Non-pharmacological Resources in Assisting Labor

U

University of Sao Paulo

Status

Completed

Conditions

Labour Pain

Treatments

Other: Non-pharmacological resources
Other: Routine care

Study type

Interventional

Funder types

Other

Identifiers

NCT01389128
FR443033

Details and patient eligibility

About

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.

Full 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%.

Enrollment

80 patients

Sex

Female

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Control Group
Active Comparator group
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.
Treatment:
Other: Routine care
Intervention Group
Experimental group
Description:
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
Treatment:
Other: Non-pharmacological resources

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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