Effects in Type of Birth of Physical Exercise During Pregnancy

Status Completed

Clinical Trial Summary

Abstract:

Objectives:[The goal is] to confirm if physical activity of medium intensity performed during gestation can influence the way of delivery, and observe the adherence to exercise among pregnant women with different education levels. Methods: Held at the Center for Breastfeeding Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008 and April 14, 2009, the prospective study involved 66 primigravid women, who were divided into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the other control group (GC) that did not exercise regularly during same period. The significance level adopted in this study was five per cent (p = 0.05).

Clinical Trial Description

Research was conducted at the Maternal Breastfeeding Incentive Center (Centro de Incentivo ao Aleitamento Materno - CIAMA) in São Sebastião, São Paulo, Brazil. The 66 primigravidas were allocated to two groups: a control group, with 29 pregnant women who had not performed any kind of physical activity during pregnancy, and another group, the exercise group, with 37 pregnant women who performed supervised aerobic physical exercises twice a week. These volunteers needed to attend at least 20 sessions to be included in the research. No pregnant women in the control group or the exercise group had performed regular physical activity in the year prior to the pregnancy. All participants received verbal information on how the research would be conducted, and after agreeing to participate they signed a free and informed consent term. The physical activity was prescribed by a physical therapist who remained available to address any doubts about the physical activity and about the research. The study followed the baselines of the American Congress of Obstetricians and Gynecologists (ACOG), where the environment temperature hasn't exceeded 28 °C. The pregnant women were told to wear comfortable clothes and to drink water before and during the activity, and not to perform physical activity while fasting. They were also instructed to interrupt the activity in case they felt dizziness, breathlessness, pain, muscle weakness, dyspnea prior to effort or in case they presented calf swelling or pain, bleeding or signs of labor, or, still, if they noticed decrease in fetal movements. Two weeks after birth the volunteers were contacted by phone to collect information on the type of birth. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Pregnancy

Clinical Trial Details

NCT number	NCT01461187
Study type	Interventional
Source	Hospital do Servidor Publico Estadual
Contact
Status	Completed
Phase	N/A
Start date	April 2008
Completion date	April 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.