Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage
- Conditions
- Interventions
- Registration Number
- NCT06733727
- Lead Sponsor
- The University of Hong Kong
- 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 an...
- Detailed Description
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.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 884
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole Letrozole Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3 Mifepristone Mifepristone Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3
- Primary Outcome Measures
Name Time Method Gestational sac expulsion 2 weeks, 30 days 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
- Secondary Outcome Measures
Name Time Method Time of tissue expulsion 6 weeks Time of tissue expulsion
Return of normal menses 6 weeks Return of normal menses without additional intervention
Requirement of repeated intervention 6 weeks Requirement of repeated intervention including repeated course of medical treatment or surgery
Unplanned re-admission 6 weeks Number of unplanned re-admission
Analgesics 6 weeks Use of analgesics
Side effects 6 weeks Abdominal pain on a visual analog scale
Vaginal bleeding 6 weeks Duration and amount of vaginal bleeding
Complications 6 weeks Including severe vaginal bleeding requiring transfusion, infection
Return of menstruation 6 weeks Timing of return of menses
Women's satisfaction 6 weeks EQ-5D-5L questionnaire