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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.