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Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery (PROLONG)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL
Vehicle
Sponsored by
AMAG Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring 17P, 17-HPC, 17-OHPC, 17-hydroxyprogesterone caproate, progestogens, preterm birth, recurrent preterm birth, spontaneous preterm birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Drug Research & Analysis Corporation
  • Tucson Medical Center (Watching Over Mothers and Babies Foundation)
  • Grossmont Center for Clinical Research
  • Naval Medical Center San Diego - Department of Obstetrics and Gynecology
  • Womens Health Specialists
  • Women's Associates, P.C.
  • Red Rocks OB/GYN - Physician's Research Options, LLC
  • Visions Clinical Research
  • Palm Beach Obstetrics & Gynecology, PA (Altus Research)
  • Global OB/GYN Centers
  • New Millennium Obstetrics & Gynecology, LLc
  • Tripler Army Medical Center
  • The Women's Clinic
  • Rosemark Women Care Specialists
  • University of Louisville
  • Women's Care Physicians/Obstetrical Specialists, PLLC
  • Steven Z. Lenowitz, MD, LLC
  • Female Pelvic Medicine and Urogynecology Institute of Michigan
  • Saginaw Valley Medical Research Group, LLC
  • Washington University School of Medicine
  • Duke University Medical Center
  • Womack Army Medical Center
  • Lyndhurst Clinical Research
  • Triad Research Partners, LLC
  • Mid Dakota clinicl, PC Center for Women
  • HWC Women's Research Center
  • Thomas Jefferson University Hospital
  • Temple University School of Medicine
  • SC Clinical Research Center, LLC
  • Greenville Hospital System University Medical Group
  • Women's Physician's Group, MPLLC
  • Practice Research Organization, Inc.
  • Carl R. Darnall Army Medical Center
  • San Antonio Military Medical Center
  • Research Associates Rio Grande Valley
  • Tanner Clinic
  • Mt. Timpanogos Women's Health Care
  • Salt Lake Women's Center, P.C.
  • Naval Medical Center - Portsmouth
  • Madigan Army Medical Center
  • Wheaton Franciscan Healthcare - St. Joseph Campus
  • MHAT "Blagoevgrad", Department of obstetrics and Gynecology
  • Medical center "Teodora", LTD
  • MHAT "Silistra", Obstetrics and Gynecology Department
  • "Medical institute of Interior ministry", Sofia city PLC, Department of Gynecology
  • Medical Centre "Avicena" Ltd
  • SHAT " Sheinovo ",PLS, Maternity Clinic
  • University of Calgary - Foothills Hospital
  • Lion's Gate Hospital (University of BC)
  • Glazier Medical Centre
  • The Ottawa Hospital, General Campus
  • Victory Reproductive Care
  • J. Leung Obstetrics and Gynaecology
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Olomouc
  • Nemocnice Ceske Budejovice, a.s. Gynekologicko-pordnicka klinika
  • Fakultni nemocnice Hradec Kralove Porodnicka a gynekologicka klinika
  • Fakultni nemocnice Ostrava Porodnicko-gynekologicka klinika
  • Fakultni nemocnice Pizen Gynekologicko-pordnicka klinika
  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Szuleszeti es Nogyogyaszati Klinika
  • Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Szuleszet - Nogyogyaszat
  • Petz Aladar Megyei Oktato Korhaz, Szuleszet-Nogyogyaszat
  • Bacs-Kiskun Megyei Onkormanyzat Korhaza, Svegedi Tudmanyegyetem Altalanos Orvostudomanyi kar Oktato Korhaza
  • Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
  • Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • Azienda Ospedaliera di Bolzano Ospedale Generale Regionale di Bolzano
  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria dell a Misericordia
  • Northern State Medical University
  • Northern State Medical University
  • Belgorod Regional Clinical Hospital of St.Ioasaf
  • State Educational Institution of Higher Professional Education "Kazan State Medical University of RosZdrav"
  • Kemerovo State Medical Academy
  • 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
  • State Educational Institution of Higher Professional Education "People's Friendship University of Russia" Department of Obstetrics and Gynecology with Course Perinatology
  • Russian National Research Medical University named after N.I. Pirogov
  • Municipal Healthcare Institution "Novosibirsk Municipal Perinatal Centre"
  • Rostov Medical State University
  • Almazov Federal Heart, Blood and Endocrinology Centre
  • State Educational Institution of Higher Professional Education "St. Petersburg l.l Mechnikov State Medical Academy of RosZdrav" Department of Obstetrics, Gynecology and Perinatology
  • State Institution "D.O. Otto Scientific Institute for Obstetrics and Gynecology"
  • Regional Perinatal Center
  • State Healthcare Institution "Regional Maternity Hospital"
  • Federal State Institution "Ural Research Institute of Maternity and Infancy Care of Rosmedtechnologies"
  • Hospital Universitari Vall D'Hebron
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario Materno Infantil de Canarias
  • Hospital Universitario La Paz
  • Hospital 12 de Octubre
  • Hospital Virgen Del Rocio
  • Hospital Universitario La Fe
  • "Hospital Universitario Miguel Servet
  • City Clinical Maternity Hospital #1
  • Donets'k Regional Centre of Mother and Child Care
  • Ivano-Frankivs'k Regional Prenatal Center, department of pregnant pathology
  • <<Institute of Pediatrics, Obstetrics and Gynecology of AMS Ukraine>> Department of Rehabilitation and Reproduktive function of Women
  • Polyclinic #1, Obolon district of Kyiv, maternity welfare department
  • Kyiv City Centre of Reproduction and perinatal medicine, obstetric department
  • SI "Institute of pediatrics, obstetrics and gynecology of AMS of Ukraine". Department of extragenital pathology and postnatal rehabilitation
  • Municipal Institution "Maternity Hospital #1"
  • Ternopil' Municipal Hospital # 2
  • Uzhgorod Municipal prenatal Centre, maternity welfare department #2
  • Clinical Maternity Hospital No 4
  • Department of Obstetrics and Gynecology of Zhaporizhzhya Medical Academy of Postgraduate Education on the Base of Healthcare Institution Maternity Hospital No 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Vehicle

Hydroxyprogesterone Caproate Injection (HPC), 250 mg/mL

Arm Description

Castor Oil

HPC 250 mg/mL in oil

Outcomes

Primary Outcome Measures

Preterm Birth <35 Weeks Gestation
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.
Neonatal Composite Index (NCI)
The composite index is defined as a liveborn neonate with any of the following occurring at any time during the birth hospitalization up through discharge from the NICU: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis or proven sepsis.

Secondary Outcome Measures

Fetal/Early Infant Death
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
Preterm Birth Prior to 32 Weeks Gestation
Preterm Birth Prior to 37 Weeks Gestation
Stillbirths
Defined as all stillbirths/fetal deaths/in utero fetal losses occurring from 20 weeks gestation until term.
Neonatal Deaths With ≥24 Weeks Gestational Age
Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater

Full Information

First Posted
October 27, 2009
Last Updated
May 10, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
Collaborators
ResearchPoint Global
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1. Study Identification

Unique Protocol Identification Number
NCT01004029
Brief Title
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
Acronym
PROLONG
Official Title
A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
Collaborators
ResearchPoint Global

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
One of the most significant risk factors for preterm birth is previous pregnancy history. Women who have had a prior preterm birth have a 2.5-fold greater risk than women with no prior history of preterm birth. Prophylactic methods for prevention of preterm birth, including tocolytic drugs, bed rest, and other interventions such as cerclage, have been shown in most studies to be ineffective. One of the preventive measures that has shown effectiveness in randomized trials is the use of progesterone agents.9,10 Progesterone has been shown to support gestation and to inhibit uterine activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
17P, 17-HPC, 17-OHPC, 17-hydroxyprogesterone caproate, progestogens, preterm birth, recurrent preterm birth, spontaneous preterm birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1740 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Castor Oil
Arm Title
Hydroxyprogesterone Caproate Injection (HPC), 250 mg/mL
Arm Type
Active Comparator
Arm Description
HPC 250 mg/mL in oil
Intervention Type
Drug
Intervention Name(s)
Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL
Other Intervention Name(s)
Makena, 17P
Intervention Description
1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Primary Outcome Measure Information:
Title
Preterm Birth <35 Weeks Gestation
Description
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
Up to 35 weeks
Title
Neonatal Composite Index (NCI)
Description
The composite index is defined as a liveborn neonate with any of the following occurring at any time during the birth hospitalization up through discharge from the NICU: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis or proven sepsis.
Time Frame
Until 28 days of life or discharge from the neonatal intensive care unit (NICU), whichever occurred later.
Secondary Outcome Measure Information:
Title
Fetal/Early Infant Death
Description
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
Time Frame
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).
Title
Preterm Birth Prior to 32 Weeks Gestation
Time Frame
Up to 32 weeks
Title
Preterm Birth Prior to 37 Weeks Gestation
Time Frame
Up to 37 weeks
Title
Stillbirths
Description
Defined as all stillbirths/fetal deaths/in utero fetal losses occurring from 20 weeks gestation until term.
Time Frame
20 weeks gestation until term
Title
Neonatal Deaths With ≥24 Weeks Gestational Age
Description
Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater
Time Frame
Until 28 days of life or discharge from the NICU whichever occurred later.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study: Age ≥ 18 years. Singleton gestation. 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. 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: Multifetal gestation. 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. 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. Heparin therapy during current pregnancy or history of thromboembolic disease. Maternal medical/obstetrical complications including: Current or planned cerclage Hypertension requiring medication Seizure disorder Subjects with a uterine anomaly (uterine didelphys or bicornate uterus). However, subjects with uterine fibroids are eligible for the study. Unwillingness to comply with and complete the study. A 14 weeks 0 days through 20 weeks 3 days of gestation ultrasound cannot be arranged before randomization. Participation in an antenatal study in which the clinical status or intervention may influence gestational age at delivery. 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. Known hypersensitivity to hydroxyprogesterone caproate or its components. 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. 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.
Facility Information:
Facility Name
Drug Research & Analysis Corporation
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Tucson Medical Center (Watching Over Mothers and Babies Foundation)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Naval Medical Center San Diego - Department of Obstetrics and Gynecology
City
San Diego
State/Province
California
ZIP/Postal Code
92134-5000
Country
United States
Facility Name
Womens Health Specialists
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Women's Associates, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80903
Country
United States
Facility Name
Red Rocks OB/GYN - Physician's Research Options, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Palm Beach Obstetrics & Gynecology, PA (Altus Research)
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Global OB/GYN Centers
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
New Millennium Obstetrics & Gynecology, LLc
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
The Women's Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Women's Care Physicians/Obstetrical Specialists, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Steven Z. Lenowitz, MD, LLC
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Facility Name
Female Pelvic Medicine and Urogynecology Institute of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Saginaw Valley Medical Research Group, LLC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Triad Research Partners, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Mid Dakota clinicl, PC Center for Women
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Greenville Hospital System University Medical Group
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Women's Physician's Group, MPLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Practice Research Organization, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Carl R. Darnall Army Medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Research Associates Rio Grande Valley
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Mt. Timpanogos Women's Health Care
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Salt Lake Women's Center, P.C.
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Wheaton Franciscan Healthcare - St. Joseph Campus
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Facility Name
MHAT "Blagoevgrad", Department of obstetrics and Gynecology
City
Blagoevgrad
Country
Bulgaria
Facility Name
Medical center "Teodora", LTD
City
Russe
Country
Bulgaria
Facility Name
MHAT "Silistra", Obstetrics and Gynecology Department
City
Silistra
Country
Bulgaria
Facility Name
"Medical institute of Interior ministry", Sofia city PLC, Department of Gynecology
City
Sofia
Country
Bulgaria
Facility Name
Medical Centre "Avicena" Ltd
City
Sofia
Country
Bulgaria
Facility Name
SHAT " Sheinovo ",PLS, Maternity Clinic
City
Sofia
Country
Bulgaria
Facility Name
University of Calgary - Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
AB T2N 2T9
Country
Canada
Facility Name
Lion's Gate Hospital (University of BC)
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 2H5
Country
Canada
Facility Name
Glazier Medical Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H2J9
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Victory Reproductive Care
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5R7
Country
Canada
Facility Name
J. Leung Obstetrics and Gynaecology
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
State/Province
Jihomoravsky KRAJ
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucky KRAJ
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice, a.s. Gynekologicko-pordnicka klinika
City
Ceske Budejovice 7
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove Porodnicka a gynekologicka klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava Porodnicko-gynekologicka klinika
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni nemocnice Pizen Gynekologicko-pordnicka klinika
City
Plzen-Lochotin
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Szuleszeti es Nogyogyaszati Klinika
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Szuleszet - Nogyogyaszat
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, Szuleszet-Nogyogyaszat
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Onkormanyzat Korhaza, Svegedi Tudmanyegyetem Altalanos Orvostudomanyi kar Oktato Korhaza
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Azienda Ospedaliera di Bolzano Ospedale Generale Regionale di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia - Ospedale Santa Maria dell a Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Northern State Medical University
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Northern State Medical University
City
Arkhangelsk
Country
Russian Federation
Facility Name
Belgorod Regional Clinical Hospital of St.Ioasaf
City
Belgorod
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Kazan State Medical University of RosZdrav"
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Kemerovo State Medical Academy
City
Kemerovo
Country
Russian Federation
Facility Name
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
City
Krasnoyarsk
ZIP/Postal Code
660100
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "People's Friendship University of Russia" Department of Obstetrics and Gynecology with Course Perinatology
City
Moscow
ZIP/Postal Code
117333
Country
Russian Federation
Facility Name
Russian National Research Medical University named after N.I. Pirogov
City
Moscow
Country
Russian Federation
Facility Name
Municipal Healthcare Institution "Novosibirsk Municipal Perinatal Centre"
City
Novosibirsk
ZIP/Postal Code
630089
Country
Russian Federation
Facility Name
Rostov Medical State University
City
Rostov-on-Don
ZIP/Postal Code
344029
Country
Russian Federation
Facility Name
Almazov Federal Heart, Blood and Endocrinology Centre
City
Saint Petersburg
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "St. Petersburg l.l Mechnikov State Medical Academy of RosZdrav" Department of Obstetrics, Gynecology and Perinatology
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
State Institution "D.O. Otto Scientific Institute for Obstetrics and Gynecology"
City
St. Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Regional Perinatal Center
City
Tomsk
Country
Russian Federation
Facility Name
State Healthcare Institution "Regional Maternity Hospital"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Federal State Institution "Ural Research Institute of Maternity and Infancy Care of Rosmedtechnologies"
City
Yekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario Materno Infantil de Canarias
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Virgen Del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
"Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
City Clinical Maternity Hospital #1
City
Chernivtsi
Country
Ukraine
Facility Name
Donets'k Regional Centre of Mother and Child Care
City
Donets'k
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Ivano-Frankivs'k Regional Prenatal Center, department of pregnant pathology
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
<<Institute of Pediatrics, Obstetrics and Gynecology of AMS Ukraine>> Department of Rehabilitation and Reproduktive function of Women
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Polyclinic #1, Obolon district of Kyiv, maternity welfare department
City
Kyiv
ZIP/Postal Code
04220
Country
Ukraine
Facility Name
Kyiv City Centre of Reproduction and perinatal medicine, obstetric department
City
Kyiv
Country
Ukraine
Facility Name
SI "Institute of pediatrics, obstetrics and gynecology of AMS of Ukraine". Department of extragenital pathology and postnatal rehabilitation
City
Kyiv
Country
Ukraine
Facility Name
Municipal Institution "Maternity Hospital #1"
City
Odessa
ZIP/Postal Code
65039
Country
Ukraine
Facility Name
Ternopil' Municipal Hospital # 2
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Uzhgorod Municipal prenatal Centre, maternity welfare department #2
City
Uzhgorod
ZIP/Postal Code
88017
Country
Ukraine
Facility Name
Clinical Maternity Hospital No 4
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Department of Obstetrics and Gynecology of Zhaporizhzhya Medical Academy of Postgraduate Education on the Base of Healthcare Institution Maternity Hospital No 3
City
Zhaporizhzhya
ZIP/Postal Code
69071
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
31652479
Citation
Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, Chauhan SP, Hughes BL, Louis JM, Manuck TA, Miller HS, Das AF, Saade GR, Nielsen P, Baker J, Yuzko OM, Reznichenko GI, Reznichenko NY, Pekarev O, Tatarova N, Gudeman J, Birch R, Jozwiakowski MJ, Duncan M, Williams L, Krop J. 17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial. Am J Perinatol. 2020 Jan;37(2):127-136. doi: 10.1055/s-0039-3400227. Epub 2019 Oct 25.
Results Reference
derived

Learn more about this trial

Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery

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