scholarly journals Randomized clinical trial of active induction versus expectant management in premature rupture of the membranes at term

2021 ◽  
Vol 8 (2) ◽  
pp. 240-243
Author(s):  
Tejashree M ◽  
Shobha Bembalgi ◽  
Preetha F Naykar

Immediate induction of labour in cases of pregnancy with PROM used to be a standard practice to avoid potential complications but induced labour is likely to be associated with increased risks of fetal and maternal complications due to oligohydramnios like cord compression and high rate of operative delivery. Purpose of this study is to determine in case the practice of actively inducing labour in women with PROM at term is preferable than expectant management for 12 hours and also to study the maternal and neonatal outcome. A total of 150 pregnant women were randomized into two groups who are between 18-35 years, at term gestation (37-40 weeks) having PROM irrespective of gravida. Women were immediately induced by Tab. Misoprostol(25microgrmas) in immediate induction group. Women who presented with PROM were observed for 12hrs from time of PROM without any intervention to accelerate the labour in conservative management group. An observation between the two groups of patients would be made with respect to maternal and fetal outcome. We observed that there was statistically insignificant increase in duration of labour and increased rate of caesarean section in expectant group. Maternal complications in both groups were found to be insignificant. However, women who were managed expectantly developed more puerperal pyrexia, wound infection and prolonged hospitalization than women who were managed with induction method. There was no statistically significant difference in the perinatal complications.

BMJ ◽  
2019 ◽  
pp. l344 ◽  
Author(s):  
Judit KJ Keulen ◽  
Aafke Bruinsma ◽  
Joep C Kortekaas ◽  
Jeroen van Dillen ◽  
Patrick MM Bossuyt ◽  
...  

Abstract Objective To compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women. Design Open label, randomised controlled non-inferiority trial. Setting 123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16. Participants 1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901). Interventions Induction at 41 weeks or expectant management until 42 weeks with induction if necessary. Primary outcome measures Primary outcome was a composite of perinatal mortality and neonatal morbidity (Apgar score <7 at five minutes, arterial pH <7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial haemorrhage, and admission to a neonatal intensive care unit (NICU). Secondary outcomes included maternal outcomes and mode of delivery. The null hypothesis that expectant management is inferior to induction was tested with a non-inferiority margin of 2%. Results Median gestational age at delivery was 41 weeks+0 days (interquartile range 41 weeks+0 days-41 weeks+1 day) for the induction group and 41 weeks+2 days (41 weeks+0 days-41 weeks+5 days) for the expectant management group. The primary outcome was analysed for both the intention-to-treat population and the per protocol population. In the induction group, 15/900 (1.7%) women had an adverse perinatal outcome versus 28/901 (3.1%) in the expectant management group (absolute risk difference −1.4%, 95% confidence interval −2.9% to 0.0%, P=0.22 for non-inferiority). 11 (1.2%) infants in the induction group and 23 (2.6%) in the expectant management group had an Apgar score <7 at five minutes (relative risk (RR) 0.48, 95% CI 0.23 to 0.98). No infants in the induction group and three (0.3%) in the expectant management group had an Apgar score <4 at five minutes. One fetal death (0.1%) occurred in the induction group and two (0.2%) in the expectant management group. No neonatal deaths occurred. 3 (0.3%) neonates in the induction group versus 8 (0.9%) in the expectant management group were admitted to an NICU (RR 0.38, 95% CI 0.10 to 1.41). No significant difference was found in composite adverse maternal outcomes (induction n=122 (13.6%) v expectant management n=102 (11.3%)) or in caesarean section rate (both groups n=97 (10.8%)). Conclusions This study could not show non-inferiority of expectant management compared with induction of labour in women with uncomplicated pregnancies at 41 weeks; instead a significant difference of 1.4% was found for risk of adverse perinatal outcomes in favour of induction, although the chances of a good perinatal outcome were high with both strategies and the incidence of perinatal mortality, Apgar score <4 at five minutes, and NICU admission low. Trial registration Netherlands Trial Register NTR3431.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042340
Author(s):  
Helena Nilvér ◽  
Anna Wessberg ◽  
Anna Dencker ◽  
Henrik Hagberg ◽  
Ulla-Britt Wennerholm ◽  
...  

ObjectiveTo compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.DesignA register-based, multicentre, randomised, controlled, superiority trial.SettingWomen were recruited at 14 hospitals in Sweden, 2016–2018.ParticipantsWomen with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.InterventionsThe women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).Outcome measuresAs main outcome, women’s childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1–10) within 3 days after delivery at the remaining eleven hospitals.ResultsThe total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22).ConclusionsThere were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.Trial registration numberISRCTN26113652.


2020 ◽  
Author(s):  
Eric-Jan Wagenmakers ◽  
Alexander Ly

In a recent randomized clinical trial, Wennerholm and colleagues compared induction of labour at 41 weeks with expectant management and induction at 42 weeks. The trial was stopped early, because six perinatal deaths occurred in the expectant management group, whereas none occurred in the induction group. Our Bayesian reanalysis finds that the SWEPIS data indeed support the hypothesis that induction of labour at 41 weeks of pregnancy is associated with a lower rate of stillbirths. However, the degree of this support is moderate at best, and arguably provides insufficient ground for terminating the study. In general, it seems hazardous to terminate clinical studies on the basis of a single P&lt;0.05 result, without converging support of a Bayesian analysis.


2020 ◽  
Vol 34 (1) ◽  
pp. 8-14
Author(s):  
Tania Noor ◽  
Tahmina Parvin ◽  
Sharmin Siddika ◽  
Farjana Begum ◽  
Selina Akter Banu ◽  
...  

Background: Gestational Diabetes Mellitus (GDM) is linked with amplified risk of variety of maternal and perinatal complications. There have been a number of studies comparing metformin with insulin in the management of GDM. Methods: A clinical trial (Quasi experimental) was conducted on fifty women with GDM at their 24 – 34 weeks of gestation with the aim to compare maternal and perinatal outcomes treated by either insulin or metformin. The study population were recruited from obstetrics and gynaecology outpatient department of Medical College for Women and Hospital, Uttara, Dhaka, from July 2012 to December 2012.The patients were divided into two groups (nonrandomized), 25 patients in each, and were subjected to either injection insulin or oral metformin medication. Results: The patients were grouped as insulin or metformin group. They were compared in terms of age, parity and developing maternal complications like preeclampsia (p=0.24), UTI (p=0.40), polyhydramnios (p=0.70). However, the incidence of preterm birth was higher among metformin group in comparison to insulin group (P=0.007).There was no significant difference between insulin and metformin group as regard to mode of delivery. The proportion of neonatal hypoglycemia in insulin group was higher than metformin group (P=0.46) but statistically not significant. Other neonatal outcomes such as macrosomia, birth asphyxia and hyperbillirubinaemia did not differ significantly between two groups. Conclusion: In women with GDM, treatment with metformin is associated with higher proportion of preterm birth than with insulin. Proportion of neonatal hypoglycemia is higher with insulin use. Bangladesh J Obstet Gynaecol, 2019; Vol. 34(1): 8-14


Author(s):  
Neetu Singh ◽  
Devyani Misra ◽  
Shubhi Srivastava

Background: Postdated pregnancy is one of the commonest obstetric conditions. Pregnancy is called term when it lies between 37 weeks to 42 weeks from the last menstrual period. If the pregnancy exceeds 40 weeks it is called as postdated pregnancy. The overall incidence of post term pregnancy is 7% of all pregnancies.Methods: This observational study was carried out in the department of obstetrics and gynecology in Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India from September 2019 to February 2020. Total 100 postdated pregnancy enrolled in the study those willing to participate and fulfilling the inclusion and exclusion criteria. Aim is to assess maternal and fetal outcome in postdated pregnancy.Results: In present study, incidence of postdated pregnancy was found to be 5% and number of normal deliveries was 66 (66%), LSCS were 32 (32%) and 2 (2%) were instrumental delivery. Maternal complications were seen in 14 (14%) cases and fetal complications were found in 23 (23%) cases.Conclusions: Postdated pregnancy was associated with perinatal complications like fetal distress, meconium aspiration syndrome and fetal asphyxia. There was increased risk of obstetrics complications like postpartum haemorrhage (PPH), perineal tear, cervical tear and shoulder dystocia. Management of postdated pregnancy is a challenge to obstetrician and a careful advice and monitoring can alleviate maternal anxiety and untoward complications.


Author(s):  
Rajani Rawat ◽  
Pragati Divedi ◽  
Sukla Debbarma ◽  
Soniya Vishwakarma ◽  
Nupur Mittal

Background: Premature rupture of membranes at term (PROM) is defined as a spontaneous rupture of membranes after 37 completed weeks of gestation and before the onset of regular painful uterine contractions. PROM occurs in 5-10% of all pregnancies of which approximately 80% occur at term. The study aimed to compare the maternal and neonatal outcome in patients with term PROM receiving active induction versus expectant management.Methods: The present study was a prospective randomised controlled trial, conducted on 100 term antenatal women with PROM in the Department of Obstetrics and Gynaecology, UPUMS, Saifai from January 2016 to June 2017. 50 antenatal women received immediate induction with oral misoprostol while another 50 antenatal women were expectantly managed for 24 hours. The latency period, PROM delivery interval, maternal and neonatal outcome were compared and subjected to statistical analysis.Results: 42% of active management group and 30% of expectant management group had a latency period of 12-20 hours and results were found to be statistically significant (p value = 0.005). There was no statistically significant difference in the rate of caesarean section, maternal and neonatal morbidity in both the groups.Conclusions: Immediate labour induction in patients with term PROM resulted in significant shortening of latent period and PROM to delivery interval without any increase in caesarean section rate as compared to expectant management group.


2020 ◽  
pp. 1-4
Author(s):  
Debika Biswas ◽  
Shalini Gainder ◽  
Debarshi Jana

Preeclampsia is a heterogeneous clinical syndrome which is a leading cause of maternal, fetal, and neonatal morbidity and mortality. The aim of the study evaluate the maternal and fetal outcome in women with diagnosis of early onset preeclampsia. The present study was conducted with the primary objective to study the maternal, fetal and neonatal outcome among women diagnosed with early onset of preeclampsia without severe feature and with severe features. The overall outcome in women where pregnancies were continued after giving Mgso4 therapy were also studied. This was a prospective hospital based study in which 119 pregnant women were enrolled from emergency ward (labour room) who were diagnosed to have early onset preeclampsia at less than 32 weeks of gestation. Women with early onset preeclampsia were given expectant management and the maternal and perinatal outcome in women were reviewed as per severity that is whether PE occurred with or without severe features. The maternal complications did not increase in women who received expectant management in women with PE with severe features, as well as the group which had received prophylactic Mgso4 therapy and in whom subsequently pregnancy continued for few days to weeks. The perinatal outcome was compromised because of early presentation of PE which probably causes the placental insufficiency even in women without severe features. Significant number of days gained during expectant management has an impact on the perinatal outcome which was from few days to weeks in this study.


Author(s):  
Sabrina Burn ◽  
Ruofan Yao ◽  
Maria Diaz ◽  
Jordan Rossi ◽  
Stephen Contag

Objective: To determine maternal and neonatal morbidity associated with induction of labor at 39 weeks compared with expectant management through 42 weeks. Design: Cohort study Setting & Population: Low risk American women who delivered between 39 and 42 weeks in 2015 to 2017. Methods: Data was abstracted from the national vital statistics database. Multivariable log-binomial regression analysis was conducted to estimate the relative risk of morbidity. Main Outcome Measures: Maternal morbidity included Triple I, blood transfusion, ICU admission, uterine rupture, cesarean hysterectomy, and cesarean delivery. Neonatal morbidity included 5 minute Apgar ≤3, prolonged ventilation, seizures, NICU admission, and neonatal death. Results: A total of 1,885,694 women were included for analysis. Women undergoing induction of labor at 39 weeks were less likely to develop Triple I (p-value < 0.001; aRR 0.66; 95% CI [0.64-0.68]) and require a cesarean section (p-value <0.01; aRR 0.69l 95% CI [0.68-0.69]) than the expectant management group. There was a small, but significant increase in cesarean hysterectomy in the induction group (p-value <0.01; aRR 1.32; 95% CI [1.05-1.65]). Neonates of the induction group were less likely to have 5 minute Apgar ≤3 (p-value < 0.01; aRR 0.69; 95% CI [0.64-0.74]), prolonged ventilation (p-value < 0.01; aRR 0.77; 95% CI [0.72-0.82]), NICU admission (p-value < 0.01; aRR 0.80; 95% CI [0.79-0.82]), and/or neonatal seizures (p-value <0.01; aRR 0.80; 95% CI [0.66-0.98]) compared to the expectant management group. Conclusions: Induction of labor at 39 weeks gestation compared with expectant management is not harmful and has maternal and neonatal benefits.


Author(s):  
Mumtaj M. ◽  
Harilakshmi M.

Background: Cervical ripening before induction of labour in women with unfavourable cervix is essential to shorten the induction to delivery interval and avoid unnecessary interventions.Methods: The study was carried out at Raja Sir Ramasamy Mudaliar hospital, Chennai during the period August 2012 to July 2013. 200 antenatal women were recruited and randomly allocated to Foleys and prostaglandin E2 gel group for induction. The change in bishops score, induction to delivery interval, mode of delivery, vaginal delivery within 24 hours, maternal complications, fetal outcome between both groups were compared.Results: The commonest indication for induction in both groups was postdated pregnancy followed by oligohydramnios in Foleys group and preeclampsia in PGE2 group. Foleys catheter induction improves bishops score better compared to PGE2 gel whereas PGE2 gel causes a significant reduction in the mean induction to delivery interval between the two groups. However, there was no significant difference between mean caesarean deliveries between the two groups. In both Foleys and the PGE2 group, failed induction was the commonest indication for caesarean section. The number of patients delivering vaginally within 24 hrs was similar between the two groups.Conclusions: Though prostaglandins are a better method of induction, this study shows that Foleys induction has reduced side effects and is also cost effective, making it a superior method for cervical ripening.


2021 ◽  
Vol 10 (3) ◽  
pp. 537
Author(s):  
Martina Kollmann ◽  
Barbara Obermayer-Pietsch ◽  
Elisabeth Lerchbaum ◽  
Sarah Feigl ◽  
Rüdiger Hochstätter ◽  
...  

Studies suggest that non-pregnant women with polycystic ovary syndrome (PCOS) may be at elevated risk of 25 hydroxyvitamin D (25(OH)D) deficiency. Furthermore, there is evidence suggesting that 25(OH)D may also play an important role during pregnancy. Data regarding 25(OH)D deficiency during pregnancy in PCOS patients and its association with perinatal outcome is scarce. The aim of the study was to investigate whether mothers with and without PCOS have different 25(OH)D levels at term, how maternal 25(OH)D levels are reflected in their offspring, and if 25(OH)D levels are associated with an adverse perinatal outcome. Therefore, we performed a cross-sectional observational study and included 79 women with PCOS according to the ESHRE/ASRM 2003 definition and 354 women without PCOS and an ongoing pregnancy ≥ 37 + 0 weeks of gestation who gave birth in our institution between March 2013 and December 2015. Maternal serum and cord blood 25(OH)D levels were analyzed at the day of delivery. Maternal 25(OH)D levels did not differ significantly in women with PCOS and without PCOS (p = 0.998), nor did the 25(OH)D levels of their respective offspring (p = 0.692). 25(OH)D deficiency (<20 ng/mL) was found in 26.9% and 22.5% of women with and without PCOS (p = 0.430). There was a strong positive correlation between maternal and neonatal 25(OH)D levels in both investigated groups (r ≥ 0.79, p < 0.001). Linear regression estimates of cord blood 25(OH)D levels are about 77% of serum 25(OH)D concentrations of the mother. Compared to healthy controls, the risk for maternal complications was increased in PCOS women (48% vs. 65%; p = 0.009), while there was no significant difference in neonatal complications (22% and 22%; p = 1.0). However, 25(OH)D levels were similar between mothers and infants with and without perinatal complications. Although the share of women and infants with 25(OH)D deficiency was high in women with PCOS and without PCOS, it seems that the incidence of adverse perinatal outcome was not affected. The long-term consequences for mothers and infants with a 25(OH)D deficiency have to be investigated in future studies.


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