RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix

Preterm Delivery Clinical Trial

— SCAN  

Official title:

A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00439374
• Other study ID #: HD36801 SCAN
• Secondary ID: U10HD021410U10HD
• Status: Terminated
• Phase: Phase 3
• Start date: April 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2019
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 657
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cervical Length
• Premature Birth
• Preterm Delivery

Intervention

Drug:
• 17 alpha-hydroxyprogesterone caproate
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.

Other:
• Placebo Oil
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
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	Dept of OB/GYN, Southwestern Medical Center, University of Texas	Dallas	Texas
United States	Dept of OB/GYN, Hutzel Hospital	Detroit	Michigan
United States	University of Texas Medical Branch - Galveston	Galveston	Texas
United States	University of Texas-Houston	Houston	Texas
United States	Columbia University-St. Luke's Hospital	New York	New York
United States	University of Pittsburgh-Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Brown University -Women and Infants Hospital	Providence	Rhode Island
United States	University of Utah Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Delivering Before 37 Weeks Gestation	Number of participants delivering before 37 weeks gestation by indication	Delivery before 37 weeks gestation
Secondary	Mean Gestational Age at Delivery	Mean gestational age at delivery	Delivery
Secondary	Number of Participants With Preterm Premature Rupture of Membranes		<37 weeks
Secondary	Number of Participants Who Delivered Before 35 Weeks Gestation	Delivery before 35 weeks gestation	Delivery
Secondary	Number of Participants Who Delivered Before 32 Weeks Gestation	Delivery before 32 weeks gestation	Delivery
Secondary	Number of Participants Who Delivered Before 28 Weeks Gestation	Delivery before 28 weeks gestation	Delivery
Secondary	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	Between randomization and 37 weeks gestation
Secondary	Number of Participants Who Underwent Tocolytic Therapy	Number of participants who underwent tocolytic therapy during pregnancy	Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Who Underwent Corticosteroid Therapy	Number of participants who underwent corticosteroid therapy in pregnancy	Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Who Had a Cerclage Placement	Number of participants who had a cerclage placement	Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Experiencing Gestational Hypertension or Preeclampsia		Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants With Gestational Diabetes Mellitus		Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Experiencing Cholestasis		Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Who Experienced Placental Abruption		Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Who Experienced Chorioamnionitis		Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	Number of Participants Who Had Cesarean Delivery		delivery
Secondary	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	Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Secondary	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	within 72 hours of delivery
Secondary	Mean Birth Weight	Birth weight as measured in grams	Delivery
Secondary	Birth Weight by Count of Participants	Birth weight by count of participants < 2500 grams and < 1500 grams	Delivery
Secondary	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.	Delivery
Secondary	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.	5 minutes post delivery
Secondary	Number of Neonates With a Major Congenital Anomaly	Presence of a major congenital anomaly at birth	Delivery
Secondary	Number of Neonates With Patent Ductus Arteriosus	Number of neonates diagnosed with the heart defect patent ductus arteriosus	Delivery through neonatal discharge
Secondary	Number of Neonates Experiencing Seizures	Number of neonates experiencing seizures from delivery to hospital discharge	Delivery through neonatal discharge
Secondary	Number of Neonates Admitted to NICU	Admission to the neonatal intensive care unit	Delivery through hospital discharge
Secondary	Median Length of NICU Stay	Median length of stay in the neonatal intensive care unit in days	NICU admission through NICU discharge

External Links

•   Click here for more information about the SCAN protocol