scholarly journals Women’s childbirth experiences in the Swedish Post-term Induction Study (SWEPIS): a multicentre, randomised, controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042340
Author(s):  
Helena Nilvér ◽  
Anna Wessberg ◽  
Anna Dencker ◽  
Henrik Hagberg ◽  
Ulla-Britt Wennerholm ◽  
...  
Keyword(s):  
Expectant Management ◽  
Induction Of Labour ◽  
Childbirth Experience ◽  
Management Group ◽  
Induction Group ◽  
Significant Difference ◽  
Small Effect Size ◽  
Induction Study ◽  
Randomised Controlled ◽  
Childbirth Experiences

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.

scholarly journals Induction of labour at 41 weeks versus expectant management until 42 weeks (INDEX): multicentre, randomised non-inferiority trial

BMJ ◽  
2019 ◽  
pp. l344 ◽  
Author(s):  
Judit KJ Keulen ◽  
Aafke Bruinsma ◽  
Joep C Kortekaas ◽  
Jeroen van Dillen ◽  
Patrick MM Bossuyt ◽  
...  
Keyword(s):  
Apgar Score ◽  
Perinatal Outcome ◽  
Primary Outcome ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Maternal Outcomes ◽  
Management Group ◽  
Induction Group ◽  
Significant Difference ◽  
Low Risk Women

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.

scholarly journals Bayesian Scepsis About SWEPIS: Quantifying the Evidence That Early Induction of Labour Prevents Perinatal Deaths

2020 ◽  
Author(s):  
Eric-Jan Wagenmakers ◽  
Alexander Ly
Keyword(s):  
Clinical Trial ◽  
Bayesian Analysis ◽  
Randomized Clinical Trial ◽  
Clinical Studies ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Perinatal Deaths ◽  
Management Group ◽  
Induction Group

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.

scholarly journals INDUCTION VERSUS EXPECTANT MANAGEMENT BETWEEN 34 TO 37 WEEKS GESTATION WITH PRETERM PRELABOUR RUPTURES OF MEMBRANE: APROSPECTIVE RANDOMISED CONTROLLED STUDY IN A PERIPHERAL MEDICAL COLLEGE, INDIA.

2020 ◽  
pp. 29-32
Author(s):  
Sima Biswas ◽  
Bivas Bala
Keyword(s):  
Intensive Care Unit ◽  
Neonatal Intensive Care ◽  
Expectant Management ◽  
Induction Of Labour ◽  
P Value ◽  
Singleton Pregnancy ◽  
Apgar Scores ◽  
Induction Group ◽  
Significant Difference ◽  
Local Protocol

Aims & Objective: To compare Feto-maternal outcome in induction versus expectant management in women with singleton pregnancy without any complication with preterm prelabour rupture of membranes between 34 to 37 weeks gestation. Materials & Methods: It was a hospital based prospective clinical observational study.100 women with singleton pregnancy between 34 to 37 weeks of gestation was selected. Randomization was done 1: 1 ratio for induction or expectant management. Women with odd numbers (1,2,3 etc) was allocated for induction of labour. Labour was induced according to the local protocol within 12 hours after randomization. Women with even numbers (2,4,6 etc) were allocated for expected management and was monitored according to standard local protocol until delivery started spontaneously. Result: There was no significant difference in mean age, parity, booking status in both group but rate of caesarean section was lower in induction group (28%) than expectant group (32%), mean randomization to delivery interval was more in expectant group (42 hours) compare to induction group (20 hours). Chorioamnionitis was 10% versus 34% and statistically significant (p value 0.0251). Foetal distress seen in 22% versus 24% in induction vs expectant group. Incidence of postpartum fever was more in expectant group than induction group (32% versus 5%) and statistically significant (p value 0.0141). Better Apgar scores at 1 minute (p value 0.0141) and 5 minutes (p value 0.0007) was in induction group as compared to expectant group. Rate of neonatal intensive care unit admission in induction group (40%) was lower than expectant group (64%) and p value 0.0277. No significant difference seen in incidence of low birth weight in both groups. Rate of neonatal death was lower in induction group (2%) than expectant group (8%). Conclusion: In this study it was observed that induction of labour in case of preterm prelabour rupture of membrane between 34 to 37 weeks leads to better Feto-maternal outcomes in terms of better Apgar scores, lesser neonatal intensive care unit admission, lower randomization to delivery interval , reduced chance of developing chorioamnionitis along with decreased incidence of postpartum fever as compared to expectant management. Hence active management by induction of labour in preterm prelabour rupture of membrane is better line of management & recommended as per our study result.

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
Keyword(s):  
Expectant Management ◽  
Cord Compression ◽  
Fetal Outcome ◽  
High Rate ◽  
Perinatal Complications ◽  
Induction Method ◽  
Maternal Complications ◽  
Management Group ◽  
Induction Group ◽  
Significant Difference

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.

scholarly journals Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial

BMJ ◽  
2019 ◽  
pp. l6131 ◽  
Author(s):  
Ulla-Britt Wennerholm ◽  
Sissel Saltvedt ◽  
Anna Wessberg ◽  
Mårten Alkmark ◽  
Christina Bergh ◽  
...  
Keyword(s):  
Perinatal Mortality ◽  
Perinatal Outcome ◽  
Expectant Management ◽  
Low Risk ◽  
Induction Of Labour ◽  
Maternal Outcomes ◽  
Open Label ◽  
Management Group ◽  
Induction Group ◽  
Superiority Trial

Abstract Objective To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks. Design Multicentre, open label, randomised controlled superiority trial. Setting 14 hospitals in Sweden, 2016-18. Participants 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group. Interventions Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks. Main outcome measures The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat. Results The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups. Conclusions This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths. Trial registration Current Controlled Trials ISRCTN26113652 .

scholarly journals The Role of Maternal Progesterone and Estradiol Levels in Predicting the Success of Induction of Labour: A Preliminary Study

2019 ◽  
pp. 126-129
Author(s):  
Kanadi Sumapraja ◽  
Hilda R Badruddin
Keyword(s):  
Cross Sectional Study ◽  
Induction Of Labour ◽  
Health Clinic ◽  
Cross Sectional ◽  
Induction Group ◽  
Significant Difference ◽  
Preliminary Study ◽  
Larger Sample ◽  
Estradiol Levels

Objective: to evaluate whether maternal progesterone and estradiol levels could be used to predictthe success ofinduction of labour (IOL) Methods:This cross-sectional study was conducted at the Women’s Health Clinic as well as delivery suite of Dr. Cipto Mangunkusumo Hospital during the period of May 2016 to April 2017. Blood samples of term pregnant women who were indicated for IOL wereobtainedbefore birth. Results:A total 44 subject were recruited in this study.Of these, 24 subjects had successful IOL while the other 20 subjects had IOL failure. There was no significant difference of progesterone among both groups (66,7% vs 75%, p=0,55). The estradiol levels in subjects who successfully performed induction had an average of 16,916.28 ± 2,574.75 pg/mL which did not differ significantly from the failed of induction group with estradiol levels of 14,832.24 ± 2374.47 pg/mL (p = 0,65). Conclusion:We found no significant association between both maternal progesterone and estradiol levels and the success rate of IOL. Further studies with larger sample sizes are required to confirm whether progesterone and estradiol play pivotal roles in the success of IOL. Keywords: progesterone, estradiol, induction of labour   Tujuan: mengevaluasi kadar progesteron dan estradiol ibu sebagai prediktor kesuksesan induksi persalinan Metode: Penelitian ini menggunakan desain potong lintang yang berlangsung pada bulan Mei 2016 hingga April 2017 di Poliklinik dan IGD Kebidanan Rumah Sakit Umum Pusat Rujukan Nasional Cipto Mangunkusumo. Pasien hamil aterm yang dilakukan induksi persalinan dan memenuhi kriteria penelitian akan diambil sampel darah sebelum persalinan. Hasil: Dari 44 subjek yang mengikuti penelitian, 24 subjek berhasil dilakukan induksi persalinan dan 20 subjek gagal.Tidakterdapatperbedaanbermaknapadakadarprogesterone Antarakeduagrup(66,7% vs 75%, p=0,55). Kadar estradiol padapasien yang berhasildilakukaninduksimemiliki rata-rata 16.916,28 + 2.574,75pg/mL yang tidakberbedajauhdengankadar estradiol pasien yang gagalinduksiyaitu 14.832,24 + 2374,47pg/mL (p = 0,65). Kesimpulan: Tidakterdapat perbedaan bermakna antara kadar progesteron dan estradiol maternal terhadap keberhasilan induksi persalinan. Penelitian lebih lanjut dengan jumlah sampel yang lebih besar dibutuhkan untuk mengkonfirmasi hubungan ini dengan lebih baik. Kata kunci: progesteron, estradiol, induksi persalinan

scholarly journals Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia: the PHOEBE mechanisms of action study within the PHOENIX RCT

2021 ◽  
Vol 8 (12) ◽  
pp. 1-28
Author(s):  
Fergus P McCarthy ◽  
Jamie O’Driscoll ◽  
Paul Seed ◽  
Anna Brockbank ◽  
Alice Cox ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Diastolic Dysfunction ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Expectant Management ◽  
England And Wales ◽  
Management Group ◽  
Randomised Controlled ◽  
The Phoenix

Background Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-eclampsia, are at increased risk of long-term cardiovascular morbidity and mortality. Objectives To investigate the hypothesis that prolongation of a pregnancy affected by preterm pre-eclampsia managed by expectant management compared with planned early delivery would result in worse cardiovascular function 6 months postpartum. Design A randomised controlled trial. Setting 28 maternity hospitals in England and Wales. Participants Women who were eligible for the Pre-eclampsia in HOspital: Early iNductIon or eXpectant management (PHOENIX) study were approached and recruited for the PHOEBE study. The PHOENIX (Pre-eclampsia in HOspital: Early iNductIon or eXpectant management) study was a parallel-group, non-masked, multicentre, randomised controlled trial that was carried out in 46 maternity units across England and Wales. This study compared planned early delivery with expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia who were 34 weeks’ gestation to less than 37 weeks’ gestation and having a singleton or dichorionic diamniotic twin pregnancy. Interventions Postpartum follow-up included medical history, blood pressure assessment and echocardiography. All women had blood sampling performed on at least two time points from recruitment to the 6-month follow-up for assessment of cardiac necrosis markers. Main outcome measures Primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines then updated by 2016 guidelines, with an amended definition of diastolic dysfunction). Analyses were by intention to treat, together with a per-protocol analysis for the primary and secondary outcomes. Results Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited across 28 maternity units in England and Wales. A total of 133 women were allocated to planned delivery, 137 women were allocated to expectant management and a further 150 received non-randomised expectant management within usual care. The mean time from enrolment to delivery was 2.5 (standard deviation 1.9) days in the planned delivery group compared with 6.8 (standard deviation 5.3) days in the expectant management group. There were no differences in the primary outcome between women in the planned delivery group and those in the expectant management group using either the 2009 (risk ratio 1.06, 95% confidence interval 0.80 to 1.40) or the 2016 definition (risk ratio 0.78, 95% confidence interval 0.33 to 1.86). Overall, 10% (31/321) of women had a left ventricular ejection fraction < 55% and 71% of the cohort remained hypertensive at 6 months postpartum. No differences were observed between groups in cardiorespiratory outcomes prior to discharge from hospital or in systolic or diastolic blood pressure measurements. Variables associated with the primary outcome (2009 definition) at 6 months postpartum were maternal body mass index (adjusted odds ratio 1.33 per 5 kg/m2, 95% confidence interval 1.12 to 1.59 per 5 kg/m2) and maternal age (adjusted odds ratio 2.16, 95% confidence interval 1.44 to 3.22 per 10 years). Limitations include changing definitions regarding systolic and/or diastolic dysfunction. Conclusions Preterm pre-eclampsia results in persistence of hypertension in the majority of women with late preterm pre-eclampsia at 6 months postpartum and systolic dysfunction in 10%. Pre-eclampsia should not be considered a self-limiting disease of pregnancy alone. Future work Interventions aimed at reducing cardiovascular dysfunction. Trial registration Current Controlled Trials ISRCTN01879376. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 12. See the NIHR Journals Library website for further project information.

scholarly journals Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046046
Author(s):  
Annemijn A de Ruigh ◽  
Noor E Simons ◽  
Janneke Van ‘t Hooft ◽  
Aleid G van Wassenaer-Leemhuis ◽  
Cornelieke S H Aarnoudse-Moens ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Late Preterm ◽  
Controlled Trials ◽  
Link Type ◽  
Long Term Follow Up ◽  
Randomised Controlled

IntroductionLate preterm prelabour rupture of membranes (PROM between 34+0 and 36+6 weeks gestational age) is an important clinical dilemma. Previously, two large Dutch randomised controlled trials (RCTs) compared induction of labour (IoL) to expectant management (EM). Both trials showed that early delivery does not reduce the risk of neonatal sepsis as compared with EM, although prematurity-related risks might increase. An extensive, structured long-term follow-up of these children has never been performed.Methods and analysisThe PPROMEXIL Follow-up trial (NL6623 (NTR6953)) aims to assess long-term childhood outcomes of the PPROMEXIL (ISRCTN29313500) and PPROMEXIL-2 trial (ISRCTN05689407), two multicentre RCTs using the same protocol, conducted between 2007 and 2010 evaluating IoL versus EM in women with late preterm PROM. The PPROMEXIL Follow-up will analyse children of mothers with a singleton pregnancy (PPROMEXIL trial n=520, PPROMEXIL-2 trial n=191, total IoL n=359; total EM n=352). At 10–12 years of age all surviving children will be invited for a neurodevelopmental assessment using the Wechsler Intelligence Scale for Children-V, Color-Word Interference Test and the Movement Assessment Battery for Children-2. Parents will be asked to fill out questionnaires assessing behaviour, motor function, sensory processing, respiratory problems, general health and need for healthcare services. Teachers will fill out the Teacher Report Form and answer questions regarding school attainment. For all tests means with SDs will be compared, as well as predefined cut-off scores for abnormal outcome. Sensitivity analyses consisting of different imputation techniques will be used to deal with lost to follow-up.Ethics and disseminationThe study has been granted approval by the Medical Centre Amsterdam (MEC) of the AmsterdamUMC (MEC2016_217). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberNL6623 (NTR6953).

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