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



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2009
End Date:December 2018

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
42
sites
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
?
mi
from
Englewood, OH
Click here to add this to my saved trials
620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
?
mi
from
Portsmouth, VA
Click here to add this to my saved trials
Bel Air, Maryland 21014
?
mi
from
Bel Air, MD
Click here to add this to my saved trials
Bismarck, North Dakota 58501
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
Blagoevgrad,
Phone: +00359 888 546 669
?
mi
from
Blagoevgrad,
Click here to add this to my saved trials
Boise, Idaho 83712
Phone: 208-947-9816
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80903
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, South Carolina 29201
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fort Bragg, North Carolina
?
mi
from
Fort Bragg, NC
Click here to add this to my saved trials
Fort Hood, Texas 76544
?
mi
from
Fort Hood, TX
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29605
Phone: 864-455-1600
?
mi
from
Greenville, SC
Click here to add this to my saved trials
1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Phone: 208-557-2900
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-561-7447
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Memphis, Tennessee 38104
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Milwaukee, Wisconsin 53210
Phone: 414-259-7480
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Montgomery, Alabama 36106
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
Pembroke Pines, Florida 33323
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19140
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pleasant Grove, Utah 84062
?
mi
from
Pleasant Grove, UT
Click here to add this to my saved trials
?
mi
from
Riverdale, GA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy, Utah 84070
?
mi
from
Sandy, UT
Click here to add this to my saved trials
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Phone: 253-968-3920
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Hills, California 91307
?
mi
from
West Hills, CA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
1950 South Hawthorne Road
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials