PREGNANT Short Cervix Trial

Phase 3

Completed

• Conditions: Preterm Delivery; Short Cervix; Short Uterine Cervical Length
• Interventions: Drug: placebo; Drug: progesterone

• Registration Number: NCT00615550
• Lead Sponsor: Juniper Pharmaceuticals, Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-14
• Study Start: 2008-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-02
• Results First Submitted: 2012-02-24
• Results First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Results First Posted: 2012-03-13
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 465

Inclusion Criteria

1. 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.
2. Singleton gestation.
3. The pregnancy has an estimated gestational age between 19 0/7 weeks and 23 6/7 weeks.
4. 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.
5. The subject speaks either English or a common local language.
6. 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.
7. 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.

Exclusion Criteria

1. The subject has a cervical length <10 or >20mm.
2. The subject has a multifetal gestation.
3. 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
4. Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
5. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
6. The subject has been treated with a progestogen within the previous 4 weeks.
7. 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).
8. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
9. The subject has active liver dysfunction or disease.
10. The subject has known or suspected malignancy of the breast or genital organs.
11. 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.
12. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
13. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
14. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.
15. 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.
16. 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.
17. Complete placenta previa.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo vaginal gel
Prochieve	progesterone	Progesterone 8% Vaginal Gel

Primary Outcome Measures

Name	Time	Method
Number of Participants With Birth <=32 6/7 Weeks Gestation.	9 to 13 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)	Delivery Hospitalization (1-212 days)	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
Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.	Gestational Age at Delivery	Number of participants at \<=27 6/7 , \<=34 6/7, and \<36 6/7.
Number of Neonates Who Died.	Delivery to 28 days
Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams	date of delivery	Assessment of birth weight \< 1500 grams or \< 2500 grams

Trial Locations

Locations (49)

Johns Hopkins Community Physicians; 🇺🇸 Baltimore, Maryland, United States

University of Miami Leonard Miller School of Medicine Department of Obstetrics and Gynecology; 🇺🇸 Miami, Florida, United States

Caritas St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Thomas Jefferson University Hospital OB/GYN / Maternal Fetal Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Louis University Health Sciences Center; 🇺🇸 St. Louis, Missouri, United States

Sri Ramchandra Medical College and Research Institute; 🇮🇳 Porur, Tamil Nadu, India

St. Joseph's Hospital and Med Ctr Women's Care Center; 🇺🇸 Phoenix, Arizona, United States

Perinatology Research Branch Hutzel Women's Hospital; 🇺🇸 Detroit, Michigan, United States

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Escuela De Medicina, Pontificia Universidad Catolica De Chile; 🇨🇱 Santiago, Chile

Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel

Spectrum Health Research Department; 🇺🇸 Grand Rapids, Michigan, United States

Charleston Area Medical Center Clinical Trials Center; 🇺🇸 Charleston, West Virginia, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Henry Ford Healthcare System; 🇺🇸 Detroit, Michigan, United States

1st Clinical Hospital of the City of Minsk; 🇧🇾 Minsk, Belarus

Public Health Services Establishment "Vitebsk City Clinical Hospital of First Aid"; 🇧🇾 Vitebsk, Belarus

Regional Obstetrical Consultants, Knoxville; 🇺🇸 Knoxville, Tennessee, United States

MediCiti Institute of Medical Sciences; 🇮🇳 Andhra Pradesh, India

Saint Petersburg State Healthcare Institution Maternity Hospital 17; 🇷🇺 Saint Petersburg, Russian Federation

Department of Obstetrics and Gynecology of Dnepropetrovsk State Medical Academy, Municipal establishment "City Maternity Hospital # 1"; 🇺🇦 Dnepropetrovsk, Ukraine

Charles University & General Teaching Hospital; 🇨🇿 Prague, Czech Republic

Government Medical College; 🇮🇳 Nagpur, India

Limited Liability Company "American Health Clinic"; 🇷🇺 Saint Petersburg, Russian Federation

BJ Medical College & Sassoon Hospital; 🇮🇳 Pune, Maharashtra, India

Sheth L.G. Hospital; 🇮🇳 Ahmedabad, India

Municipal clinical hospital #1; 🇺🇦 Kiev, Ukraine

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

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

Azienda Ospedaliera di Padova Centro Prenatale Divisione di Ostetricia; 🇮🇹 Padova, Italy

Municipal health care establishment "City Maternity Clinical Hospital"; 🇺🇦 Chernovtsy, Ukraine

UCI Medical Center; 🇺🇸 Orange, California, United States

Steve Biko Academic Hospital Dept. of OB-GYN and Maternal Fetal Medicine; 🇿🇦 Pretoria, South Africa

Albert Einstein Hospital; 🇺🇸 Bronx, New York, United States

Maternidad Hospital DR Sotero Del Rio; 🇨🇱 Santiago, Chile

Antenatal Clinic # 1, Central Polyclinics of Pechersk District; 🇺🇦 Kyiv, Ukraine

University of South Alabama Dept. of OB/GYN; 🇺🇸 Mobile, Alabama, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Kapi'olani Medical Center for Women and Children; 🇺🇸 Honolulu, Hawaii, United States

Perinatal Diagnostic Center; 🇺🇸 Lexington, Kentucky, United States

Perinatal Center of Iowa; 🇺🇸 Des Moines, Iowa, United States

Washington University School of Medicine, Dept. of OB/GYN; 🇺🇸 St. Louis, Missouri, United States

St. Joseph Mercy-Oakland; 🇺🇸 Pontiac, Michigan, United States

Winthrop University Hosital; 🇺🇸 Mineola, New York, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

UPHS Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Regional Obstetrical Consultants, Chattanooga; 🇺🇸 Chattanooga, Tennessee, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States