Safety of Fondaparinux as Post Partum Thromboprophylaxis

Зөвхөн бүртгэлтэй хэрэглэгчид л нийтлэл орчуулах боломжтой

Нэвтрэх / Бүртгүүлэх

Холбоосыг санах ойд хадгалдаг

СтатусДууссан

Ивээн тэтгэгчид

National University of Malaysia

ЭМНЭЛ ЗҮЙН ТУРШИЛТ: NCT04447378

BioSeek: nct04447378

Түлхүүр үгс

Хураангуй

Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis.

The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

Тодорхойлолт

All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home

The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.

Огноо

Сүүлд баталгаажуулсан:	05/31/2020
Эхлээд оруулсан:	06/21/2020
Тооцоолсон элсэлтийг оруулсан:	06/21/2020
Эхлээд нийтэлсэн:	06/24/2020
Сүүлийн шинэчлэлтийг оруулсан:	06/23/2020
Сүүлийн шинэчлэлтийг нийтэлсэн:	06/25/2020
Сургалтын бодит эхлэх огноо:	08/31/2017
Тооцоолсон анхан шатны ажил дуусах огноо:	05/31/2018
Судалгааны ажлыг дуусгах өдөр:	05/31/2018

Нөхцөл байдал эсвэл өвчин

Thromboembolism in the Puerperium

Хөндлөнгийн оролцоо / эмчилгээ

Drug: Fondaparinux

Үе шат

Үе шат 4

Arm Groups

Гар	Хөндлөнгийн оролцоо / эмчилгээ
Experimental: Fondaparinux Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis	Drug: Fondaparinux post natal thromboprophylaxis

Эрхийн шалгуур

Суралцах боломжтой нас	18 Years Хэнд 18 Years
Суралцах боломжтой хүйс	Female
Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг	Тийм ээ
Шалгуур үзүүлэлтүүд	Inclusion Criteria: - Malaysian - Age 18 and above - Scores asintermediate risk on 2015 Royal College of Obstetricians & Gynaecologists (RCOG) VTE risk assessment Exclusion Criteria: 1. Hypersensitivity to fondaparinux 2. Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease. 3. Weight < 50 kg 4. Patients with primary postpartum haemorrhage 5. Patients who already on anti - coagulants 6. Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user 7. Uncontrolled hypertension ( blood pressure > 200 mmHg systolic or > 120 mmHg diastolic )

Үр дүн

Анхан шатны үр дүнгийн арга хэмжээ

1. Venous thromboembolism (VTE) [Within six weeks of delivery]

VTE occurence of either deep vein thrombosis or pulmonary embolism

Хоёрдогч үр дүнгийн арга хэмжээ

1. Major Bleeding requiring hospitalisation [within six weeks of delivery]

Secondary post partum haemorrhage or spinal site bleeding

2. Minor bleeding [within six weeks of delivery]

Wound site bleeding, skin bruising

3. Allergic reaction [within 24 hours from last injection]

Any allergy symptoms following injection of fondaparinux

4. Neonatal bleeding tendency [within six weeks of delivery]

Any bruising of bleeding tendency in neonates

Safety of Fondaparinux as Post Partum Thromboprophylaxis

Түлхүүр үгс

heparin

hemorrhage

hypersensitivity

pulmonary embolism

embolism

venous thrombosis

thrombosis

thrombophilia