Dataset Information

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

ABSTRACT:

Background

Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24?h after starting induction with a single-balloon catheter.

Methods/design

This is a multi-centre randomised controlled trial in New Zealand. Eligible pregnant women, with a live singleton baby in a cephalic presentation who undergo a planned induction of labour at term, will be randomised to outpatient balloon-catheter induction or in-hospital prostaglandin induction. The primary outcome is caesarean section rate. To detect a 24% relative risk reduction in caesarean rate from a baseline of 24.8%, with 80% power and 5% type 1 error, will require 1552 participants in a one to one ratio.

Discussion

If outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women.

Trial registration

Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12616000739415. Registered on 6 June 2016.

SUBMITTER: Wise MR

PROVIDER: S-EPMC7027046 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

Wise Michelle R MR Marriott Joy J Battin Malcolm M Thompson John M D JMD Stitely Michael M Sadler Lynn L

Trials 20200217 1

<h4>Background</h4>Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24 h after starting induction with a single-balloon catheter.<h4>Methods/design</h4>This is a multi-centre randomised con ...[more]

PMID: 32066505

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Project description:BackgroundInduction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term.MethodsWomen with an unfavourable cervix requiring IOL at term (N=101) were randomised to outpatient care using Foley catheter (OPC, n=50) or inpatient care using vaginal PGE2 (IP, n=51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction.ResultsOPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p< .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p= .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p=.003), and had more sleep (5.8 Vs 3.4 hours, p< .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p=.001).ConclusionsOPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

Project description:BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire.ResultsDuring the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group.ConclusionsA third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers.Trial registrationNCT03199820. Registered on June 27, 2017.

Project description:IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required.Ethics and disseminationWritten informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial registration numberNCT03310333.

Project description:BACKGROUND:As the number of indications for labour induction continue to increase, the focus has shifted to performing these procedures in an outpatient setting. This study aims to systematically review published data from randomized controlled trials that compare outpatient with inpatient labour induction, to ascertain the role of outpatient labour induction for low-risk pregnancies. METHODS:We conducted a systematic review wherein we searched MEDLINE, EMBASE, Biosis Previews®, and International Pharmaceutical Abstracts from inception to January 2020 to identify randomized controlled trials that reported on maternal, fetal and resource-related outcomes following outpatient versus inpatient labour induction. Pooled incidences and mean differences were calculated using random-effects meta-analysis. Risk-of-bias was assessed using the Cochrane Risk of Bias tool. Subgroup analysis was conducted based on the method of induction. RESULTS:Of the 588 records identified, 12 publications, representing nine independent randomized controlled trials conducted in Australia, Europe and North America, were included. These reported on 2615 cases of labour induction (1320 outpatients versus 1295 inpatients). Overall, apart from a higher number of suspicious fetal heart rate tracings [RR?=?1.43 (1.10, 1.86)] and a shorter mean length of hospital stay [MD?=?282.48?min (160.23, 404.73) shorter] in the outpatient group, there were no differences in delivery method, adverse outcomes or resource-use between the two arms. On subgroup analysis, when comparing the use of balloon catheters in both arms, those induced as outpatients had fewer caesarean deliveries [RR?=?0.52 (0.30, 0.90)], a shorter admission-to-delivery interval [MD?=?370.86?min (19.19, 722.54) shorter], and a shorter induction to delivery interval [MD?=?330.42?min (120.13, 540.71) shorter]. CONCLUSION:Outpatient labour induction in resource-rich settings is at least as effective and safe, in carefully selected patient populations, when compared with inpatient labour induction. Whether outpatient labour induction results in lower rates of caesarean deliveries needs to be explored further. TRIAL REGISTRATION:This systematic review was prospectively registered in Prospero ( CRD42019118049 ).

Project description:INTRODUCTION:Labour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC). METHODS AND ANALYSIS:This single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (?5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12?hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12?hours' observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ?6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24?hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population. ETHICS AND DISSEMINATION:Ethical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24?hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses. TRIAL REGISTRATION NUMBER:NCT03471858; Pre-results.

Project description:IntroductionEvidence comparing double-balloon vs single-balloon catheter for induction of labor is divided. We aim to compare the efficacy and safety of double-vs single-balloon catheters using individual participant data.Material and methodsA search of Ovid MEDLINE, Embase, Ovid Emcare, CINAHL Plus, Scopus, and clinicaltrials.gov was conducted for randomized controlled trials published from March 2019 until April 13, 2021. Earlier trials were identified from the Cochrane Review on Mechanical Methods for Induction of Labour. Randomized controlled trials that compared double-balloon with single-balloon catheters for induction of labor in singleton gestations were eligible. Participant-level data were sought from trial investigators and an individual participant data meta-analysis was performed. The primary outcomes were rates of vaginal birth achieved, a composite measure of adverse maternal outcomes and a composite measure of adverse perinatal outcomes. We used a two-stage random-effects model. Data were analyzed from the intention-to-treat perspective.ResultsOf the eight eligible randomized controlled trials, three shared individual-level data with a total of 689 participants, 344 women in the double-balloon catheter group and 345 women in the single-balloon catheter group. The difference in the rate of vaginal birth between double-balloon catheter and single-balloon catheter was not statistically significant (relative risk [RR] 0.93, 95% confidence interval [CI] 0.86-1.00, p = 0.050; I2 0%; moderate-certainty evidence). Both perinatal outcomes (RR 0.81, 95% CI 0.54-1.21, p = 0.691; I2 0%; moderate-certainty evidence) and maternal composite outcomes (RR 0.65, 95% CI 0.15-2.87, p = 0.571; I2 55.46%; low-certainty evidence) were not significantly different between the two groups.ConclusionsSingle-balloon catheter is at least comparable to double-balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes.

Project description:BackgroundMechanical labour induction with a transcervical balloon is as effective as pharmacological methods, with fewer adverse effects. Its use has been limited to labour induction with an unfavourable cervix able to retain the balloon. We have developed an innovative approach using 2-3 balloons side-by-side to extend the benefits of mechanical labour induction/augmentation with a favourable cervix without having to resort to amniotomy or uterotonics.ObjectivesTo assess the effectiveness of side-by-side balloons for extended labour induction/augmentation.MethodsWe conducted a single arm proof of concept trial at Princess Marina Hospital (PMH) in Gaborone, Botswana. Participants were assessed as unsuitable for single balloon labour induction based on a modified Bishop cervical score of 7 or more. Three Foley catheters taped symmetrically side by side were passed through the cervix and inflated with 60mls each. Traction was applied with a weight of 250mls water suspended over the bed-end. The use of uterotonics, time from induction to birth, mode of birth, Apgar scores and adverse maternal and neonatal outcomes were recorded. Participants' satisfaction with the method of labour induction was assessed using a descriptive scale.ResultsWe enrolled 20 participants of whom two were nulliparous. Indications for labour induction were mainly late term (70%) and hypertensive disorders of pregnancy (25%). The mean cervical score was 7.2. Overall, 17 (85%) of the participants achieved a vaginal birth, of whom 5 required oxytocin for labour augmentation. Four of these had requested removal of the balloons, one due to discomfort and three felt the process was taking too long. Three participants underwent caesarean birth. The mean time from initiation of labour induction to vaginal birth was 16 h (standard deviation (SD) 8.4) and 20 h for caesarean birth (SD 10.5). There were no 5-minute Apgar scores below 7 nor neonatal admissions. One baby required brief resuscitation. There were no adverse maternal outcomes.ConclusionThis proof-of-concept study suggests that use of side-by-side balloons in participants with favourable cervix is effective in achieving vaginal birth in most participants without uterotonics or amniotomy. There were no adverse outcomes, though the study was too small to exclude the possibility of rare adverse outcomes. This offers a novel option for labour induction/augmentation, particularly where uterotonics or amniotomy are best avoided such as prior caesarean birth, vertical infection transmission risk and in settings with limited capacity for fetal surveillance. The results clearly justify larger randomized trials to evaluate this novel approach with greater precision. On the basis of the current study we are developing a purpose-designed balloon for extended balloon labour induction.

Dataset Information

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

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