Simulation medicine in obstetrics and gynaecology, possibilities for its use and the current state at the obstetrics and gynaecology departments in the Czech Republic.

INTRODUCTION: Simulation medicine is no longer just a modern trend and has become a standard part of education and training of the medical staff and students in many countries around the world. Its validity and benefits have been acknowledged and its necessity is reflected in the recommendations of the European Board and College of Obstetrics and Gynaecology. OBJECTIVES: The aim of our work was to map the current state of simulation training at large obstetrics and gynaecology departments in the Czech Republic including the equipment available, teaching environment conditions and human resources and to find out to what extent individual teaching methods are being used in undergraduate and postgraduate education. METHODS: We have collected the information using a questionnaire which focused on the equipment available to the departments, teaching environment conditions, human resources, and types of simulation methods being used in undergraduate and postgraduate training as well as the spectrum of courses being offered. RESULTS AND CONCLUSION: Our finding is that large obstetrics and gynaecology departments in the Czech Republic are well equipped, have good teaching environments available to them, and are able to use most of the current simulation teaching methods. On the other hand, except for an operative vaginal birth course, only a small number of other simulation courses are currently being offered. Data from the survey are further used to discuss the possibilities of developing simulation training in this field in the Czech Republic.

Prenatal diagnosis in estimating the prognosis of sacrococcygeal teratoma.

: Sacrococcygeal teratoma is a rare congenital malformation, the prognosis depends on factors affecting foetal development. The diagnosis is based on ultrasound examination, especially the evaluation of the detailed morphology of the foetus in the 20th week of pregnancy. Therefore, it is crucial to keep looking for ultrasound markers that would prenatally determine the most accurate prognosis for the foetus. Now, we rely on a small number of studies with a predominance of case reports. We offer a literature review of the essential information concerning sacrococcygeal teratoma diagnostics, therapy, and complications of sacrococcygeal teratomas in connection with prenatal diagnosis. It turns out that in cases with a favourable prognosis according to prenatal ultrasound examination and adequate surgical treatment after childbirth, the prognosis of this congenital malformation is excellent.

Conservative management of complete fetal expulsion into the abdominal cavity after silent uterine rupture - case report.

BACKGROUND: Clinically silent uterine rupture with complete fetal expulsion into the abdominal cavity is an extremely rare complication. Diagnosis can be difficult and the risk to the mother and fetus is high. Conservative management has been described only in a few cases of partial expulsion of the fetus so far. CASE PRESENTATION: We present a case of 43-year-old tercigravida with a history of previous laparotomic myomectomy and subsequent cesarean section. The subsequent pregnancy was complicated by uterine wall loosening and rupture at the site of the previous uterine scar after myomectomy and complete fetal expulsion into the abdominal cavity. The diagnosis was made at 24 + 6 weeks of gestation. Considering the absence of clinical symptomatology and the good condition of the fetus, a conservative approach was chosen with intensive monitoring of the maternal and fetal conditions. The pregnancy ended by elective cesarean section and hysterectomy at 28 + 0 weeks of gestation. The postpartum course was uneventful and the newborn was discharged to home care 63 days after delivery. CONCLUSIONS: Fetal expulsion into the abdominal cavity after silent uterine rupture of the scarred uterus may be accompanied by minimal symptomatology making early diagnosis difficult. This rare complication must be considered in the differential diagnosis in women after major uterine surgery. In selected cases and under conditions of intensive maternal and fetal monitoring, conservative management may be chosen to reduce the risks associated with prematurity.

Maternal and neonatal outcomes in pregnancies complicated by eclampsia - analysis of cases from 2008-2018.

OBJECTIVE: Evaluation of perinatal results in a set of pregnancies complicated by eclampsia. METHODS: Analysis of 67,304 births performed at the Department of Gynecology and Obstetrics, Masaryk University, Faculty of Medicine and University Hospital, Brno from 2008-2018. During the given period, eclampsia was dia-gnosed in 16 mothers (0.2). The during the time of eclampsia (week of gestation, prepartum, intrapartum, postpartum) fetal and neonatal status (signs of intrauterine distress, pH of the umbilical artery, Apgar score, intrauterine fetal death, death in the early neonatal period) were evaluated. Symptoms and course of the eclamptic attack, maternal comorbidities, associated obstetric complications (placental abruption, surgical complications, blood loss, hysterectomy) and non-obstetric complications (coagulopathy, renal and hepatic impairment, neurological complications) were monitored. RESULTS: Out of a total of 16 cases of eclampsia, 13 cases (81.3%) were confirmed during pregnancy, one case (6.2%) during childbirth, and two cases (12.5%) within 24 hours after childbirth. The mean gestational week of eclampsia was 33 weeks and 3 days. The typical course of an eclamptic attack characterized by headache and visual disturbances followed by a rapid onset of convulsions was noted in five cases (31%). Fetal hypoxia with a pH of the umbilical artery less than 7.10 occurred in four cases (25%). The dependence of the decrease in pH value on the time interval from the dia-gnosis of eclampsia to the termination of pregnancy was demonstrated. The pH of the umbilical artery decreased on average by 0.054 every 30 minutes from the onset of the eclamptic attack until the end of pregnancy. There were 3 perinatal deaths in the group (19%). Intrauterine fetal death occurred in one case due to partial abruption of the placenta during an eclamptic attack; two newborns died in the early neonatal period. The cause of death was sepsis in one case and perforation of the intestine in necrotizing enterocolitis in the other. The death of the mother was not recorded in the file. The incidence of preeclampsia in subsequent pregnancies reached 18.8%. Non-obstetric and neurological complications (amaurosis, subarachnoid hemorrhage, amnesia) occurred in the group in three cases (18.8%), and renal failure occurred in two cases (12.5%). CONCLUSION: The incidence of eclampsia at the Department of Gynecology and Obstetrics, Masaryk University, Faculty of Medicine and University Hospital, Brno reached 0.2 and was stable for a long time. Associated serious maternal complications occurred in 37.5% of cases and neonatal complications in 31.3% of cases. Early dia-gnosis of eclampsia and minimization of the time delay until the end of pregnancy is a prerequisite for reducing the risk of associated complications. An interdisciplinary approach is needed.

Guillain-Barré syndrome in pregnancy

OBJECTIVE: A case report of a 23-year-old pregnant woman diagnosed with Guillain-Barré syndrome in the 31st week of pregnancy. CASE REPORT: We present a case study of a patient in the 31st week of pregnancy hospitalized at the University Hospital in Brno for expressed bulbar syndrome, neck muscle weakness, paresthesia of the arms and medical history of diarrhea in the previous week. During hospitalization, there was a rapid progression of symptoms and respiratory failure, requiring orotracheal intubation. The diagnosis of Guillain-Barré syndrome was determined and intravenous immunoglobulin therapy was initiated. The pregnancy was terminated in the 32nd week of gestation based on the maternal indication after a completed lung maturation of the fetus. CONCLUSION: Guillain-Barré syndrome is a neurological disease that can rarely occur during pregnancy and puerperium. The syndrome presents a serious pregnancy complication with an uncertain prognosis and risk for both mother and fetus. If the syndrome is diagnosed in time and treated correctly, the prognosis is favorable despite the complicated course.

Comparison of opinions of Slovak and Czech female medical students on HPV vaccination.

OBJECTIVES: This study aims to identify the differences in the use of HPV vaccination between female medical students in the Czech and Slovak Republics and their possible causes. METHODS: We performed a cross-sectional survey among female students of general medicine in all faculties of medicine in the Czech and Slovak Republics. RESULTS: We obtained 630 questionnaires from the Czech Republic and 776 questionnaires from the Slovak Republic. In the Czech Republic, 65.4% of female medical students underwent HPV vaccination, while in the Slovak Republic, the figure was 21.1%. In the Czech Republic, residency and religion of students did not influence their rate of vaccination. However, in the Slovak Republic, village residency with less than 5,000 inhabitants lowered the probability of vaccination with OR = 0.56 (95% CI: 0.38-0.84), and the Catholic religion lowered the probability of vaccination with OR = 0.40 (95% CI: 0.28-0.57). Czech students were informed about the possibility of vaccination by a paediatrician in 55.7% of cases, while the figure for Slovak students was 26.8%. In the Czech Republic, 75.7% of students participated in regular cervical oncologic screening, while in the Slovak Republic, the figure was 57.7%. Vaccination of relatives would be recommended by 86.5% and 80.5% of Czech and Slovak students, respectively. CONCLUSIONS: The adoption of an oncologic prevention programme and the more extensive propagation by paediatricians are probably the medical reasons for the higher HPV vaccination among Czech students. Demographic factors - village residency and religion - are also important.

Analysis of obstetricians' decision making on CTG recordings.

Interpretation of cardiotocogram (CTG) is a difficult task since its evaluation is complicated by a great inter- and intra-individual variability. Previous studies have predominantly analyzed clinicians' agreement on CTG evaluation based on quantitative measures (e.g. kappa coefficient) that do not offer any insight into clinical decision making. In this paper we aim to examine the agreement on evaluation in detail and provide data-driven analysis of clinical evaluation. For this study, nine obstetricians provided clinical evaluation of 634 CTG recordings (each ca. 60min long). We studied the agreement on evaluation and its dependence on the increasing number of clinicians involved in the final decision. We showed that despite of large number of clinicians the agreement on CTG evaluations is difficult to reach. The main reason is inherent inter- and intra-observer variability of CTG evaluation. Latent class model provides better and more natural way to aggregate the CTG evaluation than the majority voting especially for larger number of clinicians. Significant improvement was reached in particular for the pathological evaluation - giving a new insight into the process of CTG evaluation. Further, the analysis of latent class model revealed that clinicians unconsciously use four classes when evaluating CTG recordings, despite the fact that the clinical evaluation was based on FIGO guidelines where three classes are defined.

Open access intrapartum CTG database.

BACKGROUND: Cardiotocography (CTG) is a monitoring of fetal heart rate and uterine contractions. Since 1960 it is routinely used by obstetricians to assess fetal well-being. Many attempts to introduce methods of automatic signal processing and evaluation have appeared during the last 20 years, however still no significant progress similar to that in the domain of adult heart rate variability, where open access databases are available (e.g. MIT-BIH), is visible. Based on a thorough review of the relevant publications, presented in this paper, the shortcomings of the current state are obvious. A lack of common ground for clinicians and technicians in the field hinders clinically usable progress. Our open access database of digital intrapartum cardiotocographic recordings aims to change that. DESCRIPTION: The intrapartum CTG database consists in total of 552 intrapartum recordings, which were acquired between April 2010 and August 2012 at the obstetrics ward of the University Hospital in Brno, Czech Republic. All recordings were stored in electronic form in the OB TraceVue®;system. The recordings were selected from 9164 intrapartum recordings with clinical as well as technical considerations in mind. All recordings are at most 90 minutes long and start a maximum of 90 minutes before delivery. The time relation of CTG to delivery is known as well as the length of the second stage of labor which does not exceed 30 minutes. The majority of recordings (all but 46 cesarean sections) is - on purpose - from vaginal deliveries. All recordings have available biochemical markers as well as some more general clinical features. Full description of the database and reasoning behind selection of the parameters is presented in the paper. CONCLUSION: A new open-access CTG database is introduced which should give the research community common ground for comparison of results on reasonably large database. We anticipate that after reading the paper, the reader will understand the context of the field from clinical and technical perspectives which will enable him/her to use the database and also understand its limitations.

Maternal body mass index and external cephalic version success rate - are they related?

OBJECTIVES: External cephalic version (ECV) is a useful method helping to reduce the incidence of planned caesarean deliveries for fetal malpresentation. There is an effort to look for the best predictors for a successful ECV, the effect of maternal weight is still unclear. The aim of our study is to determine maternal body mass index (BMI) in association with the ECV success rate and the risk of complications. MATERIAL AND METHODS: A retrospective observational cohort study in 981 women after the 36th week of gestation with a fetus in a breech presentation who had undergone an ECV attempt. We evaluated the success rate and complications of ECV in association with BMI categories according to the WHO classification of obesity. RESULTS: ECV was successful in 478 cases (48.7%). In the category of overweight patients (BMI > 25; n = 484), ECV was successful in 51% and unsuccessful in 49% (p = 0.28) of cases. In obese patients (BMI > 30; n = 187), ECV was successful in 44.8% and unsuccessful in 55.2% (p = 0.28) of cases. The effect of BMI on the success rate of ECV for the category of overweight and obesity was not proven by statistical analysis. Serious complications occurred in seven cases in similar numbers in all three subgroups according to BMI. CONCLUSIONS: BMI in the categories of overweight and obesity is not a factor influencing the success rate and risk of complications of ECV. These results can be helpful when consulting pregnant women the chance of successful ECV.

Dynamics of Selected Serum Immunological Markers During Caesarean Section.

OBJECTIVES: The presented study aimed to describe the dynamics of the serum levels of the complement components C3, C4, and C1 inhibitor in women immediately before and after giving birth by caesarean section (CS). DESIGN AND SETTING: 57 pregnant women undergoing caesarean section were included in this prospective observational study. Blood samples were taken 30 minutes before CS and 30 minutes after the delivery. C3, C4, and C1 inhibitor levels were analysed and the functional C1 inhibitor test performed. Angiotensin-converting enzyme concentrations before delivery were also determined. RESULTS: Before delivery, C3 value was elevated above the reference limits for the healthy adult population in 39% of patients. Following birth, C3 median value dropped from 1.4 to 1.2 g/L. C1 inhibitor concentrations were also reduced - the median value of the C1 inhibitor before the birth was 222 mg/L, dropping to 198 mg/L after delivery. Even before the CS, C1 inhibitor concentrations were below reference range in 40% of patients, which increased to 56% after delivery; its activity however did not significantly change. In two patients with perioperative uterine hypotonia, notable complement activation was detected. ACE levels were below the normative values for adult population in 25% of patients. CONCLUSION: Concentrations of all analysed components significantly decreased after delivery, which was not associated with blood loss or amount of intravenous liquids. This highlights the necessity of proper reporting of the time point of blood sampling in any studies or case reports detailing the immunological condition of patients in the peripartal period.

Delivery of a Healthy Baby from a Brain-Dead Woman After 117 Days of Somatic Support: A Case Report.

BACKGROUND The care and management of brain-dead pregnant women is surrounded by legal and ethical controversies. Gestational age is directly proportional to newborn survival. We report a case of a brain-dead pregnant woman at the 16th week of gestation and the successful delivery of a healthy child after 117 days of maternal somatic support. CASE REPORT A 27-year-old pregnant woman at 16 weeks' gestation with large intracerebral hematoma after rupture of an arteriovenous malformation was admitted to our intensive care unit. Signs of brain death developed early, and the woman was confirmed to be brain dead after day 6 of hospitalization. The decision-making process regarding course of medical treatment was complex and accompanied by uncertainties arising from the absence of a legal, ethical, and professional framework. A complex multidisciplinary approach was followed. The main aim was to maintain the brain-dead woman's homeostasis to allow for proper development of the fetus. Monitoring of fetal growth was considered the best endpoint, and satisfactory fetus development was achieved. A healthy child was delivered with a birth weight of 2140 g. Her Apgar score was 10/10/10 at 1, 5, and 10 minutes, respectively, and favorable outcomes were observed at a 1-year follow-up. CONCLUSIONS Brain death during pregnancy is an extremely rare but increasingly common condition. Guidelines for care management are lacking, and reporting these cases may help establish medical treatment in future cases. We show that somatic support of the body of a brain-dead pregnant woman for an extended period of time can lead to successful delivery of a healthy child.

COVID-19 Vaccine Acceptance of Pregnant and Lactating Women (PLW) in Czechia: An Analytical Cross-Sectional Study.

Pregnant and lactating women (PLW) represent a particular population subset with increased susceptibility for COVID-19 morbidity and mortality, even though the evidence about the safety and efficacy of COVID-19 vaccines was delayed due to their initial exclusion from development trials. This unclear situation could have led to increased COVID-19 vaccine hesitancy levels among PLW; therefore, this study aimed to evaluate the attitudes of Czech PLW towards COVID-19 vaccines and the determinants of their attitudes. An analytical cross-sectional survey-based study was carried out in the University Hospital Brno (South Moravia, Czechia) between August and October 2021. The study utilised a self-administered questionnaire (SAQ) adapted from previous instruments used for the same purpose. The SAQ included closed-ended items covering demographic characteristics, clinical and obstetric characteristics, attitudes towards COVID-19 vaccination, and potential psychosocial predictors of vaccine acceptance. Out of the 362 included participants, 278 were pregnant (PW) and 84 were lactating women (LW). The overall COVID-19 vaccine acceptance (immediate and delayed) level was substantially high (70.2%), with a significant difference between PW (76.6%) and LW (48.8%). Out of the 70.2% who agreed to receive the vaccine, 3.6% indicated immediate acceptance, and 66.6% indicated delayed acceptance. Only 13.3% of the participants indicated their acceptance of their physician's vaccination recommendation during pregnancy or while lactating, and 62.2% were against it. Our results agreed with the recent studies that revealed that PW tended to have a high level of COVID-19 vaccine acceptance, and they were also inclined to resist professional recommendations because they predominantly preferred to delay their vaccination. The pregnancy trimester, education level, employment status, and previous live births were significant determinants for COVID-19 vaccine acceptance. The most commonly preferred vaccine type was mRNA-based vaccines, followed by viral vector-based and inactivated virus vaccines. The first top priority of PLW was vaccine safety for their children, followed by vaccine safety for the PLW and vaccine effectiveness. Regarding psychosocial predictors, media/social media, trust in the government, the pharmaceutical industry, and healthcare professionals, partners, and a positive risk-benefit ratio were significant promoters for COVID-19 vaccine acceptance. Findings from this study suggest that promotional interventions targeting PLW should use web platforms and focus on vaccine safety evidence, the expected benefits of vaccines and potential harms of the infection.

[Shoulder dystocia during vaginal delivery]. / Dystokie ramének plodu pri vaginálním porodu.

Shoulder dystocia is defined as a complication of vaginal delivery that requires additional obstetric manoeuvres to release the shoulders of the baby. Reported incidence of shoulder dystocia is around 0.6-1.4%. Serious perinatal morbidity is associated with this type of complication. Brachial plexus injuries are one of the most important fetal complications of shoulder dystocia. Some cases results in permanent brachial plexus dysfunction. A high level of awareness and training for all birth attendants is recommended. The purpose of this article is to review the current evidence regarding the possible prediction and management of shoulder dystocia.

Predictors of vaginal delivery after cervical ripening using a synthetic osmotic dilator.

OBJECTIVE: To evaluate the determinants of vaginal delivery and safety in women undergoing cervical ripening with a synthetic osmotic dilator (Dilapan-S) prior to induction of labor. METHODS: We conducted a secondary analysis of an international multicenter prospective observational study of Dilapan-S for cervical ripening in pregnancies greater than 32 weeks. Data were obtained in a standardized fashion and entered into a centralized electronic data capture system. The association between Bishop score and vaginal delivery was further evaluated with a multivariate receiver-operating characteristic (ROC) curve analysis. A Wilcoxon rank test and multivariable logistic regression were used for statistical analysis (significance: P < .05). RESULTS: Between May 2015 and July 2016, 444 pregnant women were included. Three hundred ten (70 %) delivered vaginally. Compared to patients who underwent cesarean delivery, those who delivered vaginally were more likely to have a history of prior vaginal delivery. Vaginal delivery rates were significantly correlated with Bishop scores of pre and post Dilapan-S and difference. After adjusting for age, BMI, number of dilators, cervical ripening time, and gestational age, both prior vaginal delivery and post-Dilapan-S Bishop scores were strong predictors of vaginal delivery (estimate coefficient: 0.1275 ± 0.03 P = .0002; 0.049 ± 0.01 P = .0001; respectively). Aggregate ROC accounting for these variables further supported these findings (AUC = 0.734). The lower confidence interval limit of vaginal delivery rates was above 50 % when post-Dilapan-S Bishop scores were ≥ 5. Cox regression analyses demonstrated that the duration of labor was significant shorter in women that had vaginal delivery. CONCLUSION: Bishop scores after cervical ripening with Dilapan-S are good predictors of vaginal delivery. Bishop scores < 5 post Dilapan-S may warrant further cervical ripening. Further level 1 trials are needed to compare osmotic dilators to other ripening methods.

The effect of transient fetal bradycardia and other heart rate changes during and after external cephalic version on perinatal outcomes.

OBJECTIVES: To evaluate the effect of transient fetal bradycardia and other heart rate changes during and after external cephalic version (ECV) on perinatal outcomes. To determine factors associated with a higher risk of occurrence of transient fetal bradycardia during and after ECV. STUDY DESIGN: Prospective study in 286 women after the 36th week of gestation with a fetus in breech presentation who have undergone an ECV attempt. The study analyses the incidence of transient fetal bradycardia during and immediately after ECV, the time interval to complete adjustment of fetal bradycardia, the factors associated with the occurrence of transient fetal bradycardia, cardiotocography (CTG) changes after ECV and perinatal outcomes. All the data were statistically analyzed. RESULTS: The ECV was successful in 51 % (146/286). Transient fetal bradycardia occurred during and after ECV in 81 cases (28.3 %). A successful version was a factor significantly associated with fetal bradycardia (54; 37.0 % versus 27; 19.3 %; p < 0.01). Clinically significant hypotension of the mother was accompanied by transient fetal bradycardia in 12 cases (4.2 %). After the successful ECV there was no significant difference in the percentage of vaginal deliveries between subgroups with and without transient fetal bradycardia (85.2 % versus 83.7 %; p = 1.00). Nor in occurrence of acute fetal distress during labor (18.5 % versus 15.6 %; p = 0.65). In cases of a successful ECV transient CTG changes after ECV had no effect on the incidence of acute fetal distress during labor (23.5 % versus 15.7 %; p = 0.49). CONCLUSIONS: Transient fetal bradycardia and other heart rate changes during and immediately after ECV was not associated with a higher incidence of acute fetal distress during labor and did not affect perinatal outcomes. Higher occurrence of transient bradycardia after ECV was associated only with successful ECV. Transient hypotension of the mother as one of the causes of transient fetal bradycardia during ECV should be considered.

Association between Stress Urinary Incontinence and Depressive Symptoms after Birth: the Czech ELSPAC Study.

The study objectives were to (1) identify risk factors related to stress urinary incontinence (SUI) and postnatal depression (PD) after birth, and (2) investigate both possible directions of association between SUI and PD in population-based sample of Czech mothers. 3,701 nulliparous and multiparous women completed the self-reported questionnaires at 6 weeks and 6 months after birth and were included into the analyses of this prospective cohort study. Unadjusted and adjusted logistic regressions examined relationship between SUI a PD accounting for range of other risk factors. During the first 6 months after birth, 650 mothers (17.6%) developed SUI and 641 (17.3%) displayed signs of PD. The mode of delivery, parity and higher BMI were associated with SUI. The rate of PD symptoms was higher in mothers with positive history of prenatal depression, and in divorced or widowed mothers. Both conditions were associated with worse self-reported health, back pain and stop-smoker status. Initially, SUI at 6 weeks was slightly, but significantly associated with onset of PD at 6 months (OR 1.51, 95% CI 1.02-2.23) while PD at 6 weeks was not significantly related to new cases of SUI at 6 months (OR 1.48, 95% CI 0.91-2.39). After full adjustment these OR reduced to 1.41 and 1.38 (both non-significant), respectively. SUI and PD are common conditions in women postpartum that share some risk factors. Our study suggests that both directions of their relationship are possible although a larger study is needed to confirm our findings.

MicroRNA-210 expression during childbirth and postpartum as a potential biomarker of acute fetal hypoxia.

OBJECTIVE: To explore whether miR-210 expression can be used as a diagnostic and prognostic marker in acute fetal hypoxia. METHODS: Whole blood samples of 29 women and their fetuses without hypoxia and 24 women and their fetuses with hypoxia were analysed in this study. Reverse transcription and quantitative real-time PCR were used to measure the expression of miR-210. Expression level differences between the control and hypoxic group in labour time and postpartum change fold were analyzed by standard statistical tests. RESULTS: We confirmed that miR-210 is significantly more upregulated in fetal blood with acute hypoxia when compared to maternal blood (P Conclusions: Our study confirmed miR-210 upregulation in the blood of pregnant women with acute fetal hypoxia at the time of labour compared to pregnant women without acute fetal hypoxia. Additional investigation should be done to determine miR-210 clearance and the possibility of using miR-210 as a diagnostic and prognostic marker.

Synthetic osmotic dilators in the induction of labour-An international multicentre observational study.

INTRODUCTION: To evaluate the effects of synthetic osmotic dilators (Dilapan-S/ Dilasoft) in women who required induction of labour in a large prospective multicentre international observational study. MATERIALS AND METHODS: Primary outcomes were duration of Dilapan-S/Dilasoft insertion (hours), total induction - delivery interval (hours) and the rate of vaginal deliveries within 24 h (%). Secondary outcomes were the number of dilators inserted, Bishop score increase after extraction of Dilapan-S/Dilasoft, complications during induction (uterine contractions, uterine tachysystole and hyperstimulation, effect on the fetus) and post induction (infections and neonatal outcomes), agents / procedures used for subsequent induction of labour, immediate rate of spontaneous labours following cervical ripening period, rate of spontaneous vaginal deliveries, rate of instrumental vaginal deliveries and caesarean sections. RESULTS: Total of 543 women were recruited across 11 study sites, of which, 444 women were eligible for analysis. With Dilapan-S/Dilasoft use of <12 h (n = 188) the overall vaginal delivery rate was 76.6% with 45.7% of these births occurring within 24 h, 66% within 36 h and 75.5% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 24.3(±10.4) hours. With Dilapan-S/Dilasoft use of >12 h (n = 256), the overall vaginal delivery rate was 64.8%, with 16% of these births occurring within 24 h, 48.4% within 36 h and 54.7% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 39.1(±29.2) hours. The mean gain in the Bishops score was +3.6(±2.3). The mean number of Dilapan-S/Dilasoft dilators used was 3.8 (±1.1). The overall rate of caesarean section was 30.1%. The overall complication rate was low including infection risk. No adverse neonatal outcome was attributable to the use of Dilapan-S/Dilasoft. CONCLUSION: Dilapan-S/Dilasoft are safe and effective methods for cervical ripening. Their use is associated with low maternal and neonatal complication rates. Future research should aim at level I clinical trials comparing Dilapan-S to other mechanical or pharmacological cervical ripening agents. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02318173.