The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.
Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
657
Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University-Prentice Hospital
Chicago, Illinois, United States
Number of Participants Delivering Before 37 Weeks Gestation
Number of participants delivering before 37 weeks gestation by indication
Time frame: Delivery before 37 weeks gestation
Mean Gestational Age at Delivery
Mean gestational age at delivery
Time frame: Delivery
Number of Participants With Preterm Premature Rupture of Membranes
Time frame: <37 weeks
Number of Participants Who Delivered Before 35 Weeks Gestation
Delivery before 35 weeks gestation
Time frame: Delivery
Number of Participants Who Delivered Before 32 Weeks Gestation
Delivery before 32 weeks gestation
Time frame: Delivery
Number of Participants Who Delivered Before 28 Weeks Gestation
Delivery before 28 weeks gestation
Time frame: Delivery
Number of Participants Who Visited the Hospital Due to Preterm Labor
Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Time frame: Between randomization and 37 weeks gestation
Number of Participants Who Underwent Tocolytic Therapy
Number of participants who underwent tocolytic therapy during pregnancy
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
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Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, United States
Columbia University-St. Luke's Hospital
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve-Metrohealth
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Brown University -Women and Infants Hospital
Providence, Rhode Island, United States
...and 4 more locations
Number of Participants Who Underwent Corticosteroid Therapy
Number of participants who underwent corticosteroid therapy in pregnancy
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Who Had a Cerclage Placement
Number of participants who had a cerclage placement
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants With Gestational Diabetes Mellitus
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Experiencing Cholestasis
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Who Experienced Placental Abruption
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Who Experienced Chorioamnionitis
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Who Had Cesarean Delivery
Time frame: delivery
Number of Participants Who Reported Side Effects
Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Time frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis
Time frame: within 72 hours of delivery
Mean Birth Weight
Birth weight as measured in grams
Time frame: Delivery
Birth Weight by Count of Participants
Birth weight by count of participants \< 2500 grams and \< 1500 grams
Time frame: Delivery
Number of Neonates Who Measured Small for Gestational Age
Birth weight percentile and small for gestational age \<10th percentile based on number of weeks and gender.
Time frame: Delivery
Number of Participants With Apgar Score of Less Than 7 at 5 Minutes
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.
Time frame: 5 minutes post delivery
Number of Neonates With a Major Congenital Anomaly
Presence of a major congenital anomaly at birth
Time frame: Delivery
Number of Neonates With Patent Ductus Arteriosus
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Time frame: Delivery through neonatal discharge
Number of Neonates Experiencing Seizures
Number of neonates experiencing seizures from delivery to hospital discharge
Time frame: Delivery through neonatal discharge
Number of Neonates Admitted to NICU
Admission to the neonatal intensive care unit
Time frame: Delivery through hospital discharge
Median Length of NICU Stay
Median length of stay in the neonatal intensive care unit in days
Time frame: NICU admission through NICU discharge