Status:
COMPLETED
17OHP-C Dosing Among Obese Pregnant Women
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Premature Birth
Absorption; Chemicals
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief Summary
Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may he...
Detailed Description
Prospective three arm study of women with a prior spontaneous PTB. Non-obese women will receive the standard 250 mg weekly dose of 17 OHP-C while obese women will be randomly assigned to the standard ...
Eligibility Criteria
Inclusion
- \- Pregnant women, with a singleton gestation
- Ages 18 - 55
- Able to read and write in English and / or Spanish
- History of spontaneous PTB
- Obesity (≥ 30 kg / m2 ) vs non-obese groups (18 - 29.9 kg / m2 ) defined by first documented body mass index at an office visit
- Gestational age between 12 weeks, 0 days and 24 weeks, 6 days of gestation
- An ultrasound before 24 + 6 weeks gestation to confirm dating and to rule out major fetal anomalies
- Willing to have weekly injections at the physician's office
- The newborn will be enrolled on the mothers consent for chart review only
- https://register.clinicaltrials.gov/prs/html/definitions.html?popup=true#Eligibility
Exclusion
- \- Multifetal gestation
- Known fetal anomaly
- Current progesterone treatment
- Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
- Current or history of thrombosis or thromboembolic disorder
- Current anticoagulation
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- uncontrolled hypertension (controlled hypertension is eligible)
- A seizure disorder
- Current or planned cervical cerclage
- Plan to deliver elsewhere
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03433040
Start Date
August 23 2017
End Date
July 14 2021
Last Update
January 12 2022
Active Locations (2)
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1
University of South Florida
Tampa, Florida, United States, 33606
2
Washington University in St Louis
St Louis, Missouri, United States, 63110