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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

https://www.gfmer.ch/Medical_education_En/Live_birth_definition.htm

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

www.nice.org.uk/guidance/cg107

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

www.nice.org.uk/guidance/cg107

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.