Evidence map›Paper›PMID 26322635›Full record

Trial reportPloS one2015

Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial.

Ning Gu, Tong Ru, Zhiqun Wang, Yimin Dai, Mingming Zheng, Biyun Xu, Yali Hu

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 61 citations in OpenAlex.

  1. Tugging the Foley catheter balloon every 3 h in nulliparous induction of labor: A randomized controlled trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Mechanical methods for induction of labour.The Cochrane database of systematic reviews · 2023
    Review
  8. Article
  9. Article
  10. Mechanical methods for induction of labour.The Cochrane database of systematic reviews · 2019
    Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Ning GuDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Tong RuDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Zhiqun WangDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Yimin DaiDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Mingming ZhengDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Biyun XuDepartment of Biostatistics, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Yali HuDepartment of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.
Nanjing Drum Tower Hospital · CNNanjing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL) and the maximum time for cervical ripening (12 hours vs. 24 hours) to improve vaginal delivery rate within 24 hours of induction.

methodsWe conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6) were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1) 30-mL balloon for a maximum of 12 hours, (2) 30-mL balloon for a maximum of 24 hours, (3) 80-mL balloon for a maximum of 12 hours, and (4) 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis.

resultsFive hundred and four women were recruited and randomized (126 women in each group); nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%, p < 0.001). Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.

conclusionFor women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate.

trial registrationChinese Clinical trial registry (ChiCTR-TRC-13003044).

Indexed as

AdultCathetersCervical RipeningCervix UteriChinaDelivery, ObstetricFemaleHumansLabor, InducedPregnancyTerm BirthUrinary CatheterizationYoung Adult

Identifiers

PMID26322635
PMCPMC4556187
OpenAlexW1242214704

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.