Tobacco and Pituri Use in Pregnancy: A Protocol for Measuring Maternal and Perinatal Exposure and Outcomes in Central Australian Aboriginal Women
Abstract
:1. Introduction
1.1. Tobacco and Nicotine Pharmacodynamics and Pharmacokinetics
1.1.1. Nicotine Maternal, Placental, Fetal, and Breast Milk Distribution
1.1.2. Nicotine General Actions
1.1.3. Nicotine Metabolism and Excretion
1.1.4. Tobacco and Nicotine Biochemical Analysis
1.2. Tobacco Exposure and Adverse Pregnancy Outcomes
1.2.1. Maternal Smoked Tobacco Exposure and Adverse Pregnancy Outcomes
1.2.2. Maternal Smokeless Tobacco Exposure and Adverse Pregnancy Outcomes
1.2.3. Maternal Smoking and Australian Birth Outcomes
1.3. Chewing Tobacco Use in Central Australia
1.4. Study Aim and Research Questions
- What are the biochemical concentrations of tobacco, nicotine, and their metabolites in a range of maternal and neonatal biological samples from mothers with differing levels of self-reported tobacco use?
- Does maternal pituri chewing impact maternal and perinatal outcomes, and if so, what is the significance of that impact in comparison to smoking or non-tobacco use in pregnancy?
1.5. Research Setting and Considerations
2. Methods and Design
2.1. Study Design
Sampling, Recruitment, and Consent
3. Procedure
3.1. Data Collection
- (1)
- A maternal face-to-face interview was conducted at the time of enrolment and consisted of 23 semi-structured questions recording information not collected elsewhere, for example: Language group, skin name, employment and income, housing situation, community of origin and school leaving level, in addition to lifestyle factors including alcohol and tobacco use. The participants were clearly informed that the research was exploring the effect of tobacco and pituri use in pregnancy. The interviewer read each question to the maternal participant, and their responses were documented verbatim on the interview tool. “Yarning” [90,91] was used to navigate through the data elements of the maternal interview. Yarning was conducted in a conversational style which enabled the participant to elaborate on responses as they chose. The tool was designed to enable the participant to share their ethnobotanical knowledge of pituri preparation and use as chewing tobacco. This aspect of the data collection informed the development of a derivative project which examined Aboriginal pharmacological knowledge of pituri and its use [57].
- (2)
- The second data collection tool obtained maternal and perinatal data from each participant’s electronic medical record. In Australia, the capture of mandatory information pertaining to each Australian pregnancy and birth is directed by the Australian National Minimum Perinatal Data Set [92]. In the NT, this information is collected and electronically stored as part of the NT Perinatal Data report within CARESYS®, the electronic medical record [93], hereafter referred to as the CARESYS® data. The CARESYS® data records 80 primary and 40 secondary maternal and perinatal variables. The CARESYS® information is progressively entered by attending health care professionals throughout the pregnancy. For this research, a complete Perinatal Data record was printed from CARESYS® following the participant’s hospital discharge after birthing. Table 2 lists the maternal interview and the CARESYS® data variables and their operational definitions collected and used in this research.
- (3)
- The third data collection involved the collection of biological samples from the participant and their neonate. The objective of this was to quantify the level of tobacco and nicotine and metabolite concentrations in maternal and perinatal samples from different self-reported tobacco exposures as a question of possible causality in adverse maternal and perinatal outcomes. As such, epidemiological research [30,94,95] demonstrates that the transit of biochemical tobacco and nicotine from maternal exposure through to fetal exposure, and then to maternal and neonatal excretion [4,12,29,31,32,33,34,35] can be measured in maternal, placental and neonatal biological samples. Informed by the literature, Table 3 details the biological samples and their rationale for collection in response to this question. The biological samples and their collection procedures are standard clinical procedures and required no additional staff training and minimal clinical resources. The samples were collected at the time of enrolment (maternal venous blood, urine, and hair) and as they became available during the study and were identified with a unique participant identifier before being transferred to the hospital pathology for storage in a −80 °C freezer.
3.2. Data Processing
3.3. Biological Sample Processing
3.3.1. Reagent Setup
3.3.2. Sample Preparation
3.3.3. LC-MS/MS Analysis
3.3.4. Method Validation
3.4. Data Analysis
- Demographic variables (age, residential address, education level)
- Lifestyle factors (alcohol and tobacco use)
- Past and current medical history (cardiac, hypertension, diabetes and renal disease)
- Pregnancy-related factors (parity, gravida, elevated glucose, hypertension, STI, UTI, anemia, number of antenatal visits, placental weight and size)
- Labor and birthing factors (LUSCS, meconium staining, post-partum hemorrhage)
- Birth outcome variables (gestational length, birth weight, gender, admission to SCN and APGAR score)
4. Discussion
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Maternal Outcomes | Fetal/Neonatal Outcomes | Childhood/Adolescent Outcomes |
---|---|---|
Antepartum hemorrhage Placental previa Placental abruption | Low birthweight Small for Gestational Age (SGA) Intrauterine Growth Retardation (IUGR) | Obesity Metabolic disorders |
Miscarriage Ectopic pregnancy | Preterm labor and delivery | Type 2 diabetes |
Placental changes, hypertrophy, calcification | Stillbirth, neonatal death, SIDS | Hypertension |
Venous thrombosis, Pulmonary embolism | Microcephalus Cleft defects Clubfoot deformities | Neurobehavioural changes |
Variable | Operational Definition of Variable | Measurement Scale |
---|---|---|
Aboriginal language group | Central Australian Aboriginal language group | Nominal |
Access to secondary health care | Maternal residential distance from Alice Springs | Continuous: km |
Admission to Special Care Nursery (SCN) | Any admission of the neonate to any special care nursery following birth | Dichotomous: yes/no |
Age | Maternal age at last birthday | Continuous: years |
Alcohol use | Maternal interview, self-report of any alcohol use in this pregnancy | Dichotomous: yes/no |
Anemia | <110 g/L hemoglobin in venous blood | Dichotomous: yes/no |
Antepartum hemorrhage (APH) | Any antepartum haemorrhage | Dichotomous: yes/no |
Apgar 1, 5, 10 min | Neonatal score of 0, 1 or 2 for: Heart rate, breathing, color, muscle tone and reflex irritability. Total 0–10. | Ordinal |
Augmentation | The stimulation of ineffective uterine contractions after the onset of labor, to manage labor dystocia. | Dichotomous: yes/no |
Birthing method | Method of birth | Nominal: SVB, LUSCS, forceps, ventouse |
Body mass index (BMI) | Ratio between weight (kg) and height (cm) as measured by weight divided by height squared = kg/m2 | Ordinal: underweight, obese normal, overweight |
Born before arrival (BBA) | Birth that occurs before arrival at the Alice Springs Hospital | Dichotomous: yes/no |
Cardiac disease | Health practitioner diagnosis of any maternal cardiac disease | Dichotomous: yes/no |
Cigarette use | Maternal interview, self-reported use of cigarettes in this pregnancy | Dichotomous: yes/no |
Diabetes Mellitus | Health practitioner diagnosis of pre-gestational diabetes | Dichotomous: yes/no |
Duration of labor | Duration from onset of established labor to complete birth of neonate | Continuous: hours |
Education level | Self-reported school leaving grade | Continuous: grade |
Variable | Operational definition of variable | Measurement scale |
Elevated glucose | Maternal elevated glucose where inadequate identification of pre-gestational diabetes or gestational diabetes status exists | Dichotomous: yes/no |
Episiotomy | Perineal incision to facilitate birth of neonate | Dichotomous: yes/no |
Forceps | Instrumental delivery of the neonate via the vagina | Dichotomous: yes/no |
Gender | Gender of the neonate | Dichotomous: male/female |
Gestation at 1st antenatal visit | Time since last menstrual period and attendance at 1st antenatal visit | Continuous: completed weeks |
Gestation at 1st ultrasound | Time since last menstrual period and attendance at 1st ultrasound | Continuous: completed weeks |
Gestational diabetes mellitus (GDM) | Health practitioner diagnosis of diabetes that develops during pregnancy | Dichotomous: yes/no |
Gestational length | Time since last menstrual period and birth of neonate | Continuous: completed weeks |
Gravida | Number of times a woman has been pregnant regardless of whether the pregnancies result in a live birth | Discrete: number |
Head circumference | Neonatal head circumference at birth | Continuous: cm |
Housing situation | Self-report of number of residents that live with participant | Discrete: number |
Hypertension (pre-gestational) | Health practitioner diagnosis of pre-gestational hypertension | Dichotomous: yes/no |
Hypertension | Maternal elevated blood pressure where inadequate identification of pre-gestational hypertension or pregnancy-induced hypertension status exists | Dichotomous: yes/no |
Income | Self-report of weekly income | Continuous: Australian dollars |
Induction and indicator | The purposeful stimulation of uterine contractions for the purpose of accomplishing delivery, prior to the natural onset of labor | Dichotomous: yes/no |
Labor complications | Health practitioner diagnosis of labor complications | Dichotomous: yes/no |
Livebirth | Neonatal outcome following the complete expulsion or extraction from its mother which after separation, shows signs of life | Dichotomous: yes/no |
Lower Uterine Segment Caesarean Section (LUSCS) | Operative delivery of the neonate from the uterus via the abdomen | Dichotomous: yes/no |
Meconium stained liquor | Presence of meconium in liquor | Dichotomous: yes/no |
Membranes complete | Presence of complete membranes | Dichotomous: yes/no |
Neonatal abnormalities | Presence of any neonatal abnormalities | Dichotomous: yes/no |
Neonatal body length | Neonatal body length at birth | Continuous: cm |
Number of antenatal visits | Number of antenatal visits recorded in the perinatal record following birth | Discrete: number |
Number of cord vessels | Visual inspection of cord after separation from neonate | Discrete: number |
Parity | Number of previous pregnancies resulting in live births or stillbirths, excluding the current pregnancy | Discrete: number |
Pituri use | Maternal interview, self-reported use of pituri in this pregnancy | Dichotomous: yes/no |
Placenta complete | Presence of complete placenta | Dichotomous: yes/no |
Placental abruption | Placental separation prior to birth of the neonate | Dichotomous: yes/no |
Placental lie | Relationship of the maternal axis to the fetal axis | Nominal: longitudinal, transverse, oblique |
Placental previa | Placental lie across the cervical os | Dichotomous: yes/no |
Placental size | Diameter of placenta at the two widest points in cm. Result multiplied together to find area (cm2) | Continuous: cm2 |
Placental weight | Weight of the placenta following drainage of blood | Continuous: grams |
Post-partum hemorrhage | >500 mL blood loss in first 24 h post birth | Dichotomous: yes/no |
Pre-eclampsia – eclampsia | Hypertension, oedema and proteinuria during pregnancy | Dichotomous: yes/no |
Pregnancy complications | Health practitioner diagnosis of pregnancy complications | Dichotomous: yes/no |
Pregnancy-induced hypertension | Health practitioner diagnosis of hypertension that develops during pregnancy | Dichotomous: yes/no |
Premature rupture of membrane | Rupture of membranes <37 weeks gestation | Dichotomous: yes/no |
Presentation | Part of the neonate presenting at the superior aperture of the maternal pelvis | Nominal: cephalic, breech, shoulder |
Previous adverse obstetric history | Health practitioner diagnosis of adverse obstetric history | Dichotomous: yes/no |
Race | Self-report of race | Nominal |
Rubella immune status | Rubella IgG antibody level >10 IU/mL | Dichotomous: yes/no |
Sexually transmitted infection | Health practitioner diagnosis of sexually transmitted infection | Dichotomous: yes/no |
Significant adverse medical history | Health practitioner diagnosis of any significant adverse medical history | Dichotomous: yes/no |
Spontaneous vaginal birth (SVB) | Unassisted vaginal birth | Dichotomous: yes/no |
Stillbirth | Neonate with no signs of life following the complete expulsion or extraction from its mother | Dichotomous: yes/no |
Third stage method (active) | Method of delivery of placenta and membranes | Dichotomous: yes/no |
Urinary tract infection | Health practitioner diagnosis of any urinary tract infection | Dichotomous: yes/no |
Ventouse | Assisted birth using a suction cap applied to the neonate’s head. | Dichotomous: yes/no |
Biological Sample | Rationale for Collection | Collection Process | Collection Method |
---|---|---|---|
Maternal venous blood | Indicates recency of maternal nicotine exposure [94]. | Maternal plasma collected concurrently with other plasma collections in order to minimize participant discomfort. | FBC for Hb. If recently collected do not repeat. Standard pink top tube. U&E for standard biochemical measures. If recently collected do not repeat. Standard green top tube. Tobacco, nicotine and its metabolites: 2 × 2 mL lithium heparin light green non-gel tubes. |
Venous cord blood and Arterial cord blood | Indicates nicotine placental transfer and fetal exposure. Nicotine rapidly crosses the placental barrier with considerable amounts of nicotine occurring in the fetal blood of maternal smokers [96,97] and ST users [98]. By analyzing venous and arterial cord blood, a determination can be made of: (a) Fetal nicotine exposure (venous cord), and (b) fetal nicotine circulating levels (arterial cord). | Cord blood will be collected as per standard arterial and venous cord blood collection procedures following the complete expulsion of the placenta from the uterus and the complete separation of the placenta from the neonate. | Arterial: 2 × 2 mL lithium heparin light green non-gel tubes. Venous: 2 × 2 mL lithium heparin light green non-gel tubes. |
Amniotic fluid | Amniotic fluid demonstrates fetal exposure to nicotine that penetrates through the amniotic membrane and fetal excretion (via the fetal kidneys and lungs) of nicotine and its metabolites into the amniotic fluid. Amniotic fluid concentrations are expected to be significantly higher than the umbilical arterial and venous concentrations as the foetus ingests, metabolizes and excretes and then re-ingests the amniotic fluid through the pregnancy [10,19,99,100]. | A clean sample of amniotic fluid (visibly uncontaminated with maternal blood or meconium) will be obtained at lower uterine segment cesarean section (LUSCS). | 10 mL, sterile yellow top collection jar. |
Neonatal urine Day 1 Day 3 | Fetal urinary concentrations of nicotine fluctuate dependent on recency of exposure, level of exposure, and metabolism rate and therefore are less indicative of long-term exposure than meconium. However, comparative analysis of Day 1 and Day 3 urine and to venous and arterial cord blood concentrations may demonstrate neonatal metabolism and excretion capacity following separation from the nicotine supply through the placenta [31]. If the neonate is breastfed and the mother is using tobacco in the early post-delivery period, colostrum may contain nicotine concentration at least equivalent to that of the breast milk therefore Day 3 urine testing will not provide an absolute indication of neonatal metabolism of nicotine following placental separation as they will have been exposed to nicotine through the colostrum and/or breast milk. | Neonatal urine collection bags will be placed on the neonate after birth and again on Day 3 and collected when available and uncontaminated with meconium, i.e., a clean sample. | Day 1: 2–3 mL, sterile yellow top collection jar Day 3: 2–3 mL, sterile yellow top collection jar |
Meconium | Meconium is a fetal gut excretion product that begins to develop at about 12 weeks gestation and is generally not eliminated during the pregnancy. Meconium nicotine concentrations reflect fetal exposure throughout the second and third trimesters (i.e., longevity of exposure is demonstrated). Drug metabolite testing in meconium demonstrates high concentrations are detected in the meconium (100%) compared to urinary screens for the same drugs (37%) and that meconium testing has both high sensitivity and specificity [31,101,102]. | Mothers will be encouraged to collect the neonatal meconium when it becomes available. | One scoop: Brown top sterile fecal collection jar, within first three days of birth |
Colostrum and/or breast milk | Colostrum and breast milk is an excretion process and a possible route of post-birth nicotine exposure. The acidic milk compartments of the breast concentrate nicotine [12], with nicotine levels in breast milk reaching considerably higher levels than in the serum [103]. | Maternal colostrum and/or breast milk will be concurrently collected with colostrum and/or breast milk expression in order to minimize participant discomfort. | 2–3 mL, sterile yellow top collection jar |
Maternal hair | Nicotine and its metabolites are deposited in hair from the time of exposure [104,105,106,107,108,109,110] indicating duration of exposure, changes in exposure during pregnancy are also indicated. | The maternal and neonatal hair samples will be collected from the nape of the neck, with mothers encouraged to obtain their neonates’ hair. | Several strands, sterile yellow top collection jar |
Neonatal hair | Fetal hair begins to grow in the last three months of pregnancy, accumulating and concentrating cotinine and reflecting third-trimester exposure to nicotine [102,107] | As above | As above |
Placenta | Placental size and weight indicative of neonatal perfusion. | ________cm x ________cm __________grams | Measured across from the edge across the broadest sides and weight placenta in grams. |
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Ratsch, A.; Steadman, K.; Ryu, B.; Bogossian, F. Tobacco and Pituri Use in Pregnancy: A Protocol for Measuring Maternal and Perinatal Exposure and Outcomes in Central Australian Aboriginal Women. Methods Protoc. 2019, 2, 47. https://doi.org/10.3390/mps2020047
Ratsch A, Steadman K, Ryu B, Bogossian F. Tobacco and Pituri Use in Pregnancy: A Protocol for Measuring Maternal and Perinatal Exposure and Outcomes in Central Australian Aboriginal Women. Methods and Protocols. 2019; 2(2):47. https://doi.org/10.3390/mps2020047
Chicago/Turabian StyleRatsch, Angela, Kathryn Steadman, BoMi Ryu, and Fiona Bogossian. 2019. "Tobacco and Pituri Use in Pregnancy: A Protocol for Measuring Maternal and Perinatal Exposure and Outcomes in Central Australian Aboriginal Women" Methods and Protocols 2, no. 2: 47. https://doi.org/10.3390/mps2020047