Induction of Labor in Term Pregnancies With Unfavourable Cervix (RAND)

July 18, 2020 updated by: Katja Vince, Clinical Hospital Merkur

Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix

This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 1000
        • Clinical Hospital Merkur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • term pregnancies (> 37 weeks gestation)
  • unfavourable cervix (Bishop score <6)
  • indication for labor induction
  • absence of uterine contractions
  • reassuring cardiotocography

Exclusion Criteria:

  • ruptured membranes
  • scar uterus (previous caesarean section or uterus surgery)
  • pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: GROUP A
106 randomly selected pregnant women
Drug: Dinoprostone 0.5 MG
0.5mg dinoprostone applied intracervically
Other Names:
  • PREPIDIL
ACTIVE_COMPARATOR: GROUP B
106 randomly selected pregnant women
Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
2mg dinoprostone applied intravaginally
Other Names:
  • PROSTIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time period between beginning of labor induction to delivery
Time Frame: 5 days
hours (difference of 4 hours or more is considered significant)
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of births within 24h of start of labor induction
Time Frame: 7 days
N (%)
7 days
number of deliveries by caesarean section or instrumental deliveries
Time Frame: 7 days
N (%)
7 days
number of uterus hyperstimulation
Time Frame: 7 days
N (%)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Merkur

Investigators

  • Study Chair: Katja Vince, MD, Clinical Hospital Merkur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2018

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 18, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RANDOM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Induction of Labor Affected Fetus / Newborn

Clinical Trials on Dinoprostone 0.5 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe