PregnancyNCT04431102
Pilates and the Pelvic Floor: A Quasi-experimental Study
A study testing PILATES METHOD in people with Pregnancy and Perineum; Injury, run by University of Huelva at 1 site in Spain.
Trial summary
In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Perineum; Injury, Pilates Method
- What is being tested?
- PILATES METHOD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2018to 27 Dec 2019
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To go to the Maternal Education program.
- Give your written consent to participate in the study.
- Singleton pregnancy.
- Low-risk pregnancy.
- No contraindication to physical exercise.
- Age equals or more than 18 years old.
Show all 11Show fewer
- Excusion Criteria:
- Pregnant women with poor pregnancy control.
- Difficulty in speaking or understanding Spanish.
- Required a C-section during delivery.
- Refusal to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study
In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.
Read the detailed description
It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries.
Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.
Secondary objectives were:
Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI).
It is a parallel group clinical trial with an allocation ratio of 1:2.
All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation.
Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy.
In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).
- Conditions
- Pregnancy, Perineum; Injury, Pilates Method, Episiotomy Wound
- Being tested
- PILATES METHOD
- Keywords
- Nursing, Midwifery, Nurse, Pilates Method, Pelvic floor, Injuries, Episiotomy, Pregnancy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILATES METHODOther
It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week.
The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women.
The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day.
| Study group | Role | What they receive |
|---|---|---|
| PILATES METHOD | Experimental | It was intended the Pilates program were low supervision and easily realizable by all patients, which implied flexibility in the schedule. In this sense the sessions of Pilates was adjusted to these assumptions and the Pilates monitor offered several schedules on diferent days of the week.
The pregnant women assigned to the intervention group were supervised by the midwifery of reference and trained by a Pilates monitor who explained the training program. The women received eight sessions of Pilates, given with a frequency of two classes per week and one hour of duration during a period of four weeks. The exercises for each session were determined beforehand. In addition, the participants maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center.
The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum. Receives: Other: PILATES METHOD |
| MATERNAL EDUCATION | No intervention | The control group maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Decrease in the number of episiotomies and perineal tears
Measured: Between the eighth and tenth day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 Nov 2018
- Primary completion31 Jul 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The professionals who assessed the progress of labor in the delivery room and completed the medical history did not know whether the woman belonged to the intervention or the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Huelva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Carmen Feria Ramírez, University of Huelva
- Investigators
- Carmen Feria-Ramírez, CNM, Principal investigator, University of Huelva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431102
- Sponsor's protocol ID
- CFMP14
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
Publications
Almagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.
Aguiar M, Farley A, Hope L, Amin A, Shah P, Manaseki-Holland S. Birth-Related Perineal Trauma in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. Matern Child Health J. 2019 Aug;23(8):1048-1070. doi: 10.1007/s10995-019-02732-5.
PubMed 30915627Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.
PubMed 30941442Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth. 2005 Sep;32(3):219-23. doi: 10.1111/j.0730-7659.2005.00373.x.
PubMed 16128977Jansson MH, Nilsson K, Franzen K. Development and validation of a protocol for documentation of obstetric perineal lacerations. Int Urogynecol J. 2019 Dec;30(12):2069-2076. doi: 10.1007/s00192-019-03915-y. Epub 2019 Mar 19.
PubMed 30888454Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017 Feb 8;2(2):CD000081. doi: 10.1002/14651858.CD000081.pub3.
PubMed 28176333Latorre GFS, de Fraga R, Seleme MR, Mueller CV, Berghmans B. An ideal e-health system for pelvic floor muscle training adherence: Systematic review. Neurourol Urodyn. 2019 Jan;38(1):63-80. doi: 10.1002/nau.23835. Epub 2018 Oct 30.
PubMed 30375056Mączka M, Sass A. Pilates and mobilization methods in therapy for low back pain among pregnant women. Journal of Exercise Science & Fitness. 2017; 7(8): 473-488.
Boix-Vilella S, León-Zarceño E, Serrano-Rosa MA. Evidencias de la práctica Pilates sobre la salud mental de personas sanas. Rev Universidad y Salud. 2017; 19(2): 301-308.
Bozkurt M, Yumru AE, Sahin L. Pelvic floor dysfunction, and effects of pregnancy and mode of delivery on pelvic floor. Taiwan J Obstet Gynecol. 2014 Dec;53(4):452-8. doi: 10.1016/j.tjog.2014.08.001.
PubMed 25510682Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
PubMed 22030232Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
PubMed 20094704Davidson K, Jacoby S, Brown MS. Prenatal perineal massage: preventing lacerations during delivery. J Obstet Gynecol Neonatal Nurs. 2000 Sep-Oct;29(5):474-9. doi: 10.1111/j.1552-6909.2000.tb02768.x.
PubMed 11012126Dias NT, Ferreira LR, Fernandes MG, Resende APM, Pereira-Baldon VS. A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial. Neurourol Urodyn. 2018 Jan;37(1):379-384. doi: 10.1002/nau.23308. Epub 2017 May 23.
PubMed 28543751
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04431102
- Acronym / sponsor ID
- CFMP14
- Conditions
- Pregnancy, Perineum; Injury, Pilates Method, Episiotomy Wound
- Keywords
- Nursing, Midwifery, Nurse, Pilates Method, Pelvic floor, Injuries, Episiotomy, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of HuelvaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 16 Jun 2020 (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.
In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.
Detailed description
It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries.
Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.
Secondary objectives were:
Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI).
It is a parallel group clinical trial with an allocation ratio of 1:2.
All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation.
Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy.
In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The professionals who assessed the progress of labor in the delivery room and completed the medical history did not know whether the woman belonged to the intervention or the control group.
| Arm | Type | Receives |
|---|---|---|
| PILATES METHOD | Experimental | Other: PILATES METHODIt was intended the Pilates program were low supervision and easily realizable by all patients, which implied flexibility in the schedule. In this sense the sessions of Pilates was adjusted to these assumptions and the Pilates monitor offered several schedules on diferent days of the week. The pregnant women assigned to the intervention group were supervised by the midwifery of reference and trained by a Pilates monitor who explained the training program. The women received eight sessions of Pilates, given with a frequency of two classes per week and one hour of duration during a period of four weeks. The exercises for each session were determined beforehand. In addition, the participants maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum. |
| MATERNAL EDUCATION | No intervention | –The control group maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- To go to the Maternal Education program.
- Give your written consent to participate in the study.
- Singleton pregnancy.
- Low-risk pregnancy.
- No contraindication to physical exercise.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PILATES METHODIt is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week. The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women. The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day. | Other | PILATES METHOD |
Primary outcome
Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Time frame: Between the eighth and tenth day after birth
Decrease in the number of episiotomies and perineal tears
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 17 Jun 2020.
- BackgroundAlmagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.
- Background: PubMed 30915627Aguiar M, Farley A, Hope L, Amin A, Shah P, Manaseki-Holland S. Birth-Related Perineal Trauma in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. Matern Child Health J. 2019 Aug;23(8):1048-1070. doi: 10.1007/s10995-019-02732-5.
- Background: PubMed 30941442Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.
- Background: PubMed 16128977Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth. 2005 Sep;32(3):219-23. doi: 10.1111/j.0730-7659.2005.00373.x.
- Background: PubMed 30888454Jansson MH, Nilsson K, Franzen K. Development and validation of a protocol for documentation of obstetric perineal lacerations. Int Urogynecol J. 2019 Dec;30(12):2069-2076. doi: 10.1007/s00192-019-03915-y. Epub 2019 Mar 19.
- Background: PubMed 28176333Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017 Feb 8;2(2):CD000081. doi: 10.1002/14651858.CD000081.pub3.
- Background: PubMed 30375056Latorre GFS, de Fraga R, Seleme MR, Mueller CV, Berghmans B. An ideal e-health system for pelvic floor muscle training adherence: Systematic review. Neurourol Urodyn. 2019 Jan;38(1):63-80. doi: 10.1002/nau.23835. Epub 2018 Oct 30.
- BackgroundMączka M, Sass A. Pilates and mobilization methods in therapy for low back pain among pregnant women. Journal of Exercise Science & Fitness. 2017; 7(8): 473-488.
- BackgroundBoix-Vilella S, León-Zarceño E, Serrano-Rosa MA. Evidencias de la práctica Pilates sobre la salud mental de personas sanas. Rev Universidad y Salud. 2017; 19(2): 301-308.
- Background: PubMed 25510682Bozkurt M, Yumru AE, Sahin L. Pelvic floor dysfunction, and effects of pregnancy and mode of delivery on pelvic floor. Taiwan J Obstet Gynecol. 2014 Dec;53(4):452-8. doi: 10.1016/j.tjog.2014.08.001.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 22030232Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
- Proceso Asistencia Integrado embarazo, parto y puerperioLink provided by the sponsor.
- Episiotomy and perineal repair guideline (GL836)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Carmen Feria-Ramírez, CNM principal investigator
University of Huelva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILATES METHOD in people with Pregnancy and Perineum; Injury, run by University of Huelva at 1 site in Spain.
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 11 inclusion and 0 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 17 Jun 2020. 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 Spain. 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?
Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program (time frame: Between the eighth and tenth day after birth). 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 NCT04431102, which also lists 41 linked publications.
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 17 Jun 2020.