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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,740

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Preterm Birth
Interventions
DRUG

Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL

1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.

DRUG

Vehicle

Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.

Trial Locations (104)

1097

Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Szuleszet - Nogyogyaszat, Budapest

4032

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Szuleszeti es Nogyogyaszati Klinika, Debrecen

4400

Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Nyíregyháza

6000

Bacs-Kiskun Megyei Onkormanyzat Korhaza, Svegedi Tudmanyegyetem Altalanos Orvostudomanyi kar Oktato Korhaza, Kecskemét

6725

Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika, Szeged

9024

Petz Aladar Megyei Oktato Korhaz, Szuleszet-Nogyogyaszat, Győr

11009

Hospital Universitario Puerta del Mar, Cadiz

19107

Thomas Jefferson University Hospital, Philadelphia

19140

Temple University School of Medicine, Philadelphia

21014

Steven Z. Lenowitz, MD, LLC, Bel Air

23708

Naval Medical Center - Portsmouth, Portsmouth

27103

Lyndhurst Clinical Research, Winston-Salem

Triad Research Partners, LLC, Winston-Salem

27705

Duke University Medical Center, Durham

28046

Hospital Universitario La Paz, Madrid

28310

Womack Army Medical Center, Fort Bragg

29201

SC Clinical Research Center, LLC, Columbia

29605

Greenville Hospital System University Medical Group, Greenville

30274

New Millennium Obstetrics & Gynecology, LLc, Riverdale

33024

Global OB/GYN Centers, Pembroke Pines

33407

Palm Beach Obstetrics & Gynecology, PA (Altus Research), Lake Worth

33472

Visions Clinical Research, Boynton Beach

35016

Hospital Universitario Materno Infantil de Canarias, Las Palmas de Gran Canaria

36106

Drug Research & Analysis Corporation, Montgomery

37001

Nemocnice Ceske Budejovice, a.s. Gynekologicko-pordnicka klinika, České Budějovice

38104

Women's Physician's Group, MPLLC, Memphis

39100

Azienda Ospedaliera di Bolzano Ospedale Generale Regionale di Bolzano, Bolzano

40100

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna

40202

University of Louisville, Louisville

40207

Women's Care Physicians/Obstetrical Specialists, PLLC, Louisville

45322

HWC Women's Research Center, Englewood

46001

Ternopil' Municipal Hospital # 2, Ternopil

46009

Hospital Universitario La Fe, Valencia

48604

Saginaw Valley Medical Research Group, LLC, Saginaw

49503

Female Pelvic Medicine and Urogynecology Institute of Michigan, Grand Rapids

50009

"Hospital Universitario Miguel Servet", Zaragoza

53210

Wheaton Franciscan Healthcare - St. Joseph Campus, Milwaukee

58501

Mid Dakota clinicl, PC Center for Women, Bismarck

62500

Fakultni nemocnice Brno, Brno

63110

Washington University School of Medicine, St Louis

65039

"Municipal Institution Maternity Hospital #1", Odesa

69065

Clinical Maternity Hospital No 4, Zaporizhzhya

69071

Department of Obstetrics and Gynecology of Zhaporizhzhya Medical Academy of Postgraduate Education on the Base of Healthcare Institution Maternity Hospital No 3, Zhaporizhzhya

70852

Fakultni nemocnice Ostrava Porodnicko-gynekologicka klinika, Ostrava-Poruba

75230

Practice Research Organization, Inc., Dallas

76544

Carl R. Darnall Army Medical Center, Fort Hood

77900

Fakultni nemocnice Olomouc, Olomouc

78236

San Antonio Military Medical Center, Fort Sam Houston

78503

Research Associates Rio Grande Valley, McAllen

80228

Red Rocks OB/GYN - Physician's Research Options, LLC, Lakewood

80903

Women's Associates, P.C., Colorado Springs

83114

Donets'k Regional Centre of Mother and Child Care, Donets'k

83404

Rosemark Women Care Specialists, Idaho Falls

83712

The Women's Clinic, Boise

84041

Tanner Clinic, Layton

84062

Mt. Timpanogos Women's Health Care, Pleasant Grove

84070

Salt Lake Women's Center, P.C., Sandy City

85712

Tucson Medical Center (Watching Over Mothers and Babies Foundation), Tucson

88017

Uzhgorod Municipal prenatal Centre, maternity welfare department #2, Uzhhorod

91307

Womens Health Specialists, West Hills

91942

Grossmont Center for Clinical Research, La Mesa

96859

Tripler Army Medical Center, Honolulu

98431

Madigan Army Medical Center, Tacoma

117333

"State Educational Institution of Higher Professional Education People's Friendship University of Russia Department of Obstetrics and Gynecology with Course Perinatology", Moscow

150003

"State Healthcare Institution Regional Maternity Hospital", Yaroslavl

163000

Northern State Medical University, Arkhangelsk

195257

"State Educational Institution of Higher Professional Education St. Petersburg l.l Mechnikov State Medical Academy of RosZdrav Department of Obstetrics, Gynecology and Perinatology", Saint Petersburg

199034

"State Institution D.O. Otto Scientific Institute for Obstetrics and Gynecology", Saint Petersburg

344029

Rostov Medical State University, Rostov-on-Don

420012

"State Educational Institution of Higher Professional Education Kazan State Medical University of RosZdrav", Kazan'

620028

"Federal State Institution Ural Research Institute of Maternity and Infancy Care of Rosmedtechnologies", Yekaterinburg

630089

"Municipal Healthcare Institution Novosibirsk Municipal Perinatal Centre", Novosibirsk

660100

"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

92134-5000

Naval Medical Center San Diego - Department of Obstetrics and Gynecology, San Diego

Unknown

"MHAT Blagoevgrad, Department of obstetrics and Gynecology", Blagoevgrad

"Medical center Teodora, LTD", Rousse

"MHAT Silistra, Obstetrics and Gynecology Department", Silistra

"Medical institute of Interior ministry, Sofia city PLC, Department of Gynecology", Sofia

"Medical Centre Avicena Ltd", Sofia

"SHAT Sheinovo ,PLS, Maternity Clinic", Sofia

Northern State Medical University, Arkhangelsk

Belgorod Regional Clinical Hospital of St.Ioasaf, Belgorod

Kemerovo State Medical Academy, Kemerovo

Russian National Research Medical University named after N.I. Pirogov, Moscow

Almazov Federal Heart, Blood and Endocrinology Centre, Saint Petersburg

Regional Perinatal Center, Tomsk

Hospital 12 de Octubre, Madrid

Hospital Virgen Del Rocio, Seville

City Clinical Maternity Hospital #1, Chernivtsi

Ivano-Frankivs'k Regional Prenatal Center, department of pregnant pathology, Ivano-Frankivsk

Kyiv City Centre of Reproduction and perinatal medicine, obstetric department, Kyiv

"SI Institute of pediatrics, obstetrics and gynecology of AMS of Ukraine. Department of extragenital pathology and postnatal rehabilitation", Kyiv

AB T2N 2T9

University of Calgary - Foothills Hospital, Calgary

V7M 2H5

Lion's Gate Hospital (University of BC), North Vancouver

L1H2J9

Glazier Medical Centre, Oshawa

K1H 8L6

The Ottawa Hospital, General Campus, Ottawa

N8W 5R7

Victory Reproductive Care, Windsor

N8X 3V6

J. Leung Obstetrics and Gynaecology, Windsor

500 05

Fakultni nemocnice Hradec Kralove Porodnicka a gynekologicka klinika, Hradec Králové

304 60

Fakultni nemocnice Pizen Gynekologicko-pordnicka klinika, Plzen-Lochotin

06132

Azienda Ospedaliera di Perugia - Ospedale Santa Maria dell a Misericordia, Perugia

08035

Hospital Universitari Vall D'Hebron, Barcelona

04050

<<Institute of Pediatrics, Obstetrics and Gynecology of AMS Ukraine>> Department of Rehabilitation and Reproduktive function of Women, Kyiv

04220

Polyclinic #1, Obolon district of Kyiv, maternity welfare department, Kyiv

Sponsors
All Listed Sponsors
collaborator

ResearchPoint Global

OTHER

lead

AMAG Pharmaceuticals, Inc.

INDUSTRY