Fetal Cardiovascular Response to Maternal Exercise During... | NCT01723293

Studies
Fetal Cardiovascular Response to Maternal Exercise During Third Trimester

NCT01723293

Sponsor

Technical University of Madrid

Status

Unknown status

Last Update Posted

Nov 14, 2014Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Exercise group

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

May 2013Actual

Completion Date

Jun 2015Estimated

First Submitted Date

Nov 5, 2012

First Submission Date that Met QC Criteria

Nov 5, 2012

First Posted Date

Nov 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2014

Last Update Posted Date

Nov 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

María Perales Santaella, PhD Student, Technical University of MadridPrincipal Investigator

Lead Sponsor

Technical University of MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Sedentary pregnant women
Exercise group	Experimental		Behavioral: Exercise group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise group	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fetal heart rate	Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR	Up to 34 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fetal outcomes	Birth weight	After labor
Maternal outcomes	Type of delivery	During labor

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Perales, PhD student	Contact	913364081		m.perales.santaella@gmail.com
Ruben Barakat, PhD	Contact	913364020		barakatruben@gmail.com

Overall Officials

Name	Affiliation	Role
Rubén Barakat, PhD	Universidad Politecnica de Madrid	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Politecnica de Madrid	Recruiting	Madrid	Madrid	28040	Spain