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. 2022 Jul 25;56(6):976–990. doi: 10.1007/s43441-022-00433-w

Table 1.

MFAET v1.0.

Maternal AEs	Fetal AEs
Hemorrhage in pregnancy	Hemorrhage in pregnancy
Preterm premature rupture of membranes	Preterm premature rupture of membranes
Chorioamnionitis	Chorioamnionitis
Anemia of pregnancy	Anemia of pregnancy
Gestational hypertension	Fetal fluid collection^a
Pre-eclampsia	Fetal bradycardia: non-labor^a
Eclampsia	Fetal tachyarrhythmia^a
Premature labor	Cardiac function abnormalities^a
Puerperal infection	Fetal brain scan abnormal^a
Postpartum hemorrhage (primary)	Fetal gastrointestinal tract imaging abnormal^a
Retained placenta or membranes	Fetal musculoskeletal imaging abnormal^a
Amniotic fluid embolism	Fetal renal imaging abnormal^a
	Fetal movement disorders^a
	Fetal neoplasm^a
	Fetal structural abnormalities: not otherwise classified^a
	Abnormal fetal growth^a
	Fetal intraoperative injury^a
	Procedural hemorrhage^a
	Post-procedural hemorrhage^a

The maternal and fetal AE terms for which definitions and severity grading criteria were developed [49]

^aAdded to the Medical Dictionary for Regulatory Activities terms list