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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
884
Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage
Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage
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
Time frame: 2 weeks, 30 days
Time of tissue expulsion
Time of tissue expulsion
Time frame: 6 weeks
Return of normal menses
Return of normal menses without additional intervention
Time frame: 6 weeks
Requirement of repeated intervention
Requirement of repeated intervention including repeated course of medical treatment or surgery
Time frame: 6 weeks
Unplanned re-admission
Number of unplanned re-admission
Time frame: 6 weeks
Analgesics
Use of analgesics
Time frame: 6 weeks
Side effects
Vomiting
Time frame: 6 weeks
Side effects
Nausea
Time frame: 6 weeks
Side effects
Fever
Time frame: 6 weeks
Side effects
Diarrhoea
Time frame: 6 weeks
Side effects
Abdominal pain on a visual analog scale
Time frame: 6 weeks
Vaginal bleeding
Duration and amount of vaginal bleeding
Time frame: 6 weeks
Complications
Including severe vaginal bleeding requiring transfusion, infection
Time frame: 6 weeks
Return of menstruation
Timing of return of menses
Time frame: 6 weeks
Women's satisfaction
Client satisfaction questionnaire
Time frame: 6 weeks
Women's satisfaction
EQ-5D-5L questionnaire
Time frame: 6 weeks
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