Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Phase 4

Completed

• Conditions: Threatened Abortion
• Interventions: Drug: Placebo; Drug: Dydrogesterone

• Registration Number: NCT04788108
• Lead Sponsor: Chulalongkorn University

Brief Summary

This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-08-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• singleton pregnancy with gestational age 6 - 20 weeks
• threatened abortion
• confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion Criteria

• history of recurrent miscarriage
• having endocervical polyp
• having infection such as pneumonia, pyelonephritis, septicemia
• having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
• having cancer
• having coagulation defect
• allergy to dydrogesterone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.
Dydrogesterone	Dydrogesterone	dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Primary Outcome Measures

Name	Time	Method
continue pregnancy more than 20 weeks gestation	at 20 weeks gestation	percentage of cases with continue pregnancy more than 20 weeks gestation

Secondary Outcome Measures

Name	Time	Method
preterm delivery less than 34 weeks	at 34 weeks gestation	percentage of delivery less than 34 weeks
preterm delivery less than 37 weeks	at 37 weeks gestation	percentage of delivery less than 37 weeks
placenta previa	31 weeks	percentage of placenta previa
abruptio placenta	31 weeks	percentage of abruptio placenta
Intrauterine growth restriction	31 weeks	percentage of intrauterine growth restriction
neonatal complications	31 weeks	percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death
side effects	6 weeks	percentage of side effects such as headache, nausea/vomiting
compliance	6 weeks	percentage of complete drug use
maternal satisfaction	6 weeks	percentage of good satisfaction
time until bleeding stops	6 weeks	time from first bleeding until bleeding stops

Trial Locations

Locations (1)

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