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The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor

2021年5月23日 更新者:Alessandra Cristina Marcolin、University of Sao Paulo

Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor

Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.

調査の概要

詳細な説明

Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.

研究の種類

介入

入学 (実際)

80

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
      • Ribeirão Preto、São Paulo、ブラジル
        • Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.

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

15年~30年 (子、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

Inclusion Criteria:

  • Agreement of the patient to participate in the study after reading and signing the consent form;

    • primigravida;
    • Pregnancy unique;
    • Gestational age> 37 weeks;
    • fetal cephalic presentation;
    • chorioamniotic intact membranes;
    • spontaneous labor;
    • Admission to the beginning of the active phase of dilatation (4 cm cervical dilatation);
    • Dynamics between 2 and 4 uterine contractions in ten minutes;
    • Lack of maternal and fetal pathologies;
    • literate;
    • Absence of cognitive problems.

Exclusion Criteria:

Intolerance to non-pharmacological application of resources;

  • Increased pain by the woman that prevents the completion of the intervention;
  • Want to stop the intervention;
  • Suspected acute suffering;
  • Indication of cesarean section.

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:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Control
Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.
Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
実験的:Intervention Group
Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation> 7 cm);

Other: Non-pharmacological resources

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:

  • Walking (with cervical dilation between 4 and 5 cm)
  • Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)
  • Shower (with dilation> 7 cm);

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
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
時間枠:10 hours
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
10 hours
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
時間枠:10 hours

Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph.

A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient

10 hours
Average Duration of the Expulsive Period When Compared to Groups
時間枠:Starts with 10 centimeters of dilation until delivery
Assess the duration of the expulsion period and compare between groups
Starts with 10 centimeters of dilation until delivery
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
時間枠:10 hours

Analyze and compare between the groups the types of dystocia.

Dystocia:

b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total.

b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012).

10 hours
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
時間枠:10 hours
Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
10 hours
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
時間枠:10 hours

Analyze and compare Apgar scores of the 1-min >7 and 5-min >7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn.

Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions.

10 hours
Frequency of Suspected Fetal Distress, Between Groups
時間枠:10 hours
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
10 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Moment of Rupture of the Chorioamniorex Between the Groups.
時間枠:10 hours
Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
10 hours
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
時間枠:10 hours
Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
10 hours
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
時間枠:immediately postpartum up to 2 days after childbirth
Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
immediately postpartum up to 2 days after childbirth
The Number of Puerperal Infections Between Groups.
時間枠:immediately postpartum up to 2 days after childbirth
Analyze and compare between the groups the number of puerperal infection
immediately postpartum up to 2 days after childbirth

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。

スポンサー

捜査官

  • 主任研究者:Alessandra C Marcolin, Professor、Faculty of Medicine of São Paulo University

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。

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

2012年5月1日

一次修了 (実際)

2016年1月1日

研究の完了 (実際)

2016年1月1日

試験登録日

最初に提出

2011年9月19日

QC基準を満たした最初の提出物

2012年5月16日

最初の投稿 (見積もり)

2012年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2021年6月9日

QC基準を満たした最後の更新が送信されました

2021年5月23日

最終確認日

2021年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • FR444841

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