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17OHP-C Dosing Among Obese Pregnant Women

NCT03433040 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-01-12

Study results available
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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.

Conditions

  • Premature Birth
  • Absorption; Chemicals

Interventions

DRUG

17-Hydroxyprogesterone Capronate

17-Hydroxyprogesterone Capronate 250mg versus 500mg

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of South Florida

    lead OTHER

Principal Investigators

  • Anthony O Odibo, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2021-06-01
Completion
2021-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433040 on ClinicalTrials.gov