Exercise and Pregnancy: Randomized Clinical Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 17, 2008

Last Updated Date

March 17, 2008

Start Date ^†

April 2008

Current Primary Outcome Measures ^†

Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit [ Time Frame: nine months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Exercise and Pregnancy: Randomized Clinical Trial

Official Title ^†

Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

Brief Summary

The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

Detailed Description

The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.

The objectives are:

To describe and compare biological and obstetrical variables.
To study doppler flow velocimetry indexes.
To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Preeclampsia
Gestational Diabetes

Intervention ^†

Other: Physical exercise

Study Arms / Comparison Groups

Experimental: Pregnant women starting to practice physical exercise at 13 weeks
Experimental: Pregnant women starting exercise at 20 weeks
No Intervention: Pregnant women without exercise practice.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

150

Estimated Completion Date

June 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Gestational age < 13 weeks
Single pregnancy
Alive fetus
No previous practice of physical activity

Exclusion Criteria:

Smoking
Chronic maternal diseases
Placenta praevia
History of preterm labor
Bleeding

Gender

Female

Ages

10 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Adriana Melo, MSc	55-83-99732726	asomelo@gmail.com
Contact: Melania Amorim, PhD	55-83-88221514	melamorim@uol.com.br

Location Countries ^†

Brazil

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00641550

Responsible Party

Dr. Adriana Melo, Universidade Estadual da Paraiba

Secondary IDs ^††

Study Sponsor ^†

Universidade Estadual da Paraiba

Collaborators ^††

Investigators ^†

Study Director:

Melania Amorim, PhD

Instituto Materno Infantil Prof. Fernando Figueira

Information Provided By

Universidade Estadual da Paraiba

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.