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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

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE August 23, 2017
Estimated Primary Completion Date August 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03433040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Preterm birth <37, 34, 32, 28 weeks [ Time Frame: Up to 37 weeks ]
blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 17OHP-C Dosing Among Obese Pregnant Women
Official Title  ICMJE Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Premature Birth
  • Absorption; Chemicals
Intervention  ICMJE Drug: 17-Hydroxyprogesterone Capronate
17-Hydroxyprogesterone Capronate 250mg versus 500mg
Study Arms  ICMJE
  • non obese
    250mg 17 OHP-C
    Intervention: Drug: 17-Hydroxyprogesterone Capronate
  • obese - control
    250mg 17 OHP-C
    Intervention: Drug: 17-Hydroxyprogesterone Capronate
  • Experimental: obese
    500mg 17 OHP-C
    Intervention: Drug: 17-Hydroxyprogesterone Capronate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2018)
63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 23, 2020
Estimated Primary Completion Date August 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda Odibo, MN 813-259-0655 lodibo@health.usf.edu
Contact: Shannon Martin, BSN 314-362-8523 martins@wudosis.wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433040
Other Study ID Numbers  ICMJE 00026055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anthony Odibo, University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE Washington University School of Medicine
Investigators  ICMJE
Principal Investigator: Anthony O Odibo, MD University of South Florida
PRS Account University of South Florida
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP