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

NCT ID: NCT01601860

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Other: Routine care

Intervention Type: OTHER

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.

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);

Group Type: EXPERIMENTAL

Use of non-pharmacological

Intervention Type: OTHER

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);

Interventions

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);

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Alessandra Cristina Marcolin

Prof. Dra.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandra C Marcolin, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of São Paulo University

Locations

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

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Frenea S, Chirossel C, Rodriguez R, Baguet JP, Racinet C, Payen JF. The effects of prolonged ambulation on labor with epidural analgesia. Anesth Analg. 2004 Jan;98(1):224-229. doi: 10.1213/01.ANE.0000090317.01876.D9.

Reference Type: BACKGROUND

PMID: 14693624 (View on PubMed)

Other Identifiers

FR444841

Identifier Type: -

Identifier Source: org_study_id