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Completed

NCT Number: NCT04989400

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Induction-to-abortion interval time.

    Time frame: 2 weeks

    calculate the time needed from start of intervention till abortion occured

Secondary outcomes

  1. complete evacuation between both groups

    Time frame: 2 weeks

    number of patients experienced complete abortion between both groups

  2. need for hysterotomy

    Time frame: 2 weeks

    number of patients underwent hysterotomy

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.