Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
- Conditions
- Premature Birth
- Interventions
- Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)
- Registration Number
- NCT02913495
- Lead Sponsor
- Thomas Jefferson University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 205
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intramuscular Progesterone Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) 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. Vaginal Progesterone Vaginal Progesterone 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
- Primary Outcome Measures
Name Time Method Preterm birth <37 weeks up to 9 months (delivery) Incidence of gestational age of delivery less than 37 weeks
- Secondary Outcome Measures
Name Time Method Gestational age of delivery up to 9 months (delivery) Second trimester cervical length <25mm 2 months Preterm birth <34 weeks and <28 weeks up to 9 months (delivery) Mode of delivery up to 9 months (delivery) Delivery mode- vaginal, cesarean, operative vaginal
Maternal mortality up to 9 months (delivery) 5 minute Apgar score up to 9 months (delivery) Neonatal intensive care unit admission up to 9 months (delivery) Composite neonatal morbidity up to 9 months (delivery) (respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)
Birthweight up to 9 months (delivery) Perinatal mortality up to 28 days of life up to 10 months (4 weeks after delivery) Medication side effects up to 9 months (delivery) Satisfaction with medication (5 point Likert scale) up to 9 months (delivery) Medication adherence up to 9 months (delivery) Vaginal progesterone:
* Overall adherence: #days used/#days of treatment x 100
* Non-adherent: ≥4 days between doses
Intramuscular progesterone:
* Overall adherence: #weeks used/#weeks of treatment x 100
* Non-adherent: ≥10 days between dosesPlanned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks up to 9 months (delivery) Planned subgroup analysis for the primary outcome as well as the secondary outcomes of preterm birth \<34 weeks and \<28 weeks of patients with a cervical length \<25mm versus ≥25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks.
Trial Locations
- Locations (3)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
George Washington University
🇺🇸Washington, District of Columbia, United States