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

23. května 2021 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

15 let až 30 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Jiný: 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.
Experimentální: 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);
Jiný: 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);

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 10 hours
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
10 hours

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Moment of Rupture of the Chorioamniorex Between the Groups.
Časové okno: 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).
Časové okno: 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.
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Sao Paulo

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alessandra C Marcolin, Professor, Faculty of Medicine of São Paulo University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2012

Primární dokončení (Aktuální)

1. ledna 2016

Dokončení studie (Aktuální)

1. ledna 2016

Termíny zápisu do studia

První předloženo

19. září 2011

První předloženo, které splnilo kritéria kontroly kvality

16. května 2012

První zveřejněno (Odhad)

18. května 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. června 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. května 2021

Naposledy ověřeno

1. května 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • FR444841

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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