To study the effect of progesterone hormone containing intra uterine system in women with bleeding diorders
- Conditions
- Von Willebrands disease,
- Registration Number
- CTRI/2022/11/047538
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Bleeding disorders affects about 14 % women during their reproductive years. These women may experience abnormal uterine bleeding (AUB) which may be acute or chronic. Heavy menstrual bleeding (HMB) which is defined as excessive bleeding during menses affecting the health of women is one of the most common symptoms in women with bleeding disorders and these women present at an early age as compared to women with AUB without bleeding disorders1.
Acquired or inherited bleeding disorders are diagnosed in 10% to 17% of women presenting with AUB and in 21% to 46% of adolescents with HMB. Almost half of adolescents diagnosed as having a bleeding disorder have had HMB since menarche and 12% have required hospitalization secondary to anemia2 HMB affects around 74-93 % percent of women with underlying inherited bleeding disorders and Von Willebrand Disease(VWD) and around 35-95% of women with platelet disorders or other clotting factor deficiencies3.
Type 1 VWD is a common type of coagulopathy in women of adolescent age andis responsible for HMB in around 13% of women having HMB.
According to FIGO classification of AUB,(PALM-COIEN), abnormal uterine bleeding due to Coagulopathy or bleeding disorders is classified as AUB-C and comprise women with inherited or acquired bleeding disorders like VWD, thrombocytopenia, platelet function disorders, abnormal platelet factors, and in women on anticoagulation or anti platelet therapy2.Also women with severe anemia are at increased risk of worsening and require blood transfusion due to HMB.
In a survey done in US,79% of women with VWD reported to have HMB and out of these,71% required medical attention for the same, 13 % required hysterectomy as last resort for management of HMB4.Since heavy menstrual bleeding starts at the very onset of menarche and continues throughout reproductive life, the quality of life of these women is severely affected and around 66 % women with bleeding disorder develop iron deficiency anemia, while women with non nutritional anemia require multiple blood transfusions, they are at an increased risk of developing ironâ€deficiency anemia.Excessive bleeding every month in these young women may cause significantly low general health, loss of initiative5 and poor quality of life, leading to problems in full participation in school, athletic , social activities and depression 6,7. Further frequent visits to hospital, the cost of treatment for blood and products transfusion adds to considerable financial burden on families of these women.
The aim of treatment in both these group of disorders is complete cessation of menses without causing any adverse systemic effects. Management options for heavy menstrual bleeding in women with bleeding disorders include hormonal treatment like oral or injectable progestins or combined hormonal contraceptives (CHCs), anti-fibrinolytics, desmopressin and iron supplementations8,9,10. Severe bleeding episodes deplete coagulation factors and to control bleeding multiple blood and blood products are transfused which is fraught with its own concerns.
Oral progestins are used to control acute episode of bleeding and then cyclic progesterone or combined estrogen progesterone pills induces controlled cyclical withdrawal bleedingand reduces the amount of blood flowby 35-69% 11,12. Combined hormonal contraceptivesare considered as first line therapy in women with bleeding disorders however there are compliance issues due to daily administration and several side effects like risk of thrombosis 11.Combined hormonal contraceptiveswhen used over a period of six months reduces blood loss in women with unacceptable HMB from 12% to 77%13 and authors also reached to the conclusion that LNG IUS lead to reduction in mean blood loss in 83 % women in comparison to combined hormonal contraceptives which was 68% only13.Adherence to treatment options which needs to be taken daily, weekly or monthly seem to pose a great challenge in compliance among adolescents. Since this therapy would have to be initiated early in life and continued for a reasonably long time, it is essential that both the efficacy and safety be evidenceâ€based. Further, surgical option of endometrial ablation and hysterectomy are not an option in these young girls.
The safety and efficacy of LNG-IUS for treatment of AUB in peri menopausal women is welldemonstrated. LNG intra-uterine system causes a significant reduction in menstrual blood loss by and is effectively used as an alternative to surgery for treatment of HMB in reproductive age women. It reduces menstrual blood loss by 97% at 12 months of use14,15. Once inserted it is effective for 5 years and in most of the users causes amenorrhea. LNG IUS is being used in women with bleeding disorders however the data on the use of LNG IUS in young women with bleeding disorders is scarce3. Although LNG IUS is recommended as first line management for other causes of AUB however in AUB-C it is still recommended as second-line treatment of choice that is, where combined oral contraceptive pill is contraindicated, LNG-IUS is preferred as first-line treatment11. In 2011 a review of case series of women with inherited blood disorders who have been using LNG IUS has shown that it is an effective long-term treatment for HMB in these women3
The available treatment modalities though proven effective, their associated side effects, limited efficacy and the poor compliance led to discontinuation, and this necessitate the requisite for alternative ‘fit and forget’ methods like levonorgestrel-releasing intrauterine system (LNG-IUS)
Hence this study becomes important in a developing country like India where this problem is quite prevalent and requirement in blood banks for transfusion is very high significantly in such adolescent women with underlying bleeding disorders.So, with the intention to add the data to already existing data on efficacy of LNG IUS in women with hematological disorders, this study has been planned.Bleeding disorders affects about 14 % women during their reproductive years. These women may experience abnormal uterine bleeding (AUB) which may be acute or chronic. Heavy menstrual bleeding (HMB) which is defined as excessive bleeding during menses affecting the health of women is one of the most common symptoms in women with bleeding disorders and these women present at an early age as compared to women with AUB without bleeding disorders1.
Acquired or inherited bleeding disorders are diagnosed in 10% to 17% of women presenting with AUB and in 21% to 46% of adolescents with HMB. Almost half of adolescents diagnosed as having a bleeding disorder have had HMB since menarche and 12% have required hospitalization secondary to anemia2 HMB affects around 74-93 % percent of women with underlying inherited bleeding disorders and Von Willebrand Disease(VWD) and around 35-95% of women with platelet disorders or other clotting factor deficiencies3.
Type 1 VWD is a common type of coagulopathy in women of adolescent age andis responsible for HMB in around 13% of women having HMB.
According to FIGO classification of AUB,(PALM-COIEN), abnormal uterine bleeding due to Coagulopathy or bleeding disorders is classified as AUB-C and comprise women with inherited or acquired bleeding disorders like VWD, thrombocytopenia, platelet function disorders, abnormal platelet factors, and in women on anticoagulation or anti platelet therapy2.Also women with severe anemia are at increased risk of worsening and require blood transfusion due to HMB.
In a survey done in US,79% of women with VWD reported to have HMB and out of these,71% required medical attention for the same, 13 % required hysterectomy as last resort for management of HMB4.Since heavy menstrual bleeding starts at the very onset of menarche and continues throughout reproductive life, the quality of life of these women is severely affected and around 66 % women with bleeding disorder develop iron deficiency anemia, while women with non nutritional anemia require multiple blood transfusions, they are at an increased risk of developing ironâ€deficiency anemia.Excessive bleeding every month in these young women may cause significantly low general health, loss of initiative5 and poor quality of life, leading to problems in full participation in school, athletic , social activities and depression 6,7. Further frequent visits to hospital, the cost of treatment for blood and products transfusion adds to considerable financial burden on families of these women.
The aim of treatment in both these group of disorders is complete cessation of menses without causing any adverse systemic effects. Management options for heavy menstrual bleeding in women with bleeding disorders include hormonal treatment like oral or injectable progestins or combined hormonal contraceptives (CHCs), anti-fibrinolytics, desmopressin and iron supplementations8,9,10. Severe bleeding episodes deplete coagulation factors and to control bleeding multiple blood and blood products are transfused which is fraught with its own concerns.
Oral progestins are used to control acute episode of bleeding and then cyclic progesterone or combined estrogen progesterone pills induces controlled cyclical withdrawal bleedingand reduces the amount of blood flowby 35-69% 11,12. Combined hormonal contraceptivesare considered as first line therapy in women with bleeding disorders however there are compliance issues due to daily administration and several side effects like risk of thrombosis 11.Combined hormonal contraceptiveswhen used over a period of six months reduces blood loss in women with unacceptable HMB from 12% to 77%13 and authors also reached to the conclusion that LNG IUS lead to reduction in mean blood loss in 83 % women in comparison to combined hormonal contraceptives which was 68% only13.Adherence to treatment options which needs to be taken daily, weekly or monthly seem to pose a great challenge in compliance among adolescents. Since this therapy would have to be initiated early in life and continued for a reasonably long time, it is essential that both the efficacy and safety be evidenceâ€based. Further, surgical option of endometrial ablation and hysterectomy are not an option in these young girls.
The safety and efficacy of LNG-IUS for treatment of AUB in peri menopausal women is welldemonstrated. LNG intra-uterine system causes a significant reduction in menstrual blood loss by and is effectively used as an alternative to surgery for treatment of HMB in reproductive age women. It reduces menstrual blood loss by 97% at 12 months of use14,15. Once inserted it is effective for 5 years and in most of the users causes amenorrhea. LNG IUS is being used in women with bleeding disorders however the data on the use of LNG IUS in young women with bleeding disorders is scarce3. Although LNG IUS is recommended as first line management for other causes of AUB however in AUB-C it is still recommended as second-line treatment of choice that is, where combined oral contraceptive pill is contraindicated, LNG-IUS is preferred as first-line treatment11. In 2011 a review of case series of women with inherited blood disorders who have been using LNG IUS has shown that it is an effective long-term treatment for HMB in these women3
The available treatment modalities though proven effective, their associated side effects, limited efficacy and the poor compliance led to discontinuation, and this necessitate the requisite for alternative ‘fit and forget’ methods like levonorgestrel-releasing intrauterine system (LNG-IUS)
Hence this study becomes important in a developing country like India where this problem is quite prevalent and requirement in blood banks for transfusion is very high significantly in such adolescent women with underlying bleeding disorders.So, with the intention to add the data to already existing data on efficacy of LNG IUS in women with hematological disorders, this study has been planned
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 35
- Haematological disorders like coagulation defects and severe anaemia 2.
- Women on anti coagulant drugs 3.
- Age more than 18 years 4.
- Willing to use intrauterine device as a treatment option 5.
Uterine pathology of abnormal menstrual bleeding Mullerian anomalies Wants to conceive Vaginal or cervical infection Undiagnosed irregular vaginal bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of LNG IUS in reducing menstrual blood flow in women with haematological disorders At 3 months ,6 months post LNG IUS insertion Measure- PBAC score At 3 months ,6 months post LNG IUS insertion
- Secondary Outcome Measures
Name Time Method 1.Evaluate improvement in hemoglobin levels after LNG IUS insertion 2.To evaluate reduction in requirement of anti hemostatic drugs
Trial Locations
- Locations (1)
AIIMS New Delhi
🇮🇳Delhi, DELHI, India
AIIMS New Delhi🇮🇳Delhi, DELHI, IndiaDr Jai ShreePrincipal investigator9050268841jaishreeyadav328@gmail.com