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Preterm DeliveryPhase 3NCT00615550

PREGNANT Short Cervix Trial

A Phase 3 study testing progesterone in people with Preterm Delivery and Short Cervix, run by Juniper Pharmaceuticals, Inc. at 49 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
progesterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
465 participants
Where
49 sitesin 10 countries
Study dates
Mar 2008to Nov 2010
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 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • The subject has a short cervical length by transvaginal ultrasound (TVU) defined as 10-20mm. In cases of "dynamic cervix", the shortest observed/documented cervical length by TVU is to be used as the cervical length for inclusion purposes.
  • Singleton gestation.
  • The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
  • Maternal age between 15 (or local age of majority/emancipation) and 45 years of age at the time of screening. An alternative age range can be accepted according to the standards and applicable regulations of the study centers.
  • The subject speaks either English or a common local language.
  • The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
  • In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.

Who cannot join

  • The subject has a cervical length <10 or >20mm.
  • The subject has a multifetal gestation.
  • The subject has or is scheduled to have a cervical cerclage prior to randomization. According to ACOG Practice Bulletin Number 48 (November 2003), cerclage can be considered in a subject with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.228,229
  • Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
  • The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
  • The subject has been treated with a progestogen within the previous 4 weeks.
Show all 17Show fewer
  • The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
  • The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
  • The subject has active liver dysfunction or disease.
  • The subject has known or suspected malignancy of the breast or genital organs.
  • The subject is currently participating in another interventional study or has participated in an interventional drug study within one month prior to screening for this study.
  • The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
  • The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
  • The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.
  • The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment.
  • The subject is HIV positive with a CD4 count of <350 cells/mm3 and is receiving more than one (1) medication to prevent the transfer of AIDS to the fetus.
  • Complete placenta previa.

Trial locations and contacts

49 sites in 10 countries.

49 sites in 10 countries

United States27 sites

  • Johns Hopkins Community Physicians

    Baltimore, Maryland, 21211

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Charleston Area Medical Center Clinical Trials Center

    Charleston, West Virginia, 25304

  • Regional Obstetrical Consultants, Chattanooga

    Chattanooga, Tennessee, 37403

  • Perinatal Center of Iowa

    Des Moines, Iowa, 50314

  • Perinatology Research Branch Hutzel Women's Hospital

    Detroit, Michigan, 48201

  • Henry Ford Healthcare System

    Detroit, Michigan, 48202

  • Spectrum Health Research Department

    Grand Rapids, Michigan, 49503

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Regional Obstetrical Consultants, Knoxville

    Knoxville, Tennessee, 37920

  • Perinatal Diagnostic Center

    Lexington, Kentucky, 40503

  • University of Miami Leonard Miller School of Medicine Department of Obstetrics and Gynecology

    Miami, Florida, 33101

  • Winthrop University Hosital

    Mineola, New York, 11501

  • University of South Alabama Dept. of OB/GYN

    Mobile, Alabama, 36604

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • UCI Medical Center

    Orange, California, 92868

  • UPHS Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107-6130

  • Thomas Jefferson University Hospital OB/GYN / Maternal Fetal Medicine

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital and Med Ctr Women's Care Center

    Phoenix, Arizona, 85013

  • St. Joseph Mercy-Oakland

    Pontiac, Michigan, 48341

  • Washington University School of Medicine, Dept. of OB/GYN

    St Louis, Missouri, 63110

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63117

  • Albert Einstein Hospital

    The Bronx, New York, 10461

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

India5 sites

  • Sheth L.G. Hospital

    Ahmedabad, 380008

  • MediCiti Institute of Medical Sciences

    Andhra Pradesh, 5014

  • Government Medical College

    Nagpur, 440003

  • Sri Ramchandra Medical College and Research Institute

    Porur, Tamil Nadu, 600003

  • BJ Medical College & Sassoon Hospital

    Pune, Maharashtra, 411001

Other trials in India

Ukraine5 sites

  • Municipal health care establishment "City Maternity Clinical Hospital"

    Chernivtsi, 58001

  • Department of Obstetrics and Gynecology of Dnepropetrovsk State Medical Academy, Municipal establishment "City Maternity Hospital # 1"

    Dnipro, 49000

  • M. Gorky Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology, Maternity Hospital of 6th Central City Clinical Hospital

    Donetsk, 83062

  • Municipal clinical hospital #1

    Kiev, 2175

  • Antenatal Clinic # 1, Central Polyclinics of Pechersk District

    Kyiv, 01042

Other trials in Ukraine

Israel3 sites

  • Soroka University Medical Center

    Beersheba, 84965

  • Kaplan Medical Center

    Rehovot, 76100

  • Sheba Medical Center

    Tel HaShomer, 58291

Other trials in Israel

Belarus2 sites

  • 1st Clinical Hospital of the City of Minsk

    Minsk, 22004

  • Public Health Services Establishment "Vitebsk City Clinical Hospital of First Aid"

    Vitebsk, 210009

Other trials in Belarus

Chile2 sites

  • Escuela De Medicina, Pontificia Universidad Catolica De Chile

    Santiago

  • Maternidad Hospital DR Sotero Del Rio

    Santiago

Other trials in Chile

Russia2 sites

  • Limited Liability Company "American Health Clinic"

    Saint Petersburg, 190000

  • Saint Petersburg State Healthcare Institution Maternity Hospital 17

    Saint Petersburg, 192174

Other trials in Russia

Czechia1 site

  • Charles University & General Teaching Hospital

    Prague

Other trials in Czechia

Italy1 site

  • Azienda Ospedaliera di Padova Centro Prenatale Divisione di Ostetricia

    Padova, 35128

Other trials in Italy

South Africa1 site

  • Steve Biko Academic Hospital Dept. of OB-GYN and Maternal Fetal Medicine

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]

The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.

Read the detailed description

A Short uterine cervical length in the mid-trimester is the most powerful predictor of preterm birth.

Being tested
progesterone, placebo
Keywords
Preterm, Cervix
Medical subject headings
Premature Birth

What participants receive

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

  • progesteroneDrug

    Also called Prochieve 8%

    8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation

  • placeboDrug

    vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation

Study groups in NCT00615550
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo vaginal gel
Receives: Drug: placebo
ProchieveActive comparatorProgesterone 8% Vaginal Gel
Receives: Drug: progesterone

What is being measured

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

  1. Number of Participants With Birth <=32 6/7 Weeks Gestation.

    Measured: 9 to 13 weeks

Secondary outcomes (4)

  1. Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)

    Each infant is scored based on the 7 morbidity and mortality events above:

    0= no morbidity event

    1. 1 morbidity event
    2. 2 morbidity events
    3. 3 or more morbidity events
    4. mortality

    Measured: Delivery Hospitalization (1-212 days)

  2. Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.

    Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.

    Measured: Gestational Age at Delivery

  3. Number of Neonates Who Died.

    Measured: Delivery to 28 days

  4. Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams

    Assessment of birth weight < 1500 grams or < 2500 grams

    Measured: date of delivery

Timeline

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

  1. First posted14 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00615550
Sponsor's protocol ID
COL-1620-302
Other IDs
09-CH-N014
Status last verified
Feb 2012
First submitted
18 Jan 2008
Last updated
13 Mar 2012
Data monitoring committee
Yes

Publications

  • O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158.

    PubMed 17899572

  • DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.

    PubMed 17899571

  • Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.

    PubMed 17671254

  • Romero R. Prevention of spontaneous preterm birth: the role of sonographic cervical length in identifying patients who may benefit from progesterone treatment. Ultrasound Obstet Gynecol. 2007 Oct;30(5):675-86. doi: 10.1002/uog.5174. No abstract available.

    PubMed 17899585

  • Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.

    PubMed 21472815

  • Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.

    PubMed 22284156

  • Romero R, Meyyazhagan A, Hassan SS, Creasy GW, Conde-Agudelo A. Vaginal Progesterone to Prevent Spontaneous Preterm Birth in Women With a Sonographic Short Cervix: The Story of the PREGNANT Trial. Clin Obstet Gynecol. 2024 Jun 1;67(2):433-457. doi: 10.1097/GRF.0000000000000867. Epub 2024 Apr 5.

    PubMed 38576410

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing progesterone in people with Preterm Delivery and Short Cervix, run by Juniper Pharmaceuticals, Inc. at 49 sites in 10 countries.

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 7 inclusion and 17 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: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, India, Ukraine, Israel, Belarus and 5 more countries. 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 13 Mar 2012). 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 With Birth <=32 6/7 Weeks Gestation. (time frame: 9 to 13 weeks). 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 NCT00615550, which also lists 7 linked publications.

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 13 Mar 2012.

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