Silent MiscarriageNCT06733727
Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage
A study testing Letrozole and Mifepristone in people with Silent Miscarriage, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Silent Miscarriage
- What is being tested?
- Letrozole and Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2024to 5 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Double-blind Placebo-controlled Trial Comparing Letrozole Versus Mifepristone As Pre-treatment Before Medical Management of First Trimester Silent Miscarriage Using Misoprostol
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.
Read more
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.
Read the 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.
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
- Silent Miscarriage
- Being tested
- Letrozole, Mifepristone
- Keywords
- silent miscarriage, mifepristone, misoprostol, letrozole
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage
MifepristoneDrug
Also called Mifepristone, RU486
Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Active comparator | Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3 Receives: Drug: Letrozole |
| Mifepristone | Active comparator | Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3 Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks, 30 days
Secondary outcomes (15)
Time of tissue expulsion
Time of tissue expulsion
Measured: 6 weeks
Return of normal menses
Return of normal menses without additional intervention
Measured: 6 weeks
Requirement of repeated intervention
Requirement of repeated intervention including repeated course of medical treatment or surgery
Measured: 6 weeks
Unplanned re-admission
Number of unplanned re-admission
Measured: 6 weeks
Analgesics
Use of analgesics
Measured: 6 weeks
Side effects
Vomiting
Measured: 6 weeks
Side effects
Nausea
Measured: 6 weeks
Side effects
Fever
Measured: 6 weeks
Side effects
Diarrhoea
Measured: 6 weeks
Side effects
Abdominal pain on a visual analog scale
Measured: 6 weeks
Vaginal bleeding
Duration and amount of vaginal bleeding
Measured: 6 weeks
Complications
Including severe vaginal bleeding requiring transfusion, infection
Measured: 6 weeks
Return of menstruation
Timing of return of menses
Measured: 6 weeks
Women's satisfaction
Client satisfaction questionnaire
Measured: 6 weeks
Women's satisfaction
EQ-5D-5L questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start6 Dec 2024 (estimated)
- Primary completion5 Dec 2027 (estimated)
- Study completion5 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent MiscarriageStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 884 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwong Wah Hospital, Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Jennifer Ko, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733727
- Sponsor's protocol ID
- UW22-530
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at the current moment
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Trial Comparing Letrozole Versus Mifepristone As Pre-treatment Before Medical Management of First Trimester Silent Miscarriage Using Misoprostol
- ClinicalTrials.gov ID
- NCT06733727
- Acronym / sponsor ID
- UW22-530
- Conditions
- Silent Miscarriage
- Keywords
- silent miscarriage, mifepristone, misoprostol, letrozole
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 884 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwong Wah Hospital, Princess Margaret Hospital, Canada
- Study start
- 6 Dec 2024 (estimated)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 5 Jun 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Active comparator | Drug: LetrozoleLetrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3 |
| Mifepristone | Active comparator | Drug: MifepristoneMifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleLetrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage | Drug | Letrozole |
| MifepristoneAlso: Mifepristone, RU486Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage | Drug | Mifepristone |
Primary outcome
Gestational sac expulsion
Time frame: 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
15 secondary outcomes
Time of tissue expulsion
Time frame: 6 weeks
Return of normal menses
Time frame: 6 weeks
Requirement of repeated intervention
Time frame: 6 weeks
Unplanned re-admission
Time frame: 6 weeks
Analgesics
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Vaginal bleeding
Time frame: 6 weeks
Complications
Time frame: 6 weeks
Return of menstruation
Time frame: 6 weeks
Women's satisfaction
Time frame: 6 weeks
Women's satisfaction
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No. No plan at the current moment
Related trials for Silent Miscarriage
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingObservational study
Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion
Missed Abortion, Periodontitis
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruiting
The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
Letrozole
Not yet recruitingPhase 1
Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy
Missed Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Ko principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole and Mifepristone in people with Silent Miscarriage, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ko (22554647, jenko@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational sac expulsion (time frame: 2 weeks, 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.