Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage

Summary

Management of first trimester silent miscarriage can be by expectant, medical or surgical management. Surgical management by suction evacuation is associated with surgical risks (including risks to the womb that can affect further pregnancy), anaesthetic risks and hospital stay. Medical management of first trimester silent miscarriage using misoprostol is another common option that can reduce the risk of bleeding and those associated with surgery. However, the current standard management of using misoprostol for the management of first trimester miscarriage only has a success rate of 70-80%, which is suboptimal.

Recent large studies have shown that adding mifepristone pre-treatment before misoprostol in the management of silent miscarriage can improve the success rates of complete miscarriage after medical management. There are 2 problems with mifepristone. Firstly, it is not widely available in many countries for cultural and religious reasons because it is labelled as an 'abortifacient'. Secondly, it is expensive. One tablet of Mifepristone costs $500 HK dollars. There is a need to look for an alternative to mifepristone.

Letrozole is an aromatase inhibitor which can reduce estrogen levels. Some studies have shown that it can improve the success rate of medical management of silent miscarriage and termination of pregnancy. It is safe, more widely available and cheaper than mifepristone.

This is a randomized double blinded trial comparing the use of mifepristone versus letrozole as pre-treatment in the medical management of first trimester silent miscarriage using misoprostol.

Conditions

• Silent Miscarriage

Interventions

DRUG

Letrozole

Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage

DRUG

Mifepristone

Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Pamela Youde Nethersole Eastern Hospital

  collaborator OTHER

• Kwong Wah Hospital

  collaborator OTHER

• Princess Margaret Hospital, Canada

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Jennifer Ko · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-06

Primary Completion

2027-12-05

Completion

2028-06-05