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Non-pharmacological Resources in Assisting Labor

This study is currently recruiting participants.
Verified May 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Silvana Maria Quintana, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01389128
First received: June 30, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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 this protocol based on the 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.


Condition Intervention
Labour Pain
 Other: protocol with non pharmacological resources

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Pain Relief Of Labour [ Time Frame: One Hour ] [ Designated as safety issue: No ]
    Evaluate the effectiveness of the protocol using the combination of non-pharmacological resources during the dilation in relieving the pain of mothers.


Secondary Outcome Measures:
  • evolution of labor [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Evaluate the influence of the protocol using the combination of non-pharmacological resources in the duration of active phase of expansion and of the second stage of pregnant women.

  • Request analgesia for pain relief during the active phase of labor [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Assess the duration of time that the parturients request analgesia for pain relief during the active phase of labor.

  • Evaluate the obstetric and neonatal outcomes of pregnant women subjected to the protocol [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    To evaluate the obstetric and neonatal outcomes of pregnant women subjected to the protocol using the combination of non-pharmacological resources in assisting labor and compare them to the control group

  • Satisfaction of the parturient with labor and delivery [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    To assess the degree of satisfaction of mothers who undergo labor and birth


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Control Group (CG): Pregnant women who receive assistance from the protocol CRSM MATER, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.
Experimental: intervention group
Intervention Group (IG): Pregnant women who receive the application protocol using the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (6 and cm)and shower (> 7 cm);
 Other: protocol with non pharmacological resources
application protocol using the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;

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 protocol using 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%.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389128

Contacts
Contact: Silvana M Quintana, professor 551681459112 quintana@fmrp.usp.br
Contact: Centro de Referencia da Saude da Mulher 551639628200 crsmrpmater@hcrp.usp.br

Locations
Brazil
Referral Center Women's Health - Mater Recruiting
Ribeirão Preto, São Paulo, Brazil
Contact: Silvana M Quintana, professor     551636022587     quintana@fmrp.usp.br    
Contact: Rubneide B Gallo, physiotherap     551636022587     rubneidegallo@gmail.com    
Sub-Investigator: Rubneide B Gallo, physiotherap            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Silvana M Quintana, professor Faculty of Medicine of São Paulo University
  More Information

Publications:

Responsible Party: Silvana Maria Quintana, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01389128     History of Changes
Other Study ID Numbers: FR443033
Study First Received: June 30, 2011
Last Updated: May 29, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
labor
pain
massage
natural birth

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013