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
205
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
Time frame: up to 9 months (delivery)
Preterm birth <34 weeks and <28 weeks
Time frame: up to 9 months (delivery)
Second trimester cervical length <25mm
Time frame: 2 months
Mode of delivery
Delivery mode- vaginal, cesarean, operative vaginal
Time frame: up to 9 months (delivery)
Maternal mortality
Time frame: up to 9 months (delivery)
5 minute Apgar score
Time frame: up to 9 months (delivery)
Neonatal intensive care unit admission
Time frame: up to 9 months (delivery)
Composite neonatal morbidity
(respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)
Time frame: up to 9 months (delivery)
Birthweight
Time frame: up to 9 months (delivery)
Perinatal mortality up to 28 days of life
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Time frame: up to 10 months (4 weeks after delivery)
Medication side effects
Time frame: up to 9 months (delivery)
Satisfaction with medication (5 point Likert scale)
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 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.
Time frame: up to 9 months (delivery)