Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Second Trimester Abortion

Intervention / Treatment
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* Drug: Misoprostol
* Drug: isosorbide mononitrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once | Drug: Misoprostol<br>* induction of abortion using misoprostol<br>Drug: isosorbide mononitrate<br>* isosorbide mononitrate<br>|
| Placebo Comparator: control group<br>misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo | Drug: Misoprostol<br>* induction of abortion using misoprostol<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction abortion interval | time needed to induce abortion in second trimester abortion | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second trimester abortion