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Non-pharmacological Resources in Assisting Labor

Primary Purpose

Labour Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-pharmacological resources
Routine care
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labour Pain focused on measuring labor, pain, massage, natural birth

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;

  • Primigravida;
  • Pregnancy only;
  • Gestational age ≥ 37 weeks;
  • Presentation fetal head
  • Chorioamniotic intact membranes
  • Working with spontaneous onset of labor
  • Admission at the beginning of active phase dilation (4-5 cm)
  • Lack of maternal and fetal pathologies
  • Literacy - primary education
  • Absence of cognitive problems

Exclusion Criteria:

  • Pregnant women admitted for induction of labor
  • Rupture premature or early of chorioamniotic membranes
  • Use of uterotonic drugs before the active phase

Sites / Locations

  • Referral Center Women's Health - Mater

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.

Outcomes

Primary Outcome Measures

Pain Relief
The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were: Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) Phase II: 5-6cm of cervical dilation (lumbosacral massage) Phase III: 7cm or higher cervical dilation (warm shower)

Secondary Outcome Measures

Evolution of Labor
Amount of minutes, from admission to labor.
Moment That Women Requested Analgesia During the Active Phase of Labor
Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record
Number of Women Who Received Pharmacological Analgesia
Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
Type of Delivery
Type of delivery at the end of the active phase of labor.
Number of Participants Whose Neonates Had:
Number and type of neonatal complications as reported in medical chart
Number of Participants With:
Number and type of maternal complications as reported in medical chart

Full Information

First Posted
June 30, 2011
Last Updated
May 8, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01389128
Brief Title
Non-pharmacological Resources in Assisting Labor
Official Title
Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.
Detailed Description
The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 to obtain the statistical significance of 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labour Pain
Keywords
labor, pain, massage, natural birth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
Intervention Type
Other
Intervention Name(s)
Non-pharmacological resources
Intervention Description
A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes; Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and, Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Relief
Description
The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were: Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) Phase II: 5-6cm of cervical dilation (lumbosacral massage) Phase III: 7cm or higher cervical dilation (warm shower)
Time Frame
ten hours
Secondary Outcome Measure Information:
Title
Evolution of Labor
Description
Amount of minutes, from admission to labor.
Time Frame
10 hours
Title
Moment That Women Requested Analgesia During the Active Phase of Labor
Description
Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record
Time Frame
10 hours
Title
Number of Women Who Received Pharmacological Analgesia
Description
Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
Time Frame
10 hours
Title
Type of Delivery
Description
Type of delivery at the end of the active phase of labor.
Time Frame
10 hours
Title
Number of Participants Whose Neonates Had:
Description
Number and type of neonatal complications as reported in medical chart
Time Frame
10 hours
Title
Number of Participants With:
Description
Number and type of maternal complications as reported in medical chart
Time Frame
10 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form; Primigravida; Pregnancy only; Gestational age ≥ 37 weeks; Presentation fetal head Chorioamniotic intact membranes Working with spontaneous onset of labor Admission at the beginning of active phase dilation (4-5 cm) Lack of maternal and fetal pathologies Literacy - primary education Absence of cognitive problems Exclusion Criteria: Pregnant women admitted for induction of labor Rupture premature or early of chorioamniotic membranes Use of uterotonic drugs before the active phase
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana M Quintana, professor
Organizational Affiliation
Faculty of Medicine of São Paulo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Referral Center Women's Health - Mater
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15295342
Citation
Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.
Results Reference
background
PubMed Identifier
29289579
Citation
Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.
Results Reference
derived

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Non-pharmacological Resources in Assisting Labor

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