Pregnancy Related Clinical Trial
— DDTOfficial title:
Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: - Does the app improve overall maternal well-being during the perinatal period? - Can the app increase the early detection rates of perinatal mental health disorders? - Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? - How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: - Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. - Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. - Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.
Status | Not yet recruiting |
Enrollment | 1200 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Gestational age between 12-14 weeks of gestation. - The first obstetric ultrasound has been performed. - Women who know how to read and understand Spanish. - Women who have access to a mobile phone with an internet connection (data or wifi) - Women who have knowledge of technology tools via app. - Have signed the informed consent to participate in the study. Exclusion Criteria: - Termination of pregnancy, or early miscarriage - Perinatal loss at any time during pregnancy. - Severe mental pathology or moderate unstable mental pathology. - Consumption of toxic substances. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | Catalunya |
Spain | Universitat Rovira i Virgili | Tarragona |
Lead Sponsor | Collaborator |
---|---|
A Thousand Colibris, S.L | Hospital del Mar Research Institute (IMIM), Hospital Universitari Vall d'Hebron Research Institute, University Rovira i Virgili |
Spain,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal well-being | Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021).
Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression. |
12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum. | |
Secondary | Depression | Using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire for detecting postpartum depression symptoms, validated for pregnancy and in Spanish women (Levis et al., 2020; Vázquez & Míguez, 2019).
Min value: 0 Max value: 30 Higher scores: Indicate worse symptoms. Scores =10 suggest possible depression; scores =13 or positive for question 10 indicate a high likelihood. |
12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum. | |
Secondary | Anxiety | Using the State-Trait Anxiety Inventory (STAI), a 40-item tool for assessing state and trait anxiety (Brunton et al., 2015).
Min value: 20 per subscale (STAI-S and STAI-T) Max value: 80 per subscale Higher scores: Indicate worse anxiety outcomes. |
12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum. | |
Secondary | Birth Fear | Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A-B), a 33-item tool to quantify fear of childbirth.
Min value: 0 Max value: 165 Higher scores: Indicate higher levels of fear; scores >85 suggest high fear levels. |
12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum. | |
Secondary | Sleep | Using the Pittsburgh Sleep Quality Index (PSQI), a 19-item tool to assess sleep quality over the past 30 days.
Min value: 0 Max value: 21 Higher scores: Indicate worse sleep quality; scores >5 suggest poor sleep. |
12-14 and 33-34 weeks of pregnancy | |
Secondary | Maternal Antenatal attachment | Using the Maternal Antenatal Attachment Scale (MAAS) to assess the emotional bond with the unborn child.
Min value: 19 Max value: 95 Higher scores: Indicate a stronger emotional bond. |
29-30 weeks of pregnancy. | |
Secondary | Bonding | Using the Postpartum Bonding Questionnaire (PBQ) to measure the maternal bond with the baby post-birth.
Min value: 0 Max value: 125 Higher scores: Indicate worse bonding outcomes. |
6 weeks, 6, 12, 24 months postpartum. | |
Secondary | Birth Experience | Using the Mackey Satisfaction Childbirth Questionnaire to measure childbirth satisfaction.
Min value: 11 Max value: 55 Higher scores: Indicate higher satisfaction. |
33-34 weeks of pregnancy, 6 weeks postpartum. | |
Secondary | Traumatic stress responses related to childbirth | The City Birth Trauma Scale (BiTS): Psychological assessment tool designed to measure traumatic stress responses specifically related to childbirth. It is used to identify symptoms of birth-related post-traumatic stress disorder (PTSD) in women who have recently given birth. The scale helps healthcare providers to assess the severity and impact of traumatic childbirth experiences on mothers.
Minimum value: 0 Maximum value: 80 Higher scores: Indicate more severe symptoms of trauma related to childbirth. |
6 weeks postpartum | |
Secondary | Parental stress | Parental Stress Index (PSI): This evaluation tool measures parental stress levels in mothers and fathers. The PSI consists of 36 questions that evaluate different factors that may contribute to parental stress, such as the child's health, the relationship with the partner, social support, work demands, and parental expectations regarding the child's development.
Min value: 36 Max value: 180 Higher scores: Indicate higher stress levels. |
6, 12, 24 months postpartum. | |
Secondary | Maternal empowerment | Parenting Sense of Competence (PSOC): This evaluation tool measures the perception of parental competence in mothers and fathers. The PSOC consists of 16 questions that evaluate satisfaction with the parental role, confidence in parenting skills, the ability to adapt to the child's demands, and the perception that the parental role is a rewarding task. The questionnaire is used to identify parents who may need additional support to develop confidence and parenting skills, and improve family health and well-being.
Minimum value: 16 Maximum value: 96 Higher scores: Indicate better perceived parental competence. |
Postpartum: 6 weeks and 24 months | |
Secondary | Physical Activity | Using the International Physical Activity Questionnaire (IPAQ) to measure physical activity levels.
Min value: 0 Max value: Varies based on intensity and frequency Higher scores: Indicate higher physical activity levels. |
12-14 and 33-34 weeks of pregnancy. | |
Secondary | Pregnancy outcomes | Pregnancy complications (measured in presence of gestational diabetes, preeclampsia, preterm birth, growth restriction, diagnosis of perinatal mental health disorder, need for psychotropic drugs, smoking habit).
Higher values: Indicate higher complications during pregnancy. |
1 week after birth collected retrospectively for pregnancy and childbirth | |
Secondary | Health costs 1 | Cost for the healthcare system (measured on number of visits to obstetrician/gynecology, midwife, psychology, physiotherapy, emergency room, hospital admissions)
Higher values: Indicate higher expenses for the healthcare system. |
1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period. | |
Secondary | Health costs 2 | Duration of hospital admission (measured in days).
Higher values: Indicate higher expenses for the healthcare system. |
1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period. | |
Secondary | Neonatal outcomes 1 | Gestational age at delivery (weeks+days) Normal range: 37-42 weeks Lower values: Indicate preterm newborns. Higher values: Indicate postterm newborns. | 1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 2 | Cord arterial pH (potential of hydrogen)
Normal pH: Range: 7.25 to 7.35 Implication: Indicates that the newborn had adequate oxygenation and no significant acidosis during labor and delivery. Mild Acidosis: Range: 7.20 to 7.24 Implication: Suggests a slight decrease in oxygen levels. While it may not immediately be cause for concern, it warrants monitoring for any signs of distress or complications. Moderate Acidosis: Range: 7.10 to 7.19 Implication: Indicates moderate hypoxia and the possibility of metabolic acidosis. This condition may require intervention and close monitoring of the newborn for any further complications. Severe Acidosis: Range: Below 7.10 Implication: Suggests significant hypoxia and severe metabolic acidosis, which can be associated with perinatal asphyxia. Immediate medical evaluation and intervention are typically required to address any potential adverse outcomes. |
1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 3 | Neonatal complications at birth (descriptive: admission to the ICU, neonatal sepsis) | 1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 4 | Apgar score: The Apgar score is a quick test performed on a newborn at 1 minute and 5 minutes after birth. The purpose of the test is to determine how well the baby tolerated the birthing process and how well the baby is doing outside the mother's womb.
The Apgar score assesses five criteria, each scored on a scale of 0 to 2, with a maximum total score of 10: Score 7-10: Generally considered normal; indicates that the newborn is in good health. Score 4-6: Fairly low; may require some medical intervention such as oxygen or physical stimulation. Score 0-3: Critically low; requires immediate resuscitation and medical attention. |
1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 5 | Weight (in grams) | 1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 6 | Height (centimeters) | 1 week after birth collected retrospectively | |
Secondary | Neonatal outcomes 7 | Head circumference (centimeters) | 1 week after birth collected retrospectively | |
Secondary | Birth outcomes 1 | Type of birth. Measures in normal vaginal birth, instrumental birth and caesarian section. | 1 week after birth collected retrospectively | |
Secondary | Birth outcomes 2 | State of the perineum after delivery: Measured in intact perineum, I degree tear, II degree tear, III degree tear, IV degree tear and episiotomy. | 1 week after birth collected retrospectively | |
Secondary | Birth outcomes 3 | Type of analgesia during delivery: measured in epidural (yes/no), raquideal (yes/no), local (yes/no), and general (yes/no) | 1 week after birth collected retrospectively | |
Secondary | Birth outcomes 4 | Labor induction: Descriptive yes/no | 1 week after birth collected retrospectively | |
Secondary | Birth outcomes 5 | Maternal complications at birth (descriptive: admission to the ICU, obstetric emergency) | 1 week after birth collected retrospectively | |
Secondary | Biomarkers 1 (stress) | Maternal heart rate variability (HRV)
Heart rate: Minimum Value: Varies depending on the individual's baseline, but generally, a healthy resting heart rate for adults ranges from 60 to 100 beats per minute (bpm). Maximum Value: This can vary widely based on activity and stress levels, but for pregnant women, a heart rate consistently above 100 bpm at rest might be concerning Maternal heart rate variability (HRV) refers to the variation in time intervals between heartbeats, which is a marker of autonomic nervous system function. Minimum Value: HRV does not have a fixed minimum value, but lower HRV generally indicates reduced autonomic flexibility and poor cardiovascular health. Maximum Value: Similarly, there is no fixed maximum value, but higher HRV is generally associated with better cardiovascular fitness and autonomic regulation. |
From 12 weeks of pregnancy until 2 years postpartum | |
Secondary | Biomarkers 2 (sleep) | Sleeping patterns (measured with wearable):
Key Metrics Monitored by Wearable: Sleeping patterns refer to the habitual sleep behaviors of an individual. Bed time start (date and time), bed time end (date and time) and awake time (in minutes) will be combined to report total sleep (in minutes). The overall of this metrics will give a score for sleeping patterns. Higher levels mean higher levels of resting. |
From 12 weeks of pregnancy until 2 years postpartum | |
Secondary | Biomarkers 3 (activity) | Level of physical activity (measured with wearable):
The heart rate monitor of the wearable measures the wearer's heart rate to gauge intensity of physical activity. The amount of time (in minutes) will give us the time a day spent in physical activities of moderate or higher intensity (HR>100bpm). Higher levels mean higher levels of physical activity. |
From 12 weeks of pregnancy until 2 years postpartum | |
Secondary | Child neurodevelopment | Ages and Stages Questionnaires (ASQ): This evaluation tool measures child development in areas such as communication, social behavior, motor coordination, language, and learning. The ASQ consists of different questionnaires adapted to different ages, which are completed by parents or caregivers. The results are used to identify children with potential developmental delays and provide early interventions to improve their cognitive and emotional health. The ASQ is widely used in clinical practice and research in the field of child development.
Scores vary across different developmental domains: Communication, Social Behavior, Motor Coordination, Language, Learning. Higher scores: Indicate better developmental outcomes . |
6 months, 12 months and 24 months postpartum. | |
Secondary | Child neurodevelopment | The Bayley Scales of Infant and Toddler Development, commonly referred to as the Bayley Scales, is a standardized assessment tool used to evaluate the developmental functioning of infants and toddlers, typically from 1 month to 42 months of age.
The Bayley Scales consist of five key domains, each designed to measure different aspects of a child's development: cognitive, language, motor, social-emotional and adaptive behaviour. The result is presented in percentiles (0-100) Higher scores: Indicate better developmental outcomes. |
4 months and 24 months postpartum. | |
Secondary | Adaptative behaviour | Vineland III: This evaluation tool is designed to measure adaptive skills in individuals of all ages, from infancy to adulthood.
Scores vary across different subscales: Communication Skills, Social Skills, Daily Living Skills. Higher scores: Indicate better adaptive functioning. |
4 months and 24 months postpartum. | |
Secondary | Breastfeeding outcomes | Type of breastfeeding at discharge from hospital. Descriptive outcome reported as exclusive breastfeeding, mixed feeding or artificial feeding. | 1 week after birth collected retrospectively | |
Secondary | Breastfeeding outcomes | Breastfeeding duration (measured in days) | Postpartum: 4 months, 1 year after childbirth collected retrospectively |
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