The Impact of Vaginal and IM Progestins on the Cervix

NCT01954095 | Completed DMC

• 1 other identifier: OPRU Progestin
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to analyze how the body handles and responds to progesterone treatment in parous and nulliparous women at risk of pre-term birth.

Conditions

Preterm Birth; Short Cervical Length

Keywords

17-OHPC, Prometrium, Cerclage, Pre-term birth, Short cervix

Outcome Measures

Primary Outcomes (1)

• Biomarkers

  Proteins in the cervicovaginal fluid with expression changes two-fold or greater between day 0 and week 2 of either vaginal or IM progestin therapy.

  2 Weeks

Secondary Outcomes (7)

• Cervical sonographic changes

  8 Weeks

• Protein Expression

  8 Weeks

• Cervical cytokines

  8 Weeks

• Individual cytokines

  8 Weeks

• Cervical MMPs

  8 Weeks

Study Arms (4)

Group 1: No prior preterm birth & normal cervix length

Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had one or more term births (no prior preterm births) and have a normal cervical length (\> 25 mm). These women will serve as gestational age controls for all groups.

Group 2: No prior preterm birth & short cervix length

Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have no prior preterm births and have a short cervical length (20mm or less). These women may receive treatment (e.g. vaginal progesterone, cerclage, pessary, NSAIDs, or a combination thereof) or no treatment.

Group 3: Prior preterm birth, normal cervix length, 17-OHPC

Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length and will receive 17-OHPC treatment.

Group 4: Prior preterm birth, normal cervix length, no treat

Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length, and will not receive any treatment. These women will serve as controls for Group 3.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study consists of 4 groups of women who are between 16 0/7 - 23 6/7 weeks gestation. The allocation of a subject to a group is based on two objective assessments (history of preterm birth and cervical length) and the joint clinical decision of the woman and her physician regarding treatment options. Study participants who have no prior preterm births and a normal cervical length will be assigned to Group 1. If the participant has no prior preterm births and a short cervical length, she will be assigned to Group 2 regardless of treatment or no treatment. Group assignment for women with a prior preterm birth and normal cervical length is based on 17-OHPC use. Participants who elect to use 17-OHPC will be assigned to Group 3 and those who choose not to receive any treatment will be assigned to Group 4.

You may qualify if:

• All Groups
• Singleton gestation (16 0/7 - 23 6/7 weeks gestation)
• Willing to provide informed consent
• Age 18 - 50 years inclusive
• Additionally,
• Group 1: One or more prior term births (\>37 0/7 weeks); No prior spontaneous birth at 16 0/7 - 36 6/7 weeks; and normal cervical length (\>25 mm)
• Group 2: Cervical length of 20 mm or less at 16 0/7 - 23 6/7 weeks
• Groups 3 and 4: History of prior spontaneous birth at 16 0/7 - 34 0/7 weeks and normal cervical length (\> 25mm) at enrollment.

You may not qualify if:

• All Groups
• Active labor
• Active bleeding
• On progestin therapy, chronic steroid, or current NSAID therapy
• Actively receiving study treatment in another clinical trial (observational trials allowed)
• Major fetal malformation lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, or serious karyotypic abnormalities
• Amniotic membranes prolapsed beyond the external os (ostium of uterus) or protruding into the vagina
• Pregnancy without a viable fetus
• Prenatal care or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)
• Additionally:
• Group 1: Cervical dilation greater than or equal to 3cm
• Group 2: Prior preterm birth (16 0/7 - 34 0/7); active deep vein thrombosis, pulmonary embolism, or history of these conditions; known liver dysfunction or disease (active hepatitis, HIV)
• Group 3: inability or unwillingness to use a 17-OHPC compounded product similar in composition to the FDA-approved product; allergy to 17-OHPC or its components
• Groups 1, 3, and 4: cerclage in place or anticipated; congenital mullerian abnormality of the uterus; positive for bacterial vaginosis, chlamydia, gonorrhea, or trichomonas
• Groups 3 and 4: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy, liver tumors, benign or malignant, or active liver disease; uncontrolled hypertension

Sponsors & Collaborators

• University of Pittsburgh: lead
• Indiana University: collaborator
• University of Texas: collaborator
• University of Washington: collaborator
• RTI International: collaborator

Study Sites (4)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for DNA extraction, hormone, and metabolomic analyses Cervicovaginal fluid for proteome, cytokines, and matrix metalloproteins (MMPs)

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mary F Hebert, PharmD, FCCP

  University of Washington

  PRINCIPAL INVESTIGATOR

• Steve Caritis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Gary Hankins, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• David Flockhart, MD, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

US (4)