Doctoral Thesis project

DoctoralThesisproject:

"EVALUATIONOFTHEEFFECTIVENESSOFAPROGRAMTOSTRENGTHENTHEPELVICFLOORINTHEPOSTPARTUMWOMEN"

Alumna:Ms.ElisaHernándezLlorente.

Director1:Dr.CarmenSuárezSerrano.Director2:Dr.FátimaLeónLarios.

ThesisProject:"Evaluationoftheeffectivenessofaprogramtostrengthenthepelvicfloorofwomeninthepostpartum"

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Index:

1. Introduction3

2. TheoreticalFramework4to11

3. Justification12

4. objectives13

5. hypothesis14

6. Methodology15to20

7. WorkPlan21

8. References22to24

9. Annexes25to29


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1.INTRODUCTION:

Pelvic floor dysfunction is a problem of high prevalence in the puerperal period of

women. Urinary incontinence is one of the most frequent dysfunctions that most

affect their health after childbirth. Recent studies expose the idea that pelvic floor

muscle training using vaginal areas, generally, reduces the appearance of pelvic

dysfunction,andthusimprovesthequalityoflifeofthesewomen.

Pelvicfloorhealthisanimportantissueforwomenaroundtheworldastheimpactof

pelvic-perineal problems in any woman life is often considerable. Pelvic problems

impairthequalityoflifeofwomenwhosufferthem,becausetheyfeelvulnerable,and

experienceagreat impotencebythe inability topredicthowwill theirbodyreact to

certainsituationsofdailylife;thisaffectsnegativelytheirintimaterelationships,work

andsocialsactivities1.

Pregnancyandbirthhavehistoricallybeenidentifiedasthemajoretiologicalfactorsof

pelvicfloordysfunctions2.Theliteraturedemonstratesthat33%ofwomenexperience

urinary incontinence (UI) during the first three months postpartum, with no major

improvements until the first anniversary of birth3. We also find 10% of fecal

incontinence during quarantine, extended by 1% of women until 9 months

postpartum4.Therearealsopelvicorganprolapse,rangingbetween7.7%and56%of

women3-6monthsPostpartum5.

Ashasbeenevidenced,afunctionalweaknessofthepelvicfloormuscles,cannotonly

enhancetheinfluenceoftheUIforwomeninthepostpartumperiod,butwillalsobea

contributingfactortofecalincontinenceandprolapseofpelvicorgans2.

2.Framework:

In Spanish hospitals over the past 15 years a change is taking place in attention to

normaldelivery,becauseuntilrelativelyrecentlydays,theepisiotomywassystematic

foreverywomanwhowasperceivedthatdidnothaveasufficientlyelasticperineum

under criterion of the professional who was attending the birth. With the perineal


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consequencesthatsubsequenthealingofalateralhalfcutinthepelvicfloormuscles

had.

Fortunately,todayprofessionalsobstetricsaremoreupdatedandhavegreateraccess

to new scientific evidence that contributes to our environment, so this type of

intervention, unless the professional deems strictly necessary, are notmade.Unless

exists a risk of loss of fetal well-being, or the need to end the labor through an

instrumenteddelivery (forcepsorvacuum),althoughthese finaldecisionsarealways

underthecriterionoftheprofessionalwhoisattendingchildbirth.

Themainthemethatoccupiesourstudyisthewomen`spelvicfloor,solet'sintroduce

a little deeper into the subject concisely describing this part of the female body

anatomy.

Thepelvic floor is thesetofsoft tissue (muscles, fasciaand ligaments) that limit the

pelviccavityat thebottom. It is responsible forsupporting theweightof theviscera

andhelps toprevent the leakageofurineand stool5. Therefore it is imperative that

thesemuscleshavethestrengthandtoneneededtoperformtheirfunctionsandnot

disruptthedailylivesofwomen.

Pelvic floor dysfunctions are often caused by external aggression, such as surgery,

vaginaldelivery,orbylackofmusclestrength:hypotonia,orevenmusclehypertonia.

Thenewlinesofnormaldeliverycare,describedinthe"ClinicalPracticeGuidelinefor

NormalBirthCare"publishedbytheSpanishMinistryofHealthin2010recommended

thefollowingactions(withanAlevelofrecommendation):

• Itshouldnotbepracticedroutineepisiotomyinspontaneouslabor.

• Episiotomyshouldbeperformed if there isa clinicalneed,asan instrumental

birthorsuspectedfetalcompromise.

• Before performing an episiotomy effective analgesia should be performed,

exceptoneduetoacutefetalcompromiseemergency.


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• Whenanepisiotomyisperformed,therecommendedtechniqueismediolateral

episiotomy, starting it in the posterior commissure of the labia minora and

usually directed to the right side. The angle to the vertical axis should be

between45and60degreestoperformepisiotomy.

• Episiotomy should not be routinely performed during a vaginal delivery in

womenwithtearsinthirdorfourthgradeinpreviousbirths.

Below is a picture of the female pelvic anatomy, reflecting the network of perineal

musclesthatformthefemalepelvicfloor.

Fig.1pelvicanatomy.KSftemedicine.

Not being recommended episiotomy systematically in a normal delivery, the next

problemthatwecanfindintermsofdisruptionofthepelvicfloormuscleisaperineal

tear, physiologically produced at the time of delivery. Perineal tears types are as

follows:

I. I degree tear: when affects only the surface of the perineum (skin andsubcutaneoustissue).

II. IIdegreetear:Itaffectsbothvaginalandperinealpelvicmuscles.III. IIIdegreetear:Completemuscletearandreachestheexternalanalsphincter.IV. IVdegreetear:Whenitaffectstheanalsphincter.


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Thesetypesofperineal trauma(bothtearandepisiotomy)shouldbesuturedbythe

professionalwhoisattendingthedelivery(midwifeorobstetrician)asrecommended

bytheClinicalPracticeGuideline2010,wementionedearlier.Recommendationsasto

suturetear(recommendationA-level)are:

• Is recommended suturing first grade lacerations in order to improve healing,unlesstheedgesoftheskinarewellapproximated.

• Perineal repair of second degree tears using continuous suture technique isrecommended.

• If aftermuscle suture of a second degree tear the skin iswell approximated,stitches are not need. But if the skin needs to be approached, therecommendations requires to be performed in a continuous intradermaltechnique.

Thetypeoftearoccurredduringdelivery,orifepisiotomyneedtobedone,andeven

thetypeofsutureusedforperinealrepair,willaffectlesserorgreatertherecoveryof

the pelvic floor postpartum. Therefore, the recommendation is always to be as less

aggressive as possible, taking into account the quality of life of women pelvic floor

dysfunctioninshort-andlong-term.

2.2PelvicFloorDysfunctions:

Within the pelvic floor dysfunctions (PFD) we find the most recurrent urinary

incontinence (UI) form.Definedbythe InternationalContinenceSociety (ICS)as"the

involuntary loss of urine."6 Has a high prevalence in women of all ages7, the most

commonare:stressincontinence,urgeormixed.

Belowisatablewiththedifferenttypesofincontinence:

Fig2.TypesofIncontinence.FTEs.Associationofincontinentpatients.


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Incontinenceaffectsfiveoutoftenpregnantwomen(48.3%).Fouroutoftenpregnant

women experience urine leakage for the first time during pregnancy (40%). In

pregnant women with pre-UI severity increases during pregnancy. Urinary

incontinencebeforeandduringpregnancyisassociatedwithpreviousgestations8.

In fact, the most common reason that a woman usually consult a health care

professionalwithinthefieldofperineal-sphincterreeducation isundoubtedlyurinary

incontinence, being the postpartum period and menopause the highest incidence.

Thesedata are shown in the survey conductedbyWilsonon1,505womenat three

months postpartum with 34.3% of incontinents9, while in another study with

perimenopausal women Minaire discloses that 47.6% of these women report

involuntaryleakageofurine10

Atothertimes,thereasonforconsultationisapelvicorganprolapse,presentin30%

ofwomenbetween29and59 years according toa Swedish studyof487peopleby

SamuelssonandVictor11.However,thistypeofdysfunctionsareoftenassociatedwith

perineal pain, faecal incontinence or sexual dysfunction, that the patient will not

initiallyrefer.Buttheseproblems,mayinsteadposeabiggersocialproblem,greater

thanurinaryincontinence.

Aswediscussedearlier,vaginaldeliveryisaknownriskfactorforUIandtheresultsof

multiplestudiesconfirmitsimpactonhospitalclinicalpractice.Althoughseverecases

persist,itisincludedasignificantreductioninsymptomsduringthefirst12monthsas

longastheperinealmusculatureisbeingtonedbyperformingspecificexercises12.

Intheimmediatepostpartumitisestimatedthat50%ofwomenwithvaginaldelivery

havea transienteffortUI, evolving toward regressionor spontaneoushealing in50-

70% of cases after spending six weeks after childbirth. However, these transient

incontinence reflect a perineal alteration, represents an increased risk of 2.5%

posteriordevelopingincontinence13.

Taking into consideration, pregnancy and childbirth as a major risk for developing


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incontinence is due to a decrease of 22-35% of the strength of the pelvic floor

muscles14. In addition, if incontinencedevelopsduringpregnancyor thepostpartum

periodandnoreturnaddressbefore3monthspostpartum,there isasignificantrisk

thatpersistsfor5yearsafter15.

AccordingtoastudybyEwingsin2015“Thepresenceofoneormoreepisiotomiesis

also a significant risk factor, however, cesarean and epidural use during childbirth,

seem to be a protective factor”16. Although, this information continues to be

controversialbecause,accordingtoastudybyRotveit in2003withatotalof15,307

women, it was observed that compared with nulliparous women, women who had

given birth by Caesarean section had a probability of 1.5 to experience any

incontinence.Theexplanation isthatnotonly labor,butalsotheweightofthefetus

andposturalalterationduringpregnancyareriskfactorsofurinaryincontinenceinthe

postpartum period overloading the perineum previously17. In view of the results of

these studies, the importanceof knowing thehistoryofourobstetricalpatientsand

reflectitonitsclinichistoryisclear.

Fig.3organicincontinentpatientsFteDamages.Associationofincontinentpatients.

Thepelvicfloormuscletraining(PFMT)hasanimportantplaceinthetreatmentofUI,

withasuccessrateof56-75%18,Sothat,areviewbytheCochranein2011,concludes

that it isconsistentlybetter thannotreatmentorplacebo,andshouldbeofferedas

firsttreatmentforwomenwithUI19.


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ThemechanismofactionofPFMTishypertrophyofmusclefibers, improvingcortical

awarenessofthemuscle,connectivetissuestrengthand increasingtheeffectiveness

ofrecruitmentofmotoneurons18.

UIsignificantlyaffectsthequalityoflifeofpeople,Infact4outof10womenwithurge

UIand6outof10withmixedUIfeelembarrassedinsocialrelationsorhaveavoidance

behaviorsandlimitationintheirdailylife,forcingthemtochangetheirsocialactivities

andrelationships20.

Fig.4.Whyhasnotconsultedaprofessional?FTEs.Rehabilitationandpelvicfloor.UY.2003.

Thissectionmustmakeaspecialmentiononsexualhealthofwomen,becauseofthe

high degree of psychological, emotional and functional impairment involving such

dysfunctions and how they affect the sexual and reproductive lives of womenwho

suffer it. You need a good diagnosis to determine the causes of it and design a

personalized treatment working not only preventive and curative but also

paliative21,22,23.

To promote perineal pelvic health in women in the puerperal period, most

recommended intervention, as we have seen above, is to instruct patients in

performingstrengtheningpelvicfloorexercises21.

However,oneofthealternativemethodsforpelvicmusclerehabilitation,wewantto

show with this study, is the use of vaginal balls. They operate by a mechanism of


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involuntarymusclecontractionstopreventpossibleremovalofthespheresoutofthe

vagina.

It is demonstrated in literature (last systematic review by Oblasser 2015)25, the

shortageofscientificevidencepublishedconcerningtheeffectivenessofvaginalballs

to improve the performance of pelvic-perineal muscles and the UI during the

puerperium. Most published studies suggest that vaginal spheres can be useful to

improve theUI in the postpartum, but all suggest thatmore studies are needed to

corroboratesuggestions,asthecurrentevidenceislimited.

Thanks to the above references,we can confirm the dependence of pregnancy and

childbirthalongwithafewetiologicalfactorsofpelvicfloordysfunctionand,especially

theUI,whichisanareaofinterestinepidemiologicalresearch.Althoughthenumbers

of studies examining the prevalence of UI in the postpartum period are highly

controversialandstudiesareinsufficientinourmidst.

3.RATIONALE:

Presentlyinthecurrentliteraturethereisnoempiricalknowledgetosupporttheuse

ofvaginalspheresor itseffectivenesscomparedwithstandardpelvic floorexercises.

Allitemsandissuesfoundrequiremorestudiestosupportitsusefortherecoveryof

thepelvicfloorofwomeninthepostpartumperiod.

UI isadiseasewithahighprevalence inwomenthatdoesnot involvean increase in

mortality, but it limits the autonomy, self-esteem and significantly reduces and

deteriorate the quality of life. Often it remains undiagnosed and untreated or is

treated inappropriately. The short experience and few studies indicate that some

professionals do certain exercises without knowing exactly muscle actions and side

effectsareimplicit.

Vaginal spheres stimulateperineal type I fibers,whichmakeup80%of theperineal

musculature and give response to a reflected tonic activity. While traditional

rehabilitation exercises of the pelvic floor and postpartum (PFMT) stimulates type II


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fibers,whicharepartofother20%oftheperinealmusculatureandareresponsiblefor

voluntarymuscleactivity.

It is demonstrated the effectiveness of pelvic floor muscle training (PFMT) in

preventing both: urinary and fecal postpartum incontinence8.. However, there is no

evidenceoftheeffectofvaginalballssuchdysfunctions.

Therefore we must make three different intervention groups to integrate a

comparativestudyoftreatment.Currentlybeingcarriedoutasamethodofperineal

recovery after childbirth (PFMT) and vaginal areas as a new method to study. The

groupswouldbeasfollows:

• Group1(Control)=PFMTwouldperformtheexercisesexclusivelydesignedby

theteamofPhysiotherapyparticipatinginthestudy.

• Group 2 (Intervention a) = PFMT would perform exercises with the use of

vaginalspheres.

• Group3 (Intrervención-b) =wouldperform intensive treatment,designed for

physiotherapyequipmentvaginalareas.

4.OBJECTIVES:

4.1Mainobjective:

-Todeterminetheeffectivenessof3typesofmuscletrainingforrecoverypelvicfloor

postpartum and evaluate their effectiveness by perineometer, Test and Modified

OxfordICIQIncontinenceQuestionnaireSF.


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4.2 Specificobjectives:

- Evaluate theeffectivenessof three interventionson improving thesymptoms

of urinary incontinence in the target population (women in puerperal period

Sevilla)

- Assess the impact of improving the quality of life through King`s Health

Questionnaire(KHQ)initsSpanishversionvalidatedin2013.

- Assess the sexual satisfactionofwomenwhoparticipated in the intervention

throughthequestionnaire:FSFI(FemaleSexualFunctionIndex).

5.HYPOTHESIS:

Interventionbasedontheapplicationofthetraditionalmethod(PFMT)withtheuseof

vaginalballsincreasestheforceofperinealmusclesmeasuredbymodifiedtestOxford

and perineometer. Likewise, it decreased urine leakage in women with urinary

incontinencetreatmentversusexclusivetraditionalexercisespelvicfloor.

Similarlyinterventionbasedontheapplicationofthetraditionalmethodwiththeuse

of vaginal spheres improves quality of life and increases sexual satisfaction in the

puerperalperiodcomparedtotraditionaltreatment.

Therefore,womeninthepuerperalperiod,performpelvicfloorexercises(PFMT)with

vaginalspheres,havemorerapidandeffectiverecoveryoftheperinealstrength.

6.Methodology:

6.1typedesignandstudypopulation:

In order to determine the effectiveness of using vaginal areas for improving the

perinealstrengthofwomeninthepostpartumperiod,wehavedesignedarandomized

experimental clinical trial. We will take as a reference population all primiparous

womenwhogivebirthinthemetropolitanareaofSeville,inthecourseofayear.


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Theparticipationisvoluntaryandunpaidaskedallwomenthroughinformedconsent,

deliveredinthepuerperalvisit,themidwifeconsultationitself.

6.2EthicalAspects:

Datahavebeenobtained following theprovisionsof Law15/1999,ofDecember13,

Protectionof PersonalData. To ensure confidentiality of users, eachwas assigned a

protocolnumberwithoutstartinganypersonalinformationthatcanidentifythem,so

wehaveworkedwithanonymousdata.

Inallcases,anonymityandfreeparticipationofstudysubjectswillberespectedand,

followingthelegislationonbiomedicalresearch,amodelofinformedconsentmustbe

prepared for theparticipants in the study.Thecompletionof suchconsentwillbea

prerequisiteforparticipationintheproject.

In this model, you will be informed of the study objectives, the duration of their

participation, as well as the freedom to refuse participation, and they ensure data

confidentiality.

Thisresearcharisesfromapreviousstudy,whichwascertifiedtocomplywithethical

and scientificquality criteriaaccepted.Todo this,he issuedapermitand theEthics

Committee of the University Hospital Virgen de Valme Clinical Research, this being

favorabletoitsrealizationandattached(AnnexIII).

6.3CriteriaforInclusion/Exclusion:

Thecriteriathatwillbeusedtoincludeorexcludewomeninthestudyareasfollows:

6.3.1.Criteriousinclusion:

- Primiparouswomen.

- Womenwhoareinthepostpartumperiodbetween6weeks(quarantine)and6

monthsatthestartoftheintervention.

- NewbornbirthsTerm(from37weeks)

- CeaseLochia.


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- SufficientknowledgeoftheSpanishlanguage,bothwrittenandspoken.

- Acceptancetoparticipateinthestudythroughinformedconsent.

6.3.2Exclusioncriteria:

- Multiparouswomen

- Womenofflimitspostpartum(previousbirthto6monthsaftersurgery)

- Womenundergoingtreatmentoflowerurinarytract(ITUtreatment)

- Womenwhoarealreadyparticipatinginarecoveryprogrampelvicfloor.

- WomenwithtearIIIandIVgrade.

- Pregnant(orbecomepregnantapproachintheinterventionperiod)Women

- Starting point pelvic floormuscle balancewomen less than 2 points. (Where

retentionvaginalareasimpossible)

- Inabilitytoperformthenecessaryproceduresforintervention.

6.4Studyvariables:

Quantitativevariablestobetakenintoaccountforthestudy,all

numerictype,theyareasfollows:

- Maternalage(measuredinyears):DiscreteVariable/QuantitativeControl.

- Gestational age (measured in weeks): Variable Continuous / Quantitative

Control.

- Tearing Type: NT (No Tearing) / type I / type II / type III / type IV: Variable

quantitativecontinuous/Control.

- RNweight(measuredingrams):quantitativecontinuousvariable/Control

- ObjectiveForce1(TestOxfordDigitalScale0-5):DiscreteVariable/Dependent

quantitative.

- objective force 2 (perineometer 0 to 12): Continuous variable / Dependent

quantitative.


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Codingofqualitativevariablesstudiedwereasfollows:

- Type of delivery: eutocic 1; Forceps 2; Suction cup 3; Cesarean 4. Variable

Control

- Presentation:Cephalic1;2.Buttocks.VariableControl

- Analgesia:NA.1;Regional2;Local3.VariableControl

- Episiotomy:yes1;No2.VariableControl

- ICIQ-SF:NoIncontinence1;Smalllosses2;incontinence3.VariableControl

- Exercise conducted during the study: Control 1/2 and 3 Group Intervention

Group.Independentvariable

6.5Descriptionofthestudy:

The studywill be a Controlled and Randomized Clinical Trial, single-blind (Technical

opaque envelopes), with three parallel groups for intervention and subsequent

comparison:

Group1(Control):thisgroupwillperformpelvicfloorstandardizedexercises(PFMT),

designedby the physiotherapy team thatwill participate in the study, following the

guidelinesofcurrentclinicalpracticeanddeterminingadurationofatleast12weeks

tocarryouttheexercises.

Group 2 (Intervention-a): this group will perform pelvic floor exercises set by

physiotherapy equipment while using the vaginal balls. Its duration will also be 12

weeks.

Group3(Intervention-b):thisgroupwillusethevaginalballsintheiractivitiesofdaily

lifeduring12weeksoftheinterventionprogram,theintensityofthetimeofusingthe

balls will be determined by the physiotherapy team that participate in the study

program.


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6.5.1 samplesizeandrandomisation:

ForsamplesizecalculationwillbeusetheGP.Powerprogrammeinversion3.1.9.2.

Inwhichwewillapplyaneffectsizeof0.8,comparing inparallel thethreefocus

groups.

This yields a sample size of 23 women per group. But considering the

bibliography,referencingalackofadherencetoexerciseinpreviousstudies25,

weassume25% losses.What it creates groups coveredby31women,which

correspondtoatotalof93womeninthesample.

6.5.2. Statisticanalysis:

Afterascanstatisticof thedata input todetecterrors in thebase, thesamewillbe

described as the three study groups. Quantitative variables are expressed inmeans

and standard or medians and 25th and 75th percentiles, if skewed distributions

deviations,andqualitativevariableswithfrequencyandpercentage.

Next,ananalysisofbaselinecomparabilitybetweenthetwogroupswillbeperformed.

foranalysetherelationshipsbetweenqualitativevariables,contingencytableswillbe

madeandtheChi-squaretestornon-asymptotictestmethodsandMonteCarloexact

testwillbeapplied.


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To see if there are differences in average of numerical variables between the two

groups, T-Student's testwill beused for independent samplesor Mann-Whitney-U

Testfornon-normaldistributions.Significantmeandifferenceswillbequantifiedwith

confidenceintervalsat95%and,ifnotnormal,thedifferencesbetweenmedianswith

confidenceintervalsHodges-Lehman95%.

Furthermore,tocontrastchangesinanumericalparametermeasuredatdifferenttime

points(possibleintra-interventionassessments)withineachgroup,theFriedmanTest

orthenonparametricWilcoxonTest isappliedinthecaseofonlytwomoments.The

change between two time points of a qualitative variable is analysed with the

McNemarTest.

The data analysis will be performed with the statistical program SPSS 23.0 for

Windows.

6.6Collectinginformation:

New in this thesis, we have included involvement with the Faculty of Computer

ScienceattheUniversityofSeville.

Participation is designing a mobile phone application (APP) to facilitate monitoring,

biofeedbackandadherencetotheexercisebypatients.4thyearstudentsofComputer

EngineeringdegreemaychoosethisprojectasFinalProjectduringtheyears2019and

2020.Theprojectisofferedwiththetitleanddescription:

"Toolformonitoringpatientsintherapeuticexerciseperiod."Description:

Theprojectistodevelopamobileapplicationthatwillsupportpatientswhileperformingtherapeuticexercisesindicated.Inaddition,theinformationcollectedbytheapplicationshouldbeavailabletohealthprofessionals,sothatyoucantrackthe

patientandtheanalysisandsubsequentoperationofthedataobtained.


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Therebywe facilitatemonitoringofpatients, include theuseofnew technologies in

the study, andwehaveprovidedautility applicationhealth, learningand improving

adherencetoexercise.

7. Workplan:

- Searching:startsinJanuary2019andcontinuesthroughoutthestudy.

- APPdesigntrackingpatients:itsrealizationisofferedasafinaldegreeproject

attheFacultyofComputerEngineeringinApril2019.

- Start of Patient Recruitment: January 2019 to have the necessary sample for

thestudy.

- Data analysis: After completion of sample collection (estimated time approx

January2020)untilMarch2020

- Interpretationofresults:MarchandApril2020.

- Finalreport:July2020.

- Readingandproceduresthesisdefense:September2020.


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antenatal and postnatal women. Cochrane Database of Systematic Reviews

(10),CD007471.

25. OblasserC.,Christie J.&McCourtC. (2015)Vaginalconesorballspelvic floor

muscle to Improve performance and urinary continence in women post

partum:aquantitativesystematicreview.Midwifery31(11),1017-1025.


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9. ATTACHMENTS:

It isproposedtoparticipate inarandomizedscientificstudyentitled"Evaluationof the effectiveness of a program to strengthen thepelvic floorWOMEN INTHEPOSTPARTUM" which aims to repair the muscles of your pelvic floor muscleslocatedintheregionoftheperineuminvolvedactiveatthetimeofdeliverywiththeaimof increasing itspowerandelasticity in thepuerperalperiod.The studyaimstoassesstheextenttowhichthisstimulationofthepelvicflooriscapableofimproving the injuries of the musculature and indirectly its long-termconsequencessuchasgenitaldescents(bladder,vaginaanduterus), incontinenceorinvoluntaryleakageofurineandeventhedifficultiesvaginalintercourse.

Their participationwould, if accepted, perform a set of exercises pelvic floormuscle exercises and lower abdominal pressure previously will be taught bymidwives. The exercises would be held from 6 weeks postpartum (fulfilledquarantine)until6monthspostpartum.

If you choose to participate, you can withdraw at any time and withoutexplanation of the study. Moreover, the research team guarantees at all times,anonymityandconfidentialityoftheinformationisencryptedandwillbelimitedsolely to their age, parity, clinical data on the evolution of pregnancy, childbirthandpostpartum.

Your participation in this research study does not involve any risk to you oryourbaby,with the informationobtainedgreat interest in the future to increasethefieldofknowledgeandactiononwomen'shealthandqualityoflife.

Fieldworkwilltakeplaceinhealthcentresandatalltimesparticipantswillbecoordinated and supervised by professionals Obstetrics (midwives)whomay atanytime,consultanyaspectofthestudy.

HANDOUT FOR STUDY PARTICIPANTS:


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INFORMED CONSENT STUDY: "Influence of an exercise program low abdominal pressure modified for

pregnancy to strengthen the pelvic floor muscles in pregnant women" I, Ms. _______________________________________________, of age, I stated:

- I have successfully been informed of the nature and purpose of the study, I

have described what is my participation and have notified me that no risk to

my health.

- I understood perfectly the explanations you have offered me and I consent to

participate in the study.

- That I have been informed of my right to withdraw this consent and leave my

participation at any time, at any time of this research, without having to justify

my will, without any loss as to my attention.

Today's date __________________

Date of birth:

Telephone 1: Phone 2:

Health center to which it belongs:

Hospital where she has given birth:

Signed: ___________________________

(Name, surname)

ID: ________________


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UrinaryincontinencequestionnaireICIQ-SFICIQ(InternationalConsultationonIncontinenceQuestionnaire)isaself-administeredquestionnairethatidentifiespeoplewithurinaryincontinenceandtheimpactonqualityoflife.ICIQ-SF:totalscoresquestions1+2+3.IUdiagnosisisconsideredanythingabovezeroscore1.Howoftendoyouleakurine?(Checkonlyoneanswer).Never......................0Onceaweek...........12-3times/week.............2Onceaday................3Severaltimesaday.............4Continually................52. Give your opinion about the amount of urine you think that escapes, ie, theamountofurinethatusuallyloses(whetherornotwearingprotection).Markonlyoneanswer.nothingescapesme.........0Verylittle............2Amoderateamount........4Alotof..............63.Towhatextenttheseleaksurine,whichhasaffectedyourdailylife?12345678910Nothingmuch4.Whendidyouleakurine?Checkallthathappenstoyou.•Never.•Beforereachingtheservice.•Whencoughingorsneezing.•Whilehesleeps.•Whenperformingphysical/exerciseefforts.•Whenyoufinishurinatingandalreadydressed.•Noobviousreason.•continuously.


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DICTAMEN ÚNICO EN LA COMUNIDAD AUTÓNOMA DE ANDALUCÍA

D/Dª: Jose Salas Turrents como secretario/a del CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío

CERTIFICA

Que este Comité ha evaluado la propuesta de (No hay promotor/a asociado/a) para realizar el estudio de investigación titulado:

TÍTULO DEL ESTUDIO: Influencia de un programa de ejercicios de baja presión abdominal modificados parael embarazo para el fortalecimiento de la musculatura del suelo pélvico en la mujerembarazada

Protocolo, Versión: PDFHIP, Versión:CI, Versión: PDF

Y que considera que:

Se cumplen los requisitos necesarios de idoneidad del protocolo en relación con los objetivos del estudio y se ajusta a los principioséticos aplicables a este tipo de estudios.

La capacidad del/de la investigador/a y los medios disponibles son apropiados para llevar a cabo el estudio.

Están justificados los riesgos y molestias previsibles para los participantes.

Que los aspectos económicos involucrados en el proyecto, no interfieren con respecto a los postulados éticos.

Y que este Comité considera, que dicho estudio puede ser realizado en los Centros de la Comunidad Autónoma de Andalucíaque se relacionan, para lo cual corresponde a la Dirección del Centro correspondiente determinar si la capacidad y los mediosdisponibles son apropiados para llevar a cabo el estudio.

Lo que firmo en SEVILLA a 24/06/2015

D/Dª. Jose Salas Turrents, como Secretario/a del CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío

Código Seguro De Verificación: 5f2df9c0b7d26dc4712fbfaa47cdef336441277d Fecha 24/06/2015Normativa Este documento incorpora firma electrónica reconocida de acuerdo a la Ley 59/2003, de 19 de diciembre, de firma electrónica.

Firmado Por Jose Salas TurrentsUrl De Verificación https://www.juntadeandalucia.es/salud/portaldeetica/xhtml/ayuda/verifica

rFirmaDocumento.iface/code/5f2df9c0b7d26dc4712fbfaa47cdef336441277dPágina 1/2


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Documents

Doctoral Thesis project