title: Unfractionated heparin for second trimester placental insufficiency: a pilot randomized trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Division, Mount Sinai Hospital, Toronto, ON, Canada. jkingdom@mtsinai.on.ca
authors.forename: J C P
authors.initials: JC
authors.lastname: Kingdom
authors.forename: M
authors.initials: M
authors.lastname: Walker
authors.forename: L K
authors.initials: LK
authors.lastname: Proctor
authors.forename: S
authors.initials: S
authors.lastname: Keating
authors.forename: P S
authors.initials: PS
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: McLeod
authors.forename: J
authors.initials: J
authors.lastname: Keunen
authors.forename: R C
authors.initials: RC
authors.lastname: Windrim
authors.forename: J M
authors.initials: JM
authors.lastname: Dodd
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage*; D001007:Anxiety / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D009864:Ontario; D010865:Pilot Projects; D010927:Placental Insufficiency / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D012646:Self Administration / Q000523:psychology; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D016216:Ultrasonography, Prenatal
chemical_list: D000925:Anticoagulants; D006493:Heparin