Status:

COMPLETED

Induction of Labor in Term Pregnancies With Unfavourable Cervix

Lead Sponsor:

Clinical Hospital Merkur

Conditions:

Induction of Labor Affected Fetus / Newborn

Prostaglandins Causing Adverse Effects in Therapeutic Use

Eligibility:

FEMALE

Phase:

PHASE4

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.

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 indu...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 10 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2020

Estimated Enrollment :

212 Patients enrolled

Trial Details

Trial ID

NCT04280874

Start Date

December 10 2018

End Date

July 1 2020

Last Update

July 21 2020

Active Locations (1)

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Clinical Hospital Merkur

Zagreb, Croatia, 1000