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3D Ultrasound in Women With Vacuum or Forceps Deliveries (VADUS)

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University of Rochester

Status

Completed

Conditions

Stool Incontinence
Pelvic Floor Injury
Urinary Incontinence

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.

Enrollment

45 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Females age >18 and <45.
  • Primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery.
  • Birth weight >2500g and <4500g.
  • Delivery should have occurred more than one year ago, but less than five years ago.

Pregestational BMI <35kg40kg/m2.

Exclusion criteria

  • Presence of interim delivery.
  • Presence of both vacuum and forceps use during delivery.
  • Presence of pregestational or A2 gestational diabetes mellitus.
  • Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).

Trial design

45 participants in 4 patient groups

Forceps assisted vaginal delivery
Description:
Forceps assisted vaginal delivery within 1-5 years without any interval delivery
Vacuum assisted vaginal delivery
Description:
Vacuum assisted vaginal delivery within 1-5 years without any interval delivery
Elective cesarean delivery
Description:
Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor
Spontaneous vaginal delivery
Description:
Spontaneous vaginal delivery within 1-5 years without any interval delivery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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