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17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

NCT00809939 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2011-08-30

No results posted yet for this study

Summary

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.

The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Conditions

  • Pregnancy

Interventions

DRUG

17 alfa hydroxyprogesterone caproate

weekly injection of 250 mg until 34 weeks gestation

DRUG

natural progesterone

previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.

DRUG

17 alfa hydroxyprogesterone caproate

weekly injection, 250 mg until 34 weeks gestation

DRUG

vaginal progesterone

daily vaginal progesterone 200 mg until 34 weeks gestation.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Tal Biron-Shental, MD · Meir Medical Center, Israel, Affiliated to Tel Aviv University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Israel

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 NCT00809939 on ClinicalTrials.gov