Prolapse and Pregnancy Assessment (PAPA)
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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 |
- 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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pregnant women with uncomplicated singleton pregnancy attending the ultrasound scan clinic in the second trimester were invited to participate
Inclusion Criteria:
- Singleton Pregnancy
Exclusion Criteria:
- Multiple pregnancies
- Previous prolapse surgery
- Medical disorders including diabetes mellitus
- Inflammatory bowel disease
- Collagen disorders
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ranee Thakar, Consultant, Croydon University Hospital |
| ClinicalTrials.gov Identifier: | NCT01321762 History of Changes |
| Other Study ID Numbers: | 05/Q0806/9 |
| Study First Received: | March 11, 2011 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Croydon University Hospital:
|
Prolapse Childbirth Pregnancy |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013