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Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth — VIP  

Premature Birth Clinical Trial

Official title:
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Clinical Trial Summary

The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

Clinical Trial Description

Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02913495
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase Phase 4
Start date September 2016
Completion date September 2021
View Details
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