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

23 maggio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Brasile
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasile
        • Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 15 anni a 30 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Other: Routine care
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.
Sperimentale: 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);
Altro: Use of non-pharmacological

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);

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 10 hours
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
10 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Moment of Rupture of the Chorioamniorex Between the Groups.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo

Investigatori

  • Investigatore principale: Alessandra C Marcolin, Professor, Faculty of Medicine of São Paulo University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2012

Completamento primario (Effettivo)

1 gennaio 2016

Completamento dello studio (Effettivo)

1 gennaio 2016

Date di iscrizione allo studio

Primo inviato

19 settembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

16 maggio 2012

Primo Inserito (Stima)

18 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 maggio 2021

Ultimo verificato

1 maggio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • FR444841

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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