Table 2.
Potentially eligible published trials identified by AFFIRM’s systematic review
| 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 |
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.
Trial Names:
SPIN = Scottish Pregnancy Intervention Study; HepASA = Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss.
ALIFE = Anticoagulants for Living Fetuses.
HABENOX = Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion.
ETHIG II = Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss *final results in preparation for publication.