Anorectal Sphincter LacerationNCT00580879
Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study
An observational study of Anorectal Sphincter Laceration and Pelvic Floor Dysfunction, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorectal Sphincter Laceration, Pelvic Floor Dysfunction
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women in 36 weeks and upto 42 weeks of pregnancy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
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.
Read the detailed 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.
- Keywords
- Anorectal sphincter laceration, Pelvic floor dysfunction, Sphincter tear
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal Sphincter LacerationStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Investigators
- Karen L Noblett, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580879
- Sponsor's protocol ID
- 2005-4575
- Status last verified
- Jan 2010
- First submitted
- 20 Dec 2007
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study
- ClinicalTrials.gov ID
- NCT00580879
- Acronym / sponsor ID
- 2005-4575
- Keywords
- Anorectal sphincter laceration, Pelvic floor dysfunction, Sphincter tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in 36 weeks and upto 42 weeks of pregnancy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 6 Months
1 secondary outcome
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.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
Related trials for Anorectal Sphincter Laceration
RecruitingObservational study
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
Obstetric Anal Sphincter Injury, Severe Perineal Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Noblett, M.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Sphincter Laceration and Pelvic Floor Dysfunction, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2010.