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Table 1 Previously identified trials that meet the inclusion criteria for AFFIRM

From: Low-molecular-weight heparin for prevention of placenta-mediated pregnancy complications: protocol for a systematic review and individual patient data meta-analysis (AFFIRM)

Study name & first author Year Country & sample size Participants Intervention & control Outcomes Commitment to participate in IPDMA
TIPPS* [30] Rodger 2013 Canada, Multinational N = 292 Thrombophilia + previous high risk criteria Dalteparin 5000 IU to 20 wks then 10,000 IU to 36 wks vs no Dalteparin PE, SB, abruption, SGA <10th percentile Yes
FRUIT [20] de Vries 2012 Netherlands, Multinational N = 139 Prior early onset PE (n = 107) and/or SGA <10th percentile (n = 94) Dalteparin 5000 IU + ASA vs ASA PE prior to 34 weeks GA Yes
HAPPY [25] Martinelli 2012 Italy, Multi-center N = 135 Prior PE (n = 52), prior loss >15 weeks (n = 49), prior SGA <10th percentile (n = 28) or prior abruption (n = 5) Nadroparin 3800 IU vsno Nadroparin PE, Loss >15 weeks GA, SGA <10thpercentile and/or abruption Yes
NOH-PE [21] Gris 2011 France, Single center N = 224 Prior severe PE (n = 224) Enoxaparin 4000 IU + ASA vs ASA PE, SB, abruption, SGA <5th percentile Yes
NOH-AP [24] Gris 2010 France, Single center N = 160 Prior abruption (n = 160; 70 with PE) Enoxaparin 4000 IU+/−ASA vs +/−ASA PE, SB, abruption, SGA <5thpercentile Yes
Rey [23] 2009 Canada, Multi-center N = 116 Prior early PE (n = 60), prior abruption (n = 16), prior SGA <5th percentile (n = 21), loss >12 weeks (n = 17) Dalteparin 5000 IU+/−ASA vs +/−ASA PE, SB, abruption, SGA <5th percentile Yes
Mello [22] 2005 Italy, Single center N = 80 Prior PE with ACE DD (n = 80) Dalteparin 5000 IU vsno Dalteparin PE, SGA <10th percentile Unable to contact
  1. ASA = aspirin; GA = gestational age; IPDMA = individual patient data meta-analysis; IPDMA = individual patient data meta-analysis; PE = pre-eclampsia; RCT = randomized controlled trial; SB = stillbirth; SGA = small-for-gestational age.
  2. Trial Names:
  3. TIPPS = Thrombophilia In Pregnancy Prophylaxis Study *accepted for publication in the Lancet.
  4. FRUIT = FRactionated heparin in pregnant women with a history of Utero-placental Insufficiency and Thrombophilia.
  5. NOH-AP = Nîmes Obstetricians and HAematologist – abruptio placentae.
  6. NOH-PE = Nîmes Obstetricians and HAematologist - pre-eclampsia.
  7. HAPPY = Heparin in pregnant women with Adverse Pregnancy outcome to improve the rate of successful PregnancY.
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