Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
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- What is being studied
- The protocol lists: Letrozole.
- Who it may be relevant to
- Registry conditions: Medical; Abortion, Fetus. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
Overview
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
- 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.
Primary outcome measures
- Rate of complete abortion [Time frame: up to 7 days]
Secondary outcome measures (2)
- Side effect between both group [Time frame: up to 7 days]
- induced to abortion time between both group [Time frame: up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Sutinee Srimahachota — Bangkok
Identifiers
NCT: NCT05940233 · 014/2566