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PregnancyNCT02420288

Effect of Physical Exercise Program on Fetoplacental Growth

A study testing Exercise Group in people with Pregnancy and Healthy, run by Universidad Politecnica de Madrid at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Healthy
What is being tested?
Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSpain
Study dates
Nov 2014to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Who cannot join

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not having availability to attend to the physical exercise program
  • Younger than 18 years old
  • Older than 45 years old

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Politécnica de Madrid

    Madrid, 28040

Other trials in Spain

About this study

Official title: Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

Conditions
Pregnancy, Healthy
Being tested
Exercise Group
Keywords
Pregnancy, Fetoplacental growth, Physical exercise, Pregnant, Placental development, Active pregnancy
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise GroupBehavioural

    Also called Supervised physical exercise program group

    Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (before week 16 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.

    Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.

Study groups in NCT02420288
Study groupRoleWhat they receive
Control GroupNo interventionPregnant women not participating in supervised physical exercise program. The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.
Exercise GroupExperimentalPregnant women participating in supervised physical exercise program.
Receives: Behavioral: Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placental weight

    Measured: At delivery

  2. Fetal birth weight

    Measured: At delivery

  3. Change from baseline in maternal gestational weight

    Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy

    Measured: 38-42 weeks of gestation

Secondary outcomes (11)

  1. Pregestational weight and Body Mass Index (BMI)

    Measured: Before pregnancy

  2. pH umbilical cord

    Measured: At delivery

  3. Fetal size outcomes

    Size and height, head circumference and body mass index of the baby

    Measured: At delivery

  4. Fetal glycemia level

    Measured: At delivery

  5. Apgar score

    Apgar score will be valued 1 and 5 minutes after delivery

    Measured: At delivery

  6. Maternal delivery outcomes (composite)

    Type of labor, stage and duration of labor

    Measured: At delivery

  7. Postpartum depression

    The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)

    Measured: 0-12 postpartum months

  8. Changes from baseline in prenatal depression

    The level of maternal depression during pregnancy will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Center for Epidemiologic Studies Depression Scale (CES-D)

    Measured: Up to 36 weeks

  9. Changes from baseline in maternal quality of life

    Maternal quality of life will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Short Form-36 Health Survey (SF-36)

    Measured: Up to 36 weeks

  10. Changes from baseline in urinary incontinence

    Urinary incontinence will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)

    Measured: Up to 36 weeks

  11. Gestational diabetes

    Gestational diabetes will be measured with the O' Sullivan's test

    Measured: 24-28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2016
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420288
Sponsor's protocol ID
INEF-001
Status last verified
Jun 2019
First submitted
8 Apr 2015
Last updated
25 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

    PubMed 32378735

  • Vargas-Terrones M, Barakat R, Santacruz B, Fernandez-Buhigas I, Mottola MF. Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial. Br J Sports Med. 2019 Mar;53(6):348-353. doi: 10.1136/bjsports-2017-098926. Epub 2018 Jun 13.

    PubMed 29899050

  • Barakat R, Vargas M, Brik M, Fernandez I, Gil J, Coteron J, Santacruz B. Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial. Eval Health Prof. 2018 Sep;41(3):400-414. doi: 10.1177/0163278717706235. Epub 2017 Apr 25.

    PubMed 29179559

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group in people with Pregnancy and Healthy, run by Universidad Politecnica de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placental weight (time frame: At delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420288, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.

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