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Completed

NCT Number: NCT01601860

The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor

Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.

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Key information

Conditions

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

Age range

15 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.

Ribeirão Preto, São Paulo, Brazil

About this study

Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Agreement of the patient to participate in the study after reading and signing the consent form;
  • primigravida;
  • Pregnancy unique;
  • Gestational age> 37 weeks;
  • fetal cephalic presentation;
  • chorioamniotic intact membranes;
  • spontaneous labor;
  • Admission to the beginning of the active phase of dilatation (4 cm cervical dilatation);
  • Dynamics between 2 and 4 uterine contractions in ten minutes;
  • Lack of maternal and fetal pathologies;
  • literate;
  • Absence of cognitive problems.

Exclusion criteria

Intolerance to non-pharmacological application of resources;

  • Increased pain by the woman that prevents the completion of the intervention;
  • Want to stop the intervention;
  • Suspected acute suffering;
  • Indication of cesarean section.

Treatment and study plan

Use of non-pharmacological

Other

Other: Non-pharmacological resources

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:

  • Walking (with cervical dilation between 4 and 5 cm)
  • Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)
  • Shower (with dilation> 7 cm);

Other: Routine care

Other

Other: Routine care 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. Number of Participants Who Requested Analgesia During the Active Phase of Childbirth

    Time frame: 10 hours

    Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.

  2. The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.

    Time frame: 10 hours

    Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph.

    A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient

  3. Average Duration of the Expulsive Period When Compared to Groups

    Time frame: Starts with 10 centimeters of dilation until delivery

    Assess the duration of the expulsion period and compare between groups

  4. Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups

    Time frame: 10 hours

    Analyze and compare between the groups the types of dystocia.

    Dystocia:

    b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total.

    b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012).

  5. Admission Numbers to a Neonatal Intensive Care Unit Between Groups.

    Time frame: 10 hours

    Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram

  6. Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.

    Time frame: 10 hours

    Analyze and compare Apgar scores of the 1-min >7 and 5-min >7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn.

    Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions.

  7. Frequency of Suspected Fetal Distress, Between Groups

    Time frame: 10 hours

    Evaluate the frequency of suspected fetal distress with the presence of meconium release.

Secondary outcomes

  1. Moment of Rupture of the Chorioamniorex Between the Groups.

    Time frame: 10 hours

    Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.

  2. Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).

    Time frame: 10 hours

    Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.

  3. Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.

    Time frame: immediately postpartum up to 2 days after childbirth

    Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)

  4. The Number of Puerperal Infections Between Groups.

    Time frame: immediately postpartum up to 2 days after childbirth

    Analyze and compare between the groups the number of puerperal infection

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 18, 2012
Registry last updated
Jun 9, 2021

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.

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