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. 2021 Nov 26;3:672446. doi: 10.3389/frph.2021.672446

Table 1.

Definitions of pregnancy outcomes, infant outcomes, and pregnancy complications for the DELIVER Study and this systematic review and meta-analysis.

Category Outcome DELIVER study definition Outcome specific exclusion criteria for systematic review & analysis
Pregnancy Outcome Pregnancy loss Pregnancy loss ≥12 weeks and <20 0/7 weeks •Includes induced abortions only or unable to exclude induced abortions from prevalence estimate
Stillbirth Pregnancy loss ≥20 0/7 weeks, including stillbirth and fetal demise •Reports term stillbirths only
•Includes deaths that occurred shortly after birth
Preterm live birth Birth before 37 0/7 weeks, live birth only •Studies enrolling mothers/infants into prospective follow-up weeks after birth (survival bias)
Infant Outcome Congenital anomaly Major anomalies that would be detectable at birth or within the first 28 days, including but not limited to polydactyly, craniofacial defects, neural tube defects/hydrocephalus, anencephaly, heart defects, inguinal/umbilical hernia, micrognathia, and cleft lip/palate n/a
Low birthweight <2,500g •Only includes full-term infants
•Different definition (ex: <2,000 g) or ascertainment (self-report, measurement of chest and head circumference)
•Studies enrolling mothers/infants after birth (survival bias)
Neonatal Mortality Deaths in the first 28 days of life (Days 0–27)
•Studies that only reported perinatal (stillbirth + early neonatal deaths) or early neonatal deaths (ex: <7 days, <14 days)
•Only enrolled and reported mortality among healthy newborns
Pregnancy Complication Chorioamnionitis Clinical diagnosis following the following grading criteria:
Grade 1: Fever of 100.4°F−100.9°F with more than one of the following: FHR > 160 BPM, maternal HR > 120, uterine tenderness between contractions, purulent AF, or preterm labor
Grade 2: Grade 1 plus fever of 101°F−104°F
Grade 3: Grade 2 plus fetal distress or fever > 104°F
Grade 4: Grade 3 plus fetal demise or maternal symptoms of shock
n/a
Endometritis Puerperal sepsis and endometritis following the following grading criteria:
Grade 0: None
Grade 1: Low grade fever and uterine tenderness, resolved with oral antibiotics
Grade 2: Moderate symptoms, treated by ≤ 3 days of parenteral antibiotics
Grade 3: Severe symptoms treated with > 3 days of IV antibiotics or addition of heparin
Grade 4: Severe infection or infection for which operative intervention is indicated

•Studies using the term “puerperal sepsis” unless further defined or included endometritis/clinical features in definition
Postpartum Hemorrhage Grade 1: EBL 500–1,000 mL for vaginal delivery or 1,000–1,500 mL for Cesarean section (CS) or reported as slightly increased
Grade 2: EBL > 1,000 mL or vaginal delivery or > 1,500 mL for CS, with or without mild dizziness, no transfusion required
Grade 3: Hemorrhage at a level for which transfusion of 1–2 units of packed cells, but no other blood products indicated
Grade 4: Hemorrhage with shock or coagulopathy, for which transfusion of > 2 units of packed cells or any amount of other blood components is indicated
•Studies with self-report of hemorrhage (applied at first round of inclusion/exclusion)
Gestational hypertension Gestational hypertension
•Studies reporting women with chronic hypertension or unspecified hypertension
Preeclampsia/ Eclampsia Preeclampsia or Eclampsia n/a
PPROM PPROM n/a