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Table 3 Definitions of primary and secondary outcomes in the OTTILIA and FIRST registries

From: Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries

  Definitions Source
Clinical pregnancy A pregnancy confirmed by ultrasonographic visualization of gestational sac or fetal heartbeat Wang X et al. Fertil Steril 2003; 79: 577–9.
Live birth The delivery of a live newborn
Pregnancy loss (PL) A loss occurring ≤20 weeks Regan L. BMJ 1991; 302: 543–4
Intrauterine fetal death (IUFD) A loss occurring after 20 weeks Royal College of Obstetricians & Gynaecologists. Late intrauterine fetal death and stillbrith (Green-top Guideline 55). London: Royal College of Obstetricians & Gynaecologists; 2010 [cited 2019 May 30]
Preterm birth The delivery of an infant before completion of 37 weeks gestation ACOG Committee Opinion No 579: definition of term pregnancy. Obstet Gynecol. 2013;122: 1139–40
Gestational hypertension (GH) Blood pressure ≥ 140/90 mmHg after 20 weeks of gestation in a previously normotensive woman
Preeclampsia Blood pressure ≥ 140/90 mmHg and proteinuria of 0.3 g or more in a 24-h urine specimen occurring after 20 weeks of gestation in a previous normotensive woman
HELLP syndrome Thrombocytopenia (i.e. platelet count < 150,000 cells/μL), elevated AST and/or ALT (> 40 IU/L), increased LDH (>  600 IU/L), and hemolysis (increased LDH level) Martin JN et al. Am J Obstet Gynecol 1999; 180: 1373–84.
Small-for-gestational age (SGA) newborns Apparently healthy neonate with birthweight <10th centile for gestational age in the absence of infection and maternal drug or alcohol abuse RCOG. The investigation and management of the small–for–gestational–age fetus. Green-top Guideline. 2nd ed.; 2014
Placental abruption The early separation of the placenta from the uterus Ananth CV, et al. Am J Obstet Gynecol. 2016;214: 272
Ovarian hyperstimulation syndrome (OHSS) An exaggerated systemic response to ovarian stimulation with a wide spectrum of clinical and laboratory manifestation. According to the degree of manifestations it is classified as mild, moderate, or severe. Humaidan P, et al. Hum Reprod. 2016;31: 1997–2004
Venous thromboembolism (VTE) Deep vein thrombosis (DVT), defined as a blood clot in deep veins of the legs with or without pulmonary embolism (PE). DVT is diagnosed if confirmed by Doppler ultrasound exam. PE diagnosis is confirmed by ventilation-perfusion lung scanning, angiography, or computed tomography.
Pregnancy-related VTE is defined as a VTE occurring during the pregnancy or in the puerperium (within 6 weeks after delivery).
Kearon C, et al., Chest 2012; 141 (2 Suppl): e419S-e496S.
Hemorrhage. Bleeding events. They are classified as major or minor according the ISTH criteria. Wound hematoma in case of caesarean section Schulman S, J Thromb Haemost 2005; 3: 692–4.