Clinical trial NCT03407521: Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion
Official title: Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Second Trimester Abortion
Keywords: second trimester abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: induction abortion interval
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
Study officials:
affiliation: Ain Shams University
name: mohamed ab elsenity, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.