The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System

December 5, 2024 updated by: George Makrydimas
The investigators aim to evaluate the effect of long-term moderate intensity physical activity during pregnancy in maternal and fetal cardiovascular system. A randomized clinical trial was designed with two groups (Study group and Control Group).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Physical activity (PA) enhances not only physical but also mental health.PA contributes to the prevention of a variety of diseases in general population including hypertension, diabetes mellitus, stress, and depression. Nevertheless, pregnancy is a time period that various changes take place in a woman's body. Those alterations might be either facilitators or barriers for conducting PA during pregnancy.

When it comes to pregnancy several benefits have been associated with PA for both mother and fetus; such as low gestational weight gain, lower incidence of gestational diabetes mellitus (GDM), better management of Pre-eclampsia and post-partum weight retention. Moreover, PA improves mental health in pregnant women, while recent studies have revealed that physical exercise during pregnancy can improve oxidative stress, inflammation and endothelial function. The vast majority of Obstetricians & Gynecologists recommend that pregnant women should be urged to start or continue doing physical activity in the absence of contraindications. To be more specific, pregnant women should do at least 150 minutes of moderate intensity PA weekly. However, several studies support that pregnant women all over the world does not meet those recommendations. Relevant evidence of published literature are scarce regarding the alterations on maternal and fetal cardiovascular system due to chronic exercise .

Thus, investigators aim to evaluate the effect of long-term moderate intensity PA in maternal and fetal cardiovascular system. Thus, a randomized clinical trial with two groups (study group-control group) was designed. The study group includes pregnant women during the 1st trimester that will undergo moderate intensity PA, while the control group includes pregnant women that will receive the routine antenatal care. Participants will be followed up until 6 months postpartum.

To be more specific, all participants will receive a pedometer to record their daily steps from the first trimester until the postpartum period. The intervention group will additional receive detailed recommendations for 30 minutes of moderate intensity exercise at least 4-5 times per week (if not daily) and brochures with relevant information will be administrated as well. Moreover, brochures with dietary recommendations during pregnancy will be given to all participants.

Three routine antenatal ultrasound scans at 11-13+6 , 20-24, and 32-36 gestational weeks will be performed. Maternal Uterine Dopplers will be assessed at every scan, while fetal Dopplers will be done at 2nd and 3rd trimester. Maternal cardiovascular assessment will take place at 1st trimester, 3rd trimester and postpartum with transthoracic echocardiography, ophthalmic artery Doppler, Flow Mediated Dilatation and Arterial Stiffness . Fetal heart function will be assessed at 2nd and 3rd trimester. Evaluation of the infants' heart will also be performed at 6 months postpartum. A questionnaire evaluating mental health known as Depression-Anxiety and Stress Scale 21 (DASS-21) in pregnant women will be administered during the 1st and 3rd trimester. Maternal body fat measurements will take place at each trimester and postpartum. In addition fat composition of both the fetus will be evaluated by ultrasound before the delivery and the newborn within 48 hours following birth. Maternal blood sample will be collected during 1st trimester, 3rd trimester and postpartum and blood sample from the umbilical cord during labour, to assess several parameters.

All participants will be fully informed about the purpose of the study and will be included only after signing the Informed Consent Form. All data collected will be confidential and only accessible to members of the research team. These data will be coded according to GDPR. The clinical implementation of this study will be according to the International Code of Medical Ethics of the World Medical Association (Declaration of Helsinki), and all participants submitted a written informed consent since a detailed description of all aspects and the objectives of the study are explained and fully understood. The ethical committee of the University Hospital of Ioannina approved this study (decision number: 3/30-01-2024; date of approval; 30 January 2024).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: George Makrydimas, Professor
  • Phone Number: +306944542420
  • Email: grmak@otenet.gr

Study Locations

  • Greece
      • Ioannina, Greece, 45500
        • Recruiting
        • Department of Obstetrics and Gynecology, University Hospital of Ioannina
        • Contact:
          • George Makrydimas, Professor
          • Phone Number: +30 6944542420
          • Email: gmakrydi@uoi.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women during 1st trimester, who had the routine dating scan at 11-13+6 gestational weeks [also known as Nuchal translucency (NT) scan] and the uterine arteries (UtA) PI assessment

Exclusion Criteria:

  • Diabetes Mellitus (Type I or II)
  • Maternal age < 18 years old
  • Body Mass Index (BMI) > 40
  • Contraindications for PA: Multiple Pregnancies, Vaginal Bleeding, Hypertension or Gestational Hypertension, Uncontrolled Thyroid Diseases, Cardiovascular Diseases (e.g. valvular diseases, congenital heart diseases, cardiomyopathies, atrial fibrillation, coronary heart disease) or respiratory system diseases (asthma, chronic obstructive pulmonary disease) or systemic disease (cancer, autoimmune diseases) or several other diseases considered to be barriers for PA during pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Routine Antenatal Care. Brochures with dietary recommendations will be given.
Experimental: Experimental
Detailed recommendations and brochures regarding physical activity will be given.Moreover brochures with dietary recommendations will be administrated.
Other: Moderate intensity physical activity
Moderate intensity exercise of 30 minutes for at least 4-5 times per week (if not daily).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine Arteries Pulsatility Index at each trimester
Time Frame: 11-13+6, 20-24, and 32-36 gestational weeks
Uterine Arteries Pulsatility Index will be measured with Ultrasound Doppler by the same operator, at each trimester
11-13+6, 20-24, and 32-36 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical artery Pulsatility Index during the 2nd and 3rd trimester
Time Frame: 20-24, and 32-36 gestational weeks
Measured with Ultrasound Doppler by the same operator
20-24, and 32-36 gestational weeks
Middle Cerebral Artery Pulsatility Index during the 2nd and 3rd trimester
Time Frame: 20-24, and 32-36 gestational weeks
Measured with Ultrasound Doppler by the same operator
20-24, and 32-36 gestational weeks
Incidence of Gestational Diabetes
Time Frame: 26-29 weeks gestation
Diagnosis will be made based on oral glucose tolerance test with ingestion of 75g of glucose. Abnormal is considered either of the following: fasting glucose >92mg/dl, glucose >180mg/dl one hour after, glucose >153mg/dL two hours after.
26-29 weeks gestation
Incidence Pre-eclampsia
Time Frame: >20 weeks until 4-6 weeks postpartum
New onset of hypertension and proteinuria or the new onset of hypertension plus significant end-organ dysfunction with or without proteinuria
>20 weeks until 4-6 weeks postpartum
Maternal body fat measurements
Time Frame: 11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum
Measured with calibrated body fat scale
11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum
Gestational weight Change
Time Frame: Between 36-40 weeks gestation
Comparison of maternal weight at the time of inclusion in the study and at the final ultrasound examination.
Between 36-40 weeks gestation
Gestational age at labor
Time Frame: Delivery
Gestational weeks
Delivery
Maternal mental health
Time Frame: 11-13+6. and 32-36 gestational weeks
Depression-Anxiety and Stress Scale 21. This scale is a 21 item self report questionnaire designed to measure the severity of a range of symptoms common ot both Depression and Anxiety. Each item is scored from 0 (did not apply to me) to 3(applied to me very much or most of the time). The scale ot which each item belongs is indicated by the letters D(Depression), A(Anxiety) and S (Stress). For each scale (D, A&S) sum the scores for identified items. The higher scores indicate more severe conditions.
11-13+6. and 32-36 gestational weeks
Maternal cardiovascular adaptations during pregnancy and postpartum
Time Frame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Transthoracic echocardiography will be performed by specialist cardiologist and will assess the following parameters: PWV, cSBP, cPP, LVEF, LVEDd, LVM, GLS, EDV, ESV, LAV, LAVI, MPI, LVMI, IVS, VTI, TR, PWT, RWT, E wave velοcity, A wave velocity, Deceleration time E/A ratio, Lateral e' velocity, Septal e' velocity
11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Arterial stiffness and FMD adaptations thorough pregnancy
Time Frame: 11-13+6. and 32-36 gestational weeks and 8-12 weeks postpartum
: Arterial Stiffness will be evaluated using the Mobil-O-Graph tool as assessed by the Pulse wave Velocity (PWV). FMD represents a non-invasive method to determine the endothelial dysfunction in the brachial artery in response to reactive hyperaemia.
11-13+6. and 32-36 gestational weeks and 8-12 weeks postpartum
Maternal Blood Samples' findings
Time Frame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
: Maternal blood samples will be analyzed by certified laboratories and the findings will be evaluated. Comparisons between the two groups will take place.
11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Umbilical cord blood samples; findings
Time Frame: Delivery
Umbilical cord blood samples will be analyzed by certified laboratories and the findings will be evaluated. Comparisons between the two groups will take place
Delivery
Fetus and Neonatal Fat Composition
Time Frame: Before delivery and within 48 hours following delivery
Fat composition of the neonate will be measured with ultrasound at the level of femur, humerus abdomen and scapula. Comparisons between the two groups will take place
Before delivery and within 48 hours following delivery
Fetal heart adaptations and cardiovascular changes of the infant
Time Frame: 20-24, 32-36 gestational weeks and 5-7 months postpartum.
The following parameters were obtained via fetal echocardiography during ultrasound examinations at 20-24 and 32-36 gestational weeks as well as transthoracic echocardiography of the infant at 5-7 months old: MAPSE, TAPSE, LVCO, LVEF, E/A ratio, AoI PI, DA PI, Aorta peak velocity, Pulmonary Artery peak Velocity. A comparison between the two groups (study group-control group) will be conducted, as well.
20-24, 32-36 gestational weeks and 5-7 months postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Makrydimas

Investigators

  • Study Director: George Makrydimas, Professor, University Hospital, Ioannina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3/30-01-2024 (θ. 6)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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