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

Thomas Jefferson University

Status and phase: Completed; Phase 4

Conditions: Premature Birth

Treatments: Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate); Drug: Vaginal Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02913495

16D.542

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Vaginal Progesterone

Experimental group

Description:

200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery

Treatment:

Drug: Vaginal Progesterone

Intramuscular Progesterone

Active Comparator group

Description:

250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.

Treatment:

Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)