Effect of Physical Exercise Program on Fetoplacental Growth

Not Applicable

• Conditions: Pregnancy; Healthy
• Interventions: Behavioral: Exercise Group

• Registration Number: NCT02420288
• Lead Sponsor: Universidad Politecnica de Madrid

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Primary Completion: 2016-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-25
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise Group	Pregnant women participating in supervised physical exercise program.

Primary Outcome Measures

Name	Time	Method
Fetal birth weight	At delivery
Change from baseline in maternal gestational weight	38-42 weeks of gestation	Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy
Placental weight	At delivery

Secondary Outcome Measures

Name	Time	Method
Fetal size outcomes	At delivery	Size and height, head circumference and body mass index of the baby
Maternal delivery outcomes (composite)	At delivery	Type of labor, stage and duration of labor
Changes from baseline in prenatal depression	Up to 36 weeks	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)
Pregestational weight and Body Mass Index (BMI)	Before pregnancy
pH umbilical cord	At delivery
Apgar score	At delivery	Apgar score will be valued 1 and 5 minutes after delivery
Changes from baseline in maternal quality of life	Up to 36 weeks	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)
Gestational diabetes	24-28 weeks	Gestational diabetes will be measured with the O' Sullivan's test
Fetal glycemia level	At delivery
Postpartum depression	0-12 postpartum months	The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)
Changes from baseline in urinary incontinence	Up to 36 weeks	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)

Trial Locations

Locations (1)

Universidad Politécnica de Madrid; 🇪🇸 Madrid, Spain