Induction of Labor in Term Pregnancies With Unfavourable Cervix

Induction of Labor Affected Fetus / Newborn Clinical Trial

— RAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280874
• Other study ID #: RANDOM1
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Clinical Hospital Merkur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dinoprostone 0.5 MG
0.5mg dinoprostone applied intracervically
• Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
2mg dinoprostone applied intravaginally

Locations

Country	Name	City	State
Croatia	Clinical Hospital Merkur	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Merkur

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time period between beginning of labor induction to delivery	hours (difference of 4 hours or more is considered significant)	5 days
Secondary	number of births within 24h of start of labor induction	N (%)	7 days
Secondary	number of deliveries by caesarean section or instrumental deliveries	N (%)	7 days
Secondary	number of uterus hyperstimulation	N (%)	7 days