Trial Outcomes & Findings for Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics (NCT NCT00514618)
NCT ID: NCT00514618
Last Updated: 2023-11-07
Results Overview
Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus. The study was terminated, and no study data and/or analyzed. No study data are available.
TERMINATED
NA
5 participants
induction to delivery
2023-11-07
Participant Flow
The PI has left the institution. Efforts were exhausted in attempting to contact the PI/study team members. No study data are available
The PI has left the institution. Efforts were exhausted in attempting to contact the PI/study team members. No study data are available.
Participant milestones
| Measure |
1 - Misoprostol Treated
patients will be treated with misoprostol 50 mcg PO
|
2 - Placebo
patients will receive placebo (Vitamin C)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: induction to deliveryPopulation: No data was collected.
Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus. The study was terminated, and no study data and/or analyzed. No study data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The PI has left the institution. Efforts were exhausted in attempting to contact the PI/study team members. No study data are available.Population: No data was collected.
The study was terminated, and no study data and/or analyzed. No study data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: induction to deliveryPopulation: No data was collected.
No data was collected.
Outcome measures
Outcome data not reported
Adverse Events
1 - Misoprostol Treated
2 - Placebo
Serious adverse events
| Measure |
1 - Misoprostol Treated
patients will be treated with misoprostol 50 mcg PO
Misoprostol: patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4)
|
2 - Placebo
patients will receive placebo (Vitamin C)
Placebo: patients will receive placebo (vitamin C) q day for two days (days 1 and 4)
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
No adverse events were collected
|
—
0/0 • All-cause mortality, Serious Adverse Events and/or Other Adverse Events data were not collected.
No data was collected.
|
—
0/0 • All-cause mortality, Serious Adverse Events and/or Other Adverse Events data were not collected.
No data was collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Lorna Camfield, Research Compliance Analyst
MemorialCare Health Services LBMC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place