Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370903
Status:
COMPLETED
Last Update Posted:
2008-02-04
First Post:
2006-08-30
Brief Title:
Postpartum Depression and Cesarean Section
Sponsor:
Oklahoma State University Center for Health Sciences
Organization:
Oklahoma State University Center for Health Sciences
Study Overview
Official Title:
Retrospective Study of Relationship of Postpartum Depression to Planned Versus Emergent Cesarean Section
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this retrospective study is to determine if there is an increase in postpartum depression PPD among women who undergo an emergency cesarean section as opposed to a planned cesarean section We will analyze the hospital and clinic medical records of postpartum women who delivered by cesarean section CS at Tulsa Regional Medical Center between January 1 2003 and June 1 2005 and who obtained their postpartum care at the OSU ObGyn Clinic in Tulsa Oklahoma We will record whether the cesarean was planned or emergent and we will note the score they received on the Edinburgh Postnatal Depression Scale when they came to the clinic for their four-week postpartum visit A score of 12 or lower on the EPDS will be considered not depressed and a score of 13 or higher will be considered depressed Numbers of depressed patients will be compared among the two types of cesarean sections and analyzed for statistical differences using the chi-squared method of analysis
Detailed Description:
The purpose of this retrospective study is to determine if there is an increase in postpartum depression PPD among women who undergo an emergency cesarean section as opposed to a planned cesarean section All previous research documenting the rate of PPD in cesarean section patients looks only at the incidence of PPD in cesarean section versus vaginal delivery and does not separate emergent versus planned cesarean section The general study hypothesis is as follows An emergent cesarean section can be an emotionally traumatic experience Women who have a cesarean section for emergent causes are not psychologically prepared for surgery and thus experience an increased rate of PPD The null hypothesis is There is no significant difference in the rate of PPD among women who have a cesarean section for emergent causes versus women who have their cesarean section at the previously scheduled time
Postpartum depression PPD is diagnosed in approximately 10-20 of women DSM-IV-TR and 25 of these women still suffer from PPD twelve months after delivery Gregoire et al 1996 Risks for developing PPD include a higher subjective burden of childbirth poor relationship with spouse significant other or father of the baby unemployment or dissatisfaction with job and low socioeconomic status
Obstetrical history risk factors include previous abortions high-risk pregnancy low birth weight and cesarean section Bergant et al 1998
Delivery via cesarean section CS creates a much different emotional experience than does a vaginal delivery Disappointment in the ability to have a natural birth feelings of resentment towards the physician altered treatment expectation as well as pain and trauma associated with surgery are all contributing factors Al-Nuaim 2004 A majority of women consider an emergency cesarean section CS to be a mentally traumatic encounter One third of women who require an emergency CS will experience posttraumatic stress reactions during the postpartum period Ryding et al 1997 Fisher et al reported that there is a significant relationship between mode of delivery and negative psychological outcomes A mother who has a CS instead of a vaginal delivery is more likely to have mood deterioration lowered self-esteem grief reaction posttraumatic distress and depression Fisher et al 1997
We propose to analyze the hospital and clinic medical records of 200 postpartum women who delivered by cesarean section CS at Tulsa Regional Medical Center between January 1 2003 and June 1 2005 and who obtained their postpartum care at the OSU ObGyn Clinic in Tulsa Oklahoma Of the charts reviewed 100 women will have had a CS for emergent causes and the other 100 will have delivered via a planned CS
The hospital records will be reviewed to determine whether the cesarean delivery was for emergent causes or if it was a planned operation Planned cesarean sections are performed on patients who have had a previous CS and are scheduled for a repeat fetuses that are measuring greater than 4000 grams prior uterine scars and known breech presentations on patients not in labor Emergent causes will include nonreassuring fetal heart tones placental abruption inductions that result in CS due to failure to progress or cephalopelvic disproportion and malpresentations in active labor Malpresentations include face brow shoulder hand breech compound or transverse lie
The patients will have their clinic chart reviewed for the following data from their antenatal and postpartum visits date of delivery breastfeeding status as a simple yesno question without regard to whether or not the mother is supplementing with formula mothers age smokernon-smoker race employment status previous history psychological disorders Edinburgh Postnatal Depression Scale score routinely administered by obstetrician at the six week postpartum visit other antepartum or postpartum complications
Postpartum depression will be diagnosed with the assistance of the Edinburgh Postnatal Depression Scale EPDS The OSU ObGyn Clinic began routine use of the EPDS in 2003 As a result all patient records used in this study will be from January 1 2003 to June 1 2005 A one-year time period has been allotted for collection of data as this will allow sufficient time to review the necessary records In addition one of the collaborating investigators is a resident and the research assistants are medical students therefore the data collection must be completed in a timely manner OSU ObGyn and Tulsa Regional Medical Center are the only sites in this investigation to ensure that the diagnosis of postpartum depression is made using the same parameters
STUDY POPULATION
InclusionExclusion Criteria
Our study population will include 200 postpartum women ages 15 to 43 who have given birth via cesarean section at Tulsa Regional Medical Center In addition these same individuals must have had their postpartum follow up visits at the OSU ObGyn Clinic in Tulsa Oklahoma The study population consists predominantly of Medicaid patients These patients are generally of a lower socioeconomic status The ethnic mix includes Caucasian African-American Hispanic American Indian and Asian patients Patients who deliver vaginally have an intrauterine fetal demise known anomalies in the delivered fetus a known mood disorder during pregnancy or drug use during pregnancy or the postpartum course will be excluded
Early Termination Criteria
NA
METHODSPROCEDURES
Diagnosis
The diagnosis of postpartum depression will be given based on the use of the Edinburgh Postnatal Depression Scale EPDS The EPDS has 10 questions and possible scores range from 0-30 We used its authors recommendation that scores higher than 12 be considered a positive screen for PPD and for which sensitivity and specificity have been found to be 86 and 78 respectively Cox et al We are aware that other depression evaluations may be used to definitively diagnose PPD The OSU ObGyn clinic uses the EPDS for convenience and it was the only data available in patient charts for this retrospective study
DATA
Collection Collaborating investigators and research assistants will review each chart and extract only the following data from the patients postpartum visit Edinburgh Postnatal Depression Scale score routinely administered by obstetrician at the six week postpartum visit breastfeeding status as a simple yesno question without regard to whether or not the mother is supplementing with formula date of delivery mothers age smokernon-smoker race employment status previous history psychological disorders other antepartum or postpartum complications No additional information will be collected from patient charts The research assistants are OSU medical students employed in the work study program for the specific purpose of working on this research project They will collect the data from clinic records These assistants are under the OSU umbrella of individuals who may have access to patient charts and they have basic human use research training as well as HIPAA training
Analysis Numbers of depressed patients will be compared among the two groups and analyzed for statistical differences using the chi-squared method of analysis
Confidentiality Patients clinic records will be kept in the medical records department which is under direct security supervision or locked at all times Hospital records will be kept in the health information management department at Tulsa Regional Medical Center which is locked 24 hours a day All study records will be de-identified by conversion to numbers before review analysis or interpretation J Martin Beal DO Sarah McCoy PhD and Jennifer Howell DO will have access to these numbers which will be kept locked in the OSU ObGyn office which is separate from both medical records departments All documents linking patient names to charts will be destroyed after the data collection is complete
Postpartum depression PPD is diagnosed in approximately 10-20 of women DSM-IV-TR and 25 of these women still suffer from PPD twelve months after delivery Gregoire et al 1996 Risks for developing PPD include a higher subjective burden of childbirth poor relationship with spouse significant other or father of the baby unemployment or dissatisfaction with job and low socioeconomic status
Obstetrical history risk factors include previous abortions high-risk pregnancy low birth weight and cesarean section Bergant et al 1998
Delivery via cesarean section CS creates a much different emotional experience than does a vaginal delivery Disappointment in the ability to have a natural birth feelings of resentment towards the physician altered treatment expectation as well as pain and trauma associated with surgery are all contributing factors Al-Nuaim 2004 A majority of women consider an emergency cesarean section CS to be a mentally traumatic encounter One third of women who require an emergency CS will experience posttraumatic stress reactions during the postpartum period Ryding et al 1997 Fisher et al reported that there is a significant relationship between mode of delivery and negative psychological outcomes A mother who has a CS instead of a vaginal delivery is more likely to have mood deterioration lowered self-esteem grief reaction posttraumatic distress and depression Fisher et al 1997
We propose to analyze the hospital and clinic medical records of 200 postpartum women who delivered by cesarean section CS at Tulsa Regional Medical Center between January 1 2003 and June 1 2005 and who obtained their postpartum care at the OSU ObGyn Clinic in Tulsa Oklahoma Of the charts reviewed 100 women will have had a CS for emergent causes and the other 100 will have delivered via a planned CS
The hospital records will be reviewed to determine whether the cesarean delivery was for emergent causes or if it was a planned operation Planned cesarean sections are performed on patients who have had a previous CS and are scheduled for a repeat fetuses that are measuring greater than 4000 grams prior uterine scars and known breech presentations on patients not in labor Emergent causes will include nonreassuring fetal heart tones placental abruption inductions that result in CS due to failure to progress or cephalopelvic disproportion and malpresentations in active labor Malpresentations include face brow shoulder hand breech compound or transverse lie
The patients will have their clinic chart reviewed for the following data from their antenatal and postpartum visits date of delivery breastfeeding status as a simple yesno question without regard to whether or not the mother is supplementing with formula mothers age smokernon-smoker race employment status previous history psychological disorders Edinburgh Postnatal Depression Scale score routinely administered by obstetrician at the six week postpartum visit other antepartum or postpartum complications
Postpartum depression will be diagnosed with the assistance of the Edinburgh Postnatal Depression Scale EPDS The OSU ObGyn Clinic began routine use of the EPDS in 2003 As a result all patient records used in this study will be from January 1 2003 to June 1 2005 A one-year time period has been allotted for collection of data as this will allow sufficient time to review the necessary records In addition one of the collaborating investigators is a resident and the research assistants are medical students therefore the data collection must be completed in a timely manner OSU ObGyn and Tulsa Regional Medical Center are the only sites in this investigation to ensure that the diagnosis of postpartum depression is made using the same parameters
STUDY POPULATION
InclusionExclusion Criteria
Our study population will include 200 postpartum women ages 15 to 43 who have given birth via cesarean section at Tulsa Regional Medical Center In addition these same individuals must have had their postpartum follow up visits at the OSU ObGyn Clinic in Tulsa Oklahoma The study population consists predominantly of Medicaid patients These patients are generally of a lower socioeconomic status The ethnic mix includes Caucasian African-American Hispanic American Indian and Asian patients Patients who deliver vaginally have an intrauterine fetal demise known anomalies in the delivered fetus a known mood disorder during pregnancy or drug use during pregnancy or the postpartum course will be excluded
Early Termination Criteria
NA
METHODSPROCEDURES
Diagnosis
The diagnosis of postpartum depression will be given based on the use of the Edinburgh Postnatal Depression Scale EPDS The EPDS has 10 questions and possible scores range from 0-30 We used its authors recommendation that scores higher than 12 be considered a positive screen for PPD and for which sensitivity and specificity have been found to be 86 and 78 respectively Cox et al We are aware that other depression evaluations may be used to definitively diagnose PPD The OSU ObGyn clinic uses the EPDS for convenience and it was the only data available in patient charts for this retrospective study
DATA
Collection Collaborating investigators and research assistants will review each chart and extract only the following data from the patients postpartum visit Edinburgh Postnatal Depression Scale score routinely administered by obstetrician at the six week postpartum visit breastfeeding status as a simple yesno question without regard to whether or not the mother is supplementing with formula date of delivery mothers age smokernon-smoker race employment status previous history psychological disorders other antepartum or postpartum complications No additional information will be collected from patient charts The research assistants are OSU medical students employed in the work study program for the specific purpose of working on this research project They will collect the data from clinic records These assistants are under the OSU umbrella of individuals who may have access to patient charts and they have basic human use research training as well as HIPAA training
Analysis Numbers of depressed patients will be compared among the two groups and analyzed for statistical differences using the chi-squared method of analysis
Confidentiality Patients clinic records will be kept in the medical records department which is under direct security supervision or locked at all times Hospital records will be kept in the health information management department at Tulsa Regional Medical Center which is locked 24 hours a day All study records will be de-identified by conversion to numbers before review analysis or interpretation J Martin Beal DO Sarah McCoy PhD and Jennifer Howell DO will have access to these numbers which will be kept locked in the OSU ObGyn office which is separate from both medical records departments All documents linking patient names to charts will be destroyed after the data collection is complete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None