VIP Trial for prevention of recurrent spontaneous preterm birth

April 11, 2017
BH17-000
OB Gyn, Pregnancy
Corina Schoen, MD
Baystate Medical Center, 759 Chestnut Street, Springfield, MA
The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB), vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

Inclusion Criteria

Pregnant women with singleton pregnancies.

  • ≥18 years old
  • Estimated gestational age less than 24 weeks
  • History of prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks
  • Patients must also be able to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. English and Spanish speaking patients will be included

Exclusion Criteria

  • History of an adverse reaction to progesterone
  • Patient has a contraindication to progesterone treatment
  • Placenta previa or accrete
  • Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
  • Multi-fetal gestation
  • Preterm labor, premature rupture of membranes, or clinical chorioamnionitis at the time of enrollment
  • Allergy to peanut and/or castor oil

 

Your participation in this research study is expected to last for approximately 8 months. You will take the study medication for about 13-20 weeks depending on when the medication is started and be followed until discharge from your delivery. You will need to visit the doctor’s office for routine prenatal visits. You will receive approximately 5 phone calls or questionnaires during your prenatal visit to ask how you are tolerating the medication. Your baby will be followed until discharged from the hospital. This may range from a few days to a few weeks depending on how premature your baby is.
Ongoing
Corina Schoen, MD
413-794-3470