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

Primary Purpose

Preterm Delivery, Cervical Length

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
17 alpha-hydroxyprogesterone caproate
Placebo Oil
Sponsored by
The George Washington University Biostatistics Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Delivery focused on measuring nulliparous, pregnancy, short cervix, progesterone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama - Birmingham
  • Northwestern University-Prentice Hospital
  • Dept of OB/GYN, Hutzel Hospital
  • Columbia University-St. Luke's Hospital
  • University of North Carolina - Chapel Hill
  • Case Western Reserve-Metrohealth
  • Ohio State University Hospital
  • Oregon Health & Sciences University
  • University of Pittsburgh-Magee Womens Hospital
  • Brown University -Women and Infants Hospital
  • Dept of OB/GYN, Southwestern Medical Center, University of Texas
  • University of Texas Medical Branch - Galveston
  • University of Texas-Houston
  • University of Utah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

17 alpha-hydroxyprogesterone caproate

Placebo

Arm Description

250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery

Placebo oil given by weekly injection until 37 weeks gestation or delivery.

Outcomes

Primary Outcome Measures

Number of Participants Delivering Before 37 Weeks Gestation
Number of participants delivering before 37 weeks gestation by indication

Secondary Outcome Measures

Mean Gestational Age at Delivery
Mean gestational age at delivery
Number of Participants With Preterm Premature Rupture of Membranes
Number of Participants Who Delivered Before 35 Weeks Gestation
Delivery before 35 weeks gestation
Number of Participants Who Delivered Before 32 Weeks Gestation
Delivery before 32 weeks gestation
Number of Participants Who Delivered Before 28 Weeks Gestation
Delivery before 28 weeks gestation
Number of Participants Who Visited the Hospital Due to Preterm Labor
Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Number of Participants Who Underwent Tocolytic Therapy
Number of participants who underwent tocolytic therapy during pregnancy
Number of Participants Who Underwent Corticosteroid Therapy
Number of participants who underwent corticosteroid therapy in pregnancy
Number of Participants Who Had a Cerclage Placement
Number of participants who had a cerclage placement
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Number of Participants With Gestational Diabetes Mellitus
Number of Participants Experiencing Cholestasis
Number of Participants Who Experienced Placental Abruption
Number of Participants Who Experienced Chorioamnionitis
Number of Participants Who Had Cesarean Delivery
Number of Participants Who Reported Side Effects
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
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
Birth weight as measured in grams
Birth Weight by Count of Participants
Birth weight by count of participants < 2500 grams and < 1500 grams
Number of Neonates Who Measured Small for Gestational Age
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
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
Presence of a major congenital anomaly at birth
Number of Neonates With Patent Ductus Arteriosus
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Number of Neonates Experiencing Seizures
Number of neonates experiencing seizures from delivery to hospital discharge
Number of Neonates Admitted to NICU
Admission to the neonatal intensive care unit
Median Length of NICU Stay
Median length of stay in the neonatal intensive care unit in days

Full Information

First Posted
February 21, 2007
Last Updated
July 11, 2019
Sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00439374
Brief Title
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Acronym
SCAN
Official Title
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Halted by NICHD after recommendation by DSMC to stop for futility
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Cervical Length
Keywords
nulliparous, pregnancy, short cervix, progesterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Patients and care providers are masked to treatment assignment.
Allocation
Randomized
Enrollment
657 (Actual)

8. Arms, Groups, and Interventions

Arm Title
17 alpha-hydroxyprogesterone caproate
Arm Type
Active Comparator
Arm Description
250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oil given by weekly injection until 37 weeks gestation or delivery.
Intervention Type
Drug
Intervention Name(s)
17 alpha-hydroxyprogesterone caproate
Other Intervention Name(s)
17 AHP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Oil
Intervention Description
Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
Primary Outcome Measure Information:
Title
Number of Participants Delivering Before 37 Weeks Gestation
Description
Number of participants delivering before 37 weeks gestation by indication
Time Frame
Delivery before 37 weeks gestation
Secondary Outcome Measure Information:
Title
Mean Gestational Age at Delivery
Description
Mean gestational age at delivery
Time Frame
Delivery
Title
Number of Participants With Preterm Premature Rupture of Membranes
Time Frame
<37 weeks
Title
Number of Participants Who Delivered Before 35 Weeks Gestation
Description
Delivery before 35 weeks gestation
Time Frame
Delivery
Title
Number of Participants Who Delivered Before 32 Weeks Gestation
Description
Delivery before 32 weeks gestation
Time Frame
Delivery
Title
Number of Participants Who Delivered Before 28 Weeks Gestation
Description
Delivery before 28 weeks gestation
Time Frame
Delivery
Title
Number of Participants Who Visited the Hospital Due to Preterm Labor
Description
Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Time Frame
Between randomization and 37 weeks gestation
Title
Number of Participants Who Underwent Tocolytic Therapy
Description
Number of participants who underwent tocolytic therapy during pregnancy
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Who Underwent Corticosteroid Therapy
Description
Number of participants who underwent corticosteroid therapy in pregnancy
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Who Had a Cerclage Placement
Description
Number of participants who had a cerclage placement
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants With Gestational Diabetes Mellitus
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Experiencing Cholestasis
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Who Experienced Placental Abruption
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Who Experienced Chorioamnionitis
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Who Had Cesarean Delivery
Time Frame
delivery
Title
Number of Participants Who Reported Side Effects
Description
Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Time Frame
Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Title
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Description
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
Time Frame
within 72 hours of delivery
Title
Mean Birth Weight
Description
Birth weight as measured in grams
Time Frame
Delivery
Title
Birth Weight by Count of Participants
Description
Birth weight by count of participants < 2500 grams and < 1500 grams
Time Frame
Delivery
Title
Number of Neonates Who Measured Small for Gestational Age
Description
Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender.
Time Frame
Delivery
Title
Number of Participants With Apgar Score of Less Than 7 at 5 Minutes
Description
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.
Time Frame
5 minutes post delivery
Title
Number of Neonates With a Major Congenital Anomaly
Description
Presence of a major congenital anomaly at birth
Time Frame
Delivery
Title
Number of Neonates With Patent Ductus Arteriosus
Description
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Time Frame
Delivery through neonatal discharge
Title
Number of Neonates Experiencing Seizures
Description
Number of neonates experiencing seizures from delivery to hospital discharge
Time Frame
Delivery through neonatal discharge
Title
Number of Neonates Admitted to NICU
Description
Admission to the neonatal intensive care unit
Time Frame
Delivery through hospital discharge
Title
Median Length of NICU Stay
Description
Median length of stay in the neonatal intensive care unit in days
Time Frame
NICU admission through NICU discharge

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Grobman, MD, MBA
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Menachem Miodovnik, MD
Organizational Affiliation
NICHD Project Scientist
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35429
Country
United States
Facility Name
Northwestern University-Prentice Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dept of OB/GYN, Hutzel Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Columbia University-St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Case Western Reserve-Metrohealth
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh-Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Brown University -Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02095
Country
United States
Facility Name
Dept of OB/GYN, Southwestern Medical Center, University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9032
Country
United States
Facility Name
University of Texas Medical Branch - Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
23010094
Citation
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.
Results Reference
derived
Links:
URL
http://www.bsc.gwu.edu/mfmu
Description
Click here for more information about the SCAN protocol

Learn more about this trial

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

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