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 range

18 Years – 50 Years

Sex

FEMALE

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biomarkers

Timeframe: 2 Weeks

Trial details

NCT IDNCT01954095

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Preterm Birth trials