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

July 11, 2019 updated by: The George Washington University Biostatistics Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
657

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35429
        • University of Alabama - Birmingham
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Prentice Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Dept of OB/GYN, Hutzel Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University-St. Luke's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve-MetroHealth
      • Columbus, Ohio, United States, 43210
        • Ohio State University Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh-Magee Womens Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02095
        • Brown University -Women and Infants Hospital
    • Texas
      • Dallas, Texas, United States, 75235-9032
        • Dept of OB/GYN, Southwestern Medical Center, University of Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch - Galveston
      • Houston, Texas, United States, 77030
        • University of Texas-Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Delivery before 37 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Gestational Age at Delivery
Time Frame: Delivery
Mean gestational age at delivery
Delivery
Number of Participants With Preterm Premature Rupture of Membranes
Time Frame: <37 weeks
<37 weeks
Number of Participants Who Delivered Before 35 Weeks Gestation
Time Frame: Delivery
Delivery before 35 weeks gestation
Delivery
Number of Participants Who Delivered Before 32 Weeks Gestation
Time Frame: Delivery
Delivery before 32 weeks gestation
Delivery
Number of Participants Who Delivered Before 28 Weeks Gestation
Time Frame: Delivery
Delivery before 28 weeks gestation
Delivery
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
Between randomization and 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
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
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
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
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
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Time Frame: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
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
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
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
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
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Number of Participants Who Had Cesarean Delivery
Time Frame: delivery
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
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
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
within 72 hours of delivery
Mean Birth Weight
Time Frame: Delivery
Birth weight as measured in grams
Delivery
Birth Weight by Count of Participants
Time Frame: Delivery
Birth weight by count of participants < 2500 grams and < 1500 grams
Delivery
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.
Delivery
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.
5 minutes post delivery
Number of Neonates With a Major Congenital Anomaly
Time Frame: Delivery
Presence of a major congenital anomaly at birth
Delivery
Number of Neonates With Patent Ductus Arteriosus
Time Frame: Delivery through neonatal discharge
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Delivery through neonatal discharge
Number of Neonates Experiencing Seizures
Time Frame: Delivery through neonatal discharge
Number of neonates experiencing seizures from delivery to hospital discharge
Delivery through neonatal discharge
Number of Neonates Admitted to NICU
Time Frame: Delivery through hospital discharge
Admission to the neonatal intensive care unit
Delivery through hospital discharge
Median Length of NICU Stay
Time Frame: NICU admission through NICU discharge
Median length of stay in the neonatal intensive care unit in days
NICU admission through NICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Washington University Biostatistics Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Grobman, MD, MBA, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD36801 SCAN
  • U10HD036801 (U.S. NIH Grant/Contract)
  • U10HD021410 (U.S. NIH Grant/Contract)
  • U10HD027869 (U.S. NIH Grant/Contract)
  • U10HD027917 (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)
  • U10HD053097 (U.S. NIH Grant/Contract)
  • U10HD027915 (U.S. NIH Grant/Contract)
  • U10HD053118 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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