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

Chulalongkorn University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Labor

Interventions

dydrogesteroneDRUG

placeboDRUG

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

The recurrence of uterine contraction within 48 hours after stop tocolytic

Time frame: 48 hours

Secondary Outcomes

Time from preterm labor pain to delivery

Time frame: 9 weeks

Gestational age at delivery

Time frame: 9 weeks

Number of newborn with respiratory distress syndrome

Time frame: 9 weeks

side effects

Time frame: 9 weeks

Number of newborn with intraventricular hemorrhage

Time frame: 9 weeks

Number of newborn with necrotizing enterocolitis

Time frame: 9 weeks

Number of newborn with sepsis

Time frame: 9 weeks

Data from ClinicalTrials.gov

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