Prolapse and Pregnancy Assessment

NCT01321762 | Completed DMC

• 1 other identifier: 05/Q0806/9
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Prolapse; Childbirth; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

Pregnant Women with singleton pregnancy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Singleton Pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Croydon University Hospital: lead

Study Sites (1)

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

GB (1)