Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion

NCT07636317 | Completed

• 1 other identifier: Soh-Med-24-6-8PD.
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone.

Conditions

Misoprostol; Induction; Missed Abortion; Letrozole

Outcome Measures

Primary Outcomes (1)

• Incidence of bleeding

  Incidence of bleeding was recorded.

  7 days following the Misoprostol dose

Secondary Outcomes (3)

• Number of dosages of prostaglandins

  7 days following the Misoprostol dose

• Duration required for abortion

  7 days following the Misoprostol dose

• Incidence of adverse effects

  7 days following the Misoprostol dose

Study Arms (2)

Group 1

EXPERIMENTAL

Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.

Drug: Letrozole + Misoprostol

Group 2

ACTIVE COMPARATOR

Patients received only 800 µg of Misoprostol.

Drug: Misoprostol

Interventions

Letrozole + Misoprostol DRUG

Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.

Group 1

Misoprostol DRUG

Patients received only 800 µg of Misoprostol.

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with nonviable pregnancies undergoing 1st-trimester abortion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 18 to 45 years.
• Women with nonviable pregnancies undergoing 1st-trimester abortion.

You may not qualify if:

• Medical diseases like renal or liver disease.
• Severe bleeding and shocked patients.
• Inevitable abortion.
• Hypersensitivity to any of the drugs.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Letrozole; Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Sohag University, Sohag, Egypt.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: June 14, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)