In women with unexplained recurrent abortion, is prophylactic use of low dose aspirin and Calheparin more effective than no treatment in increasing the number of patients who complete their first trimester?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000698673
• Date of registration: 02/07/2014
• Prospective Registration: No
• Primary sponsor: Ahmed Maged
• Public title: In women with unexplained recurrent abortion, is prophylactic use of low dose aspirin and Calheparin more effective than no treatment in increasing the number of patients who complete their first trimester?
• Scientific title: In women with unexplained recurrent abortion, is prophylactic use of low dose aspirin and Calheparin more effective than no treatment in increasing the number of patients who complete their first trimester?
• Date of first enrolment: 01/06/2011
• Target sample size: 180
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000698673.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Dr Ahmed Maged

• Name: Dr Ahmed Maged

Key inclusion & exclusion criteria

Inclusion criteria: 1. Gestational age 5-7 weeks
2. history of three or more spontanous abortions without an obvious cause
Exclusion criteria: 1. Participants with documented cause of recurrent abortion as antiphospholipid syndrome
2. history of thrombo-embolic manifestations
3.medical disorder as diabetes or hypertension
4. chronic disorder like renal cardiac or liver disease
5.those with structural anomalies of the uterus

Age minimum: 19 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

unexplained recurrent abortion;
unexplained recurrent abortion

Reproductive Health and Childbirth - Abortion

Intervention(s)

180 pregnant women with history of recurrent unexplained pregnancy loss classified into 2 groups Group 1 included 90 women received low dose aspirin orally 75 mg once daily and heparin 5000 IU subcutaneous every 12 hours started at 8 weeks gestation till the end of 12th week. Group 2 included 90 women received no treatment. Monitoring adherence to treatment was done by counting drug tablets return and counting number of used syringes every 2 weeks

Primary Outcome(s)

number of patients who completed their first trimester [12 weeks pregnancy]

Secondary Outcome(s)

complications of treatment e.g Transient thrombocytopenia, Gastrointestinal troubles, Bruising at injection site, Epistaxis and bleeding gums. Complications were assessed by patients symptoms and examinations. [12 weeks pregnancy]

Secondary ID(s)

nil

Source(s) of Monetary Support

Ahmed Maged

Secondary Sponsor(s)

Aly Abdlhafiz