3D Ultrasound in Women With Vacuum or Forceps Deliveries

3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01680731

Acronym

VADUS

Enrollment

Registered

2012-09-07

Start date

2011-10-31

Completion date

2013-04-30

Last updated

2014-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Injury, Stool Incontinence, Urinary Incontinence

Keywords

Pelvic floor injury, Levator ani muscle

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
Levator ani injury on 3D ultrasound	1-5 years after delivery	Assessment of levator ani injury on trasnperineal 3D ultrasound images

Countries

United States

Outcome results