An interventional study of Letrozole and Mifepristone in Silent Miscarriage, sponsored by The University of Hong Kong. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's planned enrollment of 884 is above the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.
Browse Abortion, Incomplete studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3
Drug: Letrozole
Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3
Drug: Mifepristone
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
Also known as: Mifepristone, RU486
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
No study locations are listed for this record.
Plan to share: No — No plan at the current moment
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Letrozole · Mifepristone