Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Phase 4

Completed

• Conditions: Second Trimester Abortion
• Interventions: Drug: Misoprostol; Drug: Placebo; Drug: isosorbide mononitrate

• Registration Number: NCT03407521
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2017-04-12
• Primary Completion: 2017-10-22
• Study Completion: 2017-12-15
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age 16 -40 years
• Missed abortion
• Singelton pregnancy
• Gestationl age between 13 and 26 weeks of pregnancy
• Normal uterus and cevix on clinical examination
• Cervix is not dilatated
• No uterine activity and vaginal bleeding
• Written and informed consent by the patient
• Unscarred uterus

Exclusion Criteria

• Presence of uterine contraction or bleeding
• Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
• Multifetal pregnancy
• Suspicion of septic abortion
• History of cervical surgery or manipulation
• Uterine anomaly
• IUD in situ
• Associtaed hemorrhagic disorder
• History of adverse effects to vaginally adminstered medication
• Inability to insert vaginal medication high in vagina

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Misoprostol	misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once
control group	Placebo	misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
control group	Misoprostol	misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
study group	isosorbide mononitrate	misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once

Primary Outcome Measures

Name	Time	Method
induction abortion interval	24 hours	time needed to induce abortion in second trimester abortion

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University; 🇪🇬 Cairo, Egypt