PMID- 21689371 OWN - NLM STAT- MEDLINE DCOM- 20120203 LR - 20230829 IS - 1538-7836 (Electronic) IS - 1538-7836 (Linking) VI - 9 IP - 8 DP - 2011 Aug TI - Unfractionated heparin for second trimester placental insufficiency: a pilot randomized trial. PG - 1483-92 LID - 10.1111/j.1538-7836.2011.04407.x [doi] AB - 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] < 0.35 MoM) or second trimester (alpha-fetoprotein [AFP] > 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 < 10th percentile, 7 vs. 4; or placental infarction, 4 vs. 3. CONCLUSION: Our study design identified women at high risk of adverse maternal-infant outcomes attributable to placental insufficiency. Women with evidence of placental insufficiency were willing to undergo randomization and self-administration of UFH without increased maternal anxiety. CI - (c) 2011 International Society on Thrombosis and Haemostasis. FAU - Kingdom, J C P AU - Kingdom JC AD - Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Division, Mount Sinai Hospital, Toronto, ON, Canada. jkingdom@mtsinai.on.ca FAU - Walker, M AU - Walker M FAU - Proctor, L K AU - Proctor LK FAU - Keating, S AU - Keating S FAU - Shah, P S AU - Shah PS FAU - McLeod, A AU - McLeod A FAU - Keunen, J AU - Keunen J FAU - Windrim, R C AU - Windrim RC FAU - Dodd, J M AU - Dodd JM LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Thromb Haemost JT - Journal of thrombosis and haemostasis : JTH JID - 101170508 RN - 0 (Anticoagulants) RN - 9005-49-6 (Heparin) SB - IM MH - Adult MH - Anticoagulants/*administration & dosage MH - Anxiety/etiology MH - Feasibility Studies MH - Female MH - Heparin/*administration & dosage MH - Humans MH - Injections, Subcutaneous MH - Middle Aged MH - Ontario MH - Pilot Projects MH - Placental Insufficiency/diagnostic imaging/*drug therapy MH - Pregnancy MH - Pregnancy Outcome MH - Pregnancy Trimester, Second MH - Self Administration/psychology MH - Treatment Outcome MH - Ultrasonography, Doppler MH - Ultrasonography, Prenatal EDAT- 2011/06/22 06:00 MHDA- 2012/02/04 06:00 CRDT- 2011/06/22 06:00 PHST- 2011/06/22 06:00 [entrez] PHST- 2011/06/22 06:00 [pubmed] PHST- 2012/02/04 06:00 [medline] AID - S1538-7836(22)07057-X [pii] AID - 10.1111/j.1538-7836.2011.04407.x [doi] PST - ppublish SO - J Thromb Haemost. 2011 Aug;9(8):1483-92. doi: 10.1111/j.1538-7836.2011.04407.x.