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

Pelvic Floor Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580879
• Other study ID #: 2005-4575
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 7, 2010
• Start date: January 2005
• Est. completion date: March 2009

Study information

• Verified date: January 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorectal Sphincter Laceration
• Lacerations
• Pelvic Floor Dysfunction

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No