Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Second Trimester Abortion

Treatments: Drug: isosorbide mononitrate; Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03407521

R02 MH12345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

study group

Active Comparator group

Description:

misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once

Treatment:

Drug: isosorbide mononitrate

Drug: Misoprostol

control group

Placebo Comparator group

Description:

misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo

Treatment:

Drug: Placebo

Drug: Misoprostol