Adjunctive Vaginal Progesterone in Management of Preterm Labor

Chulalongkorn University

Status and phase: Enrolling; Phase 4

Conditions: Preterm Labor

Treatments: Drug: Micronized progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT05997563

681/2023

Details and patient eligibility

About

This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.

Enrollment: 48 estimated 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 progesterone
• contraindication to progesterone
• contraindication to tocolytic use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Micronized progesterone

Active Comparator group

Treatment:

Drug: Micronized progesterone

Control

No Intervention group