Medical Student Research Fellowship for Summer 2007
Mentor: Lisa K. Cannada MD
Department: Orthopaedic Surgery
Room number: G.840
Mail Code: 8870
Phone number: 214-648-8768
Project title: Childbirth After Pelvic Ring Disruption
Human subjects IRB approved project number (where applicable): IRB Number: 062006-027
Animal subjects IRB approved project number (where applicable):
Project Type (patient-based research, animal-based research, or basic research;
this characterization is only to permit a general classification for grouping
similar types of projects) Patient based. This is a multicenter, funded study.
The medical student will send out the research forms on all eligible patients.
The medical student will follow up with the patients who became pregnant after
pelvic trauma. The student will work with the Department of OB-GYN to collect
data on those patients who delivered here at Parkland and will follow up with
the patient's OB if they delivered elsewhere. The student will work with the
PI on collating the data from the multiple centers as the other centers are
actively enrolling patients.
CHILDBIRTH AFTER PELVIC RING DISRUPTION
PURPOSE: This is a study to look at how having a broken pelvis changes a woman's ability to have children. The pelvis is made up of hip bones and seat bones (the bones you sit on). We want to see if women who have broken their pelvis can have a normal childbirth or if they need cesarean sections.
BACKGROUND: Each year in the United States, over 100,000 patients are treated for pelvic fractures with more than 40,000 involving women. The pelvis is a stabilizing structure between the major weight bearing structures of the lower extremity and the trunk. Major structures pass through it including genitourinary, vascular, neurologic and gastrointestinal. Pelvic fractures represent severe injuries with mortality rates ranging from 5-25%. There can be significant problems for patients in terms of functional recovery. Female patients, in particular, are concerned about the future ability to bear children and participate in sexual activity. A retrospective review was completed by one of the investigators (CC) and found females to have more urinary tract complaints (specifically nocturia, stress incontinence and frequency), more dyspareunia, more anxiety about sexual activity and a significant increase in cesarean section (CS) after injury, than female trauma patients with other fractures. Subjects were more likely to be told to deliver by CS, and were more likely to be delivered by elective CS than the comparison patients. This is despite a lack of evidence in the literature to support this recommendation. Many of these women delivered vaginally in later pregnancies. Cesarean sections expose the patient and fetus to anesthetic and surgical risks, which may not be warranted.
The hypothesis of the current investigation is that women who have been treated
non-operatively for pelvic fracture, and those treated surgically with fixation
sparing the sacroiliac joints and/or the pubic symphysis can deliver children
vaginally. We hope to identify risk factors for obstetrical complications with
respect to injury patterns, residual deformity, associated injuries and types
of stabilization in order to develop clear indications for attempted vaginal
delivery versus CS after pelvic fracture.
CONCISE SUMMARY OF PROJECT: This is a retrospective chart and radiographic review with incorporation of obstetrical data. This study will involve a search of records for female patients who sustained pelvic fractures. The patients who meet our inclusion criteria will be contacted initially by phone. We will introduce ourselves, the purpose of the study, answer any questions they may have regarding the study and confirm their address. Study forms, including consent and HIPPA forms, the pelvic questionnaire, medical release forms, SF-36 forms will be sent along with a self-addressed stamped envelope (SASE). We will also request a release of their obstetrical records which the patient will have to sign for approval.
A retrospective review of the prospectively collected trauma registry data and the clinical record will be performed of all female patients who agree to participate determine the mechanism of injury, associated injuries, the Injury Severity Score and treatment. The treatment (non-operative versus operative) will be noted. In cases where surgical stabilization of the pelvis was performed, the operative record will be reviewed for surgical details (including type of hardware and subsequent removal, if applicable). The initial injury radiographs will be reviewed for fracture classification. The Young and Burgess classification will be used to classify the pelvic ring disruption type. Residual displacement of the pelvic ring will be assessed on the latest films available for review.
For those patients who became pregnant after their injury, the obstetrical records will be reviewed for pregnancy and labor complications, type of childbirth, cephalopelvic disproportion, and incidence of resymphysiolysis. This information will be combined with the childbirth history to determine trends in parturition after pelvic fractures (including pelvic pain during pregnancy, complications during childbirth, the rate and reason for cesarean section, and occurrence of resymphsiolysis). If after institutional records are reviewed, and letters sent, attempts to find patients who could not be located and/or did not respond, will be made according to that outlined in the literature.
CRITERIA FOR INCLUSION OF SUBJECTS: Parkland Trauma Registry will be used to
identify female patients ages 18-44 year old who was diagnose with pelvic fractures
CRITERIA FOR EXCLUSION OF SUBJECTS: We no not want to include minors of childbearing age in the follow-up population. Females greater than 44 years old are excluded, as they naturally have an increased risk of a complicated pregnancy, decreased fertility, and increased incidence of cesarean section. It would be difficult with these confounding variables to determine in patients older than 44 years old the effect of pelvic fractures on childbirth.
SOURCES OF RESEARCH MATERIAL: Patient's x-rays and medical chart will be reviewed. Patients will not be required to have any new medical treatments nor have any new tests or visits to the hospital. Patients will be asked to complete a questionnaire. The questionnaire will ask questions about the problems the patients are currently having with their pelvis. It will also ask if you have become pregnant or had a child after their pelvic fracture. Even if they have not had a child after the pelvic injury, their information will be helpful to the study.
RECRUITMENT OF SUBJECTS: This is a retrospective review and the Parkland and Shock Trauma Center Trauma Registry will be used to identify patients that are diagnose with pelvic fractures between 1995-2004. This study will involve a search of the records from both institutions for female patients who sustained pelvic fractures. The patient who meet our inclusion criteria will be contacted initially by phone. We will introduce ourselves, the purpose of the study, answer any questions they may have regarding the study and confirm their address. Study forms, including consent and HIPPA forms, the pelvic questionnaire, medical release forms, and the SF-36 forms will be sent along with a self-addressed stamped envelope (SASE). We will also request a release of their obstetrical records for patient approval and signature.
POTENTIAL RISKS: There will be no specific risks or discomforts as a result of participation in this study. No identifying information will be used. There is sensitive information which will only be viewed by those clinicians participating in the study. Since this a retrospective review, there is little or know risk with respect to loss of patient confidentiality.
SPECIAL PRECAUTIONS: The information will remain completely confidential. The information will be kept in a locked and secure location.
PROCEDURES TO MAINTAIN CONFIDENTIALITY: The study data sheet will be numbered to protect confidentiality. The Principal Investigator will be the only person who has access to all patient identifiers. Information will be kept in the Principal Investigator's locked office. The patient data generated will not appear in the patient's medical record and will be used for research purposes only. The data will be recorded in a password-protected, secure database within the Principal Investigator's office and will be accessible only to the primary researchers at Parkland Memorial Hospital directly involved in the study. Patient identity will be made anonymous after completion of the data accrual and prior to statistical analysis to assure confidentiality. If necessary the IRB may review the research information verification and for audit purposes.
POTENTIAL BENEFITS: The information collected from this study will help both orthopedic doctors and obstetricians improve their care for women with pelvic fractures.
BIOSTATISTICS: Data from medical records will be assessed for any significant effect on outcome results. Regardless, this study will provide information that would help future patients and their doctors make better treatment decisions when treating the pelvic fracture and when choosing methods of delivery.
RISK/BENEFIT ASSESSMENT: This is a retrospective chart review. There are no risks to the patients. No economic compensation or other tangible benefit will be provided to the patients.