Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Induction of Second Trimester Abortion

Treatments: Drug: Misoprostol; Drug: Ulipristal Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT04989400

5181

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

ulipristal group

Experimental group

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

Treatment:

Drug: Misoprostol

Drug: Ulipristal Acetate

placebo

Placebo Comparator group

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

Treatment:

Drug: Misoprostol