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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Use of non-pharmacological

• Registration Number: NCT01601860
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-19
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2021-02-04
• Results First Submitted QC: 2021-02-23
• Results First Posted: 2021-03-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Use of non-pharmacological	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);

Primary Outcome Measures

Name	Time	Method
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.	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
Average Duration of the Expulsive Period When Compared to Groups	Starts with 10 centimeters of dilation until delivery	Assess the duration of the expulsion period and compare between groups
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.	10 hours	Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth	10 hours	Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups	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).
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.	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.
Frequency of Suspected Fetal Distress, Between Groups	10 hours	Evaluate the frequency of suspected fetal distress with the presence of meconium release.

Secondary Outcome Measures

Name	Time	Method
The Number of Puerperal Infections Between Groups.	immediately postpartum up to 2 days after childbirth	Analyze and compare between the groups the number of puerperal infection
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.	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)
Moment of Rupture of the Chorioamniorex Between the Groups.	10 hours	Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).	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.

Trial Locations

Locations (1)

Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.; 🇧🇷 Ribeirão Preto, São Paulo, Brazil