Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

PHASE4CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

October 1, 2019

Study Completion Date

January 1, 2020

Conditions
Induction of Second Trimester Abortion
Interventions
DRUG

Ulipristal Acetate

Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal. Then women in had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.

DRUG

Misoprostol

Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal.Group B: received placebo tablet of same shape , texture of that of ulipristal then 12 hours later start misoprostol 100µg every 6 hours buccal. Then women in both groups had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.

Trial Locations (1)

Unknown

Ain SHams Maternity Hospital, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT04989400 - Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion | Biotech Hunter | Biotech Hunter