NCT04780269

Brief Summary

Induction of labor is one of the most common interventions in obstetrics. In the past decade, the rates of labor induction at term have doubled from approximately 9% to 23% in the United States and from 10% to 20.4% in China. The majority of women undergoing labor induction requires cervical ripening for the unfavorable cervixes. As globally, it is still required to explore an optimal induction method. Foley catheter was among the oldest mechanical approaches, while prostaglandin E2 vaginal suppository (PGE2) one of the most popular pharmacological agents for cervical ripening. There were studies reporting similar cesarean section rates between these two methods. However, there are no randomized control trials (RCTs) with adequate power to compare their frequencies of severe perinatal complications. The investigators aim to compare the effectiveness and safety of Foley catheter versus PGE2 for induction of labor among term pregnant women with an unfavourable cervix.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

February 22, 2021

Last Update Submit

September 13, 2023

Conditions

Labor InductionInduced Delivery

Keywords

Labor inductionTerm delivery with an unfavorable cervixFoley catheterProstaglandin E2

Outcome Measures

Primary Outcomes (2)

  • Number of cases with perinatal complications

    This primary outcome will be a composite of cases with severe perinatal complications and consists of one or more of the following: need for respiratory support within hours after birth, Apgar score \< 7 at 1 minutes, Apgar score \<7 at 5 minutes, umbilical cord arterial potential of hydrogen (pH ) \< 7.10, birth trauma (including bone fracture, neurologic injury, or retinal hemorrhage), hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, seizure, pneumonia, meconium aspiration syndrome, neonatal meningitis, neonatal sepsis, infant respiratory distress syndrome, pneumothorax or pneumomediastinum, apnoea, necrotising enterocolitis, clinical diagnosis of asphyxia, intraventricular haemorrhage, perinatal death (fetal or neonatal death occurring during childbirth, or up to 7 completed days after birth) or admission to the neonatal intensive care unit (NICU) for \>48 hours. Each component of this outcome is described from outcome 3 to outcome 21.

    Up to 3 weeks

  • Percentage of vaginal delivery

    The co-primary outcome is vaginal delivery.

    Up to 1 week

Secondary Outcomes (39)

  • Number of neonates need for respiratory support

    Up to 1 week

  • Number of neonates with Apgar score < 7 at 1 minutes

    On the day of delivery

  • Number of neonates with Apgar score < 7 at 5 minutes

    On the day of delivery

  • Number of neonates with umbilical cord arterial pH < 7.10

    On the day of delivery

  • Number of neonates with birth trauma

    Up to 1 week

  • +34 more secondary outcomes

Other Outcomes (2)

  • Number of cases with suspected intrapartum infection

    Up to 1 week

  • Number of cases with uterine hyperstimulation

    Up to 1 week

Study Arms (2)

Induction of labor with Foley catheter

EXPERIMENTAL

A Foley catheter will be introduced transcervically in women allocated in this group.

Device: Induction of labor with Foley catheter

Induction of labor with PGE2

EXPERIMENTAL

PGE2 (1mg) will be inserted into the posterior vaginal fornix.

Drug: Induction of labor with PGE2

Interventions

Induction of labor with Foley catheterDEVICE

A Foley catheter will be introduced transcervically in women allocated in this group, with the aid of a vaginal speculum after cervical cleaning with an aseptic solution. The balloon will be inflated with 60 mL of sterile 0.9%% sodium chloride (NaCl) after insertion past the internal os. The external end of the catheter is taped to the inner thigh without applying any traction or tension.

Also known as: Foley Catheter
Induction of labor with Foley catheter
Induction of labor with PGE2DRUG

PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.

Also known as: Dinoprostone suppositories
Induction of labor with PGE2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women scheduled for induction of labor.
  • Women aged ≥ 18 years old
  • ≥ 37 weeks of gestation
  • Live singleton pregnancy in cephalic presentation
  • Intact membranes
  • Cervical Bishop score \< 6
  • Informed consent.

You may not qualify if:

  • Contraindications for vaginal delivery.
  • Prior cesarean section
  • Known hypersensitivity for Foley catheter or PGE2
  • Non-reassuring fetal status
  • Lethal fetal congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

Related Publications (6)

  • Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Mathews TJ, Osterman MJ. Births: final data for 2008. Natl Vital Stat Rep. 2010 Dec 8;59(1):1, 3-71.

    PMID: 22145497BACKGROUND

  • Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

    PMID: 30089070BACKGROUND

  • Jozwiak M, Oude Rengerink K, Benthem M, van Beek E, Dijksterhuis MG, de Graaf IM, van Huizen ME, Oudijk MA, Papatsonis DN, Perquin DA, Porath M, van der Post JA, Rijnders RJ, Scheepers HC, Spaanderman ME, van Pampus MG, de Leeuw JW, Mol BW, Bloemenkamp KW; PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet. 2011 Dec 17;378(9809):2095-103. doi: 10.1016/S0140-6736(11)61484-0. Epub 2011 Oct 24.

    PMID: 22030144BACKGROUND

  • Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.

    PMID: 30790569BACKGROUND

  • Dos Santos F, Drymiotou S, Antequera Martin A, Mol BW, Gale C, Devane D, Van't Hooft J, Johnson MJ, Hogg M, Thangaratinam S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018 Dec;125(13):1673-1680. doi: 10.1111/1471-0528.15397. Epub 2018 Sep 10.

    PMID: 29981523BACKGROUND

  • Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.

    PMID: 26850983BACKGROUND

MeSH Terms

Interventions

Labor, InducedDinoprostone

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • JinYing Yang, MD.

    Guangzhou Women and Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 3, 2021

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)