Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments 17 alfa hydroxyprogesterone caproate, natural progesterone, vaginal progesterone
Phase phase 3
Sponsor Meir Medical Center
Start date December 2010
End date December 2012
Trial size 800 participants
Trial identifier NCT00809939, 0129-08-MMC Ver:1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
17 alfa hydroxyprogesterone caproate
weekly injection of 250 mg until 34 weeks gestation
(Active Comparator)
previous preterm delivery, treatment with daily vaginal natural progesterone
natural progesterone
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
(Active Comparator)
short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
17 alfa hydroxyprogesterone caproate
weekly injection, 250 mg until 34 weeks gestation
(Active Comparator)
short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
vaginal progesterone
daily vaginal progesterone 200 mg until 34 weeks gestation.

Primary Outcomes

Measure
efficacy
time frame: 3 years

Secondary Outcomes

Measure
comfort of use and consequently of that compliance
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week. - The subject has a short cervical length defined as 25 mm before 24 weeks gestation. - A singleton gestation. Exclusion Criteria: - Multifetal pregnancy. - The subject has or will have a cervical cerclage in place.

Additional Information

Principal investigator Tal Biron-Shental, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Meir Medical Center.