A Phase 3 interventional study of 17-Hydroxyprogesterone Capronate in Premature Birth and Absorption; Chemicals, sponsored by University of South Florida. Completed at 2 sites in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by University of South Florida · Phase 3, Interventional, and Prevention
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.
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:
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:
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 44 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
https://register.clinicaltrials.gov/prs/html/definitions.html?popup=true#Eligibility
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
250mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
250mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
500mg 17 OHP-C
Drug: 17-Hydroxyprogesterone Capronate
17-Hydroxyprogesterone Capronate 250mg versus 500mg
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
Time frame: From enrollment to 36 weeks of pregnancy
Gestational Age at Delivery
Gestational age at delivery in weeks . Too few to dichotomize to \<37, 34 and 32 weeks as previously planned.
Time frame: Up to 37 weeks
| Milestone | Non Obese | Obese - Control | Obese |
|---|---|---|---|
| Started | 19 | 16 | 9 |
| Completed | 17 | 8 | 5 |
| Not completed | 2 | 8 | 4 |
Blood levels
| ng/ml | Non Obese | Obese - Control | Obese |
|---|---|---|---|
| 20-22 weeks | 10.1 ± 4.5 | 13.0 ± 5.1 | 18.0 ± 6.7 |
| 27-29 weeks | 11.5 ± 4.8 | 8.1 ± 5.6 | 17.9 ± 2.5 |
| 34-36 weeks | 15.2 ± 12.5 | 11.1 ± 6.2 | 24.6 ± 7.1 |
Gestational age at delivery in weeks . Too few to dichotomize to \<37, 34 and 32 weeks as previously planned.
| Weeks | Non Obese | Obese - Control | Obese |
|---|---|---|---|
| Gestational Age at Delivery | 36.7 ± 2.6 | 38.4 ± 1.4 | 32.2 ± 5.5 |
Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non Obese | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Obese - Control | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Obese | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Study stopped due to futility with enrolling in the obese group with BMI \> 30.
| Age, Categorical(Participants) | Non Obese | Obese - Control | Obese | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 8 | 5 | 30 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Non Obese | Obese - Control | Obese | Total |
|---|---|---|---|---|
| Mean | 32.2 ± 5.1 | 31.6 ± 6.4 | 31.4 ± 4.6 | 31.7 ± 5.2 |
| Sex: Female, Male(Participants) | Non Obese | Obese - Control | Obese | Total |
|---|---|---|---|---|
| Female | 17 | 8 | 5 | 30 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Non Obese | Obese - Control | Obese | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 4 | 4 | 15 |
| White | 9 | 4 | 1 | 14 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Non Obese | Obese - Control | Obese | Total |
|---|---|---|---|---|
| United States | 17 | 8 | 5 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: 17 alpha-Hydroxyprogesterone Caproate