Skip to main content
OpenTrials
Completed

NCT Number: NCT01389128

Non-pharmacological Resources in Assisting Labor

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labour Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Referral Center Women's Health - Mater

Ribeirão Preto, São Paulo, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-pharmacological resources

Other

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.

Routine care

Other

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 outcomes

  1. Pain Relief

    Time frame: ten hours

    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 outcomes

  1. Evolution of Labor

    Time frame: 10 hours

    Amount of minutes, from admission to labor.

  2. Moment That Women Requested Analgesia During the Active Phase of Labor

    Time frame: 10 hours

    Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record

  3. Number of Women Who Received Pharmacological Analgesia

    Time frame: 10 hours

    Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.

  4. Type of Delivery

    Time frame: 10 hours

    Type of delivery at the end of the active phase of labor.

  5. Number of Participants Whose Neonates Had:

    Time frame: 10 hours

    Number and type of neonatal complications as reported in medical chart

  6. Number of Participants With:

    Time frame: 10 hours

    Number and type of maternal complications as reported in medical chart

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2011
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.