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Prolapse and Pregnancy Assessment (PAPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321762
First Posted: March 24, 2011
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ranee Thakar, Croydon University Hospital
  Purpose

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
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Pregnancy and Childbirth on the Pelvic Floor

Resource links provided by NLM:


Further study details as provided by Ranee Thakar, Croydon University Hospital:

Primary Outcome Measures:
  • Objective assessment of Prolapse using Pelvic organ prolapse Quantification System [ Time Frame: 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).


Enrollment: 403
Study Start Date: April 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Pregnant Women with singleton pregnancy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with uncomplicated singleton pregnancy attending the ultrasound scan clinic in the second trimester were invited to participate
Criteria

Inclusion Criteria:

  • Singleton Pregnancy

Exclusion Criteria:

  • Multiple pregnancies
  • Previous prolapse surgery
  • Medical disorders including diabetes mellitus
  • Inflammatory bowel disease
  • Collagen disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321762


Locations
United Kingdom
Croydon University Hospital
Croydon, Surrey, United Kingdom, CR7 7YE
Sponsors and Collaborators
Croydon University Hospital
  More Information

Responsible Party: Ranee Thakar, Consultant, Croydon University Hospital
ClinicalTrials.gov Identifier: NCT01321762     History of Changes
Other Study ID Numbers: 05/Q0806/9
First Submitted: March 11, 2011
First Posted: March 24, 2011
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by Ranee Thakar, Croydon University Hospital:
Prolapse
Childbirth
Pregnancy

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical