The Impact of Vaginal and IM Progestins on the Cervix (NCT01954095) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Vaginal and IM Progestins on the Cervix
United States89 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
Exclusion Criteria
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: inabil…