Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

NCT ID: NCT04989400

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-01-01

Brief Summary

The aim of this work is to assess the effectiveness and safety of Ulipristal Acetate in the management of 2nd trimester missed abortion along with misoprostol in pregnant women with previous caesarean section versus the use of misoprostol only with placebo as regards the time needed for abortion,Hypothesis: In pregnant women with 2nd trimester missed abortion with previous caesarean section , Ulipristal Acetate may decrease the time interval to achieve abortion when combined with Misoprostol in comparison to misoprostol alone.the included women divided to 2 groups Group A: will receive Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017.Group B: will receive placebo then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. then we assess Induction-to-abortion interval time.

Conditions

Induction of Second Trimester Abortion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ulipristal group

received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017,Then women 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

Group Type: EXPERIMENTAL

Ulipristal Acetate

Intervention Type: DRUG

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.

Misoprostol

Intervention Type: DRUG

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.

placebo

received placebo tablet of same shape , texture of that of ulipristal then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. 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

Group Type: PLACEBO_COMPARATOR

Misoprostol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Gestational age 13-26 weeks.
• Women with a previous caesarian section scar,(para 1cs till para 4 cs).
• Women counseled and chose medication abortion rather than surgical evacuation

Exclusion Criteria

• Women with an accompanying medical disorder such as: Preeclampsia, Diabetes Mellitus or Heart disease.
• Primigravida women or non scarred uterus.
• Women with previous myomectomy or hysterotomy scar or upper segment caesarean section scar.
• Induction of abortion in women with congenital fetal malformations or positive fetal pulsations due to medical disorder.
• Women with placenta previa .
• Allergy or contraindications to either Ulipristal acetate or Misoprostol.
• Women with inevitable abortion in the form of vaginal bleeding or uterine contractions

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Safwat

lecturer of obstetrics and gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

5181

Identifier Type: -

Identifier Source: org_study_id