Effect During Pregnancy and Intrapartum Health

NCT03348332 | Completed DMC

• 1 other identifier: Intrapartum assessment
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

exercise; intrapartum; aerobic exercise; resistance exercise; wellbeing

Outcome Measures

Primary Outcomes (1)

• Stage of labor

  Duration stages of labor (min)

  At the moment of delivery

Secondary Outcomes (5)

• Maternal gestational weight gain

  40-42 weeks of gestation

• Glucose state

  24-26 weeks of gestation

• Blood pressure

  12, 20 and 34 weeks of gestation

• Gestational age

  At the moment of delivery

• Birth weight

  At the moment of delivery

Study Arms (2)

Sedentary pregnant women

NO INTERVENTION

Pregnant women who do not exercise regularly during pregnancy

Exercise pregnant women

EXPERIMENTAL

Pregnant women who participate in a supervised exercise program

Behavioral: Exercise pregnant women

Interventions

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.

Exercise pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Madrid: lead

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ruben Barakat Carballo, PhD

  Universidad Politecnica de Madrid

  STUDY DIRECTOR

• María Perales Santaella, PhD

  Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2016
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

ES (1)