CompletedNot Applicable

3D Ultrasound in Women With Vacuum or Forceps Deliveries

United States45 participantsStarted 2011-10

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Levator ani injury on 3D ultrasound

Timeframe: 1-5 years after delivery

Trial details

NCT IDNCT01680731

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-04