Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

NCT04989400 | Completed Phase 4

• 1 other identifier: 5181
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Induction-to-abortion interval time.

  calculate the time needed from start of intervention till abortion occured

  2 weeks

Secondary Outcomes (2)

• complete evacuation between both groups

  2 weeks

• need for hysterotomy

  2 weeks

Study Arms (2)

ulipristal group

EXPERIMENTAL

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

Drug: Ulipristal Acetate; Drug: Misoprostol

placebo

PLACEBO COMPARATOR

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

Drug: Misoprostol

Interventions

Ulipristal Acetate 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.

ulipristal group

Misoprostol 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; ulipristal group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Location

MeSH Terms

Interventions

ulipristal acetate; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynaecology

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

EG (1)