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Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT02262481
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
10
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dydrogesterone

tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks

Drug: dydrogesterone
Other Names:
  • Duphaston

    		•
    Placebo Comparator: Placebo

    tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. The recurrence of uterine contraction within 48 hours after stop tocolytic [48 hours]

    Secondary Outcome Measures

    1. Time from preterm labor pain to delivery [9 weeks]

    2. Gestational age at delivery [9 weeks]

    3. Number of newborn with respiratory distress syndrome [9 weeks]

    4. side effects [9 weeks]

    5. Number of newborn with intraventricular hemorrhage [9 weeks]

    6. Number of newborn with necrotizing enterocolitis [9 weeks]

    7. Number of newborn with sepsis [9 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Singleton pregnancy

    • Preterm labor

    • GA24-34wk

    • Intact membranes

    Exclusion Criteria:

    • Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress

    • Placenta previa

    • medical and obstetric complications

    • allergy to dydrogesterone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Chulalongkorn University Bangkok Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    • Study Director: Vorapong Phupong, M.D., Chulalongkorn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vorapong Phupong, Vorapong, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT02262481
    Other Study ID Numbers:
    • RA57/104
    First Posted:
    Oct 13, 2014
    Last Update Posted:
    Jan 28, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Premature Birth
    Obstetric Labor, Premature
    Dydrogesterone

    Study Results

    No Results Posted as of Jan 28, 2016