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Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor

NCT04413890 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2023-07-19

No results posted yet for this study

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.

Conditions

  • Labor Complication
  • Cervix

Interventions

DRUG

Dinoprostone vaginal gel

Prostaglandin gel 0.5, 1 or 2 mg

Sponsors & Collaborators

  • University Hospital Center of Martinique

    lead OTHER

Principal Investigators

  • Jean-Luc VOLUMENIE · University Hospital of Martinique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2021-01-27
Completion
2021-01-27

Countries

  • Martinique

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04413890 on ClinicalTrials.gov