Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

NCT ID: NCT00580879

Last Updated: 2010-01-11

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

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to see if fetal head circumference can be used as a predictor for who will experience a sphincter laceration while delivering.

Detailed Description

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Even though much work has been invested in trying to identify risk factors that can predict which population will suffer from sphincter tears and other pelvic floor trauma, the epidemiology is still poorly understood. Factors that have been implicated to include operative vaginal delivery, birth weight, and primaparity. Up to this point little focus has been placed on antenatal factors that would help predict and prevent sphincter disruptions. At the time of birth the infant's head is the largest part of the body. Thus, head circumference of the infant may be able to predict which subjects is more likely to suffer from sphincter disruption. Thus, this study aims to determine whether or not fetal head circumference measured antenatally is predictive of pelvic floor trauma.

Conditions

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Anorectal Sphincter Laceration Pelvic Floor Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Primiparous subjects at least 18 years of age
* Gestational age greater than or equal to 36 weeks and upto 42 weeks gestation
* Subjects must have give written informed consent to participate in this study
* Subjects must be planning to deliver at UCI

Exclusion Criteria

* Subjects less than 18 years of age
* Subjects with a previous delivery
* Subjects with previous colorectal surgery or hemorrhoidal surgery
* Subjects with a history of irritable bowel syndrome, ulcerative colitis, or Crohn's disease
* Subjects with a history of colon or rectal cancer
* Gestational age less than 36 weeks
* Cesarean section
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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University of California, Irvine Medical Center

Principal Investigators

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Karen L Noblett, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California, Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2005-4575

Identifier Type: -

Identifier Source: org_study_id

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