Effect of Physical Exercise Program on Fetoplacental Growth

Healthy Clinical Trial

Official title:

Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02420288
• Other study ID #: INEF-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2021

Study information

• Verified date: June 2019
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• 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 Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

• Multiparity

• Obstetrician complications

• Being interested in the study after 18 weeks

• Not having availability to attend to the physical exercise program

• Younger than 18 years old

• Older than 45 years old

Related Conditions & MeSH terms

• Healthy
• Pregnancy

Intervention

Behavioral:
• Exercise Group
Supervised physical conditioning program of three 55—60 minute sessions per week during whole pregnancy (before week 16 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	Universidad Politécnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental weight		At delivery
Primary	Fetal birth weight		At delivery
Primary	Change from baseline in maternal gestational weight	Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy	38-42 weeks of gestation
Secondary	Pregestational weight and Body Mass Index (BMI)		Before pregnancy
Secondary	pH umbilical cord		At delivery
Secondary	Fetal size outcomes	Size and height, head circumference and body mass index of the baby	At delivery
Secondary	Fetal glycemia level		At delivery
Secondary	Apgar score	Apgar score will be valued 1 and 5 minutes after delivery	At delivery
Secondary	Maternal delivery outcomes (composite)	Type of labor, stage and duration of labor	At delivery
Secondary	Postpartum depression	The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)	0-12 postpartum months
Secondary	Changes from baseline in prenatal depression	The level of maternal depression during pregnancy will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Center for Epidemiologic Studies Depression Scale (CES-D)	Up to 36 weeks
Secondary	Changes from baseline in maternal quality of life	Maternal quality of life will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Short Form-36 Health Survey (SF-36)	Up to 36 weeks
Secondary	Changes from baseline in urinary incontinence	Urinary incontinence will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)	Up to 36 weeks
Secondary	Gestational diabetes	Gestational diabetes will be measured with the O' Sullivan's test	24-28 weeks

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