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

Study Overview
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Brief Summary
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Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Detailed Description
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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.

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

Conditions
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Medical; Abortion, Fetus

Intervention / Treatment
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* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| Side effect between both group | Side effect between both group | up to 7 days | 
| induced to abortion time between both group | induced to abortion time between both group | up to 6 months |