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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Preterm Birth Obstetric Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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17 α hydroxyprogesterone caproate

17α-Hydroxyprogesterone caproate.

Group Type EXPERIMENTAL

17 α hydroxyprogesterone caproate

Intervention Type DRUG

250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.

Placebo

Saline solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

Interventions

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17 α hydroxyprogesterone caproate

250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.

Intervention Type DRUG

Placebo

250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

Intervention Type DRUG

Other Intervention Names

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Saline solution

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.