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Table 1 Outcomes

From: ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial

Primary efficacy outcome

Live birth (defined as birth of a living child)

Principal safety outcome

Clinically relevant bleeding (that is major bleeding and clinically relevant non-major bleeding)

Secondary study outcomes

Ā 

Efficacy

Ongoing pregnancy beyond 12 weeksā€™ gestation

Preeclampsiaab

HELLP syndromeac

Intrauterine growth restrictionad

Placental abruptionae

Premature birthaf

Intra-uterine fetal deatha

Major congenital anomaliesag

Composite of confirmed deep vein thrombosis and confirmed pulmonary embolismh

Safety

Post-partum bleeding and severe post-partum bleeding

Major bleeding

Clinically relevant non-major bleeding

Minor bleeding, including increased tendency to bruising not fulfilling the criteria for clinically relevant non-major bleeding

Heparin-induced thrombocytopenia (defined according to ACCP criteria [24])

Allergic reactions (redness or itching) localized at the injection site of LMWH

Type 1 allergy: e.g. generalized symptoms including anaphylaxis

  1. aDenominator for these outcomes is ongoing pregnancies beyond 12 weeksā€™ gestation.
  2. bPreeclampsia is defined as hypertension (systolic blood pressure ā‰„ 140 mmHg and/or diastolic blood pressure ā‰„ 90 mmHg after 20 weeksā€™ gestation, measured twice in a previously normotensive woman) with new-onset proteinuria at or beyond 20 weeksā€™ gestation.
  3. cHELLP syndrome is defined as a platelet count less than 100 * 109/L and aspartate aminotransferase of 70 U/L or greater and lactate dehydrogenase of 600 U/L or greater.
  4. dIntra uterine growth restriction is defined as birth weight < 10th percentile for gestational age.
  5. ePlacental abruption (also known as abruptio placentae) is a complication of pregnancy, wherein the placental lining has separated from the uterus of the mother. Diagnosis according to clinical criteria (vaginal bleeding and uterine tenderness in combination with fetal distress necessitating prompt delivery) and examination of the placenta.
  6. fPremature birth is defined as birth < 37 weeksā€™ gestation.
  7. gMajor physical anomalies are defined as physical anomalies that have cosmetic or functional significance.
  8. hDeep vein thrombosis and pulmonary embolism are defined as abnormal compression ultrasound or an intraluminal filling defect on venography (deep vein thrombosis), or an intraluminal filling defect on spiral computed tomography (CT) scan, cut-off of vessels more than 2.5 mm in diameter on pulmonary angiogram or a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (pulmonary embolism).
  9. Criteria for bleeding are listed in TableĀ 2.
  10. ACCP, American College of Chest Physicians; LMWH, low-molecular-weight heparin.
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