Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
| Kwong Wah Hospital | OTHER |
| Princess Margaret Hospital, Canada |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Active Comparator | Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3 |
|
| Mifepristone | Active Comparator | Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole pre-treatment in addition to misoprostol as medical management for silent miscarriage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks, 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of tissue expulsion | Time of tissue expulsion | 6 weeks |
| Return of normal menses | Return of normal menses without additional intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ko | Contact | 22554647 | jenko@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ko | The University of Hong Kong | Principal Investigator |
Not provided
No plan at the current moment
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000027 | Abortion, Incomplete |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Mifepristone | Drug | Mifepristone pre-treatment in addition to misoprostol as medical management for silent miscarriage |
|
|
| 6 weeks |
| Requirement of repeated intervention | Requirement of repeated intervention including repeated course of medical treatment or surgery | 6 weeks |
| Unplanned re-admission | Number of unplanned re-admission | 6 weeks |
| Analgesics | Use of analgesics | 6 weeks |
| Side effects | Vomiting | 6 weeks |
| Side effects | Nausea | 6 weeks |
| Side effects | Fever | 6 weeks |
| Side effects | Diarrhoea | 6 weeks |
| Side effects | Abdominal pain on a visual analog scale | 6 weeks |
| Vaginal bleeding | Duration and amount of vaginal bleeding | 6 weeks |
| Complications | Including severe vaginal bleeding requiring transfusion, infection | 6 weeks |
| Return of menstruation | Timing of return of menses | 6 weeks |
| Women's satisfaction | Client satisfaction questionnaire | 6 weeks |
| Women's satisfaction | EQ-5D-5L questionnaire | 6 weeks |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |