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

NCT01317225 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-01-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

17 α hydroxyprogesterone caproate

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Saint Thomas Hospital, Panama

    lead OTHER

Principal Investigators

  • Osvaldo A Reyes, MD (Gyn/Ob) · Saint Thomas Maternity Hospital

  • Rodrigo Velarde, MD (Gyn/Ob) · Saint Thomas Maternity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • Panama

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01317225 on ClinicalTrials.gov