Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

Phase 3

• Conditions: Preterm Birth; Obstetric Labor, Premature
• Interventions: Drug: Placebo; Drug: 17 α hydroxyprogesterone caproate

• Registration Number: NCT01317225
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

Detailed Description

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Study Timeline

• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Study Start: 2011-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-03
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Pregnant women between 26 and 34 weeks of gestation.
• Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion Criteria

• Multiple gestations.
• Maternal pathologies in which preterm termination of pregnancy is required.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline solution.
17 α hydroxyprogesterone caproate	17 α hydroxyprogesterone caproate	17α-Hydroxyprogesterone caproate.

Primary Outcome Measures

Name	Time	Method
Incidence of preterm birth (before 37 weeks of gestation)	18 months	Number of patients that delivered before 37 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
Incidence of preterm birth before 32 weeks of pregnancy	18 months	To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.
Incidence of preterm birth before 35 weeks of pregnancy	18 months	To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama