The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

Launched by KK WOMEN'S AND CHILDREN'S HOSPITAL · Apr 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether letrozole, a medication that lowers certain hormone levels, can be an effective and more affordable alternative to mifepristone for women seeking a medical termination of pregnancy (mTOP) in the first trimester. The trial will compare the success rates of using letrozole followed by misoprostol to the standard treatment of mifepristone followed by misoprostol. Researchers believe that letrozole could provide similar success rates in completing the abortion process.

To participate in the trial, women must be at least 21 years old, seeking a legal abortion within the first 10 weeks of pregnancy, and willing to provide consent for the study. Participants will be randomly assigned to receive either letrozole or mifepristone, followed by misoprostol, and will be monitored for the success of the procedure. This research aims to provide important information that could make mTOP more accessible and cost-effective for women, improving their care options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 21 years and above
• • Patient requesting for medical termination of pregnancy (mTOP)
• • Patient eligible for legal abortion according to the Termination of Pregnancy Act (Chapter 324)
• • Gestational age ≤10 weeks (on day 1 of mifepristone or letrozole administration) as confirmed by the first trimester dating scan
• • Singleton pregnancy
• • Patient is agreeable to undergo surgical evacuation or repeat medical therapy if treatment fails
• • Willing and able to provide written, informed consent
• Exclusion Criteria:
• • History or evidence of adrenal pathology, steroid-dependent cancer, porphyria, poorly controlled hypertension, bronchial asthma, thromboembolism and severe cardiac/renal/liver disease
• • Haemoglobin level of \<9.5 g/L
• • Presence of an intrauterine contraceptive device
• • Breastfeeding
• • Reported allergic reaction to mifepristone, misoprostol or letrozole,
• • Participating in another trial of investigational medicinal products during the current pregnancy