Phase 3
N=44
17OHP-C Dosing Among Obese Pregnant Women
Premature Birth · Absorption; Chemicals
Bottom Line
View on ClinicalTrials.gov: NCT03433040 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks. — 10.1; 13.0; 18.0; 11.5 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 17-Hydroxyprogesterone Capronate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of South Florida
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks. |
10.1; 13.0; 18.0; 11.5; 8.1; 17.9 | — |
| SECONDARY Gestational Age at Delivery |
36.7; 38.4; 32.2 | — |
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 help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
Eligibility Criteria
Inclusion Criteria
- - 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 Criteria
- - 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
Data sourced from ClinicalTrials.gov (NCT03433040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.