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Table 1 Patient characteristics collected within the VR FETUS study. Details of data collection form the first trimester up to 6 weeks after delivery are depicted

From: First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial

Maternal Characteristics

Outcome

Age

Years (mean ± SD)

Ethnicity

Dutch/Other western/Non-western

Level of education

Low, middle, high

Postal code

 

Medical history

Unremarkable/Diabetes/Epilepsy/Other

Obstetrical history

Parity, miscarriage, previous pregnancy with congenital anomaly

Family history

Unremarkable/family members with congenital anomaly

Marital status

Married/not married

Global household income

€0–20.000/€20.000–35.000/€35.000–65.000/>€65.000 annually

BMI

Kg/m2 (mean ± SD)

Alcohol use during first trimester

No/Yes: how many units per day?

Smoking during first trimester

No/yes: how many cigarettes per day

Recreational drug use during first trimester

No/yes: what drugs; frequency per day?

Folic acid use during and/or prior to pregnancy

No/yes during pregnancy/yes started prior to pregnancy

Pregnant after artificial reproductive technology

No/yes: what type of assisted reproduction

First trimester screening for aneuploidy

No/yes: result

Medication

No/yes: what medication, dosage, starting and stopping date?

Antidepressant

Never/yes currently/yes previous use

Questionnaires

Timing

Current health statusa

At inclusion, intervention or 13 weeks’ GA, 20 weeks’ GA, 6 weeks after due date

Anxiety and depressionb

At inclusion, intervention or 13 weeks’ GA, 20 weeks’ GA, 6 weeks after due date

State and trait anxietyc

At inclusion, intervention or 13 weeks’ GA, 20 weeks’ GA, 6 weeks after due date

Current health status by VASd

At inclusion, intervention or 13 weeks’ GA, 20 weeks’ GA, 6 weeks after due date

Medical consumptione

At 20 weeks’ GA, 32 weeks’ GA, 6 weeks after due date

Patient satisfaction with 3D VR

At intervention or 13 weeks’ GA, 6 weeks after due date

Ultrasound

Measurements

At inclusion, 1st trimester

Viability, CRL, multiple pregnancies, location

Intervention: 2D + 3D VR First Trimester Ultrasound, 1st trimester

Fetal anomaly scan using 2D and 3D VR. Growth parameters, detection of anomaly. See supplement A

Advanced fetal anomaly scan, 2nd trimester

Fetal anomaly scan using 2D. Growth parameters, detection of anomaly

Pregnancy outcome

Outcome

Outcome

Live birth, termination, intra-uterine fetal demise

Mode of delivery

Vaginal / Instrumental delivery / Cesarean section

Gestational age at delivery

Days (mean ± SD)

Invasive testing

No/yes: result

Date of invasive testing

 

Neonatal outcome

Outcome

Birthweight

Birthweight, grams (mean ± SD)

Gender

Male/female

Congenital malformation

No/yes: what malformation

Prenatal diagnosis

Confirmed/discrepancy in findings: postnatal new or other findings

  1. aSF-36: MOS 36-item Short Form Health Survey, bHADS: Hospital Anxiety and Depression Scale, cSTAI: Spielberger State-Trait Anxiety Inventory, dVAS: visual analogue scale, eiMTA MCQ: iMTA Medical Consumption Questionnaire, CRL: Crown-Rump Length, 2D: two-dimensional, 3D VR: three-dimensional virtual reality