Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00439374
Recruitment Status : Terminated (Halted by NICHD after recommendation by DSMC to stop for futility)
First Posted : February 23, 2007
Results First Posted : April 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Cervical Length Drug: 17 alpha-hydroxyprogesterone caproate Other: Placebo Oil Phase 3

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?

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment with 17 alpha-hydroxyprogesterone caproate via weekly injections of 250 mg of 17p until 37 weeks gestation or delivery vs. weekly injections of placebo oil until 37 weeks gestation or delivery.
Masking: Double (Participant, Care Provider)
Masking Description: Patients and care providers are masked to treatment assignment.
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
Study Start Date : April 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: 17 alpha-hydroxyprogesterone caproate
250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
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 Name: 17 AHP

Placebo Comparator: Placebo
Placebo oil given by weekly injection until 37 weeks gestation or delivery.
Other: Placebo Oil
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative




Primary Outcome Measures :
  1. Number of Participants Delivering Before 37 Weeks Gestation [ Time Frame: Delivery before 37 weeks gestation ]
    Number of participants delivering before 37 weeks gestation by indication


Secondary Outcome Measures :
  1. Mean Gestational Age at Delivery [ Time Frame: Delivery ]
    Mean gestational age at delivery

  2. Number of Participants With Preterm Premature Rupture of Membranes [ Time Frame: <37 weeks ]
  3. Number of Participants Who Delivered Before 35 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 35 weeks gestation

  4. Number of Participants Who Delivered Before 32 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 32 weeks gestation

  5. Number of Participants Who Delivered Before 28 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 28 weeks gestation

  6. Number of Participants Who Visited the Hospital Due to Preterm Labor [ Time Frame: Between randomization and 37 weeks gestation ]
    Number of participants who visited the hospital due to preterm labor before 37 weeks gestation

  7. Number of Participants Who Underwent Tocolytic Therapy [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
    Number of participants who underwent tocolytic therapy during pregnancy

  8. Number of Participants Who Underwent Corticosteroid Therapy [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
    Number of participants who underwent corticosteroid therapy in pregnancy

  9. Number of Participants Who Had a Cerclage Placement [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
    Number of participants who had a cerclage placement

  10. Number of Participants Experiencing Gestational Hypertension or Preeclampsia [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  11. Number of Participants With Gestational Diabetes Mellitus [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  12. Number of Participants Experiencing Cholestasis [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  13. Number of Participants Who Experienced Placental Abruption [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  14. Number of Participants Who Experienced Chorioamnionitis [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  15. Number of Participants Who Had Cesarean Delivery [ Time Frame: delivery ]
  16. Number of Participants Who Reported Side Effects [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
    Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site

  17. Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components [ Time Frame: within 72 hours of delivery ]
    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

  18. Mean Birth Weight [ Time Frame: Delivery ]
    Birth weight as measured in grams

  19. Birth Weight by Count of Participants [ Time Frame: Delivery ]
    Birth weight by count of participants < 2500 grams and < 1500 grams

  20. Number of Neonates Who Measured Small for Gestational Age [ Time Frame: Delivery ]
    Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender.

  21. Number of Participants With Apgar Score of Less Than 7 at 5 Minutes [ Time Frame: 5 minutes post delivery ]
    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.

  22. Number of Neonates With a Major Congenital Anomaly [ Time Frame: Delivery ]
    Presence of a major congenital anomaly at birth

  23. Number of Neonates With Patent Ductus Arteriosus [ Time Frame: Delivery through neonatal discharge ]
    Number of neonates diagnosed with the heart defect patent ductus arteriosus

  24. Number of Neonates Experiencing Seizures [ Time Frame: Delivery through neonatal discharge ]
    Number of neonates experiencing seizures from delivery to hospital discharge

  25. Number of Neonates Admitted to NICU [ Time Frame: Delivery through hospital discharge ]
    Admission to the neonatal intensive care unit

  26. Median Length of NICU Stay [ Time Frame: NICU admission through NICU discharge ]
    Median length of stay in the neonatal intensive care unit in days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439374


Locations
Layout table for location information
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, 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, 97239
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, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: William Grobman, MD, MBA Northwestern University
Study Director: Menachem Miodovnik, MD NICHD Project Scientist

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00439374     History of Changes
Other Study ID Numbers: HD36801 SCAN
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2007    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Keywords provided by The George Washington University Biostatistics Center:
nulliparous
pregnancy
short cervix
progesterone
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists