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Completed

NCT Number: NCT04280874

Induction of Labor 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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital Merkur

Zagreb, 1000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dinoprostone 0.5 MG

Drug

0.5mg dinoprostone applied intracervically

Other names: PREPIDIL

Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Drug

2mg dinoprostone applied intravaginally

Other names: PROSTIN

Primary outcomes

  1. time period between beginning of labor induction to delivery

    Time frame: 5 days

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

Secondary outcomes

  1. number of births within 24h of start of labor induction

    Time frame: 7 days

    N (%)

  2. number of deliveries by caesarean section or instrumental deliveries

    Time frame: 7 days

    N (%)

  3. number of uterus hyperstimulation

    Time frame: 7 days

    N (%)

Sponsors and collaborators

Lead sponsor

Clinical Hospital Merkur

Other

Registry information

Official study title

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

Acronym: RAND

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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