NCT04413890

Brief Summary

The study compares two rhythms of administration of prostaglandin vaginal gels for cervical priming before induction of labor in term patients. In our institution, prostaglandin gels are given for a maximum of three times, with induction by oxytocin and amniotomy the day after the last gel whatever Bishop score has been obtained. This management results in some patient spending four days in hospital before delivery. The aim of the study is to compare our classical management scheme with a reduced interval between to gels, of 12h instead of 24 h. The primary outcome will be the time elapsed between the first prostaglandin gel and delivery. Tolerance of both management patterns will also be evaluated through a satisfaction survey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

April 7, 2020

Last Update Submit

July 18, 2023

Conditions

Labor ComplicationCervix

Keywords

InductionTermLaborRhythmProstaglandins

Outcome Measures

Primary Outcomes (4)

  • Time between gel administration and delivery

    Time between first gel administration for cervical priming and delivery

    At inclusion (Day 0)

  • Time between gel administration and delivery

    Change between cervical priming and delivery

    At 12 hours or 24 hours (after each gel administration)

  • Time between gel administration and delivery

    Time between first gel administration for cervical priming and delivery

    Time 0 after the childbirth

  • Time between gel administration and delivery

    Time between first gel administration for cervical priming and delivery

    Until 5 days postpartum (during in-hospital postpartum period)

Secondary Outcomes (12)

  • Maternal satisfaction

    Until 5 days postpartum

  • Cesarean section rate

    During labor

  • Hypertonia / hypercinesia rate

    During priming and induction

  • Oxytocin dose during labor

    During labor

  • Length of active first phase of labor

    During labor

  • +7 more secondary outcomes

Study Arms (2)

Classical administration

ACTIVE COMPARATOR

One prostaglandin vaginal gel every 24 hours

Drug: Dinoprostone vaginal gel

Experimental administration

EXPERIMENTAL

One prostaglandin vaginal gel every 12 hours

Drug: Dinoprostone vaginal gel

Interventions

Dinoprostone vaginal gelDRUG

Prostaglandin gel 0.5, 1 or 2 mg

Also known as: cervical priming with prostaglandin gel
Classical administrationExperimental administration

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients above 18 years
  • Gestational age ≥ 37 weeks
  • With indicated induction of labor and initial Bishop score under 6
  • Without any contraindication to vaginal delivery
  • Who consent to participate to the clinical research
  • With French Medical Public Insurance

You may not qualify if:

  • Multiple pregnancy
  • Previous uterine scar (for myomas or cesarean section)
  • Fetus not in cephalic presentation
  • Allergy to prostaglandins
  • Who not consent to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jean-Luc VOLUMENIE

    University Hospital of Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

June 4, 2020

Study Start

December 17, 2019

Primary Completion

January 27, 2021

Study Completion

January 27, 2021

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

MA(1)