drugset / Trial / NCT02144064

Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin

NCT02144064

Phase 3 Unknown 200 enrolled Benha University
RandomizedSingle-groupSingle-blindPrevention

Summary

Objective To determine maternal and fetal outcomes in women with Unexplained RPL managed with aspirin or unfractionated heparin (UFH) plus aspirin during pregnancy. Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha university hospital. Methods: Pregnant women with unexplained recurrent miscarriage attending high-risk pregnancy unit. 200 selected patients with previous unexplained recurrent miscarriage are divided into 2 groups: group A (n = 100) receive low-dose aspirin (81 mg once daily orally) plus heparin (5000 IU) every 12 h with the first positive pregnancy test while group B (n = 100) receive no thing . Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic complications and pregnancy-induced hypertension .Prematurity, intrauterine growth restriction and neonatal death were considered as maternal and fetal complications

Timeline

Start
2019-06-23
Primary completion
2022-10
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 81 mg Oral
Comparator Heparin Other / unclassified 5000 iu Subcutaneous