The Impact of Vaginal and IM Progestins on the Cervix

Completed

Conditions studied: Preterm Birth, Short Cervical Length

In brief

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.

Key facts

Study ID

NCT01954095

Run by

University of Pittsburgh

People needed

89

Starts

2013-08-01

Expected to finish

2015-03-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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