Prolapse and Pregnancy Assessment

Pelvic Organ Prolapse Clinical Trial

— PAPA  

Official title:

Effect of Pregnancy and Childbirth on the Pelvic Floor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321762
• Other study ID #: 05/Q0806/9
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: April 18, 2012
• Start date: April 2005
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: Croydon University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Singleton Pregnancy

Exclusion Criteria:

• Multiple pregnancies

• Previous prolapse surgery

• Medical disorders including diabetes mellitus

• Inflammatory bowel disease

• Collagen disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United Kingdom	Croydon University Hospital	Croydon	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Croydon University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective assessment of Prolapse using Pelvic organ prolapse Quantification System	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).	2nd trimester, 3rd trimester, 14 weeks, 12 months and 5 years after childbirth	No