Tranexamic acid with norethisterone versus tranexamic acid alone in treatment of vaginal bleeding during dengue infection

Efficacy of the combination of oral tranexamic acid with oral norethisterone versus oral tranexamic acid alone in treatment of bleeding per vagina during dengue infection - A single blinded,randomized controlled study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2017/037

Enrollment

Unknown

Registered

2017-10-16

Start date

2017-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue

Interventions

Study setting: The study will be conducted in all female medical wards in National Institute of Infectious Disease, IDH, Angoda. Method of randomization: After recruiting in to the study all patient

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients aged over 18 years 2. Confirmed to have dengue infection (either by dengue NS1 antigen test or by the presence of dengue specific IgM antibodies(rapid strip tests) ) 3. Presence of bleeding per vagina (including menstrual bleeding, inter menstrual bleeding or peri-menopausal bleeding)

Exclusion criteria

Exclusion criteria: 1. Patients who are too ill to give consent 2. Patients who already have per vaginal bleeding on admission. 3. Pregnant dengue patients 4. Patients with per vaginal bleeding due to loss of undetected pregnancy (confirmed by urine hCG strip test) 5. Past history of thrombo-embolic events including myocardial infarction (MI), transient ischaemic attack (TIA), Cerebro-vascular attack (CVA), pulmonary embolism (PE), deep vein thrombosis (DVT), and disseminated intravascular coagulation (DIC). 6. History of convulsions. 7. Women who have reached menopause. 8. Known clotting disorders. 9. Anti-coagulant treatment. 10. History of liver tumors, gynaecological or breast cancers

Design outcomes

Primary

Measure	Time frame
Reduction in the quantity of per vaginal bleeding assessed using Pictorial Blood loss Assessment Charts (PBACs) by asking the patient to mark the pattern of soiling (Higham et al, 1990). The soiling will be scored on a 10 point scale. Presence of clots > 1cm will be given a score of 5 points. 100 points in this scoring system will be considered equal to 80ml of blood loss. When the score exceeds this level during the period it will be considered heavy menstrual bleeding. [Daily until cessation of per vaginal bleeding.] Reduction in the duration of per vaginal bleeding by 35% or more in those who are treated with the combination of tranexamic acid and norethisterone compared to those who are treated with tranexamic acid alone. The first day of bleeding will be defined as the day in which patient develops vaginal bleeding or starts passing clots. Cessation of bleeding will be considered when the patient free of bleeding for 24 hours. Patient will be re-assessed at 24 hours after bleeding ceases. [ Daily until cessation of per vaginal bleeding.]	—

Measure

Time frame

Reduction in the quantity of per vaginal bleeding assessed using Pictorial Blood loss Assessment Charts (PBACs) by asking the patient to mark the pattern of soiling (Higham et al, 1990). The soiling will be scored on a 10 point scale. Presence of clots > 1cm will be given a score of 5 points. 100 points in this scoring system will be considered equal to 80ml of blood loss. When the score exceeds this level during the period it will be considered heavy menstrual bleeding. [Daily until cessation of per vaginal bleeding.] Reduction in the duration of per vaginal bleeding by 35% or more in those who are treated with the combination of tranexamic acid and norethisterone compared to those who are treated with tranexamic acid alone. The first day of bleeding will be defined as the day in which patient develops vaginal bleeding or starts passing clots. Cessation of bleeding will be considered when the patient free of bleeding for 24 hours. Patient will be re-assessed at 24 hours after bleeding ceases. [ Daily until cessation of per vaginal bleeding.]

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Secondary

Measure	Time frame
Requirement of blood transfusions: It will be decided by the treating physician, based on the Sri Lanka National Guidelines on Management of Dengue Fever and Dengue Haemorrhagic Fever In Adults by Ministry of Health. [Daily until recovery: The day of recovery will be defined when all of the following 3 criteria are fulfilled: 1. Patient afebrile for 24 hours 2. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value 3. Return of the haematocrit to the patients baseline ] Duration of illness: The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all of the following 3 criteria are fulfilled: i. Patient afebrile for 24 hours ii. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value iii. Return of the haematocrit to the patient's baseline [Daily until recovery]	—

Measure

Time frame

Requirement of blood transfusions: It will be decided by the treating physician, based on the Sri Lanka National Guidelines on Management of Dengue Fever and Dengue Haemorrhagic Fever In Adults by Ministry of Health. [Daily until recovery: The day of recovery will be defined when all of the following 3 criteria are fulfilled: 1. Patient afebrile for 24 hours 2. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value 3. Return of the haematocrit to the patients baseline ] Duration of illness: The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all of the following 3 criteria are fulfilled: i. Patient afebrile for 24 hours ii. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value iii. Return of the haematocrit to the patient's baseline [Daily until recovery]

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Countries

Sri Lanka

Contacts

Public ContactDr. Ananda Wijewickrama

Visiting Physician

anandawijewickrama@hotmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026