Effectiveness of Using the Swiss Ball in Birth

NCT04124835 | Completed

• 1 other identifier: BIRTHBALL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial will be conducted to evaluate the effectiveness of using the Swiss Ball as a resource that reduces the length of labor time. The study will be conducted in the Low Risk Labor and Delivery sector of (Instituto Materno Infantil Professor Fernando Figueira) IMIP, which has a team of obstetric nurses, medical coordination and physical therapy support. The study population will be composed of low risk parturients admitted to the sector. Parturients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups: Group A (experimental) and Group B (control). Group A will be encouraged to use the Swiss Ball through pelvic movements, and Group B will go through the usual routine. Study results will be evaluated by assistants during labor and immediately after delivery.

Conditions

Labor Pain

Keywords

Labor, Obstetric; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• Length of the first period of labor

  Duration in minutes of the first period of labor: that will be considered from the time of admission with active labor (at least 3 contractions every 10 minutes associated with cervical dilatation of at least five centimeters), until complete dilation and urge to push

  12 hours

Secondary Outcomes (14)

• Length of the second period of labor

  5 hours

• Maternal pain

  30, 60 and 90 minutes

• Severe Perineal laceration

  1 hour postpartum

• Rate of episiotomy

  1 hour postpartum

• Type of delivery

  1 hour postpartum

Study Arms (2)

Intervention Group

EXPERIMENTAL

In the intervention group, the use of the Swiss Ball will be performed through active exercises of pelvic anteversion and retroversion, lateralization and circumduction according to the obstetric evaluation.

Other: Swiss Ball

Control Group

OTHER

The control group will receive the usual routine care of the service.

Other: Control Grup

Interventions

Swiss Ball OTHER

Top narrow (DeLee Plan -5 to -1 or Hodge Plan 1-3) Retroversion, lateralization and pelvic circumference exercises with abducted hips and external rotation will be encouraged. Exercises according to fetal positioning: Four ball-assisted supports and / or biped stance with anterior trunk inclination with asymmetrical opening of lower limbs with the aid of the ball. The hips will be in abduction and external rotation. Lower Narrow (DeLee Plan +1 to +5 or Hodge Plan 3-4) Pelvic anteversion, tilt, and circumference exercises with abducted hips and internal rotation will be encouraged. Exercises according to fetal positioning: Four ball-assisted supports and / or biped stance with anterior trunk inclination with asymmetrical opening of lower limbs with the aid of the ball. The hips will be in abduction and internal rotation.

Intervention Group

Control Grup OTHER

Habitual Care of the Service.

Control Group

Eligibility Criteria

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

You may qualify if:

• Pregnant woman in the first period of active labor;
• usual risk pregnancy;
• Single fetal pregnancy in cephalic presentation.

You may not qualify if:

• Pregnancy with dead fetus;
• Pregnant women with cesarean section indicated upon admission or until the time of approach;
• Pregnant women with limited mobility;
• Pregnant women with hip and pelvic fractures presenting difficulties in sitting position;
• Use of psychoactive drugs;
• Use of epidural analgesia or oxytocin before 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)

• Delgado A, Amorim MM, Oliveira ADAP, Souza Amorim KC, Selva MW, Silva YE, Lemos A, Katz L. Active pelvic movements on a Swiss ball reduced labour duration, pain, fatigue and anxiety in parturient women: a randomised trial. J Physiother. 2024 Jan;70(1):25-32. doi: 10.1016/j.jphys.2023.11.001. Epub 2023 Nov 29.

  PMID: 38036399 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• LEILA KATZ, MD, PhD

  Instituto Materno Infantil Prof. Fernando Figueira

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This will be a randomized, open-label study aimed at evaluating the effectiveness of using the Swiss Ball, without comparing it with usual care in maternal and neonatal outcomes. Patients will be randomized to receive standard care, as the ward is already a humanized, position-free approach, and to press or join all of this standard product, receive guidance on the use of the Swiss Ball.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 11, 2019
• Study Start: January 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

BR (1)