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

January 3, 2015 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Recruiting
        • Saint Thomas Maternity Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Osvaldo A Reyes, MD (Gyn/Ob)
        • Principal Investigator:
          • Rodrigo Velarde, MD (Gyn/Ob)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 17 α hydroxyprogesterone caproate
17α-Hydroxyprogesterone caproate.
Drug: 17 α hydroxyprogesterone caproate
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
Placebo Comparator: Placebo
Saline solution.
Drug: Placebo
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of preterm birth (before 37 weeks of gestation)
Time Frame: 18 months
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
Time Frame: 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.
18 months
Incidence of preterm birth before 32 weeks of pregnancy
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

  • Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob), Saint Thomas Maternity Hospital
  • Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob), Saint Thomas Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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