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

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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

Tracking Information
First Submitted Date  ICMJE February 21, 2007
First Posted Date  ICMJE February 23, 2007
Results First Submitted Date  ICMJE February 28, 2019
Results First Posted Date  ICMJE April 11, 2019
Last Update Posted Date July 15, 2019
Study Start Date  ICMJE April 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
Delivery prior to 37 weeks
Change History Complete list of historical versions of study NCT00439374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Mean Gestational Age at Delivery [ Time Frame: Delivery ]
    Mean gestational age at delivery
  • Number of Participants With Preterm Premature Rupture of Membranes [ Time Frame: <37 weeks ]
  • Number of Participants Who Delivered Before 35 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 35 weeks gestation
  • Number of Participants Who Delivered Before 32 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 32 weeks gestation
  • Number of Participants Who Delivered Before 28 Weeks Gestation [ Time Frame: Delivery ]
    Delivery before 28 weeks gestation
  • 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
  • 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
  • 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
  • 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
  • Number of Participants Experiencing Gestational Hypertension or Preeclampsia [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  • Number of Participants With Gestational Diabetes Mellitus [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  • Number of Participants Experiencing Cholestasis [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  • Number of Participants Who Experienced Placental Abruption [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  • Number of Participants Who Experienced Chorioamnionitis [ Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks ]
  • Number of Participants Who Had Cesarean Delivery [ Time Frame: delivery ]
  • 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
  • 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
  • Mean Birth Weight [ Time Frame: Delivery ]
    Birth weight as measured in grams
  • Birth Weight by Count of Participants [ Time Frame: Delivery ]
    Birth weight by count of participants < 2500 grams and < 1500 grams
  • 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.
  • 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.
  • Number of Neonates With a Major Congenital Anomaly [ Time Frame: Delivery ]
    Presence of a major congenital anomaly at birth
  • Number of Neonates With Patent Ductus Arteriosus [ Time Frame: Delivery through neonatal discharge ]
    Number of neonates diagnosed with the heart defect patent ductus arteriosus
  • Number of Neonates Experiencing Seizures [ Time Frame: Delivery through neonatal discharge ]
    Number of neonates experiencing seizures from delivery to hospital discharge
  • Number of Neonates Admitted to NICU [ Time Frame: Delivery through hospital discharge ]
    Admission to the neonatal intensive care unit
  • Median Length of NICU Stay [ Time Frame: NICU admission through NICU discharge ]
    Median length of stay in the neonatal intensive care unit in days
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • 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?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Official Title  ICMJE A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
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.
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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Preterm Delivery
  • Cervical Length
Intervention  ICMJE
  • 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
  • Other: Placebo Oil
    Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
Study Arms  ICMJE
  • Active Comparator: 17 alpha-hydroxyprogesterone caproate
    250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
    Intervention: Drug: 17 alpha-hydroxyprogesterone caproate
  • Placebo Comparator: Placebo
    Placebo oil given by weekly injection until 37 weeks gestation or delivery.
    Intervention: Other: Placebo Oil
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 26, 2012)
657
Original Enrollment  ICMJE
 (submitted: February 21, 2007)
1000
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00439374
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: William Grobman, MD, MBA Northwestern University
Study Director: Menachem Miodovnik, MD NICHD Project Scientist
PRS Account The George Washington University Biostatistics Center
Verification Date July 2019

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