RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
- Conditions
- Preterm DeliveryCervical Length
- Interventions
- Drug: 17 alpha-hydroxyprogesterone caproateOther: Placebo Oil
- Registration Number
- NCT00439374
- Lead Sponsor
- The George Washington University Biostatistics Center
- Brief Summary
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.
- Detailed Description
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?
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 657
- Nulliparous
- Cervical length as measured on transvaginal examination < 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
- Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization
- Multifetal gestation
- Progesterone treatment after 14 weeks 6 days during current pregnancy
- Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
- Amniotic membranes prolapsed beyond external os
- Preterm rupture of membranes
- Fetal anomaly
- Pregnancy without a viable fetus
- Current or planned cervical cerclage
- Congenital Mullerian abnormality of the uterus
- Contraindication to intra-muscular injections
- Hypertension requiring medication
- Diabetes managed with insulin or oral hypoglycemic agents
- DES exposure
- Cervical surgery such as cold knife conization
- Planned indicated preterm delivery
- Participation in another interventional study that influences age at delivery
- Participation in this trial in a previous pregnancy
- Prenatal care or delivery planned outside a MFMU Network center
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate 250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery Placebo Placebo Oil Placebo oil given by weekly injection until 37 weeks gestation or delivery.
- Primary Outcome Measures
Name Time Method Number of Participants Delivering Before 37 Weeks Gestation Delivery before 37 weeks gestation Number of participants delivering before 37 weeks gestation by indication
- Secondary Outcome Measures
Name Time Method Mean Gestational Age at Delivery Delivery Mean gestational age at delivery
Number of Participants With Gestational Diabetes Mellitus Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of Participants Who Delivered Before 28 Weeks Gestation Delivery Delivery before 28 weeks gestation
Number of Participants With Preterm Premature Rupture of Membranes <37 weeks Number of Participants Who Delivered Before 35 Weeks Gestation Delivery Delivery before 35 weeks gestation
Number of Participants Who Delivered Before 32 Weeks Gestation Delivery Delivery before 32 weeks gestation
Number of Participants Who Visited the Hospital Due to Preterm Labor Between randomization and 37 weeks gestation Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Number of Participants Who Underwent Tocolytic Therapy Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of participants who underwent tocolytic therapy during pregnancy
Number of Participants Who Underwent Corticosteroid Therapy Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of participants who underwent corticosteroid therapy in pregnancy
Number of Participants Who Had a Cerclage Placement 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 Experiencing Gestational Hypertension or Preeclampsia Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of Participants Experiencing Cholestasis Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of Participants Who Experienced Placental Abruption Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of Participants Who Had Cesarean Delivery delivery Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components within 72 hours of delivery 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
Mean Birth Weight Delivery Birth weight as measured in grams
Birth Weight by Count of Participants Delivery Birth weight by count of participants \< 2500 grams and \< 1500 grams
Number of Neonates Who Measured Small for Gestational Age Delivery Birth weight percentile and small for gestational age \<10th percentile based on number of weeks and gender.
Number of Neonates With a Major Congenital Anomaly Delivery Presence of a major congenital anomaly at birth
Number of Participants Who Experienced Chorioamnionitis Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of Participants Who Reported Side Effects Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Number of Participants With Apgar Score of Less Than 7 at 5 Minutes 5 minutes post delivery 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.
Number of Neonates With Patent Ductus Arteriosus Delivery through neonatal discharge Number of neonates diagnosed with the heart defect patent ductus arteriosus
Number of Neonates Experiencing Seizures Delivery through neonatal discharge Number of neonates experiencing seizures from delivery to hospital discharge
Number of Neonates Admitted to NICU Delivery through hospital discharge Admission to the neonatal intensive care unit
Median Length of NICU Stay NICU admission through NICU discharge Median length of stay in the neonatal intensive care unit in days
Trial Locations
- Locations (14)
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Dept of OB/GYN, Hutzel Hospital
🇺🇸Detroit, Michigan, United States
University of Texas-Houston
🇺🇸Houston, Texas, United States
Northwestern University-Prentice Hospital
🇺🇸Chicago, Illinois, United States
Case Western Reserve-Metrohealth
🇺🇸Cleveland, Ohio, United States
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
University of Pittsburgh-Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
🇺🇸Dallas, Texas, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Columbia University-St. Luke's Hospital
🇺🇸New York, New York, United States
University of Texas Medical Branch - Galveston
🇺🇸Galveston, Texas, United States
Brown University -Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States