Exercise During Pregnancy and Perinatal Outcome

Healthy Clinical Trial

Official title:

Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756143
• Other study ID #: PERINATEXER
• Status: Completed
• Phase: N/A
• First received: April 21, 2016
• Last updated: October 26, 2017
• Start date: November 2014
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: University Hospital of Torrejon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

Description:

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines

• Able to communicate in spanish

• Giving birth at Torrejon Universitary Hospital

Exclusion Criteria:

• Medical or obstetric complication excluding exercise ( ACOG guideline)

• Interested in the study after 18 weeks or pregnancy

• Not availability to attend to the physical exercise program

Related Conditions & MeSH terms

• Healthy
• Pregnancy

Intervention

Behavioral:
• Exercise
Supervised physical conditioning program of three 55—60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists 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 heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.

Locations

Country	Name	City	State
Spain	University Hospital de Torrejon	Torrejon de Ardoz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Torrejon	Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal weight gain during pregnancy		From the beginning of the pregnancy to 1 month postdelivery
Secondary	Cesarean Section Rate		Birth
Secondary	Gestational Diabetes		Birth
Secondary	Preeclampsia		birth
Secondary	Fetal TAPSE	Tricuspid Annular Plane Systolic Excursion meassured by echocardiogram	up to 36 weeks of pregnancy
Secondary	Fetal Tei Index	Myocardial Performance Index meassured by echocardiogram	up to 36 weeks of pregnancy
Secondary	Ductus Arteriosus PI	Ductus Arteriosus Pulsatility Index meassured by echocardiogram	up to 36 weeks
Secondary	Aortic Isthmus PI	Aortic Isthmus Pulsatility Index meassured by echocardiogram	up to 36 weeks
Secondary	Fetal Heart Rate Variability	Fetal Heart Rate Variability meassured by cardiotocogram	birth
Secondary	Newborn weight	birth	birth
Secondary	Placental weight		birth

External Links

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