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

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

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

Study Overview

• Status: Recruiting
• Conditions: Medical; Abortion, Fetus
• Intervention / Treatment: Drug: Letrozole

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sutinee Srimahachota, M.D.; Phone Number: 0847202666; Email: srimahachota@gmail.com
• Study Contact Backup: Name: Chuenrutai Yeekian, Ph.D.; Phone Number: 0818624534; Email: jayeekian88@gmail.com

Study Locations

• Thailand
  • Yannawa
    • Bangkok, Yannawa, Thailand, 10120
      • Recruiting
      • Sutinee Srimahachota
      • Contact: Sutinee Srimahachota; Phone Number: 0847202666; Email: srimahachota@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Letrozole plus Misoprostol; We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.	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.; Other Names: Femara
Active Comparator: Misoprostol; We give only Misoprostol 800 mcg SL.	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.; Other Names: Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complete abortion	Rate of complete abortion	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
induced to abortion time between both group	induced to abortion time between both group	up to 6 months
Side effect between both group	Number of patients with side effects between both group	up to 7 days

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
• Investigators: Study Chair: ชื่นฤทัย ยี่เขียน, Ph.D., Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Estrogen Antagonists; Aromatase Inhibitors; Letrozole
• Other Study ID Numbers: 014/2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No