Prolapse and Pregnancy Assessment

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT01321762
• Lead Sponsor: Croydon University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 403

Inclusion Criteria

• Singleton Pregnancy

Exclusion Criteria

• Multiple pregnancies
• Previous prolapse surgery
• Medical disorders including diabetes mellitus
• Inflammatory bowel disease
• Collagen disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Croydon University Hospital; 🇬🇧 Croydon, Surrey, United Kingdom