Induction of Labor in Term Pregnancies With Unfavourable Cervix

NCT04280874 | Completed Phase 4

• 1 other identifier: RANDOM1
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induction of Labor Affected Fetus / Newborn; Prostaglandins Causing Adverse Effects in Therapeutic Use

Keywords

dinoprostone; Bishop score; labor induction; term pregnancy

Outcome Measures

Primary Outcomes (1)

• time period between beginning of labor induction to delivery

  hours (difference of 4 hours or more is considered significant)

  5 days

Secondary Outcomes (3)

• number of births within 24h of start of labor induction

  7 days

• number of deliveries by caesarean section or instrumental deliveries

  7 days

• number of uterus hyperstimulation

  7 days

Study Arms (2)

GROUP A

ACTIVE COMPARATOR

106 randomly selected pregnant women

Drug: Dinoprostone 0.5 MG

GROUP B

ACTIVE COMPARATOR

106 randomly selected pregnant women

Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Interventions

Dinoprostone 0.5 MG DRUG

0.5mg dinoprostone applied intracervically

Also known as: PREPIDIL

GROUP A

Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly DRUG

2mg dinoprostone applied intravaginally

Also known as: PROSTIN

GROUP B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Merkur: lead

Study Sites (1)

Clinical Hospital Merkur

Zagreb, 1000, Croatia

Location

MeSH Terms

Interventions

Dinoprostone; KLK15 protein, human

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Katja Vince, MD

  Clinical Hospital Merkur

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: two dinoprostone agents are randomly applied and compared - one in patient's cervix and the other in vagina without the patient knowing which agent is applied
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 21, 2020
• Study Start: December 10, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)