Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage
NCT ID: NCT06733727
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
884 participants
INTERVENTIONAL
2024-12-06
2028-06-05
Brief Summary
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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.
Detailed Description
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Both groups will receive misoprostol (which is the standard management for medical management of silent miscarriage locally), but they will be randomized to either adding mifepristone or letrozole as pre-treatment. Mifepristone is usually taken once 2 days before misoprostol, whereas letrozole is taken 10mg daily for 3 days before misoprostol. Placebo of letrozole and mifepristone will be given to maintain double blindness of the groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Letrozole
Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3
Letrozole
Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage
Mifepristone
Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3
Mifepristone
Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage
Interventions
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Letrozole
Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage
Mifepristone
Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Queen Mary Hospital, Hong Kong
OTHER
Pamela Youde Nethersole Eastern Hospital
OTHER
Kwong Wah Hospital
OTHER
Princess Margaret Hospital, Canada
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Jennifer Ko
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Central Contacts
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Other Identifiers
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UW22-530
Identifier Type: -
Identifier Source: org_study_id