3D Ultrasound in Women With Vacuum or Forceps Deliveries

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.

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Key information

Conditions

Pelvic Floor Injury Behavior Behavioral Symptoms Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stool Incontinence Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Levator ani injury on 3D ultrasound

Time frame: 1-5 years after delivery

Assessment of levator ani injury on trasnperineal 3D ultrasound images

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: VADUS

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 7, 2012
Registry last updated: Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed