Premature BirthPhase 3NCT03433040
17OHP-C Dosing Among Obese Pregnant Women
A Phase 3 study testing 17-Hydroxyprogesterone Capronate in people with Premature Birth and Absorption; Chemicals, run by University of South Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Premature Birth, Absorption; Chemicals
- What is being tested?
- 17-Hydroxyprogesterone Capronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2017to 14 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - 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
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- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University in St Louis
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
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.
Read the 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.
- Conditions
- Premature Birth, Absorption; Chemicals
- Being tested
- 17-Hydroxyprogesterone Capronate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-Hydroxyprogesterone CapronateDrug
17-Hydroxyprogesterone Capronate 250mg versus 500mg
| Study group | Role | What they receive |
|---|---|---|
| non obese | Other | 250mg 17 OHP-C Receives: Drug: 17-Hydroxyprogesterone Capronate |
| obese - control | Other | 250mg 17 OHP-C Receives: Drug: 17-Hydroxyprogesterone Capronate |
| obese | Experimental | 500mg 17 OHP-C Receives: Drug: 17-Hydroxyprogesterone Capronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 36 weeks of pregnancy
Secondary outcomes (1)
Gestational Age at Delivery
Gestational age at delivery in weeks . Too few to dichotomize to <37, 34 and 32 weeks as previously planned.
Measured: Up to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Aug 2017
- Primary completion1 Jun 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Anthony Odibo MD, University of South Florida
- Investigators
- Anthony O Odibo, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433040
- Sponsor's protocol ID
- 00026055
- Status last verified
- Nov 2021
- First submitted
- 28 Aug 2017
- Last updated
- 12 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
- ClinicalTrials.gov ID
- NCT03433040
- Acronym / sponsor ID
- 00026055
- Conditions
- Premature Birth, Absorption; Chemicals
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non obese | Other | Drug: 17-Hydroxyprogesterone Capronate250mg 17 OHP-C |
| obese - control | Other | Drug: 17-Hydroxyprogesterone Capronate250mg 17 OHP-C |
| obese | Experimental | Drug: 17-Hydroxyprogesterone Capronate500mg 17 OHP-C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- - 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
Key exclusion criteria (13 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17-Hydroxyprogesterone Capronate17-Hydroxyprogesterone Capronate 250mg versus 500mg | Drug | non obese, obese, obese - control |
Primary outcome
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
1 secondary outcome
Gestational Age at Delivery
Time frame: Up to 37 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony O Odibo, MD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17-Hydroxyprogesterone Capronate in people with Premature Birth and Absorption; Chemicals, run by University of South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.