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Preterm DeliveryPhase 3SCANNCT00439374

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

A Phase 3 study testing 17 alpha-hydroxyprogesterone caproate in people with Preterm Delivery and Cervical Length, run by The George Washington University Biostatistics Center at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Delivery, Cervical Length
What is being tested?
17 alpha-hydroxyprogesterone caproate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
657 participants
Where
14 sitesUnited States
Study dates
Apr 2007to Dec 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35429

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University-Prentice Hospital

    Chicago, Illinois, 60611

  • Case Western Reserve-Metrohealth

    Cleveland, Ohio, 44109

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • Dept of OB/GYN, Southwestern Medical Center, University of Texas

    Dallas, Texas, 75235-9032

  • Dept of OB/GYN, Hutzel Hospital

    Detroit, Michigan, 48201

  • University of Texas Medical Branch - Galveston

    Galveston, Texas, 77555

  • University of Texas-Houston

    Houston, Texas, 77030

  • Columbia University-St. Luke's Hospital

    New York, New York, 10032

  • University of Pittsburgh-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

  • Brown University -Women and Infants Hospital

    Providence, Rhode Island, 02095

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: 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.

Read the 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?

Being tested
17 alpha-hydroxyprogesterone caproate, Placebo Oil
Keywords
nulliparous, pregnancy, short cervix, progesterone
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 17 alpha-hydroxyprogesterone caproateDrug

    Also called 17 AHP

    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 OilOther

    Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative

Study groups in NCT00439374
Study groupRoleWhat they receive
17 alpha-hydroxyprogesterone caproateActive comparator250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
Receives: Drug: 17 alpha-hydroxyprogesterone caproate
PlaceboPlacebo comparatorPlacebo oil given by weekly injection until 37 weeks gestation or delivery.
Receives: Other: Placebo Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Delivering Before 37 Weeks Gestation

    Number of participants delivering before 37 weeks gestation by indication

    Measured: Delivery before 37 weeks gestation

Secondary outcomes (26)

  1. Mean Gestational Age at Delivery

    Mean gestational age at delivery

    Measured: Delivery

  2. Number of Participants With Preterm Premature Rupture of Membranes

    Measured: <37 weeks

  3. Number of Participants Who Delivered Before 35 Weeks Gestation

    Delivery before 35 weeks gestation

    Measured: Delivery

  4. Number of Participants Who Delivered Before 32 Weeks Gestation

    Delivery before 32 weeks gestation

    Measured: Delivery

  5. Number of Participants Who Delivered Before 28 Weeks Gestation

    Delivery before 28 weeks gestation

    Measured: Delivery

  6. 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

    Measured: Between randomization and 37 weeks gestation

  7. Number of Participants Who Underwent Tocolytic Therapy

    Number of participants who underwent tocolytic therapy during pregnancy

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  8. Number of Participants Who Underwent Corticosteroid Therapy

    Number of participants who underwent corticosteroid therapy in pregnancy

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  9. Number of Participants Who Had a Cerclage Placement

    Number of participants who had a cerclage placement

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  10. Number of Participants Experiencing Gestational Hypertension or Preeclampsia

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  11. Number of Participants With Gestational Diabetes Mellitus

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  12. Number of Participants Experiencing Cholestasis

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  13. Number of Participants Who Experienced Placental Abruption

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  14. Number of Participants Who Experienced Chorioamnionitis

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  15. Number of Participants Who Had Cesarean Delivery

    Measured: delivery

  16. 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

    Measured: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

  17. 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

    Measured: within 72 hours of delivery

  18. Mean Birth Weight

    Birth weight as measured in grams

    Measured: Delivery

  19. Birth Weight by Count of Participants

    Birth weight by count of participants < 2500 grams and < 1500 grams

    Measured: Delivery

  20. 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.

    Measured: Delivery

  21. 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.

    Measured: 5 minutes post delivery

  22. Number of Neonates With a Major Congenital Anomaly

    Presence of a major congenital anomaly at birth

    Measured: Delivery

  23. Number of Neonates With Patent Ductus Arteriosus

    Number of neonates diagnosed with the heart defect patent ductus arteriosus

    Measured: Delivery through neonatal discharge

  24. Number of Neonates Experiencing Seizures

    Number of neonates experiencing seizures from delivery to hospital discharge

    Measured: Delivery through neonatal discharge

  25. Number of Neonates Admitted to NICU

    Admission to the neonatal intensive care unit

    Measured: Delivery through hospital discharge

  26. Median Length of NICU Stay

    Median length of stay in the neonatal intensive care unit in days

    Measured: NICU admission through NICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMay 2011
  4. Study completionDec 2011

Why it stopped: Halted by NICHD after recommendation by DSMC to stop for futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider
Enrolment
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00439374
Sponsor's protocol ID
HD36801 SCAN
Other IDs
U10HD021410, U10HD027869, U10HD027917, U10HD053097, U10HD027915, U10HD034116, U10HD034208, U10HD034136
Acronym
SCAN
Status last verified
Jul 2019
First submitted
21 Feb 2007
Last updated
15 Jul 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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

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.

    PubMed 23010094

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 17 alpha-hydroxyprogesterone caproate in people with Preterm Delivery and Cervical Length, run by The George Washington University Biostatistics Center at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Delivering Before 37 Weeks Gestation (time frame: Delivery before 37 weeks gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00439374, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.

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