Trial reportBMC pregnancy and childbirth2015
A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial.
Trial report in BMC pregnancy and childbirth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Outpatient or Inpatient Setting for Cervical Ripening Before Induction of Labour: An Individual Participant Data Meta-Analysis.BJOG : an international journal of obstetrics and gynaecology · 2025Pooled it
- Home versus inpatient induction of labour for improving birth outcomes.The Cochrane database of systematic reviews · 2020Pooled it
- Inpatient versus outpatient induction of labour: a systematic review and meta-analysis.BMC pregnancy and childbirth · 2020Pooled it
- Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial.Singapore medical journal · 2018Trial
- Outcomes of Outpatient Versus Inpatient Induction of Labor: A Systematic Review and Meta-Analysis.Cureus · 2024Review
- Effect of cervical Bishop score on induction of labor at term in primiparas using Foley catheter balloon: a retrospective study.BMC pregnancy and childbirth · 2024Article
- Mechanical methods for induction of labour.The Cochrane database of systematic reviews · 2023Review
- Article
- Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 h versus within 12-24 h.BMC pregnancy and childbirth · 2021Article
- A Tribute to Nancy C. Chescheir, MD.Obstetrics and gynecology · 2021Article
- Outpatient Induction of Labor - Are Balloon Catheters an Appropriate Method?Geburtshilfe und Frauenheilkunde · 2021Article
- Effectiveness of Dinoprostone and Cook's Balloon for Labor Induction in Primipara Women at Term.Current medical science · 2020Article
- Mechanical methods for induction of labour.The Cochrane database of systematic reviews · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOne in four Australian births are induced. If cervical ripening using a prostaglandin is required, a pre-labour overnight hospitalisation and separation from family and support companions is necessary. Recent evidence shows that balloon catheter cervical ripening is just as effective as prostaglandins, but does not cause uterine stimulation. For women with low risk pregnancies, this offers the possibility of undergoing the overnight ripening process in their own home. We conducted a pilot randomised trial to assess the outcomes, clinical pathways and acceptability to both women and clinicians of outpatient balloon catheter ripening compared with usual inpatient care.
methodsForty-eight women with low risk term pregnancies were randomised (2:1) to either outpatient (n = 33) or inpatient double-balloon catheter (n = 15) cervical ripening. Although not powered for statistically significant differences, the study explored potential direction of effect for key clinical outcomes such as oxytocin use, caesarean section and morbidities. Feedback on acceptability was sought from women at catheter insertion and 4 weeks after the birth, and from midwives and doctors, at the end of the study.
resultsClinical and perinatal outcomes were similar. Most women required oxytocin (77 %). The outpatient group were 24 % less likely to require oxytocin (risk difference -23.6 %, 95 % CI -43.8 to -3.5). There were no failed inductions, infections or uterine hyperstimulation attributable to the catheter in either group. Most women in both groups reported discomfort with insertion and wearing the catheter, but were equally satisfied with their care and felt the baby was safe (91 % both groups). Outpatient women reported feeling less isolated or emotionally alone. Most midwives and doctors (n = 90) agreed that they are more comfortable in sending home a woman with a catheter than prostaglandins and 90 % supported offering outpatient ripening to eligible women.
conclusionsOutpatient balloon catheter ripening should be further investigated as an option for women in an adequately powered randomised trial.
trial registrationProspectively registered, Australian New Zealand Clinical Trials Registry ACTRN12612001184864 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.