Clincosm LogoSign in Get a demo

PAPA: Prolapse and Pregnancy Assessment

Sponsor
Croydon University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01321762
Collaborator
(none)
403
Enrollment
1
Location
68
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient.

Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    403 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Pregnancy and Childbirth on the Pelvic Floor
    Study Start Date :
    Apr 1, 2005
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Pregnant Women with singleton pregnancy

    Outcome Measures

    Primary Outcome Measures

    1. Objective assessment of Prolapse using Pelvic organ prolapse Quantification System [2nd trimester, 3rd trimester, 14 weeks, 12 months and 5 years after childbirth]

      Prospective evaluation of the impact of mode of delivery on pelvic organ support using the International Continence Society recommended Pelvic Organ Prolapse Quantification system (POPQ).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Singleton Pregnancy
    Exclusion Criteria:

    • Multiple pregnancies

    • Previous prolapse surgery

    • Medical disorders including diabetes mellitus

    • Inflammatory bowel disease

    • Collagen disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Croydon University Hospital Croydon Surrey United Kingdom CR7 7YE

    Sponsors and Collaborators

    • Croydon University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ranee Thakar, Consultant, Croydon University Hospital
    ClinicalTrials.gov Identifier:
    NCT01321762
    Other Study ID Numbers:
    • 05/Q0806/9
    First Posted:
    Mar 24, 2011
    Last Update Posted:
    Apr 19, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Ranee Thakar, Consultant, Croydon University Hospital
    Prolapse
    Childbirth
    Pregnancy
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Apr 19, 2012