Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

• Status: Completed
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborators: Baystate Medical Center; George Washington University; Ohio State University; Vriginia Commonwealth University
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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