Mental Health Wellness Clinical Trial
— GESTACTIVEOfficial title:
Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19
The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health. Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well. Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety. According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 30, 2025 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Pregnant women fulfilling the following criteria: >18 years old, singleton pregnancies and planning management and delivery at the research hospitals, and also do not participate in any other program of supervised physical exercise. Exclusion Criteria: Women with absolute contraindications. Women with relative contraindications need permission from obstetric care providers prior to participation: Absolute contraindications to exercise: - Ruptured membranes. - Premature labor. - Unexplained persistent vaginal bleeding. - Placenta praevia after 28 weeks gestation. - Pre-eclampsia. - Incompetent cervix. - Intrauterine growth restriction. - High-order multiple pregnancies (eg, triplets). - Uncontrolled type I diabetes. - Uncontrolled hypertension. - Uncontrolled thyroid disease. - Other serious cardiovascular, respiratory, or systemic disorders. Relative contraindications to exercise: - Recurrent pregnancy loss. - Gestational hypertension. - A history of spontaneous preterm birth. - Mild/moderate cardiovascular or respiratory disease. - Symptomatic anemia. - Malnutrition. - Eating disorder. - Twin pregnancy after the 28th week. - Other significant medical conditions. Women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" and those who are excessively actives were excluded. |
Country | Name | City | State |
---|---|---|---|
Spain | Facultad de Ciencias de la Actividad Física y el Deporte - INEF | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Politecnica de Madrid | Clinica Zuatzu, Hospital Clinic of Barcelona, Hospital Severo Ochoa, Hospital Universitario de Torrejón de Ardoz, Hospital Vall d'Hebron, Puerta de Hierro University Hospital |
Spain,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recovery of pelvic floor muscles ultrasound | analyze the diameter and thickness of muscles in the perineal area and their interrelationship with physical exercise patterns | 6 months | |
Other | Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ) | analyze with a questionnaire how it varies during and after pregnancy | 12 months | |
Other | Pregestational maternal patterns | analyze sociodemographic and behavioral habits like (smoking, alcoholism, previous illness, COVID-19, parity, occupation, previous miscarriage...) | 9 months | |
Other | Coronavirus disease | analyze the coronavirus condition during pregnancy and its interrelationship with other variables | 9 months | |
Primary | Prenatal depression (CES-D) | analyze with a questionnaire the variability during pregnancy (Likert scale 0-3) | 9 months | |
Primary | Prenatal anxiety, State-Trait Anxiety Inventory (STAI) | analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3) | 9 months | |
Primary | Prenatal stress, Perceived Stress Scale (PSS) | analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-3) | 9 months | |
Primary | Postnatal depression, Edinburgh Postnatal Depression Scale (EPDS). | analyze with a questionnaire the value and its interrelationship with physical exercise during pregnancy(Likert scale 0-5) | 6 months | |
Primary | Postnatal anxiety, State-Trait Anxiety Inventory (STAI) | analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3) | 6 months | |
Primary | Postnatal stress, PSS (Perceived Stress Scale) | analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-5; higher scores mean a worse outcome) | 6 months | |
Secondary | Maternal weight gain | analyze the increase during pregnancy | 9 months | |
Secondary | Blood pressure | analyze how it varies during pregnancy | 9 months | |
Secondary | O'Sullivan test (OGTT) | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Urinary Incontinence Questionnaire (ICIQ-SF) | analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)(Likert scale 0-5; higher scores mean a worse outcome) | 9 months | |
Secondary | Behavior of Fetal Heart Rate | analyze variability during pregnancy | 3 months | |
Secondary | Gestational age | analyze the value and its interrelationship with physical exercise patterns | 9 months | |
Secondary | Type of delivery (Vaginal, instrumental or cesarean) | analyze whether women have had a vaginal, instrumental, or cesarean delivery and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Duration of labor | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Birthweight | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Child's weight | analyze the value and its interrelationship with physical exercise patterns during pregnancy | 24 months | |
Secondary | Child's height | analyze the value and its interrelationship with physical exercise patterns during pregnancy | 24 months | |
Secondary | Mental assessment of the child (depression questionnaire adapted to childhood) | analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3) | 24 months | |
Secondary | Psychomotor behavior of the child | analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise | 24 months | |
Secondary | Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.) | analyze the value and its interrelationship with physical exercise patterns | 9 months | |
Secondary | Fetal growth and development | analyze the value and its interrelationship with physical exercise patterns | 9 months | |
Secondary | Delivery tears | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Performing episiotomy during childbirth | analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Apgar Score | analyze the value and its interrelationship with physical exercise patterns (1 to 10) | 1 month | |
Secondary | Birth length | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Head circumference | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Landau reflexes test | analyze the value and its interrelationship with physical exercise pattern | 1 month | |
Secondary | Neonatal intensive care unit (NICU) | analyze the number of admissions and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Postpartum recovery of pre-pregnancy weight | analyze how it varies during postpartum period | 12 months | |
Secondary | Umbilical cord Ph | analyze the value and its interrelationship with physical exercise patterns | 1 month | |
Secondary | Fetal development | analyze variables (estimated fetal weight, Fetal cardiac function, fetal measures, uterine arteries...) by ultrasound | 9 months, once a trimester | |
Secondary | Carotid intima-media thickness (CIMT) | Measurement of carotid intima-media thickness (CIMT) with B-mode ultrasound is a noninvasive, sensitive, and reproducible technique for identifying and quantifying subclinical vascular disease and for evaluating cardiovascular disease (CVD) risk. | 9 months | |
Secondary | Maternal sleep habits | analyze with Pittsburgh´s sleep quality index (Likert scale 0-5; higher scores mean a worse outcome) | 9 months | |
Secondary | Maternal body self-perception | analyze using Ben-Toby Walker Body Attitude Questionnaire (Likert scale 0-5; higher scores mean a worse outcome) | 9 months | |
Secondary | Newborn sleep habits | analyze using Brief Infant Sleep Questionnaire (Likert scale 0-5; higher scores mean a worse outcome) | 24 months | |
Secondary | Perception of health status - Short Form 36 health scale | analyze the value and its interrelationship with physical exercise patterns (Likert scale 0-5; higher scores mean a better outcome) | 9 months | |
Secondary | Placental angiogenic factors | placental growth factor (PIGF) | measured at 24-25 weeks and at 34-35 weeks | |
Secondary | Placental angiogenic factors | soluble fms-like tyrosinekinase-1 (sFlt1) | measured at 24-25 weeks and at 34-35 weeks | |
Secondary | Lipidic profile | ( Total Cholesterol, LDL-Cholesterol, HDL- Cholesterol, Tryglicerids) | measured at 24-25 weeks and at 34-35 weeks |
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