NCT03407521

Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Second Trimester Abortion

Interventions

Type	Name	Description
DRUG	Misoprostol	induction of abortion using misoprostol
DRUG	isosorbide mononitrate	isosorbide mononitrate
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-04-12
• Primary completion: 2017-10-22
• Completion: 2017-12-15
• First posted: 2018-01-23
• Last updated: 2018-02-28

Locations

1 site across 1 country: Egypt