临床试验雷达

Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.

Neonatal birth weight (grams) will be measured using a digital infant weighing scale within 24 hours of birth. Birth weight will be converted into WGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low WGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with WGAZ \< -2 SD

Within 24 hours of delivery

Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.

Neonatal birth height (cm) will be measured using a standardized neonate's height scale within 24 hours of birth. Birth height will be converted into LGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low LGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with LGAZ \< -2 SD

Within 24 hours of delivery

Gestational age at delivery

Gestational age will be determined based on first-trimester ultrasound and/or last menstrual period (LMP). Unit of Measure: Weeks

At delivery date

Mode of delivery

Mode of delivery will be recorded as vaginal or cesarean section. Unit of Measure: Percentage (%) of cesarean deliveries

At delivery

Maternal serum ferritin concentration

Maternal serum ferritin will be measured using standardized immunoturbidimetric assay on an automated chemistry analyzer. Unit of Measure: ng/mL

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Maternal serum folate concentration

Maternal serum folate will be measured using standardized laboratory assay on automated immunoassay analyzer.

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Maternal serum 25-hydroxyvitamin D concentration

Maternal serum 25-hydroxyvitamin D concentration will be measured using standardized laboratory assay on automated immunoassay analyzer. Unit of Measure: ng/mL

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Generalized anxiety symptoms

Maternal mental health will be assessed using a validated psychological questionnaires Generalized Anxiety Disorder-7 (GAD-7) for assessing generalized anxiety symptoms over the past two weeks. Unit of Measure: The scale comprises 7 items, each rated on a 4-point Likert scale from 0 (not at all) to 3 (almost every day), with a total score ranging from 0 to 21. Interpretation: A score of 15 or higher is indicative of severe anxiety.

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Maternal gut microbiome alpha diversity

Alpha diversity of maternal gut microbiome will be assessed using 16S rRNA gene sequencing of stool samples. Unit of Measure: Shannon diversity index

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Placental gene expression levels

Placental gene expression will be quantified using RNA sequencing. Expression levels will be reported as normalized transcript counts. Unit of Measure: Normalized transcript counts

At delivery

Estimated fetal weight during pregnancy

Estimated fetal weight will be calculated using ultrasound biometric measurements according to standard obstetric formulas. Unit of Measure: Grams

Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Perceived stress score

Perceived Stress Scale-10 (PSS-10) to assess perceived stress over the past month. Unit of Measure: The scale consists of 10 items, each rated on a 5-point Likert scale from 0 (never) to 4 (very often), with a total score ranging from 0 to 40. Interpretation: A score of 27 or higher indicates higher perceived stress.

Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).

Postnatal depression symptoms

Edinburgh Postnatal Depression Scale (EPDS) to assess postnatal depression symptoms over the past week. Unit of Measure: The scale comprises 10 items, each rated on a 4-point Likert scale from 0 (no) to 3 (yes), with a total score ranging from 0 to 30. Interpretation: A score of 13 or greater is indicative of postnatal depression.

Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).

Depression symptoms

Patient Health Questionnaire-9 (PHQ-9) to assess depression symptoms over the past two weeks. Unit of Measure: The scale consists of 9 items, each rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Interpretation: A score of 10 or greater indicates moderate to severe depression.

Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).

Combined Depression, Anxiety, and Stress score

Depression, Anxiety, and Stress Scale-21 (DASS-21) to Assesses depression, anxiety, and stress over the past week. Unit of Measure: The scale consists of 21 items, divided into three subscales, each rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me most of the time). Each subscale score is multiplied by 2 to match the original DASS-42 format. Interpretation: A score of 14 or greater is indicative of moderate to severe depression, anxiety, and stress.

Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).