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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.