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
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Purpose
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?
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 ClinicalTrials.gov identifier: NCT00439374
Locations
| 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
Investigators
| 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 ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov 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):
|
nulliparous pregnancy short cervix progesterone |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications 17-alpha-hydroxy-progesterone caproate 11-hydroxyprogesterone Progesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Estradiol Antagonists Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013