NCT00580879

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

4.2 years

First QC Date

December 20, 2007

Last Update Submit

January 7, 2010

Conditions

Anorectal Sphincter LacerationPelvic Floor Dysfunction

Keywords

Anorectal sphincter lacerationPelvic floor dysfunctionSphincter tear

Outcome Measures

Primary Outcomes (1)

  • Fetal head circumference and position, maternal pelvis, infant weight, maternal weight, length of the second stage, the incidence of sphincter tears as diagnosed by transvaginal ultrasound as well as the incidence of fecal urgency and incontinence.

    6 Months

Secondary Outcomes (1)

  • The magnitude of the effect of other factors such as maternal obesity, maternal age, duration of labor and pelvimetry on the risk of anorectal lacerations will be examined.

    6 Months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women in 36 weeks and upto 42 weeks of pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Study Officials

  • Karen L Noblett, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 27, 2007

Study Start

January 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

US(1)