Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

NCT03407521 | Completed Phase 4 DMC

• 1 other identifier: R02 MH12345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Second Trimester Abortion

Keywords

second trimester abortion

Outcome Measures

Primary Outcomes (1)

• induction abortion interval

  time needed to induce abortion in second trimester abortion

  24 hours

Study Arms (2)

study group

ACTIVE COMPARATOR

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

Drug: Misoprostol; Drug: isosorbide mononitrate

control group

PLACEBO COMPARATOR

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

Drug: Misoprostol; Drug: Placebo

Interventions

Misoprostol DRUG

induction of abortion using misoprostol

control group; study group

isosorbide mononitrate DRUG

isosorbide mononitrate

study group

Placebo DRUG

Placebo

control group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, 11566, Egypt

Location

Related 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. doi: 10.1016/s0002-9378(96)70270-3.

  PMID: 8694046 RESULT

MeSH Terms

Interventions

Misoprostol; isosorbide-5-mononitrate

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• mohamed ab elsenity, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer MD

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: April 12, 2017
• Primary Completion: October 22, 2017
• Study Completion: December 15, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)