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Clinical Trial Summary

Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery. At the Department of Obstetrics and Gynaecology, Akershus University Hospital there are approximately 4500 deliveries annually and 1500 women are giving birth for the first time.

Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in it self.

Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic caesarean section to avoid disabling incontinence and prolapse later in life.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT01045135
Study type Observational
Source University Hospital, Akershus
Contact
Status Completed
Phase
Start date December 2009
Completion date June 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05317364 - Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery Phase 4
Completed NCT06069596 - Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study Phase 4
Active, not recruiting NCT02304016 - Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations N/A