Trial Outcomes & Findings for 17OHP-C Dosing Among Obese Pregnant Women (NCT NCT03433040)
NCT ID: NCT03433040
Last Updated: 2022-01-12
Results Overview
Blood levels
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
From enrollment to 36 weeks of pregnancy
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
Non Obese
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese - Control
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese
500mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
9
|
|
Overall Study
COMPLETED
|
17
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
17OHP-C Dosing Among Obese Pregnant Women
Baseline characteristics by cohort
| Measure |
Non Obese
n=17 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese - Control
n=8 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese
n=5 Participants
500mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From enrollment to 36 weeks of pregnancyBlood levels
Outcome measures
| Measure |
Non Obese
n=17 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese - Control
n=8 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese
n=5 Participants
500mg 17 OHP-C
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.
34-36 weeks
|
15.2 ng/ml
Standard Deviation 12.5
|
11.1 ng/ml
Standard Deviation 6.2
|
24.6 ng/ml
Standard Deviation 7.1
|
|
Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks.
20-22 weeks
|
10.1 ng/ml
Standard Deviation 4.5
|
13.0 ng/ml
Standard Deviation 5.1
|
18.0 ng/ml
Standard Deviation 6.7
|
|
Change in Mean Trough Levels of 17-OHPC in the Three Groups at 20-22 Weeks, 27-29 Weeks and 34-36 Weeks.
27-29 weeks
|
11.5 ng/ml
Standard Deviation 4.8
|
8.1 ng/ml
Standard Deviation 5.6
|
17.9 ng/ml
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Up to 37 weeksGestational age at delivery in weeks . Too few to dichotomize to \<37, 34 and 32 weeks as previously planned.
Outcome measures
| Measure |
Non Obese
n=17 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese - Control
n=8 Participants
250mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
Obese
n=5 Participants
500mg 17 OHP-C
17-Hydroxyprogesterone Capronate: 17-Hydroxyprogesterone Capronate 250mg versus 500mg
|
|---|---|---|---|
|
Gestational Age at Delivery
|
36.7 Weeks
Standard Deviation 2.6
|
38.4 Weeks
Standard Deviation 1.4
|
32.2 Weeks
Standard Deviation 5.5
|
Adverse Events
Non Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Wendy Duncan, QA/QI Research Compliance Manager
University of South Florida
Phone: 8139747454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place