Non-pharmacological Resources in Assisting Labor
|ClinicalTrials.gov Identifier: NCT01389128|
Recruitment Status : Unknown
Verified May 2012 by Silvana Maria Quintana, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : July 7, 2011
Last Update Posted : May 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Labour Pain||Other: protocol with non pharmacological resources||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||December 2013|
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;
- Pain Relief Of Labour [ Time Frame: One Hour ]Evaluate the effectiveness of the protocol using the combination of non-pharmacological resources during the dilation in relieving the pain of mothers.
- evolution of labor [ Time Frame: 10 hours ]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 ]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 ]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 ]To assess the degree of satisfaction of mothers who undergo labor and birth
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389128
|Contact: Silvana M Quintana, firstname.lastname@example.org|
|Contact: Centro de Referencia da Saude da Mulheremail@example.com|
|Referral Center Women's Health - Mater||Recruiting|
|Ribeirão Preto, São Paulo, Brazil|
|Contact: Silvana M Quintana, professor 551636022587 firstname.lastname@example.org|
|Contact: Rubneide B Gallo, physiotherap 551636022587 email@example.com|
|Sub-Investigator: Rubneide B Gallo, physiotherap|
|Principal Investigator:||Silvana M Quintana, professor||Faculty of Medicine of São Paulo University|