Study Stopped
Halted by NICHD after recommendation by DSMC to stop for futility
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
SCAN
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
17 other identifiers
interventional
657
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2007
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
April 11, 2019
CompletedJuly 15, 2019
July 1, 2019
4.1 years
February 21, 2007
February 28, 2019
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Delivering Before 37 Weeks Gestation
Number of participants delivering before 37 weeks gestation by indication
Delivery before 37 weeks gestation
Secondary Outcomes (26)
Mean Gestational Age at Delivery
Delivery
Number of Participants With Preterm Premature Rupture of Membranes
<37 weeks
Number of Participants Who Delivered Before 35 Weeks Gestation
Delivery
Number of Participants Who Delivered Before 32 Weeks Gestation
Delivery
Number of Participants Who Delivered Before 28 Weeks Gestation
Delivery
- +21 more secondary outcomes
Study Arms (2)
17 alpha-hydroxyprogesterone caproate
ACTIVE COMPARATOR250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
Placebo
PLACEBO COMPARATORPlacebo oil given by weekly injection until 37 weeks gestation or delivery.
Interventions
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.
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alabama - Birmingham
Birmingham, Alabama, 35429, United States
Northwestern University-Prentice Hospital
Chicago, Illinois, 60611, United States
Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, 48201, United States
Columbia University-St. Luke's Hospital
New York, New York, 10032, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Case Western Reserve-Metrohealth
Cleveland, Ohio, 44109, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Brown University -Women and Infants Hospital
Providence, Rhode Island, 02095, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, 75235-9032, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, 77555, United States
University of Texas-Houston
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 23010094DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Grobman, MD
- Organization
- Northwestern University Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
William Grobman, MD, MBA
Northwestern University
- STUDY DIRECTOR
Menachem Miodovnik, MD
NICHD Project Scientist
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Patients and care providers are masked to treatment assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 23, 2007
Study Start
April 1, 2007
Primary Completion
May 1, 2011
Study Completion
December 1, 2011
Last Updated
July 15, 2019
Results First Posted
April 11, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu