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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02420288
Date of registration:	08/04/2015
Prospective Registration:	No
Primary sponsor:	Universidad Politecnica de Madrid
Public title:	Effect of Physical Exercise Program on Fetoplacental Growth
Scientific title:	Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
Date of first enrolment:	November 2014
Target sample size:	124
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02420288
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Spain

Contacts

Name:	Rubén Barakat Carballo, PhD
Address:
Telephone:
Email:
Affiliation:	Universidad Politécnica de Madrid

Key inclusion & exclusion 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 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

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Healthy

Pregnancy

Intervention(s)

Behavioral: Exercise Group

Primary Outcome(s)

Fetal birth weight [Time Frame: At delivery]

Change from baseline in maternal gestational weight [Time Frame: 38-42 weeks of gestation]

Placental weight [Time Frame: At delivery]

Secondary Outcome(s)

Postpartum depression [Time Frame: 0-12 postpartum months]

pH umbilical cord [Time Frame: At delivery]

Pregestational weight and Body Mass Index (BMI) [Time Frame: Before pregnancy]

Apgar score [Time Frame: At delivery]

Maternal delivery outcomes (composite) [Time Frame: At delivery]

Changes from baseline in maternal quality of life [Time Frame: Up to 36 weeks]

Changes from baseline in prenatal depression [Time Frame: Up to 36 weeks]

Fetal glycemia level [Time Frame: At delivery]

Changes from baseline in urinary incontinence [Time Frame: Up to 36 weeks]

Fetal size outcomes [Time Frame: At delivery]

Gestational diabetes [Time Frame: 24-28 weeks]

Secondary ID(s)

INEF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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