- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433040
17OHP-C Dosing Among Obese Pregnant Women
Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
Study Overview
Status
Conditions
Intervention / Treatment
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 (250 mg) or higher dose (500 mg). The resulting three groups will consist of:
- Normal weight women on 250mg 17OHPC
- Obese women on 250mg 17OHPC
- Obese women on 500mg of 17OHPC
Initial Enrollment: Pregnant patients receiving prenatal care at one of the USF affiliated sites or Washington University in St. Louis sites who report a history of a PTB will be approached by the research nurse. The research nurse will explain the study, review inclusion/exclusion criteria with the patient, and invite interested potential study candidates to sign a medical records release so that records from the previous PTB can be reviewed. If the medical records confirm the birth of a previous PTB was of a live born singleton gestation between the gestational ages of 20 weeks and 36 weeks and 6 days then the patient will be invited to participate in the study. At that time the informed consent form will be thoroughly reviewed with the patient, and if the patient desires to enroll, the patient will provide informed consent to enroll in the study. Consecutive women with normal BMI or obese women meeting the inclusion criteria will be approached to avoid selection bias.
Randomization: will occur at the time of enrollment. The randomization will be computer generated. Randomization envelopes indicating the randomization arm will be prepared ahead of time and the next consecutive envelope will be used at time of enrollment.
Pharmacokinetic studies: Sampling schedule in order to investigate the pharmacokinetics of 250 mg 17OHP-C weekly as compared to 500 mg 17OHP-C weekly in obese women as well as 250 mg in non-obese women will be performed as follows:
- Using principles described by Caritis et al., four completed weeks of 17OHP-C therapy is required prior to sampling anticipating that steady state will be achieved by this time point.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33606
- University of South Florida
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University in St Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: non obese
250mg 17 OHP-C
|
17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
OTHER: obese - control
250mg 17 OHP-C
|
17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
EXPERIMENTAL: obese
500mg 17 OHP-C
|
17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks.
Time Frame: From enrollment to 36 weeks of pregnancy
|
Blood levels
|
From enrollment to 36 weeks of pregnancy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational Age at Delivery
Time Frame: Up to 37 weeks
|
Gestational age at delivery in weeks .
Too few to dichotomize to <37, 34 and 32 weeks as previously planned.
|
Up to 37 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony O Odibo, MD, University of South Florida
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Progestins
- 17 alpha-Hydroxyprogesterone Caproate
- 11-hydroxyprogesterone
Other Study ID Numbers
- 00026055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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