Medical; Abortion, Fetus
Conditions
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.
Interventions
DRUGLetrozole
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.
Sponsors
Queen Savang Vadhana Memorial Hospital, Thailand
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete abortion | up to 7 days | Rate of complete abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Contacts
STUDY_CHAIRชื่นฤทัย ยี่เขียน, Ph.D.
Queen Savang Vadhana Memorial Hospital, Thailand
Outcome results
None listed