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

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Enrolling

Conditions: Medical; Abortion, Fetus

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT05940233

014/2566

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Letrozole plus Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Letrozole

Misoprostol

Active Comparator group

Description:

We give only Misoprostol 800 mcg SL.

Treatment:

Drug: Letrozole