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Effects in Type of Birth of Physical Exercise During Pregnancy

2011年10月26日 更新者:Lilian Cristina da Silveira、Hospital do Servidor Publico Estadual

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).

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

介入

入学 (実際)

66

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • São Paulo
      • São Sebastião、São Paulo、ブラジル、11600-000
        • center of encouraging breastfeeding (CIAMA)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~30年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

The inclusion criteria:

  • nulliparae,
  • sedentary women,
  • ages between 18 and 30,
  • gestation age superior to 18 weeks without clinical or obstetrical complications

Exclusion Criteria:

The volunteers in the GE couldn't have a gestation age superior to 20 weeks, had to participate on regular physical activity twice a week, and have a total frequency of at least 20 sessions. The EG pregnant women with frequency inferior to 20 sessions were discarded from the study.

The volunteers in the CG couldn't have performed regular physical activity during pregnancy. In both groups, the participants hadn't performed regular physical activity in the year prior to the pregnancy.

However, 31 women were discarded during the research: three for miscarriage, being two from the GE and one from the GC; one from the GE for anemia; one from the GC for pre-eclampsia; two for loss of contact after birth, being one from each group; 11 from the GE for not reaching the minimum frequency; seven claimed personal reasons for leaving the research, being five from the GC and two from the GE; and six participants abandoned the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:exercise in pregnancy
37 pregnant women who performed supervised aerobic physical exercises twice a week
supervised aerobic physical exercises twice a week.
介入なし:Control group
29 pregnant women who had not performed any kind of physical activity during pregnancy

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Predomination of type of birth, vaginal birth or Cesarean section among pregnant women participating in the exercise group and the control group.
時間枠:Research conducted between April 7, 2008 and April 14, 2009 (one year)
Of the 66 volunteers, 37 were part of the exercise group (EG) and 29 of the control group (CG). Of the 37 in the control group, 25 had vaginal birth, while 12 had a Cesarean. In contrast, of the 29 in the CG, 11 had vaginal birth and 18 had a Cesarean.
Research conducted between April 7, 2008 and April 14, 2009 (one year)

二次結果の測定

結果測定
メジャーの説明
時間枠
Adhesion to exercise among the pregnant women with undergraduate and elementary education.
時間枠:The investigation lasted for one year
Of the 66 volunteers, 12 had undergraduate education. Of these, 11 were part of the EG and one of the CG. In contrast, 15 of the 66 pregnant volunteers had primary education, six of which were part of the EG, while nine were part of the CG.
The investigation lasted for one year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Lílian Cristina da Silveira、hostital public servant's state sao paulo (HSPE)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年4月1日

一次修了 (実際)

2009年1月1日

研究の完了 (実際)

2009年4月1日

試験登録日

最初に提出

2011年10月4日

QC基準を満たした最初の提出物

2011年10月26日

最初の投稿 (見積もり)

2011年10月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2011年10月27日

QC基準を満たした最後の更新が送信されました

2011年10月26日

最終確認日

2011年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Líliancsilveira

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

exercise during pregnancyの臨床試験

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