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Completed

NCT Number: NCT01321762

Prolapse and Pregnancy Assessment

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton Pregnancy

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Croydon University Hospital

Other

Registry information

Official study title

Effect of Pregnancy and Childbirth on the Pelvic Floor

Acronym: PAPA

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2011
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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