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OpenTrials
Completed

NCT Number: NCT03348332

Effect During Pregnancy and Intrapartum Health

Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.

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Key information

Conditions

Pregnancy Behavior Motor Activity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Politécnica de Madrid

Madrid, 28040, Spain

About this study

The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).

Exclusion criteria

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Treatment and study plan

Exercise pregnant women

Behavioral

A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted 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 maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity.

Primary outcomes

  1. Stage of labor

    Time frame: At the moment of delivery

    Duration stages of labor (min)

Secondary outcomes

  1. Maternal gestational weight gain

    Time frame: 40-42 weeks of gestation

    Change from baseline in maternal gestational weight gain (g)

  2. Glucose state

    Time frame: 24-26 weeks of gestation

    Maternal glucose state (O´Sullivan test)

  3. Blood pressure

    Time frame: 12, 20 and 34 weeks of gestation

    Maternal blood pressure during pregnancy (mmHg)

  4. Gestational age

    Time frame: At the moment of delivery

    Gestational age (weeks)

  5. Birth weight

    Time frame: At the moment of delivery

    Newborn weight (g)

Sponsors and collaborators

Lead sponsor

Technical University of Madrid

Other

Registry information

Official study title

Effect of Supervised Exercise During Pregnancy on Maternal and Newborn Intrapartum Health

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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