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

NCT01601860 | Completed Results DMC

• 1 other identifier: FR444841
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Labor; vaginal delivery; pain

Outcome Measures

Primary Outcomes (7)

• Number of Participants Who Requested Analgesia During the Active Phase of Childbirth

  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.

  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

  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

  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.

  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.

  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

  Evaluate the frequency of suspected fetal distress with the presence of meconium release.

  10 hours

Secondary Outcomes (4)

• Moment of Rupture of the Chorioamniorex Between the Groups.

  10 hours

• Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).

  10 hours

• Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.

  immediately postpartum up to 2 days after childbirth

• The Number of Puerperal Infections Between Groups.

  immediately postpartum up to 2 days after childbirth

Study Arms (2)

Control

ACTIVE COMPARATOR

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: Other: Routine care

Intervention Group

EXPERIMENTAL

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: Use of non-pharmacological

Interventions

Use of non-pharmacological 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);

Intervention Group

Other: Routine care 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.

Control

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 14693624 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Dra. Alessandra Cristina Marcolin
• Organization: University of São Paulo

dralemar@uol.com.br

+55(16)36022813

Study Officials

• Alessandra C Marcolin, Professor

  Faculty of Medicine of São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dra.

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: May 18, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 9, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-05

Locations

BR (1)