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NCT Number: NCT03407521

Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

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.

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Key information

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Ain Shams University

Cairo, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

induction of abortion using misoprostol

Isosorbide Mononitrate

Drug

isosorbide mononitrate

Placebo

Drug

Placebo

Primary outcomes

  1. induction abortion interval

    Time frame: 24 hours

    time needed to induce abortion in second trimester abortion

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2018
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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