Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Phase 4

Completed

• Conditions: Induction of Second Trimester Abortion
• Interventions: Drug: Ulipristal Acetate; Drug: Misoprostol

• Registration Number: NCT04989400
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-10-01
• Study Completion: 2020-01-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Women with 2nd trimester missed abortions

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ulipristal group	Misoprostol	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
placebo	Misoprostol	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
ulipristal group	Ulipristal Acetate	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

Primary Outcome Measures

Name	Time	Method
Induction-to-abortion interval time.	2 weeks	calculate the time needed from start of intervention till abortion occured

Secondary Outcome Measures

Name	Time	Method
need for hysterotomy	2 weeks	number of patients underwent hysterotomy
complete evacuation between both groups	2 weeks	number of patients experienced complete abortion between both groups

Trial Locations

Locations (1)

Ain SHams Maternity Hospital; 🇪🇬 Cairo, Abbaseya, Egypt