Active Pregnancy Against COVID-19

Pregnancy Complications Clinical Trial

— ACPREGCOV  

Official title:

Active Pregnancy, Prevention Against the Effects of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04563065
• Other study ID #: UPM-2020-32/33
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Universidad Politecnica de Madrid
• Contact: Cristina Silva-Jose, Msc
• Phone: +34662556019
• Email: cristina.silva.jose[@]upm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women. Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period. Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists. The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants. In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active. This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy. It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women. In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.

Description:

Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of prevention of alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children. Objective Examine the influence of a supervised aerobic exercise program during pregnancy, by non-face-to-face and face-to-face ways, on the prevention of maternal, fetal, newborn and infant alterations during the pandemic state and in the near future. Material and Methods - Study design. A randomized clinical trial (RCT) will be carried out, not masked with healthy pregnant women, giving rise to two study groups: exercise group (EG), pregnant women participating in a regular program of supervised physical exercise and control group ( CG), pregnant women who receive normal obstetric monitoring of their pregnancy, including recommendations regarding dietary-nutritional factors, as well as the benefits of an active pregnancy. All selected pregnant women will sign an Informed Consent before participating in the study. Women randomly assigned to the 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). Intervention General characteristics of the physical exercise program: - The minimum adherence required will be 80% of the total sessions. - Onset: gestational week 9-11, immediately after the first prenatal ultrasound, in order to rule out Obstetric Contraindications for physical exercise. - End: gestational week 38-39. - Frequency: 3 weekly sessions, various possibilities will be offered at different times from which the pregnant woman can choose, in order to promote work and family conciliation. Basic Considerations: 1. All the activity carried out will be aerobic. 2. Avoid working positions in which areas normally overloaded by pregnancy are further affected. 3. The work corresponding to flexibility will be carried out always bearing in mind that these are pregnant women, this forces us once again not to include forced operating positions in the exercises or to excessively maintain the stretching times in each area. 4. An adequate fluid intake will be maintained before and after the activity. 5. Also as a general rule and to eliminate potential risks, the following will be avoided: - Activities that include the Valsalva maneuver. - High ambient temperatures or very humid environments in order to avoid hyperthermia (body temperature higher than 38º C). - Sudden movements. - Positions of extreme muscular tension. Structure: 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). Below we offer a greater detail of each part: I. Warm-up-General activation. Displacements varied without impact activities (avoiding jumps, falls). Mild work of mobility of the main joints. II. Aerobic section. Exercise to increase intensity up to moderate activities, play with sports equipment (balls, ropes, pikes) or choreographies of different musical styles. III. Muscle strengthening, general toning exercises of the whole body: lower part (calf, quadriceps, hamstrings, adductors, abductors), upper part (abdominal, pectoral, shoulders, paravertebral musculature). Also exercises for the most weakened and needy muscle groups during pregnancy, the aim is to avoid muscular decompensation. IV. Coordination and balance exercises: simple tasks of eye-hand and eye-foot coordination with sports equipment, as well as body axis balance exercises. V. Strengthening the pelvic floor muscles, Kegel exercises will be applied and is basically composed of contractions (slow and fast) of the different structures of the pelvic floor musculature. VI. Cool down section during 7-8 minutes, aiming to gradually lower the intensity of work with flexibility-stretching and relaxation exercises. VII. Final Talk. This part is intended for pregnant women to express clearly and openly the sensations and perceptions experienced during the session. The reflection of each participant on the effect of physical practice is sought, not only in the physical or physiological aspect, but also in the psychic and emotional section. The exchange of impressions between the pregnant women, enhances the role of a correctly designed and conducted physical exercise program, as a social mobile of maintenance and improvement of the quality of life of the pregnant woman.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 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 provider prior to participation(1,2):

Absolute contraindications to exercise:

• Ruptured membranes.
• Premature labour.
• Unexplained persistent vaginal bleeding.
• Placenta praevia after 28 weeks' gestation.
• Pre-eclampsia.
• Incompetent cervix.
• Intrauterine growth restriction.
• High-order multiple pregnancy (eg, triplets).
• Uncontrolled type I diabetes.
• Uncontrolled hypertension.
• Uncontrolled thyroid disease.
• Other serious cardiovascular, respiratory or systemic disorder.

Relative contraindications to exercise:

• Recurrent pregnancy loss.
• Gestational hypertension.
• A history of spontaneous preterm birth.
• Mild/moderate cardiovascular or respiratory disease.
• Symptomatic anaemia.
• Malnutrition.
• Eating disorder.
• Twin pregnancy after the 28th week.
• Other significant medical conditions.

References:

1. Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray, C. E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-1346. https://doi.org/10.1136/bjsports-2018-100056.

2. Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI: 10.20960/j.pog.00231.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Fetus Disorder
• Gestational Weight Gain
• Hypertension, Pregnancy-Induced
• Maternal-Fetal Relations
• Newborn Morbidity
• Pregnancy Complications
• Pregnancy Induced Hypertension
• Pregnancy, High Risk
• Weight Gain
• Weight Gain, Maternal

Intervention

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 infographics 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.

Locations

Country	Name	City	State
Spain	Facultad de Ciencias de la Actividad Física y el Deporte (INEF)	Madrid
Spain	Facultad de Ciencias de la Actividad Física y el Deporte - INEF	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid	Clínica Zuatzu de San Sebastián, Hospital Severo Ochoa, Hospital Universitario de Torrejón de Ardoz, Hospital Vall d'Hebron, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (20)

Badon SE, Littman AJ, Chan KCG, Tadesse MG, Stapleton PL, Bammler TK, Sorensen TK, Williams MA, Enquobahrie DA. Physical activity and epigenetic biomarkers in maternal blood during pregnancy. Epigenomics. 2018 Nov;10(11):1383-1395. doi: 10.2217/epi-2017-0169. Epub 2018 Oct 16. — View Citation

Barakat R, Franco E, Perales M, López C, Mottola MF. Exercise during pregnancy is associated with a shorter duration of labor. A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 May;224:33-40. doi: 10.1016/j.ejogrb.2018.03.009. Epub 2018 Mar 6. — View Citation

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. — View Citation

Barakat R, Perales M, Garatachea N, Ruiz JR, Lucia A. Exercise during pregnancy. A narrative review asking: what do we know? Br J Sports Med. 2015 Nov;49(21):1377-81. doi: 10.1136/bjsports-2015-094756. Epub 2015 Jul 1. Review. — View Citation

Barakat R, Refoyo I, Coteron J, Franco E. Exercise during pregnancy has a preventative effect on excessive maternal weight gain and gestational diabetes. A randomized controlled trial. Braz J Phys Ther. 2019 Mar - Apr;23(2):148-155. doi: 10.1016/j.bjpt.2018.11.005. Epub 2018 Nov 17. — View Citation

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. Review. — View Citation

Contreras ZA, Ritz B, Virk J, Cockburn M, Heck JE. Maternal pre-pregnancy and gestational diabetes, obesity, gestational weight gain, and risk of cancer in young children: a population-based study in California. Cancer Causes Control. 2016 Oct;27(10):1273-85. doi: 10.1007/s10552-016-0807-5. Epub 2016 Sep 9. — View Citation

Della Gatta AN, Rizzo R, Pilu G, Simonazzi G. Coronavirus disease 2019 during pregnancy: a systematic review of reported cases. Am J Obstet Gynecol. 2020 Jul;223(1):36-41. doi: 10.1016/j.ajog.2020.04.013. Epub 2020 Apr 18. — View Citation

Fernández-Buhigas I, Brik M, Martin-Arias A, Vargas-Terrones M, Varillas D, Barakat R, Santacruz B. Maternal physiological changes at rest induced by exercise during pregnancy: A randomized controlled trial. Physiol Behav. 2020 Jun 1;220:112863. doi: 10.1016/j.physbeh.2020.112863. Epub 2020 Mar 8. — View Citation

Khan S, Jun L, Nawsherwan, Siddique R, Li Y, Han G, Xue M, Nabi G, Liu J. Association of COVID-19 with pregnancy outcomes in health-care workers and general women. Clin Microbiol Infect. 2020 Jun;26(6):788-790. doi: 10.1016/j.cmi.2020.03.034. Epub 2020 Apr 8. — View Citation

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. — View Citation

Mourtakos SP, Tambalis KD, Panagiotakos DB, Antonogeorgos G, Arnaoutis G, Karteroliotis K, Sidossis LS. Maternal lifestyle characteristics during pregnancy, and the risk of obesity in the offspring: a study of 5,125 children. BMC Pregnancy Childbirth. 2015 Mar 21;15:66. doi: 10.1186/s12884-015-0498-z. — View Citation

Novakovic B, Saffery R. The ever growing complexity of placental epigenetics - role in adverse pregnancy outcomes and fetal programming. Placenta. 2012 Dec;33(12):959-70. doi: 10.1016/j.placenta.2012.10.003. Epub 2012 Oct 24. — View Citation

Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050. — View Citation

Perales M, Refoyo I, Coteron J, Bacchi M, Barakat R. Exercise during pregnancy attenuates prenatal depression: a randomized controlled trial. Eval Health Prof. 2015 Mar;38(1):59-72. doi: 10.1177/0163278714533566. Epub 2014 May 28. — View Citation

Perales M, Valenzuela PL, Barakat R, Cordero Y, Peláez M, López C, Ruilope LM, Santos-Lozano A, Lucia A. Gestational Exercise and Maternal and Child Health: Effects until Delivery and at Post-Natal Follow-up. J Clin Med. 2020 Jan 31;9(2). pii: E379. doi: 10.3390/jcm9020379. — View Citation

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. — View Citation

Shrestha D, Workalemahu T, Tekola-Ayele F. Maternal dyslipidemia during early pregnancy and epigenetic ageing of the placenta. Epigenetics. 2019 Oct;14(10):1030-1039. doi: 10.1080/15592294.2019.1629234. Epub 2019 Jun 14. — View Citation

Vargas-Terrones M, Nagpal TS, Barakat R. Impact of exercise during pregnancy on gestational weight gain and birth weight: an overview. Braz J Phys Ther. 2019 Mar - Apr;23(2):164-169. doi: 10.1016/j.bjpt.2018.11.012. Epub 2018 Nov 22. Review. — View Citation

Yang Z, Wang M, Zhu Z, Liu Y. Coronavirus disease 2019 (COVID-19) and pregnancy: a systematic review. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1619-1622. doi: 10.1080/14767058.2020.1759541. Epub 2020 Apr 30. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perception of health status - SF36 health scale	analyze the value and its interrelationship with physical exercise patterns (Likert scale)	24 months
Other	Recovery of pelvic floor muscles ultrasound	analyze the diameter and thickness of muscles in the perineal area and its 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 behavioural habits like (smoking, alcoholism, pervious illness, COVID-19, parity, occupation, previous miscarriage...)	9 months
Other	Edimburgh postpartum depression scale	analyze with a questionnaire the variability in the postpartum	6 months
Other	Covid-19 disease	analyze the covid-19 condition durign pregnancy and its interrelationship with other variables	9 months
Primary	Maternal weight gain	analyze the increase during pregnancy	9 months
Primary	blood pressure	analyze how it varies during pregnancy	9 months
Primary	OGTT-O'Sullivan test	analyze the value and its interrelationship with physical exercise patterns	1 month
Primary	Urinary Incontinence Questionnaire (ICIQ-SF)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)	9 months
Primary	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	depression scale (CES-D)	analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)	9 months
Primary	Behavior of Fetal Heart Rate	analyze variability during pregnancy	3 months
Primary	gestational age	analyze the value and its interrelationship with physical exercise patterns	9 months
Primary	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
Primary	duration of labor	analyze the value and its interrelationship with physical exercise patterns	1 month
Primary	birthweight	analyze the value and its interrelationship with physical exercise patterns	1 month
Primary	child's weight	analyze the value and its interrelationship with physical exercise patterns during pregnancy	24 months
Primary	child's height	analyze the value and its interrelationship with physical exercise patterns during pregnancy	24 months
Primary	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
Primary	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 month
Secondary	length	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	cranial perimeter	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 patterns	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	Edinburgh Postpartum Depression Scale (EPDS)	analyze with a questionnaire how it varies during postpartum period (Likert scale 0-3)	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, FCF, DBT, CRL, SNT, 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 CVD risk.	9 months
Secondary	Maternal sleep habits	analyze with Pittsburgh´s sleep quality index	9 months
Secondary	maternal body self-perception	analyze using Ben-Tobim Walker Body Attitude Questionnaire	9 months
Secondary	Newborn sleep habits	analyze using Brief Infant Sleep Questionnaire	24 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

External Links

•   Reference of the Spanish clinical guidelines of physical exercise for pregnancy