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NCT04989400

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Completed Phase 4 Last updated 4 August 2021
What this trial tests

Phase 4 trial testing Ulipristal Acetate in Induction of Second Trimester Abortion in 24 participants. Completed in 1 January 2020.

Timeline
1 January 2019
Primary endpoint
1 October 2019
1 January 2020

Quick facts

Lead sponsorAin Shams University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment24
Start date1 January 2019
Primary completion1 October 2019
Estimated completion1 January 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Eligibility, female only, with Induction of Second Trimester Abortion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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