Vaginal Progesterone Supplementation in the Management of Preterm Labor

Chulalongkorn University

Status: Completed

Conditions: Preterm Labor

Treatments: Drug: Tocolytics; Drug: progesterone; Drug: Steroids

Study type: Interventional

Funder types: Other

Identifiers

NCT03202836

230/2017

Details and patient eligibility

About

This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton pregnant women with preterm labor, gestational age 24-34 weeks

Exclusion criteria

• have indicated preterm birth
• allergy to progesterone
• fetal anomalies
• cervical dilate > 5 cm.
• have medical disease
• have obstetric complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

vaginal progesterone

Experimental group

Description:

Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours

Treatment:

Drug: Tocolytics

Drug: progesterone

Drug: Steroids

no medication

Other group

Description:

only tocolysis plus corticosteroid for 48 hours

Treatment:

Drug: Tocolytics

Drug: Steroids