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Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

NCT ID: NCT03407521

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2017-12-15

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.

Conditions

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Second Trimester Abortion

Keywords

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second trimester abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

induction of abortion using misoprostol

isosorbide mononitrate

Intervention Type DRUG

isosorbide mononitrate

control group

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

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

induction of abortion using misoprostol

Placebo

Intervention Type DRUG

Placebo

Interventions

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Misoprostol

induction of abortion using misoprostol

Intervention Type DRUG

isosorbide mononitrate

isosorbide mononitrate

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed abd elfatah elsenity

lecturer MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamed ab elsenity, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Medicine Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 8694046 (View on PubMed)

Other Identifiers

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R02 MH12345

Identifier Type: -

Identifier Source: org_study_id