, there was a significant reduction in the incidence of preterm delivery (11.1% versus 23.5%; RR 0.41; 95% 0.20-0.85) in the acyclovir and placebo arms respectively. Conclusions: Oral acyclovir given to HSV-2 positive pregnant women from 28 to 36 weeks reduced incidence of preterm delivery but did not significantly reduce incidence of pre-PROM. Trial registration: www.pactr.org, PACTR201311000558197. [ABSTRACT FROM AUTHOR]

Background: Postpartum haemorrhage (PPH) remains the leading cause of maternal morbidity and mortality worldwide. The main strategy for preventing PPH is the use of uterotonic drugs given prophylactically by skilled health workers. However, in settings where many women still deliver at home without skilled attendants, uterotonics are often inaccessible. In such cases, women and their caregivers need to recognize PPH promptly so, as to seek expert care. For this reason, it is important to understand how women and their caregivers recognize PPH, as well as the actions they undertake to prevent and treat PPH in home births. Such knowledge can also inform programs aiming to make uterotonics accessible at the community level.Methods: Between April and June 2012, a phenomenological study was carried out in a rural Ugandan district involving 15 in-depth interviews. Respondents were purposively sampled and included six women who had delivered at home in the past year and nine traditional birth attendants (TBAs). The interviews explored how PPH was recognized, its perceived causes, and the practices that respondents used in order to prevent or treat it. Phenomenological descriptive methodology was used to analyse the data.Results: Bleeding after childbirth was considered to be a normal cleansing process, which if stopped or inhibited would lead to negative health consequences to the mother. Respondents used a range of criteria to recognize PPH: rate of blood flow, amount of blood (equivalent to two clenched fists), fainting, feeling thirsty, collapsing or losing consciousness immediately after birth. As a group, respondents seemed to correctly identify women at risk of PPH (those with twin pregnancies, high parity or prolonged labour), but many individuals did not know all the reasons. Respondents used cold drink, uterine massage and traditional medicine to treat PPH.Conclusion: The community viewed bleeding after childbirth as a normal process and their methods of determining excessive bleeding are imprecise and varied. This opens the door for intervention for reducing delays in the home diagnosis of PPH. This includes increasing awareness among TBAs, women and their families about the risk of death due to excessive bleeding in the immediate postpartum period. [ABSTRACT FROM AUTHOR]

Background: Although East Africa, like other countries in sub-Saharan Africa, has a lower incidence of breast cancer than high-income countries, the disease rate is rising steeply in Africa; it has nearly tripled in the past few decades in Uganda. There is a paucity of studies that have examined the relation between reproductive factors and breast cancer risk factors in Ugandan women. Objective: To determine breast cancer risk factors among indigenous Ugandan women. Methods: This is a hospital-based unmatched case-control study. Interviews were conducted between 2011 and 2012 using structured questionnaires. Patients with histologyproven breast cancer were recruited over a 2-year period. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Results: A total of 350 women were recruited; 113 were cases and 237 were controls. The mean age was 47.5 years (SD 14) for the cases and 45.5 years (SD 14.1) for the controls. The odds of breast cancer risk seemed lower for those who breastfed (adjusted OR = 0.04; 95% CI: 0.01, 0.18). There was no significance for early age at first full-term birth (adjusted OR = 1.96; 95% CI: 0.97, 3.96; p = 0.061), and urban residence carried no increased odds of breast cancer either (p = 0.201). Conclusion: Breastfeeding seems to be associated with reduced odds of breast cancer. [ABSTRACT FROM AUTHOR]

Background: Globally, postpartum haemorrhage (PPH) remains a leading cause of maternal deaths. However in many low and middle income countries, there is scarcity of information on magnitude of and risk factors for PPH (blood loss of 500 ml or more). It is important to understand the relative contributions of different risk factors for PPH. We assessed the incidence of, and risk factors for postpartum hemorrhage among rural women in Uganda. Methods: Between March 2013 and March 2014, a prospective cohort study was conducted at six health facilities in Uganda. Women were administered a questionnaire to ascertain risk factors for postpartum hemorrhage, defined as a blood loss of 500 mls or more, and assessed using a calibrated under-buttocks drape at childbirth. We constructed two separate multivariable logistic regression models for the variables associated with PPH. Model 1 included all deliveries (vaginal and cesarean sections). Model 2 analysis was restricted to vaginal deliveries. In both models, we adjusted for clustering at facility level. Results: Among the 1188 women, the overall incidence of postpartum hemorrhage was 9.0 %, (95 % confidence interval [CI]: 7.5-10.6 %) and of severe postpartum hemorrhage (1000 mls or more) was 1.2 %, (95 % CI 0.6-2.0 %). Most (1157 [97.4 %]) women received a uterotonic after childbirth for postpartum hemorrhage prophylaxis. Risk factors for postpartum hemorrhage among all deliveries (model 1) were: cesarean section delivery (adjusted odds ratio [aOR] 7.54; 95 % CI 4.11-13.81); multiple pregnancy (aOR 2.26; 95 % CI 0.58-8.79); foetal macrosomia ≥4000 g (aOR 2.18; 95 % CI 1.11-4.29); and HIV positive sero-status (aOR 1.93; 95 % CI 1.06-3.50). Risk factors among vaginal deliveries only, were similar in direction and magnitude as in model 1, namely: multiple pregnancy, (aOR 7.66; 95 % CI 1.81-32.34); macrosomia, (aOR 2.14; 95 % CI 1.02-4.47); and HIV positive sero-status (aOR 2.26; 95 % CI 1.20-4.25). Conclusion: The incidence of postpartum hemorrhage was high in our setting despite use of uterotonics. The risk factors identified could be addressed by extra vigilance during labour and preparedness for PPH management in all women giving birth. [ABSTRACT FROM AUTHOR]

Background: 600 mcg of oral misoprostol reduces the incidence of postpartum haemorrhage (PPH), but in previous research this medication has been administered by health workers. It is unclear whether it is also safe and effective when self-administered by women.Methods: This placebo-controlled, double-blind randomised trial enrolled consenting women of at least 34 weeks gestation, recruited over a 2-month period in Mbale District, Eastern Uganda. Participants had their haemoglobin measured antenatally and were given either 600 mcg misoprostol or placebo to take home and use immediately after birth in the event of delivery at home. The primary clinical outcome was the incidence of fall in haemoglobin of over 20% in home births followed-up within 5 days.Results: 748 women were randomised to either misoprostol (374) or placebo (374). Of those enrolled, 57% delivered at a health facility and 43% delivered at home. 82% of all medicine packs were retrieved at postnatal follow-up and 97% of women delivering at home reported self-administration of the medicine. Two women in the misoprostol group took the study medication antenatally without adverse effects. There was no significant difference between the study groups in the drop of maternal haemoglobin by >20% (misoprostol 9.4% vs placebo 7.5%, risk ratio 1.11, 95% confidence interval 0.717 to 1.719). There was significantly more fever and shivering in the misoprostol group, but women found the medication highly acceptable.Conclusions: This study has shown that antenatally distributed, self-administered misoprostol can be appropriately taken by study participants. The rarity of the primary outcome means that a very large sample size would be required to demonstrate clinical effectiveness.Trial Registration: This study was registered with the ISRCTN Register (ISRCTN70408620). [ABSTRACT FROM AUTHOR]

HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up. Because HIV infection rates are often lower than 3 per 100 person-years even in high prevalence settings, tens of thousands of clinic visits may take place before the number of infections required to achieve adequate study power has been observed. In addition to clinical outcomes, the multitude of study visits provides an opportunity to assess adherence and related participant behaviors in great detail. These data may be used to refine counseling messages, gain insight into patterns of behavior, and perform supporting analyses in an attempt to obtain more precise estimates of treatment efficacy. Exploratory analyses were performed to assess how our understanding of participant behaviors and their relationships to biological outcomes in two recent prevention trials might have been impacted had the frequency of routine behavioral data collection been reduced from monthly to just months 1, 3, 6, 9, and 12. Results were comparably informative in the reduced case, suggesting that unnecessarily extensive amounts of routine behavioral data may be collected in these trials. [ABSTRACT FROM AUTHOR]

Background: Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH.Methods: Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant.Results: 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3.7%), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4% in the intervention arm (mean difference = 7.1%, 95% CI -3.1% to 17.3%, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95% CI -12.7 to 2.9), p = 0.17).Conclusion: This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network ( PACTR201303000459148, on 19/11/2012). [ABSTRACT FROM AUTHOR]