Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage

NCT06733727 | Not Yet Recruiting

• 1 other identifier: UW22-530
• Study Type: interventional
• Target: 884
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

silent miscarriage; mifepristone; misoprostol; letrozole

Outcome Measures

Primary Outcomes (1)

• Gestational sac expulsion

  Gestational sac expulsion by the first follow up visit after 2 weeks of misoprostol administration and no additional surgical or medical intervention within 30 days after randomization

  2 weeks, 30 days

Secondary Outcomes (15)

• Time of tissue expulsion

  6 weeks

• Return of normal menses

  6 weeks

• Requirement of repeated intervention

  6 weeks

• Unplanned re-admission

  6 weeks

• Analgesics

  6 weeks

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3

Drug: Letrozole

Mifepristone

ACTIVE COMPARATOR

Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3

Drug: Mifepristone

Interventions

Letrozole DRUG

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

Letrozole

Mifepristone DRUG

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

Also known as: Mifepristone, RU486

Mifepristone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with silent miscarriage \<= 12 weeks of gestation by ultrasonography
• Single intrauterine gestational sac
• No heavy per-vaginal bleeding
• No severe abdominal pain
• No features of intrauterine infection
• Able to understand the proposed research and able to comply with instructions
• Having given voluntary written informed consent

You may not qualify if:

• Known allergy to mifepristone, misoprostol or letrozole
• On drugs with potential drug interactions with mifepristone e.g. aspirin, clopidogrel, anti-coagulants etc.
• Suspected ectopic or molar pregnancy or multiple pregnancy
• Distorted uterine cavity by uterine septum or submucosal fibroids
• Presence of intrauterine contraceptive device
• History of bleeding tendencies e.g. haemorrhagic diseases, current anti-coagulant treatment
• Previous history of retained products of gestation/ failed medical management of miscarriage
• Opt for expectant or surgical management of miscarriage

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator
• Kwong Wah Hospital: collaborator
• Princess Margaret Hospital, Canada: collaborator

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Letrozole; Mifepristone

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jennifer Ko

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ko

CONTACT

22554647; jenko@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 13, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 5, 2027
• Study Completion (Estimated): June 5, 2028
• Last Updated: December 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share