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

NCT05295264 | Unknown

• 1 other identifier: Gestactive2022
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pregnancy; exercise; lifestyle; physical activity; fetal-maternal health

Outcome Measures

Primary Outcomes (6)

• Prenatal depression (CES-D)

  analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)

  9 months

• 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

• 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

• 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

• 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

• 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 Outcomes (33)

• Maternal weight gain

  9 months

• Blood pressure

  9 months

• O'Sullivan test (OGTT)

  1 month

• Urinary Incontinence Questionnaire (ICIQ-SF)

  9 months

• Behavior of Fetal Heart Rate

  3 months

Other Outcomes (4)

• Recovery of pelvic floor muscles ultrasound

  6 months

• Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ)

  12 months

• Pregestational maternal patterns

  9 months

Study Arms (2)

Exercise group

EXPERIMENTAL

The design of the physical exercise program will be supported by the Canadian and Spanish Guidelines for exercise throughout pregnancy and published by Barakat model. Frequency: The program will consist of three weekly sessions. The duration of every session will be 55-60 minutes. The intensity of the workload will be 55-60% of the maximum maternal Heart Rate, and controlled by Polar monitor (FT60). Likewise, once a week, the Borg Scale of Perceived Effort will be administered to participants, in order to have a more reliable assessment of the intensity of the activities, 12-14 (moderate; out of a 20 point scale) will be the level used. The minimum adherence required for the participants will be 80% of the total sessions (approximately 80 sessions).

Other: Moderate exercise program

Control group

NO INTERVENTION

Women randomly assigned to the control group (CG) received general advice from their health care provider about the positive effects of physical activity. Participants in the CG had their usual visits with health care providers during pregnancy, which were equal to the exercise group. Women were not discouraged from exercising on their own. However, women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" (by telephone).

Interventions

Moderate exercise program OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead
• Hospital Severo Ochoa: collaborator
• Puerta de Hierro University Hospital: collaborator
• Hospital Universitario de Torrejón,Madrid: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Vall d'Hebron: collaborator
• Clinica Zuatzu: collaborator

Study Sites (1)

Facultad de Ciencias de la Actividad Física y el Deporte - INEF

Madrid, 28040, Spain

RECRUITING

Related Publications (28)

• Khaire A, Wadhwani N, Madiwale S, Joshi S. Maternal fats and pregnancy complications: Implications for long-term health. Prostaglandins Leukot Essent Fatty Acids. 2020 Jun;157:102098. doi: 10.1016/j.plefa.2020.102098. Epub 2020 Apr 21.

  PMID: 32380367 BACKGROUND

• Abbasi H, Puusepp-Benazzouz H. Pregnancy Stress, Anxiety, and Depression Sequela on Neonatal Brain Development. JAMA Pediatr. 2020 Sep 1;174(9):908. doi: 10.1001/jamapediatrics.2020.1073. No abstract available.

  PMID: 32568372 BACKGROUND

• Wenzel ES, Gibbons RD, O'Hara MW, Duffecy J, Maki PM. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec;24(6):979-986. doi: 10.1007/s00737-021-01139-y. Epub 2021 May 10.

  PMID: 33970310 BACKGROUND

• Li H, Bowen A, Bowen R, Muhajarine N, Balbuena L. Mood instability, depression, and anxiety in pregnancy and adverse neonatal outcomes. BMC Pregnancy Childbirth. 2021 Aug 25;21(1):583. doi: 10.1186/s12884-021-04021-y.

  PMID: 34429072 BACKGROUND

• Graham RM, Jiang L, McCorkle G, Bellando BJ, Sorensen ST, Glasier CM, Ramakrishnaiah RH, Rowell AC, Coker JL, Ou X. Maternal Anxiety and Depression during Late Pregnancy and Newborn Brain White Matter Development. AJNR Am J Neuroradiol. 2020 Oct;41(10):1908-1915. doi: 10.3174/ajnr.A6759. Epub 2020 Sep 10.

  PMID: 32912873 BACKGROUND

• Hunter SK, Freedman R, Law AJ, Christians U, Holzman JBW, Johnson Z, Hoffman MC. Maternal corticosteroids and depression during gestation and decreased fetal heart rate variability. Neuroreport. 2021 Oct 6;32(14):1170-1174. doi: 10.1097/WNR.0000000000001711.

  PMID: 34284445 BACKGROUND

• Ullah R, Hasan TN, Rahman MU, Naqvi SS, Sharif N, Ahmad I, Ullah B, Khan I, Ammad M, Arshad N. Coronavirus Family: Responsible Agents for Stress, Depression, and Anxiety during Pregnancy. Psychiatr Danub. 2021 Fall;33(3):425-426. No abstract available.

  PMID: 34795194 BACKGROUND

• Bivia-Roig G, La Rosa VL, Gomez-Tebar M, Serrano-Raya L, Amer-Cuenca JJ, Caruso S, Commodari E, Barrasa-Shaw A, Lison JF. Analysis of the Impact of the Confinement Resulting from COVID-19 on the Lifestyle and Psychological Wellbeing of Spanish Pregnant Women: An Internet-Based Cross-Sectional Survey. Int J Environ Res Public Health. 2020 Aug 15;17(16):5933. doi: 10.3390/ijerph17165933.

  PMID: 32824191 BACKGROUND

• Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.

  PMID: 30337460 BACKGROUND

• Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.

  PMID: 32217980 BACKGROUND

• Meander L, Lindqvist M, Mogren I, Sandlund J, West CE, Domellof M. Physical activity and sedentary time during pregnancy and associations with maternal and fetal health outcomes: an epidemiological study. BMC Pregnancy Childbirth. 2021 Feb 27;21(1):166. doi: 10.1186/s12884-021-03627-6.

  PMID: 33639879 BACKGROUND

• Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.

  PMID: 33124060 BACKGROUND

• Atkinson L, De Vivo M, Hayes L, Hesketh KR, Mills H, Newham JJ, Olander EK, Smith DM. Encouraging Physical Activity during and after Pregnancy in the COVID-19 Era, and beyond. Int J Environ Res Public Health. 2020 Oct 7;17(19):7304. doi: 10.3390/ijerph17197304.

  PMID: 33036326 BACKGROUND

• Dadi AF, Miller ER, Bisetegn TA, Mwanri L. Global burden of antenatal depression and its association with adverse birth outcomes: an umbrella review. BMC Public Health. 2020 Feb 4;20(1):173. doi: 10.1186/s12889-020-8293-9.

  PMID: 32019560 BACKGROUND

• Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1.

  PMID: 32777604 BACKGROUND

• Kolding L, Ehrenstein V, Pedersen L, Sandager P, Petersen OB, Uldbjerg N, Pedersen LH. Obstetric care for women that use antidepressants in pregnancy. BJOG. 2022 Jan;129(1):172. doi: 10.1111/1471-0528.16918. Epub 2021 Sep 29. No abstract available.

  PMID: 34590410 BACKGROUND

• Kolding L, Ehrenstein V, Pedersen L, Sandager P, Petersen OB, Uldbjerg N, Pedersen LH. Antidepressant use in pregnancy and severe cardiac malformations: Danish register-based study. BJOG. 2021 Nov;128(12):1949-1957. doi: 10.1111/1471-0528.16772. Epub 2021 Jun 22.

  PMID: 34036715 BACKGROUND

• Wolgast E, Lindh-Astrand L, Lilliecreutz C. Women's perceptions of medication use during pregnancy and breastfeeding-A Swedish cross-sectional questionnaire study. Acta Obstet Gynecol Scand. 2019 Jul;98(7):856-864. doi: 10.1111/aogs.13570. Epub 2019 Mar 20.

  PMID: 30739330 BACKGROUND

• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  PMID: 33239350 BACKGROUND

• Reichetzeder C. Overweight and obesity in pregnancy: their impact on epigenetics. Eur J Clin Nutr. 2021 Dec;75(12):1710-1722. doi: 10.1038/s41430-021-00905-6. Epub 2021 Jul 6.

  PMID: 34230629 BACKGROUND

• Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, Li N, Hu G, Corrado F, Rode L, Kim YJ, Haugen M, Song WO, Kim MH, Bogaerts A, Devlieger R, Chung JH, Teede HJ. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017 Jun 6;317(21):2207-2225. doi: 10.1001/jama.2017.3635.

  PMID: 28586887 BACKGROUND

• Amezcua-Prieto C, Olmedo-Requena R, Jimenez-Mejias E, Hurtado-Sanchez F, Mozas-Moreno J, Lardelli-Claret P, Jimenez-Moleon JJ. Changes in leisure time physical activity during pregnancy compared to the prior year. Matern Child Health J. 2013 May;17(4):632-8. doi: 10.1007/s10995-012-1038-3.

  PMID: 22569946 BACKGROUND

• Ribeiro MM, Andrade A, Nunes I. Physical exercise in pregnancy: benefits, risks and prescription. J Perinat Med. 2021 Sep 6;50(1):4-17. doi: 10.1515/jpm-2021-0315. Print 2022 Jan 27.

  PMID: 34478617 BACKGROUND

• Sanchez-Polan M, Franco E, Silva-Jose C, Gil-Ares J, Perez-Tejero J, Barakat R, Refoyo I. Exercise During Pregnancy and Prenatal Depression: A Systematic Review and Meta-Analysis. Front Physiol. 2021 Jun 28;12:640024. doi: 10.3389/fphys.2021.640024. eCollection 2021.

  PMID: 34262468 BACKGROUND

• Sanchez-Polan M, Silva-Jose C, Franco E, Nagpal TS, Gil-Ares J, Lili Q, Barakat R, Refoyo I. Prenatal Anxiety and Exercise. Systematic Review and Meta-Analysis. J Clin Med. 2021 Nov 24;10(23):5501. doi: 10.3390/jcm10235501.

  PMID: 34884202 BACKGROUND

• Barakat R, Pelaez M, Cordero Y, Perales M, Lopez C, Coteron J, Mottola MF. Exercise during pregnancy protects against hypertension and macrosomia: randomized clinical trial. Am J Obstet Gynecol. 2016 May;214(5):649.e1-8. doi: 10.1016/j.ajog.2015.11.039. Epub 2015 Dec 15.

  PMID: 26704894 BACKGROUND

• Monk C, Fifer WP, Myers MM, Sloan RP, Trien L, Hurtado A. Maternal stress responses and anxiety during pregnancy: effects on fetal heart rate. Dev Psychobiol. 2000 Jan;36(1):67-77.

  PMID: 10607362 BACKGROUND

• Barakat R. An exercise program throughout pregnancy: Barakat model. Birth Defects Res. 2021 Feb 1;113(3):218-226. doi: 10.1002/bdr2.1747. Epub 2020 Jul 2.

  PMID: 32613735 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rubén Barakat, PhD

  Universidad Politécnica de Madrid (UPM)

  STUDY DIRECTOR

Central Study Contacts

Cristina Silva-Jose, Msc

CONTACT

662556019; cristina.silva.jose@upm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: March 25, 2022
• Study Start: March 17, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 30, 2025
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)