Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section

NCT ID: NCT02661867

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

865 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2014-12-31

Brief Summary

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Objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).

Detailed Description

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Pelvic floor disorders (PFD) usually refers to three definable groups of symptoms that include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). The prevalence of these conditions increases with age, but in general, PFD affect 20-50 % of women throughout their lives. Thus, PFD are common and have significant societal impact. Another important PFD risk factor is childbearing. Specifically, these disorders are more common among multiparas. Vaginal delivery (VD) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.

Conditions

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Pelvic Floor Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VD

Vaginal delivery group - women who gave birth of offspring through the vagina without the use of special instruments such as forceps or a vacuum extractor (instrumental vaginal delivery)

delivery

Intervention Type BEHAVIORAL

delivery either vaginal or by cesarean section

CS

Cesarean section group - women delivered by surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby. Cesarean section is performed when a vaginal delivery would put the baby's or mother's life or health at risk.

delivery

Intervention Type BEHAVIORAL

delivery either vaginal or by cesarean section

Interventions

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delivery

delivery either vaginal or by cesarean section

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* cephalic presentation
* delivery in term (gestational week 38-42)
* no other childbirth during study period

Exclusion Criteria

\- operative vaginal delivery (vacuum extraction or forceps delivery)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Huser

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Memon H, Handa VL. Pelvic floor disorders following vaginal or cesarean delivery. Curr Opin Obstet Gynecol. 2012 Oct;24(5):349-54. doi: 10.1097/GCO.0b013e328357628b.

Reference Type BACKGROUND
PMID: 22907482 (View on PubMed)

Huser M, Janku P, Hudecek R, Zbozinkova Z, Bursa M, Unzeitig V, Ventruba P. Pelvic floor dysfunction after vaginal and cesarean delivery among singleton primiparas. Int J Gynaecol Obstet. 2017 May;137(2):170-173. doi: 10.1002/ijgo.12116. Epub 2017 Mar 1.

Reference Type DERIVED
PMID: 28171703 (View on PubMed)

Other Identifiers

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Plure

Identifier Type: -

Identifier Source: org_study_id

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