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)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00439374
First received: February 21, 2007
Last updated: October 26, 2012
Last verified: September 2012

February 21, 2007
October 26, 2012
April 2007
May 2011   (final data collection date for primary outcome measure)
Delivery prior to 37 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Delivery prior to 37 weeks
Complete list of historical versions of study NCT00439374 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Does 17P increase the interval from randomization to delivery?
  • Does 17P reduce neonatal morbidity and mortality?
  • Does 17P reduce the use of labor inhibition therapy?
  • Does 17P reduce the placement of cervical cerclage?
Not Provided
Not Provided
 
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix

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?

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Preterm Delivery
  • Cervical Length
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.
Active Comparator: 17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate
Intervention: Drug: 17 alpha-hydroxyprogesterone caproate
Grobman WA, Thom EA, Spong CY, Iams JD, Saade GR, Mercer BM, Tita AT, Rouse DJ, Sorokin Y, Wapner RJ, Leveno KJ, Blackwell S, Esplin MS, Tolosa JE, Thorp JM Jr, Caritis SN, Van Dorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. Am J Obstet Gynecol. 2012 Nov;207(5):390.e1-8. doi: 10.1016/j.ajog.2012.09.013. Epub 2012 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
657
December 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439374
HD36801 SCAN, HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: William Grobman, MD, MBA Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP