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17OHP-C Dosing Among Obese Pregnant Women

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ClinicalTrials.gov Identifier: NCT03433040
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Anthony Odibo, University of South Florida

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.

Condition or disease Intervention/treatment Phase
Premature Birth Absorption; Chemicals Drug: 17-Hydroxyprogesterone Capronate Phase 3

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:

  1. Normal weight women on 250mg 17OHPC
  2. Obese women on 250mg 17OHPC
  3. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : August 23, 2020
Estimated Study Completion Date : August 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
non obese
250mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
17-Hydroxyprogesterone Capronate 250mg versus 500mg

obese - control
250mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
17-Hydroxyprogesterone Capronate 250mg versus 500mg

Experimental: obese
500mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
17-Hydroxyprogesterone Capronate 250mg versus 500mg




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Preterm birth <37, 34, 32, 28 weeks [ Time Frame: Up to 37 weeks ]
    blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • Hypertension requiring medication
  • A seizure disorder
  • Current or planned cervical cerclage
  • Plan to deliver elsewhere

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433040


Contacts
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Contact: Linda Odibo, MN 813-259-0655 lodibo@health.usf.edu
Contact: Shannon Martin, BSN 314-362-8523 martins@wudosis.wustl.edu

Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Linda Odibo, MN    813-259-0655    aodibo@health.usf.edu   
United States, Missouri
Washington University in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Shannon Martin, BSN    314-362-8523    martins@wudosis.wustl.edu   
Sponsors and Collaborators
University of South Florida
Washington University School of Medicine
Investigators
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Principal Investigator: Anthony O Odibo, MD University of South Florida

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Responsible Party: Anthony Odibo, Director Ultrasound and Fetal Therapy, University of South Florida
ClinicalTrials.gov Identifier: NCT03433040     History of Changes
Other Study ID Numbers: 00026055
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones