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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
210
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
Preterm Birth <37 Weeks
Incidence of gestational age of delivery less than 37 weeks
Time frame: up to 9 months (delivery)
Gestational Age of Delivery
Gestational age at delivery (weeks)
Time frame: up to 9 months (delivery)
Preterm Birth <34 Weeks
Delivery of pregnancy 20 0/7 - 33 6/7 weeks gestation
Time frame: up to 9 months (delivery)
Second Trimester Cervical Length <25mm
Short cervix diagnosis (transvaginal ultrasound cervical length \<=25mm prior to 24 weeks gestation
Time frame: 2 months
Mode of Delivery: Cesarean Section
Delivery mode- vaginal, cesarean, operative vaginal
Time frame: up to 9 months (delivery)
Maternal Mortality
Maternal death for any reason from enrollment through hospital discharge from delivery hospitalization.
Time frame: up to 9 months (delivery)
5 Minute Apgar Score<7
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Time frame: up to 9 months (delivery)
Neonatal Intensive Care Unit Admission
Admission to neonatal intensive care unit for any reason (yes/no)
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Time frame: up to 9 months (delivery)
Composite Neonatal Morbidity
Having at least one of the following: respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, or perinatal mortality up to 28 days of life
Time frame: up to 9 months (delivery)
Birthweight
Birthweight assessed at delivery (grams)
Time frame: up to 9 months (delivery)
Perinatal Mortality up to 28 Days of Life
In utero or neonatal death from enrollment through 28 days of neonatal life.
Time frame: up to 10 months (4 weeks after delivery)
Medication Side Effects
Medication side effects
Time frame: up to 9 months (delivery)
Satisfaction With Medication (5 Point Likert Scale)
5 point scale, 0 is very dissatisfied, 5 is very satisfied, 3 is neutral
Time frame: up to 9 months (delivery)
Medication Adherence
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 doses
Time frame: up to 9 months (delivery)
Planned Subgroup Analysis for the Outcome Preterm Birth <37 Weeks, <34 Weeks, <28 Weeks
Planned subgroup analysis for the primary outcome 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.
Time frame: up to 9 months (delivery)