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Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03407521
Enrollment
60
Registered
2018-01-23
Start date
2017-04-12
Completion date
2017-12-15
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second Trimester Abortion

Keywords

second trimester abortion

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.

Detailed 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.

Interventions

DRUGPlacebo

Placebo

DRUGMisoprostol

induction of abortion using misoprostol

isosorbide mononitrate

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
induction abortion interval24 hourstime needed to induce abortion in second trimester abortion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026