Oral Dydrogesterone in the Management of Preterm Labor

Phase 4

Completed

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

• Registration Number: NCT03935152
• Lead Sponsor: Chulalongkorn University

Brief Summary

This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-05-11
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

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

Inclusion Criteria

• singleton pregnancy with gestational age 24-33 weeks 6 days
• preterm labor
• received treatment with tocolysis and corticosteroids

Exclusion Criteria

• conditions that need immediate delivery such as fetal distress, chorioamnionitis
• have medical complications such as heart disease, seizure
• fetal anomalies
• cervical dilatation more than 5 cm
• allergy to dydrogesterone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo by mouth every 8 hours until delivery
Dydrogesterone	Dydrogesterone	dydrogesterone 10 mg by mouth every 8 hours until delivery

Primary Outcome Measures

Name	Time	Method
latency period	13 weeks	time from preterm labor to delivery

Secondary Outcome Measures

Name	Time	Method
compliance	13 weeks	percentage of complete drug use
preterm delivery less than 34 weeks	10 weeks	percentage of delivery less than 34 weeks
Time to the recurrence of uterine contractions	13 weeks	Time to the recurrence of uterine contractions
neonatal complications	13 weeks	percentage of newborn with RDS, IVH, NEC, death
satisfaction	13 weeks	percentage of good satisfaction
preterm delivery less than 37 weeks	13 weeks	percentage of delivery less than 37 weeks
side effects	13 weeks	percentage of side effects such as headache, nausea/vomiting

Trial Locations

Locations (1)

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