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

Medical; Abortion, Fetus Clinical Trial

Official title:

Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940233
• Other study ID #: 014/2566
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: June 2023
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: Sutinee Srimahachota, M.D.
• Phone: 0847202666
• Email: srimahachota[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

Drug:
• Letrozole
In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.

Locations

Country	Name	City	State
Thailand	Sutinee Srimahachota	Bangkok	Yannawa

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete abortion	Rate of complete abortion	up to 7 days
Secondary	Side effect between both group	Side effect between both group	up to 7 days
Secondary	induced to abortion time between both group	induced to abortion time between both group	up to 6 months