Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)

NCT05295264 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Mental Health Wellness
  • Emotional Problem

Interventions

OTHER

Moderate exercise program

Exercise program All sessions will begin with a warm-up of 7-8 minutes composed of mild movements and joint mobility of upper and lower limbs exercises. Then a central part of 35-40 minutes, four types of activities will be included (aerobic work, muscle strengthening, coordination/balance tasks, pelvic floor exercises), finally a section of flexibility, relaxation, and final talk (comments and sharing) will be performed (12-15 minutes). Healthy lifestyle advise This intervention consists of providing guidelines and videos with advice on healthy habits throughout the pregnancy process. This type of content will be related to daily physical activity, food recommendations, and fundamental exercises to perform during pregnancy.

Sponsors & Collaborators

  • Hospital Severo Ochoa

    collaborator OTHER
  • Puerta de Hierro University Hospital

    collaborator OTHER
  • Hospital Universitario de Torrejón,Madrid

    collaborator OTHER
  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Hospital Vall d'Hebron

    collaborator OTHER
  • Clinica Zuatzu

    collaborator UNKNOWN
  • Universidad Politecnica de Madrid

    lead OTHER

Principal Investigators

  • Rubén Barakat, PhD · Universidad Politécnica de Madrid (UPM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2024-01-01
Completion
2025-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05295264 on ClinicalTrials.gov