3D Ultrasound in Women With Vacuum or Forceps Deliveries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Pelvic Floor Injury Urinary Incontinence Stool Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Forceps assisted vaginal delivery

Forceps assisted vaginal delivery within 1-5 years without any interval delivery

No interventions assigned to this group

Vacuum assisted vaginal delivery

Vacuum assisted vaginal delivery within 1-5 years without any interval delivery

No interventions assigned to this group

Elective cesarean delivery

Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor

No interventions assigned to this group

Spontaneous vaginal delivery

Spontaneous vaginal delivery within 1-5 years without any interval delivery

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No