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Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery (PROLONG)

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ClinicalTrials.gov Identifier: NCT01004029
Recruitment Status : Active, not recruiting
First Posted : October 29, 2009
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
ResearchPoint Global
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.

Condition or disease Intervention/treatment Phase
Preterm Birth Drug: Hydroxyprogesterone Caproate Injection, 250mg/mL Drug: Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery
Study Start Date : October 2009
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Vehicle
Castor Oil
Drug: Vehicle
Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Other Name: Placebo

Active Comparator: Hydroxyprogesterone Caproate Injection, 250 mg/mL
HPC 250 mg/mL in oil
Drug: Hydroxyprogesterone Caproate Injection, 250mg/mL
1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Other Names:
  • Makena
  • 17P




Primary Outcome Measures :
  1. Determine if treatment with 17P reduces the rate of preterm birth < 35 weeks, 0 days of gestation in women with a previous singleton spontaneous preterm delivery. [ Time Frame: Delivery ]
    Co-primary endpoint #1

  2. Determine if 17P reduces the rate of neonatal mortality or morbidity [ Time Frame: 28 days of life or discharge from the NICU ]
    Co-primary endpoint #2 Neonatal mortality or morbidity is measured by a composite index comprised of: Neonatal death, Grade 3 or 4 intraventricular hemorrhage, Respiratory distress syndrome, Bronchopulmonary dysplasia, Necrotizing enterocolitis, Proven sepsis


Secondary Outcome Measures :
  1. Exclude a doubling of the risk of fetal/early infant death [ Time Frame: Delivery ]
    Defined as spontaneous abortion/miscarriage (delivery from 16 weeks 0 days through 19 weeks 6 days of gestation) or neonatal death occurring in liveborns born at less than 24 weeks gestation or stillbirth (antepartum or intrapartum death from 20 weeks gestation through term), in the 17P group compared to the vehicle group

  2. Preterm birth prior to 32 weeks 0 days of gestation [ Time Frame: Delivery ]
  3. Preterm birth prior to 37 weeks 0 days of gestation [ Time Frame: Delivery ]
  4. Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater [ Time Frame: 28 days of life or discharge from the NICU ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study:

  1. Age ≥ 18 years.
  2. Singleton gestation.
  3. Project gestational age 16 weeks 0 days of gestation or more and less than or equal to 20 weeks 6 days of gestation at the time of randomization, based on clinical information and evaluation of the first ultrasound.
  4. Documented history of a previous singleton spontaneous preterm delivery. Spontaneous preterm birth is defined as delivery from 20 weeks 0 days to 36 weeks 6 days of gestation following spontaneous preterm labor or pPROM. Where possible, the gestational age of the previous preterm birth (referred to as the qualifying delivery) should be determined as described in "Gestational Age Determination". If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the latest will be used. As a validation of the gestational age of the previous delivery, if the infant weighed more than 3300 grams (the birth weight 90th percentile for 36 weeks gestational age), this will not qualify as preterm. The previous preterm delivery cannot be an antepartum stillbirth.

Exclusion Criteria:

  1. Multifetal gestation.
  2. Known major fetal anomaly or fetal demise. An ultrasound examination between 14 weeks 0 days through 20 weeks 3 days of gestation must be performed to rule out fetal anomalies.
  3. Progesterone treatment in any form (i.e., vaginal, oral, intramuscular) during current pregnancy, other than micronized progesterone delivered orally or vaginally provided it is stopped at least 4 weeks prior to the first dose of study medication.
  4. Heparin therapy during current pregnancy or history of thromboembolic disease.
  5. Maternal medical/obstetrical complications including:

    • Current or planned cerclage
    • Hypertension requiring medication
    • Seizure disorder
  6. Subjects with a uterine anomaly (uterine didelphys or bicornate uterus). However, subjects with uterine fibroids are eligible for the study.
  7. Unwillingness to comply with and complete the study.
  8. A 14 weeks 0 days through 20 weeks 3 days of gestation ultrasound cannot be arranged before randomization.
  9. Participation in an antenatal study in which the clinical status or intervention may influence gestational age at delivery.
  10. Participation in this trial in a previous pregnancy. Women who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
  11. Known hypersensitivity to hydroxyprogesterone caproate or its components.
  12. Have any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug including those listed in section 5.3.2 of the investigational brochure. Other examples to consider include uncontrolled diabetes, known HIV infection or renal dysfunction.
  13. Have any significant medical disorder that, in the opinion of the investigator, would preclude accurate evaluation of the subject's condition or outcome in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004029


  Hide Study Locations
Locations
United States, Alabama
Drug Research & Analysis Corporation
Montgomery, Alabama, United States, 36106
United States, Arizona
Tucson Medical Center (Watching Over Mothers and Babies Foundation)
Tucson, Arizona, United States, 85712
United States, California
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
Naval Medical Center San Diego - Department of Obstetrics and Gynecology
San Diego, California, United States, 92134-5000
Womens Health Specialists
West Hills, California, United States, 91307
United States, Colorado
Women's Associates, P.C.
Colorado Springs, Colorado, United States, 80903
Red Rocks OB/GYN - Physician's Research Options, LLC
Lakewood, Colorado, United States, 80228
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Palm Beach Obstetrics & Gynecology, PA (Altus Research)
Lake Worth, Florida, United States, 33407
Global OB/GYN Centers
Pembroke Pines, Florida, United States, 33024
United States, Georgia
New Millennium Obstetrics & Gynecology, LLc
Riverdale, Georgia, United States, 30274
United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Idaho
The Women's Clinic
Boise, Idaho, United States, 83712
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Women's Care Physicians/Obstetrical Specialists, PLLC
Louisville, Kentucky, United States, 40207
United States, Maryland
Steven Z. Lenowitz, MD, LLC
Bel Air, Maryland, United States, 21014
United States, Michigan
Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, United States, 49503
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States, 48604
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Triad Research Partners, LLC
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Mid Dakota clinicl, PC Center for Women
Bismarck, North Dakota, United States, 58501
United States, Ohio
HWC Women's Research Center
Englewood, Ohio, United States, 45322
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
SC Clinical Research Center, LLC
Columbia, South Carolina, United States, 29201
Greenville Hospital System University Medical Group
Greenville, South Carolina, United States, 29605
United States, Tennessee
Women's Physician's Group, MPLLC
Memphis, Tennessee, United States, 38104
United States, Texas
Practice Research Organization, Inc.
Dallas, Texas, United States, 75230
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78236
Research Associates Rio Grande Valley
McAllen, Texas, United States, 78503
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
Mt. Timpanogos Women's Health Care
Pleasant Grove, Utah, United States, 84062
Salt Lake Women's Center, P.C.
Sandy, Utah, United States, 84070
United States, Virginia
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
United States, Wisconsin
Wheaton Franciscan Healthcare - St. Joseph Campus
Milwaukee, Wisconsin, United States, 53210
Bulgaria
MHAT "Blagoevgrad", Department of obstetrics and Gynecology
Blagoevgrad, Bulgaria
Medical center "Teodora", LTD
Russe, Bulgaria
MHAT "Silistra", Obstetrics and Gynecology Department
Silistra, Bulgaria
"Medical institute of Interior ministry", Sofia city PLC, Department of Gynecology
Sofia, Bulgaria
Medical Centre "Avicena" Ltd
Sofia, Bulgaria
SHAT " Sheinovo ",PLS, Maternity Clinic
Sofia, Bulgaria
Canada, Alberta
University of Calgary - Foothills Hospital
Calgary, Alberta, Canada, AB T2N 2T9
Canada, British Columbia
Lion's Gate Hospital (University of BC)
North Vancouver, British Columbia, Canada, V7M 2H5
Canada, Ontario
Glazier Medical Centre
Oshawa, Ontario, Canada, L1H2J9
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Victory Reproductive Care
Windsor, Ontario, Canada, N8W 5R7
J. Leung Obstetrics and Gynaecology
Windsor, Ontario, Canada, N8X 3V6
Czechia
Fakultni nemocnice Brno
Brno, Jihomoravsky KRAJ, Czechia, 62500
Fakultni nemocnice Olomouc
Olomouc, Olomoucky KRAJ, Czechia, 77900
Nemocnice Ceske Budejovice, a.s. Gynekologicko-pordnicka klinika
Ceske Budejovice 7, Czechia, 37001
Fakultni nemocnice Hradec Kralove Porodnicka a gynekologicka klinika
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Ostrava Porodnicko-gynekologicka klinika
Ostrava-Poruba, Czechia, 70852
Fakultni nemocnice Pizen Gynekologicko-pordnicka klinika
Plzen-Lochotin, Czechia, 304 60
Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Szuleszeti es Nogyogyaszati Klinika
Debrecen, Hajdu-bihar, Hungary, 4032
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Szuleszet - Nogyogyaszat
Budapest, Hungary, 1097
Petz Aladar Megyei Oktato Korhaz, Szuleszet-Nogyogyaszat
Gyor, Hungary, 9024
Bacs-Kiskun Megyei Onkormanyzat Korhaza, Svegedi Tudmanyegyetem Altalanos Orvostudomanyi kar Oktato Korhaza
Kecskemet, Hungary, 6000
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Nyiregyhaza, Hungary, 4400
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
Szeged, Hungary, 6725
Italy
Azienda Ospedaliera di Perugia
Sant' Andrea Della Fratte, Perugia, Italy, 06132
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy, 40100
Azienda Ospedaliera di Bolzano Ospedale Generale Regionale di Bolzano
Bolzano, Italy, 39100
Russian Federation
Northern State Medical University
Arkhangelsk, Russian Federation, 163000
Northern State Medical University
Arkhangelsk, Russian Federation
Belgorod Regional Clinical Hospital of St.Ioasaf
Belgorod, Russian Federation
State Educational Institution of Higher Professional Education "Kazan State Medical University of RosZdrav"
Kazan, Russian Federation, 420012
Kemerovo State Medical Academy
Kemerovo, Russian Federation
State Educational Institution of Higher Professional Education "Krasnoyarsk State University named After Prof. V.F. Voino-Yasenetsky of Ministry of Health Russia" Department of Perinatology, Obstetrics and Gynecology of Medical Faculty
Krasnoyarsk, Russian Federation, 660100
State Educational Institution of Higher Professional Education "People's Friendship University of Russia" Department of Obstetrics and Gynecology with Course Perinatology
Moscow, Russian Federation, 117333
Russian National Research Medical University named after N.I. Pirogov
Moscow, Russian Federation
Municipal Healthcare Institution "Novosibirsk Municipal Perinatal Centre"
Novosibirsk, Russian Federation, 630089
Rostov Medical State University
Rostov-on-Don, Russian Federation, 344029
Almazov Federal Heart, Blood and Endocrinology Centre
Saint Petersburg, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg l.l Mechnikov State Medical Academy of RosZdrav" Department of Obstetrics, Gynecology and Perinatology
St. Petersburg, Russian Federation, 195257
State Institution "D.O. Otto Scientific Institute for Obstetrics and Gynecology"
St. Petersburg, Russian Federation, 199034
Regional Perinatal Center
Tomsk, Russian Federation
State Healthcare Institution "Regional Maternity Hospital"
Yaroslavl, Russian Federation, 150003
Federal State Institution "Ural Research Institute of Maternity and Infancy Care of Rosmedtechnologies"
Yekaterinburg, Russian Federation, 620028
Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Hospital Universitario Materno Infantil de Canarias
La Palmas De Gran Canarias, Spain, 35016
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital 12 de Octubre
Madrid, Spain
Hospital Virgen Del Rocio
Sevilla, Spain
Hospital Universitario La Fe
Valencia, Spain, 46009
"Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Ukraine
City Clinical Maternity Hospital #1
Chernivtsi, Ukraine
Donets'k Regional Centre of Mother and Child Care
Donets'k, Ukraine, 83114
Ivano-Frankivs'k Regional Prenatal Center, department of pregnant pathology
Ivano-Frankivs'k, Ukraine
<<Institute of Pediatrics, Obstetrics and Gynecology of AMS Ukraine>> Department of Rehabilitation and Reproduktive function of Women
Kyiv, Ukraine, 04050
Polyclinic #1, Obolon district of Kyiv, maternity welfare department
Kyiv, Ukraine, 04220
Kyiv City Centre of Reproduction and perinatal medicine, obstetric department
Kyiv, Ukraine
SI "Institute of pediatrics, obstetrics and gynecology of AMS of Ukraine". Department of extragenital pathology and postnatal rehabilitation
Kyiv, Ukraine
Municipal Institution "Maternity Hospital #1"
Odessa, Ukraine, 65039
Ternopil' Municipal Hospital # 2
Ternopil, Ukraine, 46001
Uzhgorod Municipal prenatal Centre, maternity welfare department #2
Uzhgorod, Ukraine, 88017
Clinical Maternity Hospital No 4
Zaporizhzhya, Ukraine, 69065
Department of Obstetrics and Gynecology of Zhaporizhzhya Medical Academy of Postgraduate Education on the Base of Healthcare Institution Maternity Hospital No 3
Zhaporizhzhya, Ukraine, 69071
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
ResearchPoint Global

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01004029     History of Changes
Other Study ID Numbers: 17P-ES-003
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by AMAG Pharmaceuticals, Inc.:
17P
hydroxyprogesterone caproate
preterm birth
progesterone
women with a singleton pregnancy aged 18 years or older with a history of a previous singleton spontaneous preterm delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones