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

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: 17 alfa hydroxyprogesterone caproate (Drug); natural progesterone (Drug); 17 alfa hydroxyprogesterone caproate (Drug); vaginal progesterone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Meir Medical Center

Official(s) and/or principal investigator(s):
Tal Biron-Shental, MD, Principal Investigator, Affiliation: Meir Medical Center, Israel, Affiliated to Tel Aviv University

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.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: efficacy

Secondary outcome: comfort of use and consequently of that compliance

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Meir Medical Center, Kfar Saba, Israel
Additional Information

Starting date: December 2010
Last updated: August 27, 2011

Page last updated: August 23, 2015

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