Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Induction of Second Trimester Abortion
• Intervention / Treatment: Drug: Ulipristal Acetate; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt
      • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Placebo Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction-to-abortion interval time.	calculate the time needed from start of intervention till abortion occured	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete evacuation between both groups	number of patients experienced complete abortion between both groups	2 weeks
need for hysterotomy	number of patients underwent hysterotomy	2 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Gastrointestinal Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Ulipristal acetate
• Other Study ID Numbers: 5181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No