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Comparing IM vs. Vaginal Progesterone for Pre-term Birth

NCT00579553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2021-05-19

Study results available
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Summary

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Conditions

  • Infant, Premature
  • Premature Birth

Interventions

DRUG

Intramuscular Progesterone

Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P

DRUG

Vaginal Progesterone

Vaginal Progesterone: 100 mg vaginal suppository daily

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Andrew Elimian, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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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 NCT00579553 on ClinicalTrials.gov