Fetal Cardiovascular Response to Maternal Exercise During Third Trimester

Pregnancy Clinical Trial

Official title:

Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01723293
• Other study ID #: Fetal responses to exercise
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 13, 2014
• Start date: March 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2012
• Source: Technical University of Madrid
• Contact: Maria Perales, PhD student
• Phone: 913364081
• Email: m.perales.santaella[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women

Description:

Fetal heart rate is considered an important index of fetal well-being, especially during the third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise has remained unclear for several reasons

Most of the studies are focused on obtain data in order to examine the fetal heart rate response to maternal exercise using cardiotocography measurements prior to and following maternal exercise

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2015
• Est. primary completion date: May 2013
• 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 Fuenlabrada

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Exercise group
The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.

Locations

Country	Name	City	State
Spain	Universidad Politecnica 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	Fetal heart rate	Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR	Up to 34 weeks	No
Secondary	Fetal outcomes	Birth weight	After labor	No
Secondary	Maternal outcomes	Type of delivery	During labor	No