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Table 2 Potentially eligible published trials identified by AFFIRM’s systematic review

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 Relevant outcomes Comment re: inclusion in IPDMA
ETHIG II *Schleussner [35] Abstract 2013 Germany N = 449 Recurrent pregnancy loss Dalteparin 5000 IU + vitamins vs multivitamins Intact pregnancy at 24 wks GA; PE; IUGR <5th percentile; abruption Yes
Giancotti [36] 2012 Italy N = 167 (pregnant) Recurrent pregnancy loss Enoxaparin 40 mg vs Enoxaparin 40 mg + ASA vs ASA Live births Not eligible (All losses <12 weeks GA)
Salman [37] Abstract 2012 Egypt N = 150 Recurrent pregnancy loss Tinzaparin 4500 IU vs folic acid Continuation of pregnancy after 20 weeks Not eligible (All women with early losses)
HABENOX [38] Visser 2011 Finland, Sweden, Netherlands N = 207 Women with recurrent early or late miscarriage Enoxaparin 40 mg vs Enoxaparin 40 mg + ASA vs ASA Live birth rate; PE; IUGR <2 SD; abruption Yes
SPIN [39] Clark 2010 UK, New Zealand N = 294 Recurrent pregnancy loss Enoxaparin 40 mg + ASA vsno drug Pregnancy loss GA of past losses not available centrally
ALIFE [40] Kaandorp 2010 Netherlands N = 299 (pregnant) Recurrent pregnancy loss Nadroparin 2850 IU + ASA vs ASA vs placebo Pregnancy loss, SGA <10th percentile; PE; HELLP; abruption Yes
HepASA [41] Laskin 2009 Canada N = 88 Terminated at interim analysis Recurrent pregnancy loss Dalteparin 5000 IU + ASA vs ASA Live births Unable to contact
  1. ASA = aspirin; GA = gestational age; HELLP = HELLP syndrome (hemolysis, elevated liver enzymes, low platelet count); IPDMA = individual patient data meta-analysis; IUGR = intrauterine growth restriction; PE = pre-eclampsia; SB = stillbirth; SGA = small-for-gestational age.
  2. Trial Names:
  3. SPIN = Scottish Pregnancy Intervention Study; HepASA = Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss.
  4. ALIFE = Anticoagulants for Living Fetuses.
  5. HABENOX = Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion.
  6. ETHIG II = Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss *final results in preparation for publication.