Trial Outcomes & Findings for Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix? (NCT NCT02680314)

NCT ID: NCT02680314

Last Updated: 2022-09-14

Results Overview

To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 243 participants
• Primary outcome timeframe: within 24 hours
• Results posted on: 2022-09-14

Participant Flow

Participant milestones

Measure	Single Dose single dose of misoprostol	Multiple Dose multiple doses of misoprostol
Overall Study STARTED	120	123
Overall Study COMPLETED	120	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

Baseline characteristics by cohort

Measure	Single Dose n=120 Participants single dose of misoprostol Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.	Multiple Dose n=123 Participants multiple doses of misoprostol Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.	Total n=243 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
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants	123 Participants n=7 Participants	243 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	123 Participants n=7 Participants	243 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized other	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	123 participants n=7 Participants	243 participants n=5 Participants

PRIMARY outcome

Timeframe: within 24 hours

To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.

Outcome measures

Measure	Single Dose n=120 Participants single dose of misoprostol	Multiple Dose n=123 Participants multiple doses of misoprostol
Number of Participants With Vaginal Delivery Within 24 Hours	50 Participants	55 Participants

SECONDARY outcome

Timeframe: within 24 hours from the initial intervention

Population: Minutes from initiation of misoprostol to delivery

To determine the interval from initiation of misoprostol to delivery in each group

Outcome measures

Measure	Single Dose n=120 Participants single dose of misoprostol	Multiple Dose n=123 Participants multiple doses of misoprostol
To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group	1187 Median number of Minutes Interval 695.0 to 1628.0	1321 Median number of Minutes Interval 900.5 to 1735.0

Adverse Events

Single Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multiple Dose

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

Peter Bernstein, MD

Montefiore Medical Center

Phone: 718-904-2767

Email: pbernste@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place