- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Bagkeris, 2015	prospective cohort	Not specified.	Linked data anonymised by use of study serial numbers are collected on study-specific questionnaires and include delivery (mother and neonate) characteristics.	Adjusted for study centre, antenatal ART, history of injecting drug use, social deprivation index, parity, WHO HIV stage, maternal age, and calendar time.
Bérard (Controls exposed to other ARV), 2017	population based cohort propective	The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration).	The Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives [MedEcho; Le ministère de la Santé et des Services sociaux du Québec (MSSS), Quebec, Canada)] databases.	No adjustment for this group of exposure.
Bérard (Controls unexposed, disease free), 2017	population based cohort propective	The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration).	The Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives [MedEcho; Le ministère de la Santé et des Services sociaux du Québec (MSSS), Quebec, Canada)] databases.	No adjustment for this group of exposure.
Bérard (Controls unexposed, sick), 2017	population based cohort propective	The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration).	The Régie de l’assurance maladie du Québec (RAMQ) and the Quebec hospitalization archives [MedEcho; Le ministère de la Santé et des Services sociaux du Québec (MSSS), Quebec, Canada)] databases.	No adjustment for this group of exposure.
Brogly, 2010	prospective cohort	Not specified.	Physical examinations performed at regular study visits. In protocol 219, birth defects were recorded on diagnosis case report forms. Protocol 219C included a direct question regarding birth defects. Clinicians blinded to ARV exposure classified the defects as major defects or conditional defects.	Adjusted for participation in a PACTG perinatal study, 1st trimester folate antagonist exposure and year of birth. Potential confounders with a p-value <0.25 in univariate analysis were initially included in adjusted models, but only those that produced at least a 10% change in the estimated odds ratio were retained in final models.
Calitri, 2014	prospective cohort	Center enroll all children born to HIV-infected mothers and forward data to 2 coordinating center, using specific individual forms for registration and followup. The registration form includes notably treatment with antiretroviral therapy during pregnancy.	Data regarding mother-child pairs are collected using specific individual forms for registration and followup. The registration form includes notably gestational age, birth weight. Follow-up forms are filled out every 6 months by an appointed pediatrician at each center.	None
Caniglia, 2018	retrospective cohort	ART start date, ART regimen were collected via the obstetric cards.	Medical and obstetric history and birth outcomes were collected via the obstetric cards.	Adjusted for years from HIV diagnosis to ART initiation, age, marital status, occupation, education and parity.
Celen, 2013	retrospective cohort	Not specified.	Not specified.	None.
Chang, 2019	prospective cohort	Women were invited to join the trial and could choose to participate in either the control or the tenofovir group based on their willingness.	Not specified (for non laboratories outcomes).	None
Chen, 2015	prospective cohort	The TDF group received treatment (NOS).	A physical examination including measurements of body weight, length, head girth, was performed. Any congenital malformation or diseases of the infants were recorded.	None.
Chetty, 2018	retrospective cohort	Clinic staff collected antenatal data. Dates of ART initiation or change were retrieved from the HIV clinical database.	Birth outcomes were abstracted from hospital and clinic records. Gestational age was recorded on the maternal delivery record.	Multivariate analysis adjusted for ART timing, age, CD4 , antenatal clinic and calendar delivery year.
Chi, 2007	randomized controlled trial	Pregnant women were randomised to receive oral tenofovir and emtricitabine, given under direct observation or no intervention above the standard of care.	Trained study staff monitor and report adverse clinical events for both mothers and infants. Adverse events were reviewed by the chair of an independent project oversight committee within 2 days of the initial report. This committee also reviewed all adverse events twice a year.	No adjustment. Randomisation.
Colbers, 2015	prospective cohort	The PANNA network is a European network of hospitals collecting pharmacokinetic curves of several antiretrovirals (ARVs) during pregnancy in a prospective study. Concentrations of ATV and RTV in plasma were analysed by use of a validated (ultra) high-performance liquid chromatography method	Patients were asked for adverse events at each visit. Birth weight, congenital abnormalities and HIV status of the infants were collected (NOS).	None
Crain, 2011	cohort	Information on maternal drug use during pregnancy was obtained by maternal self-report (shortly after delivery for the Dynamic Cohort, and at the entry visit for the Static Cohort).	Gestational age, birth weight, and any clinical diagnoses were abstracted from medical records.	Adjusted for non-White race and maternal use of any hard drug (cocaine, opiates) during pregnancy.
Dadabhai, 2019	retrospective cohort	Information related to treatment is available in a “Health Passport” that women present at health facilities. Trained study nurses used study-specific structured questionnaires and case report forms to collect exposures.	At the enrollment visit (delivery), a physical examination and anthropometric measurements were completed. Trained study nurses used study-specific structured questionnaires and case report forms to collect outcomes.	Multivariable logistic (binary outcome of PTB, LBW and SGA) regression analysis was used and included covariates based on biological, epidemiological and statistical importance (NOS).
Ejigu, 2019	retrospective cohort	Information on antiretroviral treatment (ART) exposure during pregnancy was extracted from the Antiretroviral Treatment and Follow-up Form (medical record review). The form is completed by healthcare providers as part of the routine care of HIV-infected individuals.	Retrospective medical record review.	The multivariable analyses were adjusted for maternal age, weight, marital status, education, parity, CD4 cell count during pregnancy, WHO clinical stage during pregnancy and timing of treatment initiation.
Favarato, 2019	prospective cohort	All pregnancies are notified prospectively by a named respondent in each maternity unitthrough an active, quarterly surveillance scheme.	Data are collected on pregnancy complications and outcomes using study reporting forms.	None for this group of exposure.
Floridia, 2013	prospective cohort	Treatment of HIV infection or prophylaxis for mother- to-child transmission were decided by the treating doctor. Laboratory and clinical data are collected from the hospital records of Obstetrics, Infectious Diseases, and Paediatrics departments, following the women’s consent.	Laboratory and clinical data are collected from the hospital records of Obstetrics, Infectious Diseases, and Paediatrics departments, following the women’s consent.	None
Floridia, 2018	cohort	The women and infants are followed during routine clinical care, and treatments are decided by the treating physician. Data were extracted from the general database.	All sites report major pregnancy and infant outcomes. Data were extracted from the general database.	Multivariate analysis and adjustment performed for outcomes with a significant association in univariate analysis (very preterm delivery and anemia). Multivariate analysis included variables as treatment, maternal infection, history of comorbidities, age, BMI, smoking, alcohol, substance use, body mass index...
Fowler, 2016	randomized controlled trial	Pregnant women were randomly assigned to one of three regimens. Randomization was stratified according to HBV status and country.	Infant visits, including HIV nucleic acid testing and measurement of safety laboratory values occurred at birth and week 1.	No adjustment. Randomisation.
Garcia-Otero, 2016	case control	Maternal epidemiological and obstetric parameters were collected by interview and review of medical records. The specific cART regimen during pregnancy was decided by the practitioner following local and international guidelines. Type and duration of ART before and during pregnancy were recorded.	Ultrasounds were performed by maternal– fetal medicine specialists skilled in fetal echocardiography who were blinded to the particular ART but not to the HIV status.	None for this outcome.
Gibb, 2012	prospective cohort	Information on all pregnancies and ART taken by the mother throughout pregnancy and the infant at birth were collected within DART. High levels of adherence to ART were reported in DART using pharmacy refill, pill counts, and questionnaires (no randomisation to maternal ART regimens).	Clinical status, adverse events, infant feeding, weight, head, and mid-upper-arm circumference (MUAC), and growth were ascertained, and a neurodevelopment screen was undertaken at each visit.	No adjustment for the safety outcomes.
Greenup (Controls exposed to lamivudine), 2014	prospective cohort	Not specified.	Delivery and neonatal data was retrospectively collected from obstetric and paediatric discharge summaries.	None.
Greenup (Controls unexposed, sick), 2014	prospective cohort	Not specified.	Delivery and neonatal data was retrospectively collected from obstetric and paediatric discharge summaries.	None.
Heffron, 2018	prospective cohort	Participants using PrEP were issued electronic medication event monitoring (MEMS) bottle caps that recorded the date and time when every opening occurred. Archived plasma samples collected monthly from pregnant women dispensed PrEP were used for tenofovir quantification.	In both studies, the outcome of the current pregnancy was verified through antenatal records with careful follow up by the study safety monitor to ensure data completeness and accuracy.	Adjustment for maternal age at study enrollment, and history of pregnancy loss and preterm delivery, and/or smoking or using alcohol during pregnancy (adjustments varied according to outcomes).
Jourdain a, 2018	randomized controlled trial	Participants were randomly assigned in a 1:1 ratio to receive treatment or placebo. The participants, the trial staff on site and at the coordination center, the investigators, and the laboratory personnel were unaware of the trial-group assignments.	Infant visits were performed for physical examination, for the recording of vaccinations and for added scrutiny for signs or conditions suggesting possible mitochondrial dysfunction	No adjustment. Randomisation.
Knapp, 2012	prospective cohort	Not specified.	Potential congenital anomalies were identified by physical examination at the study sites and/or through review of prenatal and neonatal records. Case report forms completed at each visit asked whether any congenital anomalies had been identified.	Adjusted for infant HIV status, year of birth, birth weight, and maternal age at enrollment.
Kolgelier, 2016	retrospective cohort	The files of patients were reviewed retrospectively and the following data were recorded: antiviral treatment received before pregnancy and, if so, the duration of the treatment; antiviral treatment started during pregnancy, the date it was started, and the antiviral used.	The postnatal files of the infants who received treatment during pregnancy were reviewed retrospectively.	None
Lin, 2018	randomized controlled trial	The pregnant women were randomly divided into two groups then treatment was initiated. During the double-blind study, the participants did not know which type of intervention they accepted until the end of the intervention.	All subjects were followed up every 4 weeks. The participants, care providers and persons who evaluated the outcomes of the patients did not know whether the patients had accepted the intervention.	No adjustment. Randomisation.
Liu (Controls exposed to LDT), 2019	prospective cohort	Based on patient‐physician mutual decision, the subjects were prescribed with antiviral drugs (treated groups) or underwent regular observation (the untreated group).	Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (version 5.0). Safety for infants was assessed using data from medical records during follow‐up visits.	None
Liu (Controls unexposed, sick), 2019	prospective cohort	Based on patient‐physician mutual decision, the subjects were prescribed with antiviral drugs (treated groups) or underwent regular observation (the untreated group).	Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (version 5.0). Safety for infants was assessed using data from medical records during follow‐up visits.	None
Malaba, 2017	prospective cohort	Initiation at the antenatal care (ANC) visit of under antiretroviral therapy (ART) at inclusion.	Obstetric outcomes, including date and mode of delivery and birthweight were abstracted from obstetric records at delivery facilities.	Adjustment for age, parity, height, previous preterm delivery and HIV infection.
Mehta, 2019	retrospective cohort	Five surveillance nurses surveyed the hospital’s maternity wards and labour ward registers to identify women who had recently delivered. The surveillance nurses notably collected information on medicine use.	A systematic neonatal surface examination was performed on all live infants and stillbirths (whenever feasible) by trained nurses. For major congenital malformations, a confirmation form was completed by a neonatologist or senior clinician. Anthropometric data were collected from maternity records.	None for the considered outcome (major congenital malformations).
Moodley (Controls exposed to other treatments), 2016	retrospective cohort	Data abstracted from maternity registers of a regional hospital. The maternity register is routinely completed by the midwife immediately after a delivery, including ARV regimen.	Data abstracted from maternity registers of a regional hospital. The maternity register is routinely completed by the midwife immediately after a delivery, including the mode of delivery, Live birth/Still birth, Birth Weight, and infant’s gestational age at delivery.	No adjustment for this group of comparison.
Moodley (Controls unexposed, sick), 2016	retrospective cohort	Data abstracted from maternity registers of a regional hospital. The maternity register is routinely completed by the midwife immediately after a delivery, including ARV regimen.	Data abstracted from maternity registers of a regional hospital. The maternity register is routinely completed by the midwife immediately after a delivery, including the mode of delivery, Live birth/Still birth, Birth Weight, and infant’s gestational age at delivery.	Multivariate analysis adjusted for in the multivariable adjusted model, year age group, mode of delivery, pregnancy term category, HIV status, CD4 (HIV positive mothers only), ART regimen (HIV positive mothers only).
Mugo, 2014	randomized controlled trial	At monthly follow-up visits for up to 36 months, participants received individualized adherence counseling and a month’s supply of study medication.	Pregnancy data were ascertained through standardized case report forms completed through participant report and summarization of medical records, when available.	No adjustment. Randomisation.
Pan, 2016	randomized controlled trial	Using a randomization table, women were randomly assigned to control and TDF groups. Adherence to the TDF regimen was monitored by means of pill counts at each visit.	Before delivery, all the mothers were followed every 4 weeks for assessment of adverse events and laboratory results. After delivery, all mother–infant dyads were evaluated, the surveillance of birth defects was conducted by a clinical examination during each visit.	No adjustment. Randomisation.
Phiri, 2014	retrospective cohort (claims database)	Prescriptions for ARVs identified from the mothers’ Medicaid pharmacy claims.	Birth defects identified from maternal diagnosis claims, infant diagnosis claims, birth certificate checkbox data, fetal death certificates and death certificates. Two physicians blinded to ARV exposure, independently reviewed all the potential cases using a standardized outcome adjudication.	Logistic regression models adjusted for calendar year of delivery (categorical), maternal age (continuous) and race (categorical) were used.
Pintye, 2017	prospective cohort	TDF use was captured as part of information on maternal ART use during pregnancy, including the type of ART regimen and date of initiation self-reported by women and verified with clinical records or pill bottles when available.	Pregnancy outcome (induced abortion, pregnancy loss, or live birth), the date the pregnancy ended, and occurrence of neonatal death were self-reported by women.	Multivariate models adjusted for study cohort, maternal age, time since HIV diagnosis, and HIV RNA (log10 copies/mL) at first pregnancy visit.
Pintye, 2015	retrospective cohort	At enrollment a nurse administered the study questionnaire. Maternal-child health (MCH) booklets confirmed clinical data self-reported on questionnaires. Data were abstracted from MCH booklets if mothers were not sure of ART regimen used during pregnancy.	At enrollment a nurse administered the study questionnaire and obtained anthropometric measurements of the mother and infant. Trained study nurses obtained standardized anthropometric measurements from each infant.	Adjustment for maternal age, maternal education, breastfeeding, gestational age at birth, time since maternal HIV diagnosis, maternal WHO clinical stage, timing of ART initiation (before or during pregnancy), and trimester of first combination ART regimen use during pregnancy and PI- containing ART.
Prieto (Controls exposed to other ARVs), 2014	prospective cohort	Women were visited during pregnancy, at delivery and at postpartum. At each visit, start and stop dates were recorded for each antiretroviral agent used.	A collaboration of medical specialists provided prospective and active follow-up as soon as pregnancy in a HIV-positive women was identified in order to determine the presence of birth defects and age-appropriate development in children follow-up.	aOR obtained by multivariate logistic regression adjusted for age, alcohol and illegal drug use during pregnancy.
Prieto (Controls unexposed, sick), 2014	prospective cohort	Women were visited during pregnancy, at delivery and at postpartum. At each visit, start and stop dates were recorded for each antiretroviral agent used.	A collaboration of medical specialists provided prospective and active follow-up as soon as pregnancy in a HIV-positive women was identified in order to determine the presence of birth defects and age-appropriate development in children follow-up.	No adjustment for this group of exposure.
Ransom, 2013	prospective cohort	Obstetrical history, substance use information, maternal antiretroviral use, and laboratory testing results were collected through medical chart abstraction or self-administered questionnaires.	Not specified.	Multivariable regression models. Potential covariates of interest included maternal viral load, CD4 lymphocyte count, and CDC class at delivery, pre-gestational and gestational diabetes and hypertension, smoking during pregnancy, body mass index (BMI) closest to delivery, age, race, ethnicity, education, and year of delivery.
Rice, 2018	cohort	Maternal antiretroviral (ARV) history during pregnancy was collected through medical record review and from prior studies.	Administration of standards test validated: the Goldman Fristoe Test of Articulation (GFTA-2), the Test of Early Language Development (TELD-3), the Peabody Picture Vocabulary Test (PPVT-3) and Test of Language Development (TOLD-P:3), the Bayley Screener and the WPPSI-III.	ll models adjusted for age, sex, race, and ethnicity. Model of age 3 PSI also adjusted for caregiver health problems and caregiver difficulty caring for the child; model of age 3 PLI/language: maternal alcohol use during pregnancy and caregiver lack high school degree. Model of age 5 CLI/grammar also adjusted for caregiver health problems.
Rice, 2013	cohort	Maternal ARV history during pregnancy was collected through medical record review and from prior studies where PHACS had received permission to obtain participant-level data.	language assessments based on caregiver report obtained by trained neuropsychologists at ages 12 months (theMacArthur-Bates Communicative Development Inventory (CDI)) and 24 months (the Communication scale of the Ages and Stages Questionnaire (ASQ)) were analyzed prospectively.	Adjusted for: At 12-month visit: sex, multilingual exposure, combination neonatal prophylaxis, low caregiver verbal IQ, latest maternal CD4, and early maternal VL>400 cp/mL during pregnancy; At 24-month visit: age at assessment, sex, latest maternal CD4, caregiver health problems, caregiver too tired for everyday activities, caregiver inability to do other activities.
Rough, 2018	prospective cohort	Information on maternal antiretroviral exposure, including regimen start and stop dates, was abstracted from medical records.	Not specified.	Modified Poisson models adjusted for race/ethnicity, smoking, diabetes, sexually transmitted infection, and timing of antiretroviral therapy initiation.
Samadi Kochaksaraei, 2016	prospective cohort	In the prenatal screening programme, all women are screened for HBV. Therapy with TDF 300 mg orally daily was recommended at ~28– 32 weeks gestation if HBV-DNA level was >7 log IU/mL.	In treated CHB mothers, obstetrics outcomes including mode of delivery and prematurity rate of both cohorts were collected retrospectively by chart abstraction. In untreated CHB mothers, general infant birth data and development were determined by verbal report in the post- partum clinic visit.	None.
Seidel, 2020	retrospective cohort	Maternal data on combination antiretroviral therapy (cART) regimen start and stop dates were obtained by medical chart data abstraction.	Medical data were obtained by medical chart data abstraction.	None.
Seo, 2018	retrospective cohort	Gestational age at the initiation of antiviral therapy, the duration of antiviral treatment until delivery, and the types of antiviral agents were recorded from medical records.	Review of medical records.	None.
Siberry, 2012	cohort	Maternal antiretroviral drug use early during pregnancy and prior to delivery were obtained by chart abstraction both overall and by trimester.	Weight, length, and head circumference measurements followed standardized protocols, with each measurement performed three times at each visit.	Adjusted for covariates with p<0.10 in multivariate models, including: for LBW, SGA, short birth length and/or small head circumference at birth: infant sex, annual household income, maternal viral load, maternal tobacco use during pregnancy, non-white race, birth cohort, maternal gonorrhea during pregnancy low caregiver education, and maternal age at delivery.
Sibiude, 2014	prospective cohort	All ART combinations administered during pregnancy were recorded, with the dates when started and stopped.	All clinical events in infants were recorded at each visit (at birth, and after delivery) with standardized questionnaires filled out by clinicians. Birth defects classified with International Classification of Diseases (ICD-10) codes then categorized with EUROCAT inclusion criteria.	Multivariate analysis adjusting for other ARV drugs, maternal age, geographical origin, intravenous drug use, and type of maternity center.
Sibiude, 2019	prospective cohort	All ART combinations were recorded with dates at initiation and end.	Liver function tests were recorded 3 times during pregnancy, before 28-week gestation (2–27 WG), after 28 WG (28–40 WG), and at delivery (or up to 7 days after delivery if no results were available at delivery).	Adjusted hazard ratio, adjusting for parity, twin pregnancy and number of years since diagnosis of HIV infection.
The EPPICC study group, 2019	cohort	Not specified.	Not specified.	Adjusted a priori for potential confounders (for PTD models: calendar year and country of delivery, parity, maternal IDU history, CD4 cell count, maternal age, third agent in the ART regimen; for SGA model: all variables included in the PTD models and infant sex and ART duration) and also for country of delivery.
Torre, 2016	prospective cohort	Maternal ARV data were retrospectively collected for the entire pregnancy through chart review or from prior studies.	Newborn hearing screening and follow-up screening results were collected from the medical record. Maternal and birth characteristics were collected by questionnaire and medical record review.	Adjusted for maternal use of tobacco and ototoxic medications.
Vigano, 2011	prospective cohort	Data regarding pattern and duration of HAART exposure during fetal life, antiretroviral prophylaxis at delivery and in the first weeks of life, and vitamin administration in the first 12 months of life were collected from clinical charts.	Weight, head circumference and length were measured at birth and at enrolment. At enrolment, all cases underwent quantitative ultrasound (QUS) bone measurements.	None for dichotomous variables (multivariate analyses performed for continuous variables).
Wakano (Controls exposed to lamivudine), 2018	prospective cohort	To prevent mother-to-child transmission of HBV in subsequent pregnancies, the mothers were referred for antepartum antiviral therapy and treated if they consented.	Not mentioned.	None
Wakano (Controls unexposed, sick), 2018	prospective cohort	To prevent mother-to-child transmission of HBV in subsequent pregnancies, the mothers were referred for antepartum antiviral therapy and treated if they consented.	Not mentioned.	None
Watts, 2004	prospective cohort	Health care providers register exposed pregnant women before the pregnancy outcome is known. Shortly after delivery, the health care providers submit data on additional antiretroviral exposures in pregnancy.	The health care providers submit details of pregnancy outcome. If a birth defect is reported, the health care provider is asked to provide more detailed information, then all birth defects are reviewed and classified by a physician specializing in genetics and dysmorphology,	None
Wilkinson, 2013	cohort	Not specified.	Children underwent a single echocardiogram and blood draw between the ages of 3 and 5 years. Cardiac biomarker evaluation was initiated prior to performing an echocardiogram on all children, and only a subset of children had biomarker assays performed within 3 months of the echocardiogram.	Odd ratios adjusted for age at biomarker draw and gestational age at birth <37 weeks (for hsCRP), for sex, ethnicity, birth weight <2500g, maternal viral load during pregnancy, and maternal tobacco use during pregnancy (for NT-proBNP) or for age at biomarker draw, mother's age at delivery, and maternal alcohol use during pregnancy (for cTnT).
Williams, 2015	cohort	Information on ARV use during pregnancy was collected by medical chart abstraction.	Information on medical conditions, including pregnancy outcomes, was collected by medical chart abstraction. Study authors blinded to ARV exposures reviewed the reported CAs and classified them according to the MACDP classification scheme.	For any anomaly: models adjusted low maternal CD4 count (< 250 cells/mm3) early in pregnancy and birth cohort.
Williams, 2020	cohort	At study entry, dates of prenatal antiretroviral use were obtained from medical charts and participant interview.	After enrolment, children and their mothers or caregivers were followed up at annual study visits, in which a complete physical examination including anthropometric assessments was performed. Diagnoses and clinical information were abstracted from the medical chart or by interview.	Adjusted model includes low education, low household income, alcohol use during pregnancy, and birth cohort (2007–10, 2011–14, and 2015–17 vs before 2007).
Williams, 2016	cohort	At study entry, dates of prenatal antiretroviral therapy use were obtained from medical charts and participant interview.	Cognitive, hearing, and language assessments were conducted at specified ages. For each domain, a study “trigger” was established using a non-invasive or inexpensive laboratory or clinical evaluation.	Potential confounders were based on past literature and descriptive statistics from the cohort (using direct acyclic graph). Adjusted model includes black race or Puerto Rican origin, low caregiver education (< high school), 1st trimester maternal tobacco use, and birth cohort (2010 vs <2010).
Zash, 2016	retrospective cohort	Data were abstracted from maternal obstetric records (covering outpatient antenatal care and inpatient care during labor and delivery) including medications taken at the time of conception, and ARV start date, regimen, and any switch or discontinuation during pregnancy.	Data were abstracted from maternal obstetric records (covering outpatient antenatal care and inpatient care during labor and delivery), including maternal diagnoses during pregnancy and infant outcomes.	Adjusted analysis including CD4 cell count and covariates that was determined through stepwise selection with retention of variables with P<0.2.
Zash (Controls exposed to other treatments), 2017	retrospective cohort	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	None for this group of exposure.
Zash (Controls unexposed, disease free), 2017	retrospective cohort	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	None for this group of exposure.
Zash (Controls unexposed, sick), 2017	retrospective cohort	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	Deidentified data were abstracted from obstetric cards (used throughout pregnancy).	None for this group of exposure.
Zeng (Controls exposed to telbivudine), 2019	prospective cohort	The patients were allocated to 3 groups according to their antiviral agents.	The following data were collected: height, weight, head circumference, Apgar score, and birth defects. Adverse pregnancy events (e.g., eclampsia, premature rupture of membranes, and premature delivery), postpartum hemorrhage, and cesarean section were recorded.	None.
Zeng (Controls unexposed, sick), 2019	prospective cohort	The patients were allocated to 3 groups according to their antiviral agents.	The following data were collected: height, weight, head circumference, Apgar score, and birth defects. Adverse pregnancy events (e.g., eclampsia, premature rupture of membranes, and premature delivery), postpartum hemorrhage, and cesarean section were recorded.	None.

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