Effect During Pregnancy and Intrapartum Health

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348332
• Other study ID #: Intrapartum assessment
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 16, 2017
• Start date: March 2012
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: Technical University of Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: September 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Politécnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage of labor	Duration stages of labor (min)	At the moment of delivery
Secondary	Maternal gestational weight gain	Change from baseline in maternal gestational weight gain (g)	40-42 weeks of gestation
Secondary	Glucose state	Maternal glucose state (O´Sullivan test)	24-26 weeks of gestation
Secondary	Blood pressure	Maternal blood pressure during pregnancy (mmHg)	12, 20 and 34 weeks of gestation
Secondary	Gestational age	Gestational age (weeks)	At the moment of delivery
Secondary	Birth weight	Newborn weight (g)	At the moment of delivery