Labor PainBIRTHBALLNCT04124835
Effectiveness of Using the Swiss Ball in Birth
A study testing Swiss Ball in people with Labor Pain, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Swiss Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman in the first period of active labor;
- usual risk pregnancy;
- Single fetal pregnancy in cephalic presentation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, 50.070-550
About this study
Official title: Effectiveness of Using the Swiss Ball in Birth Compared to Habitual Care on Maternal and Neonatal Outcomes: Randomized and Pragmatic Clinical Trial
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.
Read the detailed description
Background: The Birth Ball, in childbirth care, has become a widely used resource in obstetrical centers, as it allows the adoption of vertical postures and exercises of pelvic mobility. It is an inexpensive and user-friendly feature that can facilitate pelvic exercise and thus contribute to positive maternal and neonatal outcomes.
Aim: To evaluate the effectiveness of the use of the Birth Ball compared to usual care in reducing the time of the first period of labor.
Methods: This is a randomized and pragmatic clinical trial that will be developed at the IMIP Childbirth Center in the state of Pernambuco. Pregnant women with normal risk, will be included in the first period of labor, with term gestation of the single and cephalic fetus, and pregnant women with a fetus dead, with a psychiatric disorder, using psychoactive drugs and in use of epidural analgesia or oxytocin prior to randomization. The sample size was calculated in 200 parturients, being randomly allocated 100 pregnant women for the experimental group and 100 for the control group, according to a list of random numbers specifically generated for this purpose. The duration of the first period of labor and, as secondary, pain, duration of the second period, birth routes, use of analgesia and oxytocin before randomization, fatigue, anxiety, maternal satisfaction, APGAR in the 5th neonatal resuscitation and hospitalization in a neonatal intensive care unit. The intervention group will use Birth Ball to perform active anteversion and pelvic retroversion exercises, lateralization and circumference according to the obstetric evaluation. The control group will receive the usual routine care of the service. Measurements will be made during and after fetal birth. The control group will receive the usual routine care of the service. Measurements will be made during and after fetal birth. To compare the continuous variables, the mean difference with the 95% Confidence Interval and Student's t-Test will be used. In order to compare the dichotomous variables, the Chi-square Test will be used. The Relative Risk will be calculated with the respective Confidence Interval of 95%. Data analysis will be performed using the Epi Info for Windows, version 3.5.4. The data will be presented in tables.
Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and will be submitted to the IMIP Research Ethics Committee, beginning only after its approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form. The research protocol will be registered in Clinical Trials.gov.
There are no conflicts of interest.
- Conditions
- Labor Pain
- Being tested
- Swiss Ball, Control Grup
- Keywords
- Labor, Obstetric, Physical Therapy Modalities
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swiss BallOther
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.
Control GrupOther
Habitual Care of the Service.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Swiss Ball |
| Control Group | Other | The control group will receive the usual routine care of the service. Receives: Other: Control Grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours
Secondary outcomes (14)
Length of the second period of labor
Duration in minutes of the second period: second period will be considered from the that complete dilation and spontaneous pushes start, until delivery of the baby
Measured: 5 hours
Maternal pain
The level of pain reported by the patient at each assessment (30, 60 and 90 minutes of use of the Swiss Ball), ranging from zero to ten, with zero being considered the total absence of pain and ten the most extreme, unbearable pain, never before felt. throughout life. Evaluated by visual analog scale (VAS)
Measured: 30, 60 and 90 minutes
Severe Perineal laceration
Rate of severe perineal laceration (including third and fourth degree laceration)
Measured: 1 hour postpartum
Rate of episiotomy
Incidence of episiotomy (incision made in the perineum -muscle area between the vagina and anus- to enlarge the birth canal with the theoretical objective of preventing irregular laceration during the passage of the baby. It may be median or mid-lateral.
Measured: 1 hour postpartum
Type of delivery
Frequency of the type of birth, which may be: vaginal, instrumental birth (assisted with forceps or vacuum extraction) or cesarean.
Measured: 1 hour postpartum
Instrumental birth
Incidence of instrumental birth, corresponding to the rate of forceps or vacuum extractor for vaginal delivery
Measured: 1 hour postpartum
Oxytocin use
Frequency of Oxytocin use rate after randomization.
Measured: 10 hours
Use of Pharmacological Analgesia for childbirth
Rate of childbirth pharmacological analgesia use (including various substances and techniques such as epidural and spinal block)
Measured: 10 hour
Maternal fatigue level
Maternal fatigue level will be evaluated using a validated questionnaire known as MATERNAL PERCEPTION OF CHILDBIRTH FATIGUE QUESTIONNAIRE (MCFQ).
It consists of 17 items whose intensities are verified by means of a five-point score (1 to 5), with a total ranging from 17 to 85 points, in which the highest values indicate a higher level of maternal fatigue.
Measured: 10 hours
Maternal anxiety level
Maternal anxiety during labor will be assessed using the State-Trait Anxiety Inventory (STAI).
It consists of 19 items whose intensities are verified by means of a four-point score (1 to 4), with a total ranging from 16 to 76 points, in which the highest values indicate a higher level of anxiety.
Measured: 10 hours
Maternal satisfaction level
The level of satisfaction with the technique (Swiss ball), reported by the participant at each assessment, may vary from zero to ten, with zero being less than satisfied and ten very satisfied with the use of the ball. Evaluated by visual analog scale (VAS).
Measured: 1 hour postpartum
Apgar scores
Performed in the first and fifth minutes of the child's life, the test is based on five assessment criteria: heart rate, breathing, muscle tone, reflex readiness and skin color, which, individually, can be rated from 0 to 2, totaling 10 points.
Measured: 5 minutes
Neonatal ICU admission
Rate of neonatal ICU admission according to the neonate's medical record.
Measured: 24 hour
Need of resuscitation of the neonate
Rate of need for resuscitation of the neonate according to the neonate's medical record.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Jan 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- LEILA KATZ, MD, PhD, Principal investigator, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124835
- Sponsor's protocol ID
- BIRTHBALL
- Acronym
- BIRTHBALL
- Status last verified
- Feb 2022
- First submitted
- 3 Oct 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38036399
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using the Swiss Ball in Birth Compared to Habitual Care on Maternal and Neonatal Outcomes: Randomized and Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04124835
- Acronym / sponsor ID
- BIRTHBALL / BIRTHBALL
- Conditions
- Labor Pain
- Keywords
- Labor, Obstetric, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The Birth Ball, in childbirth care, has become a widely used resource in obstetrical centers, as it allows the adoption of vertical postures and exercises of pelvic mobility. It is an inexpensive and user-friendly feature that can facilitate pelvic exercise and thus contribute to positive maternal and neonatal outcomes.
Aim: To evaluate the effectiveness of the use of the Birth Ball compared to usual care in reducing the time of the first period of labor.
Methods: This is a randomized and pragmatic clinical trial that will be developed at the IMIP Childbirth Center in the state of Pernambuco. Pregnant women with normal risk, will be included in the first period of labor, with term gestation of the single and cephalic fetus, and pregnant women with a fetus dead, with a psychiatric disorder, using psychoactive drugs and in use of epidural analgesia or oxytocin prior to randomization. The sample size was calculated in 200 parturients, being randomly allocated 100 pregnant women for the experimental group and 100 for the control group, according to a list of random numbers specifically generated for this purpose. The duration of the first period of labor and, as secondary, pain, duration of the second period, birth routes, use of analgesia and oxytocin before randomization, fatigue, anxiety, maternal satisfaction, APGAR in the 5th neonatal resuscitation and hospitalization in a neonatal intensive care unit. The intervention group will use Birth Ball to perform active anteversion and pelvic retroversion exercises, lateralization and circumference according to the obstetric evaluation. The control group will receive the usual routine care of the service. Measurements will be made during and after fetal birth. The control group will receive the usual routine care of the service. Measurements will be made during and after fetal birth. To compare the continuous variables, the mean difference with the 95% Confidence Interval and Student's t-Test will be used. In order to compare the dichotomous variables, the Chi-square Test will be used. The Relative Risk will be calculated with the respective Confidence Interval of 95%. Data analysis will be performed using the Epi Info for Windows, version 3.5.4. The data will be presented in tables.
Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and will be submitted to the IMIP Research Ethics Committee, beginning only after its approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form. The research protocol will be registered in Clinical Trials.gov.
There are no conflicts of interest.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Swiss BallIn 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. |
| Control Group | Other | Other: Control GrupThe control group will receive the usual routine care of the service. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant woman in the first period of active labor;
- usual risk pregnancy;
- Single fetal pregnancy in cephalic presentation.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swiss BallTop 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. | Other | Intervention Group |
| Control GrupHabitual Care of the Service. | Other | Control Group |
Primary outcome
Length of the first period of labor
Time frame: 12 hours
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
14 secondary outcomes
Length of the second period of labor
Time frame: 5 hours
Maternal pain
Time frame: 30, 60 and 90 minutes
Severe Perineal laceration
Time frame: 1 hour postpartum
Rate of episiotomy
Time frame: 1 hour postpartum
Type of delivery
Time frame: 1 hour postpartum
Instrumental birth
Time frame: 1 hour postpartum
Oxytocin use
Time frame: 10 hours
Use of Pharmacological Analgesia for childbirth
Time frame: 10 hour
Maternal fatigue level
Time frame: 10 hours
Maternal anxiety level
Time frame: 10 hours
Maternal satisfaction level
Time frame: 1 hour postpartum
Apgar scores
Time frame: 5 minutes
Neonatal ICU admission
Time frame: 24 hour
Need of resuscitation of the neonate
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 38036399Delgado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEILA KATZ, MD, PhD principal investigator
Instituto Materno Infantil Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swiss Ball in people with Labor Pain, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of the first period of labor (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.