Obstetric; Injury Pelvic Floor Clinical Trial
Official title:
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
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.
n/a
| 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 |