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

Chulalongkorn University

Status: Completed

Conditions: Preterm Labor

Treatments: Drug: dydrogesterone; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02262481

RA57/104

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

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:

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

Treatment:

Drug: dydrogesterone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo