Clinical trial NCT01588171: Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
Official title: Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolic Diseases
Keywords: Deep vein thrombosis
Pulmonary embolism
Low molecular weight heparin
Enoxaparin
Bemiparin
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 7020
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis.

Detailed description: Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery

Eligibility criteria: Inclusion Criteria:

* Presence of risk factors for venous thromboembolism
* Any parity
* Mode of delivery:vaginal, Emergency and Elective Caesarean section
* No any contraindications for Heparin

Exclusion Criteria:

* Active antenatal or postpartum vaginal bleeding.
* Placenta previa
* Thrombocytopenia
* Sever renal or liver diseases
* Uncontrolled sever hypertension
* Any patient who is already on Heparin during pregnancy

Primary outcomes:
measure: Venous thromboembolism
timeFrame: 40 days after delivery
Secondary outcomes:
measure: adverse effects
timeFrame: after receiving the injections and till 40 days
Other outcomes:
Locations:
city: Erbil city
country: Iraq
facility: Hawler medical university
state: Kurdistan region
city: Erbil
country: Iraq
facility: Hawler medical university
state: Kurdistan region
Study officials:
affiliation: Hawler Medical University
name: Shahla K. Alalaf, Ass.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawler Medical University
name: Rojan K. Jawad, High Diploma
role: STUDY_CHAIR
affiliation: Hawler Medical University
name: Parez R. Muhammad, High Diploma
role: STUDY_CHAIR
affiliation: Hawler ministry of Health, Directorate of Health
name: Mahabad S. Ali, High Diploma
role: STUDY_CHAIR
affiliation: Hawler Medical University
name: Namir G. Al Tawil, Professor
role: STUDY_DIRECTOR
References:
citation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
citation: Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.