Clinical trial NCT01601860: The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
Official title: Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Labor
vaginal delivery
pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
timeFrame: 10 hours
measure: The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
timeFrame: 10 hours
measure: Average Duration of the Expulsive Period When Compared to Groups
timeFrame: Starts with 10 centimeters of dilation until delivery
measure: Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
timeFrame: 10 hours
measure: Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
timeFrame: 10 hours
measure: Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
timeFrame: 10 hours
measure: Frequency of Suspected Fetal Distress, Between Groups
timeFrame: 10 hours
Secondary outcomes:
measure: Moment of Rupture of the Chorioamniorex Between the Groups.
timeFrame: 10 hours
measure: Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
timeFrame: 10 hours
measure: Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
timeFrame: immediately postpartum up to 2 days after childbirth
measure: The Number of Puerperal Infections Between Groups.
timeFrame: immediately postpartum up to 2 days after childbirth
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo.
state: São Paulo
Study officials:
affiliation: Faculty of Medicine of São Paulo University
name: Alessandra C Marcolin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frenea S, Chirossel C, Rodriguez R, Baguet JP, Racinet C, Payen JF. The effects of prolonged ambulation on labor with epidural analgesia. Anesth Analg. 2004 Jan;98(1):224-229. doi: 10.1213/01.ANE.0000090317.01876.D9.