Unfractionated heparin for second trimester placental insufficiency: a pilot randomized trial

• Published in: Journal of thrombosis and haemostasis 2011-08, Vol.9 (8), p.1483-1492
• Main Authors: KINGDOM, J. C. P., WALKER, M., PROCTOR, L. K., KEATING, S., SHAH, P. S., MCLEOD, A., KEUNEN, J., WINDRIM, R. C., DODD, J. M.
• Format: Article
• Language: English
• Subjects: Adult; Anticoagulants - administration & dosage; Anxiety - etiology; birth weight; clinical trials; Doppler ultrasound; Feasibility Studies; Female; Heparin - administration & dosage; Humans; Injections, Subcutaneous; Middle Aged; Mortality; Ontario; Pilot Projects; placental insufficiency; Placental Insufficiency - diagnostic imaging; Placental Insufficiency - drug therapy; placental pathology; placental ultrasound; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Second; randomized control trial; Risk factors; Self Administration - psychology; thromboembolism; Treatment Outcome; Ultrasonography, Doppler; Ultrasonography, Prenatal; unfractioned heparin
• ISSN: 1538-7933; 1538-7836; 1538-7836
• DOI: 10.1111/j.1538-7836.2011.04407.x

Objective: To conduct a pilot randomized controlled trial of unfractionated heparin (UFH) in women considered at high risk of placental insufficiency in the second trimester. Methods: Women with either false‐positive first trimester (pregnancy‐associated placental protein‐A [PAPP‐A]  2.0 MoM, inhibin > 3.0 MoM, human chorionic gonadotropin > 4.0 MoM) serum screening tests or medical/obstetric risk factors were screened for placental insufficiency by sonographic evaluation of the placenta and uterine artery Doppler between 18 and 22 weeks. Thrombophilia screen‐negative women with two or three abnormal test categories were randomized by 23+6 weeks to self‐administration of subcutaneous unfractionated heparin (UFH) 7500 IU twice daily until birth or 34 weeks, or to standard care. Maternal anxiety and other maternal‐infant outcomes were determined. Results: Thirty‐two out of 41 eligible women consented, with 16 women randomized to UFH and 16 to standard care. There was no statistically significant difference identified between the two treatment groups (standard care vs. UFH) for the following: maternal anxiety score (mean [standard deviation]), 14.2 [± 1.6] vs. 14.0 [± 1.8]; birth weight (median [range]), 1795 [470–3295]g vs. 1860 [730–3050]g; perinatal death, 3 vs. 0; severe preeclampsia, 2 vs. 6; placental weight