Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Second Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407521
• Other study ID #: R02 MH12345
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2018
• Last updated: February 26, 2018
• Start date: April 12, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: February 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2017
• Est. primary completion date: October 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Second Trimester Abortion

Intervention

Drug:
• Misoprostol
induction of abortion using misoprostol
• isosorbide mononitrate
isosorbide mononitrate
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction abortion interval	time needed to induce abortion in second trimester abortion	24 hours