NCT02913495

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DRUG	Vaginal Progesterone
DRUG	Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-08-01
• Completion: 2021-09-01
• First posted: 2016-09-23
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

3 sites across 1 country: United States