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

Not Applicable

Completed

• Conditions: Preterm Labor
• Interventions: Drug: placebo; Drug: dydrogesterone

• Registration Number: NCT02262481
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Singleton pregnancy
• Preterm labor
• GA24-34wk
• Intact membranes

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Exclusion Criteria

• Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
• Placenta previa
• medical and obstetric complications
• allergy to dydrogesterone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The recurrence of uterine contraction within 48 hours after stop tocolytic	48 hours

Secondary Outcome Measures

Name	Time	Method
side effects	9 weeks
Number of newborn with intraventricular hemorrhage	9 weeks
Number of newborn with necrotizing enterocolitis	9 weeks
Number of newborn with sepsis	9 weeks
Time from preterm labor pain to delivery	9 weeks
Number of newborn with respiratory distress syndrome	9 weeks
Gestational age at delivery	9 weeks

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand