Status:
RECRUITING
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy
Lead Sponsor:
KK Women's and Children's Hospital
Conditions:
Abortion in First Trimester
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief Summary
Medical termination of pregnancy (mTOP) generally involves using either a combined regimen consisting of mifepristone and misoprostol, or a misoprostol-only regimen. Complete abortion rates of first t...
Detailed Description
The standard of care for termination of pregnancy (TOP) has shifted from a predominantly surgical approach towards medical strategy. Medical termination of pregnancy (mTOP) has increased in popularity...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05341817
Start Date
November 22 2022
End Date
November 1 2025
Last Update
January 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
KK Women's and Children's Hospital
Singapore, Singapore, 229899