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Effect of misoprostol plus isosorbide mononitrate and misoprostol plus placebo in induction of second trimester abortion

Comparison of Misoprostol plus Isosorbide Mono Nitrate and Misoprostol plus placebo at the end of second trimester pregnancy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100525004025N5
Enrollment
54
Registered
2017-12-15
Start date
2016-12-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Termination of pregnancy. Pregnancy with abortive outcome

Interventions

Intervention 1: In group A(control), vitamin B6, 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, misoprostol 400mcg, equivalent to two 200mcg tablets stained with saline wi
Placebo
Treatment - Other
In group A(control), vitamin B6, 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, misoprostol 400mcg, equivalent to two 200mcg tablets stained with saline will be inserted .
In group B(case) Isosorbide Mononitrate 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg stained with saline will be inserted.

Sponsors

Research deputy Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Gestational age 22-13 weeks can be a condition for entering the study. nulliparous Can be a condition for entering the study. Multiparous to parity 5 Can be a condition for entering the study. singleton pregnancy can be a condition for entering the study.

Exclusion criteria

Exclusion criteria: Women with contra indication of misoprostol (active Cardiac-pulmonary disease, Placenta Previa, history of 2 or more previous cesarean section, or history of major uterine surgeries such as myomectomy and uterine reconstruction surgery)Conditions for not admitting to study. Women with contraindication of Isosorbide mono nitrate (IMN) (sensitivity to nitrates, hypotension, hypovolemia, heart disease, significant anemia Hb below 7 gr / dl and closed angle glaucoma )Conditions for not admitting to study.

Design outcomes

Primary

MeasureTime frame
The abortion rate is 12 hours. Timepoint: 12 hours later intervention. Method of measurement: View the disposal of pregnancy products.;The abortion rate is 24-12 hours. Timepoint: Abortion after 12 hours to 24 hours of intervention. Method of measurement: View the disposal of pregnancy products.;Abortion rate after 24 hours. Timepoint: In the 24th hour of the intervention. Method of measurement: View the disposal of pregnancy products.

Secondary

MeasureTime frame
Nausea. Timepoint: Every 4 hours after intervention   until the Disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Vomiting. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Diarrhea. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Fever and chills. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Headache. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Heart beat. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.;Confusion. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mona Khorami

Kermanshah University of Medical Sciences

saeedkhorami87@gmail.com+98 83 3427 6301

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026