17OHP-C Dosing Among Obese Pregnant Women

NCT03433040 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 00026055
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (1)

• Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks.

  Blood levels

  From enrollment to 36 weeks of pregnancy

Secondary Outcomes (1)

• Gestational Age at Delivery

  Up to 37 weeks

Study Arms (3)

non obese

OTHER

250mg 17 OHP-C

Drug: 17-Hydroxyprogesterone Capronate

obese - control

OTHER

250mg 17 OHP-C

Drug: 17-Hydroxyprogesterone Capronate

obese

EXPERIMENTAL

500mg 17 OHP-C

Drug: 17-Hydroxyprogesterone Capronate

Interventions

17-Hydroxyprogesterone Capronate DRUG

17-Hydroxyprogesterone Capronate 250mg versus 500mg

non obese; obese; obese - control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of South Florida: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

Location

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

17 alpha-Hydroxyprogesterone Caproate

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

17-alpha-Hydroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Wendy Duncan, QA/QI Research Compliance Manager
• Organization: University of South Florida

wduncan3@usf.edu

8139747454

Study Officials

• Anthony O Odibo, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Ultrasound and Fetal Therapy

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: February 14, 2018
• Study Start: August 23, 2017
• Primary Completion: June 1, 2021
• Study Completion: July 14, 2021
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)