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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.

Conditions
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Preterm Birth, Obstetric Labor, Premature

Intervention / Treatment
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* Drug: 17 α hydroxyprogesterone caproate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 17 α hydroxyprogesterone caproate<br>17α-Hydroxyprogesterone caproate. | Drug: 17 α hydroxyprogesterone caproate<br>* 250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.<br>|
| Placebo Comparator: Placebo<br>Saline solution. | Drug: Placebo<br>* 250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preterm birth (before 37 weeks of gestation) | Number of patients that delivered before 37 weeks of pregnancy | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preterm birth before 35 weeks of pregnancy | 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. | 18 months | 
| Incidence of preterm birth before 32 weeks of pregnancy | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progesterone, Obstetric labor, premature, Short cervix