The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]

Juniper Pharmaceuticals, Inc.49 sites in 10 countries465 target enrollmentMarch 2008

ConditionsPreterm Delivery Short Cervix Short Uterine Cervical Length

Interventionsplacebo progesterone

Drugsprogesterone placebo

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Preterm Delivery
Sponsor: Juniper Pharmaceuticals, Inc.
Enrollment: 465
Locations: 49
Primary Endpoint: Number of Participants With Birth <=32 6/7 Weeks Gestation.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

November 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Juniper Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

•The subject has a cervical length \<10 or \>20mm.
•The subject has a multifetal gestation.
•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
•Subjects diagnosed to have acute cervical insufficiency with bulging membranes passing the external os.
•The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
•The subject has been treated with a progestogen within the previous 4 weeks.
•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).
•The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
•The subject has active liver dysfunction or disease.
•The subject has known or suspected malignancy of the breast or genital organs.

Arms & Interventions

Placebo

placebo vaginal gel

Intervention: placebo

Prochieve

Progesterone 8% Vaginal Gel

Intervention: progesterone

Outcomes

Primary Outcomes

Number of Participants With Birth <=32 6/7 Weeks Gestation.

Time Frame: 9 to 13 weeks

Secondary Outcomes

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))
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 Neonates Who Died.(Delivery to 28 days)
Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams(date of delivery)