Trial Outcomes & Findings for Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy (NCT NCT00671060)

NCT ID: NCT00671060

Last Updated: 2013-05-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2013-05-08

Participant Flow

This randomized trial was conducted at Montefiore Medical Center, Stanford University, Stroger Hospital, Christiana Care Hospital, the Huong Vuong Hospital in Ho Chi Minh City, Viet Nam. Women who sought medical care for possible fetal demise in pregnancies of between 14 and 28 weeks from December 2008 to December 2011 were screened.

No participants were excluded from the trial before assignment to groups.

Participant milestones

Measure	200 Mcg Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	100 Mcg Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
Overall Study STARTED	77	76
Overall Study COMPLETED	76	75
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	200 Mcg Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	100 Mcg Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Baseline characteristics by cohort

Measure	200 Mcg n=77 Participants Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	100 Mcg n=76 Participants Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.6 years STANDARD_DEVIATION 5.6 • n=5 Participants	25.8 years STANDARD_DEVIATION 5.9 • n=7 Participants	25.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	76 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Vietnam	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.

Outcome measures

Measure	200 Mcg n=76 Participants Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	100 Mcg n=76 Participants Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
Successful Expulsion of Fetus and Placenta Within 48 Hours	60 participants	47 participants

Adverse Events

200 Mcg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

100 Mcg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	200 Mcg n=77 participants at risk Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.	100 Mcg n=76 participants at risk Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
Surgical and medical procedures Other adverse event	1.3% 1/77 • Number of events 1 • 3 years	0.00% 0/76 • 3 years

Additional Information

Hillary Bracken

Gynuity Health Projects

Phone: 2124481230

Email: hbracken@gynuity.org

Results disclosure agreements

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

Restriction type: OTHER