A Phase 4 interventional study of Misoprostol and isosorbide mononitrate in Second Trimester Abortion, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.
the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.
the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.
In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.
The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.
The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.
Exclusion Criteria:
misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once
Drug: Misoprostol · Drug: isosorbide mononitrate
misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
Drug: Misoprostol · Drug: Placebo
induction of abortion using misoprostol
isosorbide mononitrate
Placebo
induction abortion interval
time needed to induce abortion in second trimester abortion
Time frame: 24 hours
Plan to share: No — publish in scientific journals
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Ain Shams University