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NCT Number: NCT05940233

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

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sutinee Srimahachota

Bangkok, Yannawa, 10120, Thailand

Location status: Recruiting

Location contact

Sutinee Srimahachota

CONTACT

[email protected]

0847202666

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

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.

Other names: Femara

Primary outcomes

  1. Rate of complete abortion

    Time frame: up to 7 days

    Rate of complete abortion

Secondary outcomes

  1. Side effect between both group

    Time frame: up to 7 days

    Number of patients with side effects between both group

  2. induced to abortion time between both group

    Time frame: up to 6 months

    induced to abortion time between both group

Study contacts

Contact information is provided by the study sponsor or research team.

Chuenrutai Yeekian, Ph.D.

CONTACT

[email protected]

0818624534

Sutinee Srimahachota, M.D.

CONTACT

[email protected]

0847202666

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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