Effect During Pregnancy and Intrapartum Health

November 16, 2017 updated by: María Perales Santaella, Technical University of Madrid

Effect of Supervised Exercise During Pregnancy on Maternal and Newborn 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

530

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 Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Politecnica de Madrid

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Sedentary pregnant women
Pregnant women who do not exercise regularly during pregnancy
Experimental: Exercise pregnant women
Pregnant women who participate in a supervised exercise program
Behavioral: Exercise pregnant women
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage of labor
Time Frame: At the moment of delivery
Duration stages of labor (min)
At the moment of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal gestational weight gain
Time Frame: 40-42 weeks of gestation
Change from baseline in maternal gestational weight gain (g)
40-42 weeks of gestation
Glucose state
Time Frame: 24-26 weeks of gestation
Maternal glucose state (O´Sullivan test)
24-26 weeks of gestation
Blood pressure
Time Frame: 12, 20 and 34 weeks of gestation
Maternal blood pressure during pregnancy (mmHg)
12, 20 and 34 weeks of gestation
Gestational age
Time Frame: At the moment of delivery
Gestational age (weeks)
At the moment of delivery
Birth weight
Time Frame: At the moment of delivery
Newborn weight (g)
At the moment of delivery

Collaborators and Investigators

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

Sponsor

Technical University of Madrid

Investigators

  • Study Director: Rubén Barakat Carballo, PhD, Universidad Politécnica de Madrid.
  • Principal Investigator: María Perales Santaella, PhD, Universidad Politécnica de Madrid.

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)

March 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Intrapartum assessment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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