Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Completed · Phase 4

Conditions studied: Premature Birth

In brief

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.

Key facts

Study ID

NCT02913495

Run by

Thomas Jefferson University

People needed

210

Starts

2016-09-01

Expected to finish

2021-09-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women with singleton pregnancies
• ≥18 years old
• Estimated gestational age less than 24 0/7 weeks
• Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
• Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

You may not qualify if…

• History of an adverse reaction to progesterone;
• A contraindication to progesterone treatment;
• Placenta previa or accreta;
• Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
• Multifetal gestation;
• Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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