Trial record 1 of 1 for:    NCT00439374
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RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix (SCAN)

This study has been terminated.
(Halted by NICHD after recommendation by DSMC to stop for futility)
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: February 21, 2007
Last updated: October 26, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Preterm Delivery
Cervical Length
Drug: 17 alpha-hydroxyprogesterone caproate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Delivery prior to 37 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does 17P increase the interval from randomization to delivery? [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Does 17P reduce neonatal morbidity and mortality? [ Time Frame: Delivery, Early life ] [ Designated as safety issue: No ]
  • Does 17P reduce the use of labor inhibition therapy? [ Time Frame: Duration of pregnancy ] [ Designated as safety issue: No ]
  • Does 17P reduce the placement of cervical cerclage? [ Time Frame: Duration of pregnancy ] [ Designated as safety issue: No ]

Enrollment: 657
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate
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.

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?


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00439374

United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35429
United States, Illinois
Northwestern University-Prentice Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
Columbia University-St. Luke's Hospital
New York City, New York, United States, 10032
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Western Reserve-Metrohealth
Cleveland, Ohio, United States, 44109
Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University -Women and Infants Hospital
Providence, Rhode Island, United States, 02095
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, United States, 75235-9032
University of Texas Medical Branch - Galveston
Galveston, Texas, United States, 77555
University of Texas-Houston
Houston, Texas, United States
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Principal Investigator: William Grobman, MD, MBA Northwestern University
  More Information

Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT00439374     History of Changes
Other Study ID Numbers: HD36801 SCAN, HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801
Study First Received: February 21, 2007
Last Updated: October 26, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
short cervix

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists processed this record on April 14, 2014