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RAND: Induction of Labor in Term Pregnancies With Unfavourable Cervix

Sponsor
Clinical Hospital Merkur (Other)
Overall Status
Completed
CT.gov ID
NCT04280874
Collaborator
(none)
212
Enrollment
1
Location
2
Arms
18.7
Actual Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dinoprostone 0.5 MG
  • Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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)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)
Masking:
Single (Participant)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
Actual Study Start Date :
Dec 10, 2018
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time period between beginning of labor induction to delivery [5 days]

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

    Secondary Outcome Measures

    1. number of births within 24h of start of labor induction [7 days]

      N (%)

    2. number of deliveries by caesarean section or instrumental deliveries [7 days]

      N (%)

    3. number of uterus hyperstimulation [7 days]

      N (%)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Hospital Merkur Zagreb Croatia 1000

    Sponsors and Collaborators

    • Clinical Hospital Merkur

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katja Vince, Principal Investigator, Clinical Hospital Merkur
    ClinicalTrials.gov Identifier:
    NCT04280874
    Other Study ID Numbers:
    • RANDOM1
    First Posted:
    Feb 21, 2020
    Last Update Posted:
    Jul 21, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Katja Vince, Principal Investigator, Clinical Hospital Merkur
    dinoprostone
    Bishop score
    labor induction
    term pregnancy
    Additional relevant MeSH terms:
    Dinoprostone

    Study Results

    No Results Posted as of Jul 21, 2020