Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone

Not Applicable

Recruiting

• Conditions: Medical; Abortion, Fetus
• Interventions: Drug: Letrozole

• Registration Number: NCT05940233
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief Summary

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Detailed Description

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT

This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.

The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.

Study Timeline

• Study First Submitted: 2023-05-24
• Study Start: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
• GA <= 14 weeks
• Os open <= 1 cm and no conceptus per os
• Hematicrit >= 30
• Systolic blood pressure >= 95 mmHg
• Informed consent done and can follow up and comunicate in Thai language

Exclusion Criteria

• Allerguc to Letrozole or Misoprostol
• Intrauterine contraceptive device use
• Breast feeding
• Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
• Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
• Multiple pregnancy
• Myoma uteri that involves the endometrium ex. Submucous myoma uteri
• Thromboembolism or has a history of thromboembolism
• Serum creatinine >= 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Letrozole plus Misoprostol	Letrozole	We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.
Misoprostol	Letrozole	We give only Misoprostol 800 mcg SL.

Primary Outcome Measures

Name	Time	Method
Rate of complete abortion	up to 7 days	Rate of complete abortion

Secondary Outcome Measures

Name	Time	Method
Side effect between both group	up to 7 days	Number of patients with side effects between both group
induced to abortion time between both group	up to 6 months	induced to abortion time between both group

Trial Locations

Locations (1)

Sutinee Srimahachota; 🇹🇭 Bangkok, Yannawa, Thailand