NCT02661867

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

5.9 years

First QC Date

January 16, 2016

Last Update Submit

January 22, 2016

Conditions

Pelvic Floor Disorders

Keywords

ChildbirthPelvic organ prolapseUrinary incontinenceFecal incontinence

Outcome Measures

Primary Outcomes (1)

  • Pelvic organ prolapse symptoms score

    calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

    seven years after delivery

Secondary Outcomes (2)

  • Urinary incontinence symptoms score

    seven years after delivery

  • Fecal incontinence symptoms score

    seven years after delivery

Study Arms (2)

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)

Behavioral: delivery

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.

Behavioral: delivery

Interventions

deliveryBEHAVIORAL

delivery either vaginal or by cesarean section

CSVD

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center

You may qualify if:

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

You may not qualify if:

  • \- operative vaginal delivery (vacuum extraction or forceps delivery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22907482BACKGROUND

  • 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.

    PMID: 28171703DERIVED

MeSH Terms

Conditions

Pelvic Floor DisordersPelvic Organ ProlapseUrinary IncontinenceFecal Incontinence

Interventions

Parturition

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 25, 2016

Study Start

January 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2014

Last Updated

January 25, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share