Prolapse and Pregnancy Assessment (PAPA)
|ClinicalTrials.gov Identifier: NCT01321762|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : April 19, 2012
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|
|Pelvic Organ Prolapse|
|Study Type :||Observational|
|Actual Enrollment :||403 participants|
|Official Title:||Effect of Pregnancy and Childbirth on the Pelvic Floor|
|Study Start Date :||April 2005|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Pregnant Women with singleton pregnancy
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321762
|Croydon University Hospital|
|Croydon, Surrey, United Kingdom, CR7 7YE|