Vocalization for the Second Stage of Labor (VOCAL)

NCT03605615 | Completed

• 1 other identifier: VOCAL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor. The study will be carried out in the "Espaço Aconchego" sector of the IMIP, which has a team of obstetrical nurses, medical coordination and physiotherapeutic support. The study population will consist of low-risk parturients, with no prior cesarean indication, admitted to the sector. Those parturients who meet the inclusion criteria, after signing the Informed Consent Term, will be allocated to two groups: Group A (experimental) and Group B (control). Group A will be stimulated to keep the glottis minimally open during spontaneous pushing and to emit sounds when exhaling (vocalization), and Group B will undergo usual routine. Study outcomes will be evaluated by assistents immediately after delivery. After 24 hours of delivery, the conditions of the perineum will be assessed by inspection and palpation of the region,evaluating the presence of edema or other abnormality.

Conditions

Perineal Tear; Perineum; Rupture

Keywords

vaginal delivery; perineal tear; randomized controled trial

Outcome Measures

Primary Outcomes (1)

• PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent

  Presence of perineal lacerations observed by the attending staff

  1 hour postpartum

Secondary Outcomes (13)

• DURATION OF SECOND STAGE

  5 hours

• DURATION OF ACTIVE SECOND STAGE

  5 hours

• oxytocin use

  5 hours

• episiotomy

  5 hours

• instrumental delivery

  5 hours

Study Arms (2)

CONTROL

NO INTERVENTION

In this group parturients will be attended in standardized manner, which in our hospital means a humanized approach with choice of position in socond stage and without routine episiotomy.

VOCALIZATION

EXPERIMENTAL

In this group parturients will besides being be attended with our standar care, will receive training to vocalize during second stage.

Other: vocalization

Interventions

vocalization OTHER

The vocalization will be taught in voice form exhaled / sung in grave tones with the vowels, A, O and U.

Also known as: vocalization technique, open glottis

VOCALIZATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Low risk patients in active labor admitted to the IMIP; Gestational age between 37 and 42 weeks;
• Cephalic fetus;

You may not qualify if:

• Indication of cesarean section at the time of the approach;
• Inability to understand and / or perform vocalization maneuvers.
• Patients with Dysphonia
• Deaf and mute patients
• Use of Oxytocin prior to randomization

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, 50.070-550, Brazil

Location

Related Publications (1)

• Neta JN, Amorim MM, Guendler J, Delgado A, Lemos A, Katz L. Vocalization during the second stage of labor to prevent perineal trauma: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2022 Aug;275:46-53. doi: 10.1016/j.ejogrb.2022.06.007. Epub 2022 Jun 15.

  PMID: 35728488 DERIVED

MeSH Terms

Conditions

Rupture

Interventions

Singing

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a randomized open-label trial with the objective of evaluating the effect of vocalization as a perineal protection maneuver during the second stage of labor. Paerturients will be randomized to receive standard care, which in the ward is already a humanized approach, with freedom of position, and to push, ou to, toguether with all this standard prodedure, receive orientation about vocalization techniques.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 30, 2018
• Study Start: August 1, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

BR (1)