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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02326051
Date of registration:	22/12/2014
Prospective Registration:	No
Primary sponsor:	Mohamed Sayed Abdelhafez
Public title:	Timing of Initiation of LMWH Administration in Pregnant Women With APS
Scientific title:	Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
Date of first enrolment:	December 2014
Target sample size:	100
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02326051
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Egypt

Contacts

Name:	Ahmed Badawy, Prof
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Mohamed S Abdelhafez, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Waleed El-refaie, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Ahmed El-Zayadi, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Mohamed I Eid, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant women with APS diagnosed according to the revised classification criteria for
APS in 2006 in Sydney, Australia

- Early pregnancy body weight is 50-90 Kg

Exclusion Criteria:

- Women with systemic lupus erythematosus (SLE)

- Women with active thromboembolic disorders

- Women with history of previous thromboembolic disorders

Age minimum: 20 Years
Age maximum: 38 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Recurrent Miscarriage

Antiphospholipid Syndrome

Intervention(s)

Drug: Enoxaparin

Primary Outcome(s)

Ongoing pregnancy rate [Time Frame: After 12 weeks gestational age]

Secondary Outcome(s)

Preterm delivery [Time Frame: From 20 weeks to 34 weeks gestational age]

Intrauterine growth restriction (IUGR) [Time Frame: At birth]

Congenital fetal malformations [Time Frame: At birth]

Fetal loss [Time Frame: From 20 weeks to 42 weeks gestational age]

Secondary ID(s)

MIE2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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