The role of adding isosorbide nitrate to intravaginal misoprostol in inducing second-trimester abortion

The role of adding isosorbide nitrate to intravaginal misoprostol in inducing second-trimester abortion, a randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250412065291N1

Enrollment

Registered

2025-04-18

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Medical abortion.

Interventions

Intervention 1: Intervention group: Group A received a combination of isosorbide nitrate 20 mg (Efox 20 mg) vaginally with misoprostol 400 mcg (2 Cytotec tablets) initially, and then one tablet every

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Maternal age 18 to 35 years second trimester (between 13 and 22 weeks) ultrasound-confirmed missed pregnancy singleton pregnancy unscarred uterus unopened cervix

Exclusion criteria

Exclusion criteria: Presence of uterine contractions or bleeding septic abortion history of previous cervical surgery or manipulation uterine abnormalities presence of an IUD in place underlying medical conditions history of allergies or side effects to medications administered vaginally those who do not wish to participate in the trial

Design outcomes

Primary

Measure	Time frame
Severe bleeding. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Pelvic pain. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Severe hypotension. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Back pain. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.	—

Measure

Time frame

Severe bleeding. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Pelvic pain. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Severe hypotension. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.;Back pain. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.

—

Secondary

Measure	Time frame
Nausea and vomiting. Timepoint: The first 24 hours after starting the first dose. Method of measurement: By viewing and reviewing the doctor's order in the patient's file documentation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Khorami

Ilam University of Medical Sciences

khorami-m@medilam.ac.ir+98 84 3222 3721

Outcome results

None listed

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