Oral Dydrogesterone in the Management of Preterm Labor

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Preterm Labor

Treatments: Drug: Dydrogesterone; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03935152

286/2019

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Dydrogesterone

Active Comparator group

Description:

dydrogesterone 10 mg by mouth every 8 hours until delivery

Treatment:

Drug: Dydrogesterone

Placebo

Placebo Comparator group

Description:

placebo by mouth every 8 hours until delivery

Treatment:

Drug: placebo