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Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Primary Purpose

Induction of Second Trimester Abortion

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ulipristal Acetate
Misoprostol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction of Second Trimester Abortion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ain SHams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ulipristal group

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Induction-to-abortion interval time.
calculate the time needed from start of intervention till abortion occured

Secondary Outcome Measures

complete evacuation between both groups
number of patients experienced complete abortion between both groups
need for hysterotomy
number of patients underwent hysterotomy

Full Information

First Posted
July 26, 2021
Last Updated
July 26, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04989400
Brief Title
Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion
Official Title
Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Second Trimester Abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ulipristal group
Arm Type
Experimental
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate
Intervention Description
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
Intervention Name(s)
Misoprostol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Induction-to-abortion interval time.
Description
calculate the time needed from start of intervention till abortion occured
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
complete evacuation between both groups
Description
number of patients experienced complete abortion between both groups
Time Frame
2 weeks
Title
need for hysterotomy
Description
number of patients underwent hysterotomy
Time Frame
2 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

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