A study comparing two drugs in medical termination of pregnancy

Letrozole versus mifepristone pre-treatment with misoprostol in medical termination of pregnancy; A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091947

Enrollment

100

Registered

2025-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O048- (Induced) termination of pregnancywith other and unspecified complications

Interventions

Intervention1: LETROZOLE VERSUS MIFEPRISTONE PRE-TREATMENT WITH MISOPROSTOL IN MEDICAL TERMINATION OF PREGNANCY

A RANDOMIZED CONTROLLED TRIAL The duration of the study will be 1 year: After assessment by senior consultant all women planned for medical termination of pregnancy will be counselled for recruitment

A RANDOMIZED CONTROLLED TRIAL : Group 2 Fifty women randomized to group 2 will receive 200 mg of Mifepristone on day 1 under supervision. On 3rd day 800mcg Misoprostol will be kept vaginally by the in

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with age 18 to 40 years 2. Singleton pregnancy 3. Gestational age less than or equal to 9 weeks or 63 days of amenorrhea based on history, clinical examination, or ultrasonography if required 4. Patient requesting for mTOP and eligible for legal abortion according to the Termination of Pregnancy act.

Exclusion criteria

Exclusion criteria: 1.Inevitable or incomplete abortion 2.Suspected ectopic pregnancy 3.Anemia (Hemoglobin less than 8gm %) 4.Any history suggestive of drug allergy or allergy to mifepristone ,misoprostol or letrozole drugs 5.Presence of maternal disease such as cardiovascular disease, liver failure , respiratory distress ,asthma , adrenal insufficiency, renal failure , history of thromboembolism and on anticoagulant therapy 6. Any history of joint pain and stiffness , osteoporosis .

Design outcomes

Primary

Measure	Time frame
To compare effectiveness of Letrozole versus Mifepristone pre-treatment with Misoprostol in medical termination of pregnancy of gestation equal to or less than 9 weeksTimepoint: 2 weeks	—

Secondary

Measure	Time frame
Incomplete abortion Yes No Timepoint: If sonography after 2 weeks suggests retained products or causes anemia;Complete abortion Yes NoTimepoint: Products of conception are seen grossly, progressive decrease in the bleeding, urinary pregnancy test will become negative after 2 weeks, confirmed on sonography;Total no. Of misoprostol dose requiredTimepoint: Given 4 hourly if signs of expulsion are not evident;Need for incomplete evacuation Yes NoTimepoint: If sonography after 2 weeks suggests retained products or causes anemia	—

Measure

Time frame

Incomplete abortion Yes No Timepoint: If sonography after 2 weeks suggests retained products or causes anemia;Complete abortion Yes NoTimepoint: Products of conception are seen grossly, progressive decrease in the bleeding, urinary pregnancy test will become negative after 2 weeks, confirmed on sonography;Total no. Of misoprostol dose requiredTimepoint: Given 4 hourly if signs of expulsion are not evident;Need for incomplete evacuation Yes NoTimepoint: If sonography after 2 weeks suggests retained products or causes anemia

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Countries

India

Contacts

Public ContactDr Mamta Mahajan

Dr RPGMC Kangra at Tanda Himachal Pradesh

mamtamahajan@gmail.com8219953230

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026