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Prolapse and Pregnancy Assessment (PAPA)

C

Croydon University Hospital

Status

Completed

Conditions

Pelvic Organ Prolapse

Study type

Observational

Funder types

Other

Identifiers

NCT01321762
05/Q0806/9

Details and patient eligibility

About

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.

Enrollment

403 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Singleton Pregnancy

Exclusion criteria

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

Trial design

403 participants in 1 patient group

1
Description:
Pregnant Women with singleton pregnancy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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