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Objectives: To compare the effectiveness, safety and patient satisfaction of a double balloon catheter (DB) with a synthetic osmotic cervical dilator (OD) for pre-induction cervical ripening in an outpatient setting., Methods: This is a prospective, dual-center pilot study including 94 patients with an unripe cervix (Bishop Score <6) near term; 50 patients received the DB and 44 patients the OD. The primary outcomes were the difference in BishopScore (BS) and cervical shortening. Pain perception at insertion and during the cervical ripening period was evaluated by a visual analogue scale and patient satisfaction by a predefined questionnaire., Results: The use of DB was associated with a significantly higher increase in BS (median 3) compared to OD (median 2; p=0.002) and resulted in significantly greater cervical shortening (median -14 mm vs. -9 mm; p=0.003). There were no serious adverse events at placement of devices or during the cervical ripening. There were no significant differences in perinatal outcomes. Pain perception during cervical ripening was significantly higher (p<0.001), and patient satisfaction regarding sleep, relaxing time and performing desired daily activities were significantly lower in patients with DB compared to patients with OD (p<0.001)., Conclusions: DB was superior to OD regarding cervical ripening based on BS and on sonographic measurement of the cervical length. Patients with OD experienced less pain during cervical ripening and were more satisfied with the method compared to patients with DB., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: The Organisation for Economic Cooperation and Development (OECD) estimates an average maternal mortality rate (MMR) of around 3.4 maternal deaths per 100,000 live births for 2019-2021, based on relevant diagnoses on death certificates. However, Germany does not currently have a registry for recording the number of maternal deaths. The aim of this study is to identify the actual number of maternal deaths in Berlin between 2019 and 2022, as well as sources of underreporting and causes of death., Methods: Potential maternal mortality cases were identified through a search at the Berlin Central Archive for Death Certificates, inquiring women aged 15-50 years with indications of present or recent pregnancy on the death certificate. To cross match the database, an additional search at the Charité University Hospital Berlin was carried out, checking each individual file for pregnancy-association., Results: The data search resulted in 2,316 women, 18 of which presented an association to pregnancy. Of these, 12 could be classified as maternal mortality cases (MMR 7.8/100,000). The additional search in a university setting revealed two further maternal mortality cases without prior indication of pregnancy on the death certificate. This results in a total MMR of 9.1/100,000 live births, which is over double the official estimate by the OECD., Conclusions: Based on our findings in Berlin, it can be estimated that there is significant underreporting regarding maternal death cases in Germany. A more comprehensive recording system is needed to more accurately portray maternal mortality., (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: With an increasing incidence of labor induction the socioeconomic costs are increasing and the burden on hospital capacities is rising. In addition, the worldwide SARS-CoV-2 pandemic asks for improvements in patient care during pregnancy and delivery while decreasing the patient-staff contact. Here, we are retrospectively analyzing and comparing a mechanical ripening device that is utilized as an outpatient procedure to misoprostol and dinoprostone as inpatient induction methods in a low risk cohort., Methods: This is a retrospective comparative analysis of obstetric data on patients who presented for cervical ripening and labor induction. Ninety-six patients received a mechanical ripening agent as an outpatient procedure. As a control group, we used 99 patients with oral misoprostol (PGE1) and 42 patients with vaginal dinoprostone (PGE2) for cervical ripening in an inpatient setting. Data from 2016 until 2020 were analysed., Results: Baseline characteristics showed no significant differences. Delivery modes were similar in all groups. The time period from patient admission to onset of labor was significantly shorter in the outpatient group (p<0.001): 10.9 h/0.5 days (±13.6/0.6) for osmotic dilator vs. 17.9 h/0.7 days (±13.1/0.5) for oral misoprostol vs. 21.8 h/0.8 days (±15.9/0.7) for vaginal dinoprostone. With 20.4 h/0.8 days (±14.3/0.6) the osmotic dilator group displayed significantly the shortest inpatient stay from admission to delivery (p=0.027). The patient subgroup of misoprostol had 25.7 h/1.1 days (±14.9/0.6) of inpatient stay from admission to delivery and the patient group of dinoprostone 27.5 h/1.1 days (±16.0/0.7). There were fewer hospital days in the outpatient group: 84.9 h/3.5 days vs. 88.9 h/3.7 days vs. 93.6 h/3.9 days (outpatient osmotic dilator vs. inpatient misoprostol and dinoprostone, respectively)., Conclusions: New approaches are required to decrease individual contacts between patients and staff while maintaining a high quality patient care in obstetrics. This analysis reveals that outpatient mechanical cervical ripening can be as safe and effective as inpatient cervical ripening with PGE1/PGE2, while lowering patient-staff contact and total hospital stays and therefore decreasing the socioeconomic costs., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: The fifth of the United Nations' Millennium Development Goals proposed for 2000-2015 was to improve maternal health, which has only partially been achieved. Worldwide, the maternal mortality ratio is currently estimated at 216/100.000 livebirths, compared to 380/100,000 in 1990. As yet, there has been no published comprehensive analysis of maternal mortality data as it pertains to Berlin and by extension Germany. Aim of the study was to evaluate and analyze the maternal mortality rate of Berlin as a result of shortcomings in healthcare provision and identify possible solutions., Methods: The Institute for Quality and Transparency in the Healthcare Sector sourced external quality control from the Qualitätsbüro Berlin to provide maternal mortality data from Berlin hospitals from 2007 to 2020., Results: Nineteen maternal deaths were registered between 2007 and 2020 in total. Case analysis shows that two main events occur: thrombosis and hemorrhage at 31.6%, respectively, followed by hypertensive disorder (15.8%), and sepsis (15.8%). After detailed analysis of each case report, we determined 8/19 (42.1%) maternal deaths as being potentially preventable given slightly altered circumstances., Conclusions: The system of registration of perinatal data in Germany does not allow for a comprehensive recording of maternal death and requires alteration to provide a more accurate picture of the phenomenon of maternal mortality; presumably, there exist twice as many unreported cases. Symptoms, risks, and primary prevention tactics of thromboembolism during pregnancy and birth should be imparted to every licensed professional in individual hospital settings, along with evidence-based simulation training for the event of obstetric or prepartum hemorrhage., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)

Experimental and clinical studies suggest that prenatal experiences may influence health trajectories up to adulthood and high age. According to the hypothesis of developmental origins of health and disease exposure of pregnant women to stress, nutritional challenges, infection, violence, or war may "program" risks for diseases in later life. Stress and anxieties can exist or be provoked in parents after fertility treatment, after information or diagnosis of fetal abnormalities and demand simultaneous caring concepts to support the parents. In vulnerable groups, it is therefore important to increase the stress resilience to avoid harmful consequences for the growing child. "Enriched environment" defines a key paradigm to decipher how interactions between genes and environment change the structure and function of the brain. The regulation of the fetal hippocampal neurogenesis and morphology during pregnancy is one example of this complex interaction. Animal experiments have demonstrated that an enriched environment can revert consequences of stress in the offspring during critical periods of brain plasticity. Epigenetic markers of stress or wellbeing during pregnancy might even be diagnosed by fragments of placental DNA in the maternal circulation that show characteristic methylation patterns. The development of fetal senses further illustrates how external stimulation may impact individual preferences. Here, we therefore not only discuss how maternal stress influences cognitive development and resilience, but also design possibilities of non-invasive interventions for both mothers and children summarized and evaluated in the light of their potential to improve the health of future generations., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: Worldwide, the overall cesarean section is rising. Trial of labor after cesarean (TOLAC) is an overall safe option with an immediate impact on neonatal and maternal short- and long-term health. Since the use of prostaglandins in cervical ripening is associated with an increased risk of uterine rupture, mechanical methods as balloon catheters or osmotic dilators have been suggested for cervical ripening prior to induction of labour. Here we are analyzing and comparing the VBAC rate, as well as maternal and fetal outcome in cervical ripening prior to TOLAC., Methods: This prospective dual center study analyses maternal and neonatal outcomes of TOLAC in women with an unfavorable cervix requiring cervical ripening agent. The prospective application of an osmotic dilator (Dilapan-S, n=104) was analysed in comparison to the retrospective application of off-label dinoprostone (n=102)., Results: The overall fetal and neonatal outcome revealed no significant differences in both groups. Patients receiving cervical ripening with the osmotic dilator delivered vaginally/by ventouse in 52% of cases, compared to 53% when using dinoprostone (p=0.603). The interval between application to onset of labor was significantly higher in the osmotic dilator group (37.9 vs.20.7 h, p=<0.001). However, time from onset of labor to delivery was similar in both groups (7.93 vs. 7.44 h, p=0.758). There was one case of uterine rupture in the dinoprostone group., Conclusions: Our data shows that the application of the osmotic dilator leads to similar outcomes in VBAC rate and time from onset of labor to delivery as well as safety in both groups compared to off-label use dinoprostone. Cervical ripening using the mechanical dilator is a viable and effective option, without the risk of uterine hyperstimulation., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; p<0.001), birthweight (OR: 1.17, 95% CI 1.09-1.12.7 per 100 g decrease; p=0.012) and maternal ventilatory support, including either need for oxygen or CPAP (OR: 4.12, 95% CI 2.3-7.9; p=0.001) were independently associated with composite adverse fetal outcome. Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.

Background: Trial of labor after cesarean (TOLAC) is a viable option for safe delivery. In some cases cervical ripening and subsequent labor induction is necessary. However, the commonly used prostaglandins are not licensed in this subgroup of patients and are associated with an increased risk of uterine rupture., Methods: This cohort study compares maternal and neonatal outcomes of TOLAC in women (n=82) requiring cervical ripening agents (osmotic dilator vs. prostaglandins). The initial Bishop scores (BSs) were 2 (0-5) and 3 (0-5) (osmotic dilator and prostaglandin group, respectively). In this retrospective analysis, Fisher's exact test, the Kruskal-Wallis rank sum test and Pearson's chi-squared test were utilized., Results: Vaginal birth rate (including operative delivery) was 55% (18/33) in the osmotic dilator group vs. 51% (25/49) in the dinoprostone group (P 0.886). Between 97% and 92% (32/33 and 45/49) (100%, 100%) of neonates had an Apgar score of >8 after 1 min (5, 10 min, respectively). The time between administration of the agent and onset of labor was 36 and 17.1 h (mean, Dilapan-S® group, dinoprostone group, respectively). Time from onset of labor to delivery was similar in both groups with 4.4 and 4.9 h (mean, Dilapan-S® group, dinoprostone group, respectively). Patients receiving cervical ripening with Dilapan-S® required oxytocin in 97% (32/33) of cases. Some patients presented with spontaneous onset of labor, mostly in the dinoprostone group (24/49, 49%). Amniotomy was performed in 64% and 49% (21/33 and 24/49) of cases (Dilapan-S® group and dinoprostone group, respectively)., Conclusions: This pilot study examines the application of an osmotic dilator for cervical ripening to promote vaginal delivery in women who previously delivered via cesarean section. In our experience, the osmotic dilator gives obstetricians a chance to perform induction of labor in these women.

Background: Overweight and obesity is a serious health risk in both developed and developing nations. It is a common finding among women in their reproductive age. Half of patients entering their pregnancy in the US have a BMI >25.0 and therefore qualify as overweight or obese. Moreover, there is a tendency towards increased weight gain during pregnancy. Studies have shown that gestational overweight is associated with complications in pregnancy and birthing as well as short-term and long-term impacts on neonatal outcome in childhood and adulthood., Methods: Five hundred and ninety-one women visiting our tertiary perinatal center in 2014 were analyzed for antenatal BMI, gestational weight gain, as well as pregnancy outcome and complication together with neonatal weight and outcome. Pregnancy weight gain was assessed based on the IOM guidelines (Institute of Medicine) issued in 2009., Results: Twenty-nine percent of our population was overweight with a BMI of more than 25.0. The general weight gain was in every BMI group similar (median ranging from 12.0 to 14.0 kg). Approximately one third gained more than the appropriate amount (37%, P<0.001). Women with more gestational weight were at risk of labor induction (55.0% vs. 45.7% labor induction in total, P=0.007). Strikingly, those patients were found to have significantly higher rates of secondary cesarean section (22.4% vs. 15.4%) and decreased chances of spontaneous vaginal birth (57.5% vs. 61.4%) (P=0.008). Furthermore women with a pregnancy weight gain in excess of the guidelines gave birth to neonates with a higher birth weight (>75.centile, 28.3% vs. 21.3%, P<0.001)., Conclusions: Altogether, one third of the analyzed population is already overweight or obese when entering pregnancy. A higher gestational weight gain than the recommended amount was found in 37% of cases. We found an association with pregnancy and birthing complications as well as higher infant weight. This highlights the importance of preconceptive and prenatal advice, and if necessary, intervention on BMI and weight gain.

Objective: To compare the impact of electronic fetal monitoring (EFM) alone vs. EFM with additional fetal blood sampling (FBS) in vaginal deliveries complicated by pathologic fetal heart rate (FHR)., Methods: All deliveries in Hesse between 1990 and 2000 were evaluated for participation in this study. Inclusion criteria comprised (1) pathologic fetal heart rate, (2) singleton pregnancy, (3) cephalic presentation, (4) vaginal delivery, and (5) gestational age at delivery of more than 35 weeks' gestation. In order to analyze the meaning of additional risk factors at birth for the effectiveness of FBS two subgroups were selected depending on the presence of additional risk factors at birth. To examine the impact of FBS in deliveries with pathologic FHR on the mode of delivery and on neonatal outcome, univariate regression analysis was performed and odds ratios (OR) and their corresponding 95% confidence intervals (95% CI) were calculated., Results: The study population comprised 49,560 deliveries, among deliveries complicated by pathologic FHR, 26% underwent FBS. Deliveries with pathologic FHR and controlled by FBS, with no additional antepartum risk factors, were associated with an increase in spontaneous births OR 1.41 (95% CI 1.27-1.58), and in the presence of additional risk factors OR 1.24 (1.19-1.30). Short-term neonatal outcome parameters were characterized by a lower frequency of severe fetal acidosis (umbilical artery pH <7.0) OR 0.55 (0.42-0.72), and Apgar score <5 after 5 min, OR 0.71 (0.55-0.90)., Conclusion: In vaginal deliveries with pathologic FHR the use of FBS as an additional means of intrapartum fetal surveillance is associated with less vaginal operative deliveries, and with an improved short-term neonatal outcome.

Aims: To determine the TH-1/TH-2 cytokine pattern in peripheral blood leukocytes (PBL) in late second- and third trimester in normal pregnancies, in comparison to patients with spontaneous preterm delivery (PTD; < 37 completed weeks' gestation)., Methods: A cross-sectional retrospective study was performed in a tertiary care obstetric unit with healthy non-pregnant women (n=7); healthy pregnant women (n=25); patients (n=25) with preterm labor (defined as uterine contractions or changes in cervical length). The phenotypic analysis of TH-1/TH-2 immune deviation was examined in PBL., Results: 26% PTD (n=13) were recorded. Patients delivering at term (n=37, 74%) were characterized by an upregulation of IL-2, IFN-gamma and IL-4 production during weeks 20-25, followed by a strong suppression in cytokine production, except for TGF-beta. Towards the end of pregnancy cytokine levels returned to normal as observed in non-pregnant women. In contrast, PTD showed an inverse pattern for IL-2 and IFN-gamma with marked suppression in IL-2 and IFN-gamma production between weeks 20-25, followed by a strong stimulation of these cytokines. No differences were observed in IL-4 and TGF-beta production., Conclusion: An inverse pattern in IL-2 and IFN-gamma production in PBLs between weeks 20-30 is seen in PTD as compared to patients delivering at term.