Postpartum DepressionNCT00370903
Postpartum Depression and Cesarean Section
An observational study of Postpartum Depression, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2007
- 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 15 to 43 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Included are postpartum women ages 15 to 43 who have given birth via cesarean section at Tulsa Regional Medical Center between January 1, 2003 and June 1, 2005. Postpartum follow up visit(s) must have occurred at the OSU Ob/Gyn Clinic in Tulsa, Oklahoma.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Center for Health Sciences Houston Parke Clinic
Tulsa, Oklahoma, 74127
About this study
Official title: Retrospective Study of Relationship of Postpartum Depression to Planned Versus Emergent Cesarean Section
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 Ob/Gyn 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.
Read the 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 Ob/Gyn 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 yes/no question without regard to whether or not the mother is supplementing with formula, mother's age, smoker/non-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 Ob/Gyn 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 Ob/Gyn 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
Inclusion/Exclusion 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 visit(s) at the OSU Ob/Gyn 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
N/A
METHODS/PROCEDURES
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 author's 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 Ob/Gyn 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 patient's postpartum visit: Edinburgh Postnatal Depression Scale score (routinely administered by obstetrician at the six week postpartum visit), breastfeeding status as a simple yes/no question without regard to whether or not the mother is supplementing with formula, date of delivery, mother's age, smoker/non-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 Patient's 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, D.O., Sarah McCoy, Ph.D., and Jennifer Howell, D.O. will have access to these numbers which will be kept locked in the OSU Ob/Gyn 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.
- Conditions
- Postpartum Depression
- Keywords
- cesarean, planned, emergent, postpartum depression
- Medical subject headings
- Depression, Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- John M. Beal, D.O., Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370903
- Sponsor's protocol ID
- 2005009
- Status last verified
- Jan 2008
- First submitted
- 30 Aug 2006
- Last updated
- 4 Feb 2008
- Results posted
- No
Publications
Ryding EL, Wijma B, Wijma K. Posttraumatic stress reactions after emergency cesarean section. Acta Obstet Gynecol Scand. 1997 Oct;76(9):856-61. doi: 10.3109/00016349709024365.
PubMed 9351412
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Relationship of Postpartum Depression to Planned Versus Emergent Cesarean Section
- ClinicalTrials.gov ID
- NCT00370903
- Acronym / sponsor ID
- 2005009
- Conditions
- Postpartum Depression
- Keywords
- cesarean, planned, emergent, postpartum depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 1 Sep 2006 (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 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 Ob/Gyn 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 Ob/Gyn 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 yes/no question without regard to whether or not the mother is supplementing with formula, mother's age, smoker/non-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 Ob/Gyn 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 Ob/Gyn 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
Inclusion/Exclusion 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 visit(s) at the OSU Ob/Gyn 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
N/A
METHODS/PROCEDURES
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 author's 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 Ob/Gyn 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 patient's postpartum visit: Edinburgh Postnatal Depression Scale score (routinely administered by obstetrician at the six week postpartum visit), breastfeeding status as a simple yes/no question without regard to whether or not the mother is supplementing with formula, date of delivery, mother's age, smoker/non-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 Patient's 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, D.O., Sarah McCoy, Ph.D., and Jennifer Howell, D.O. will have access to these numbers which will be kept locked in the OSU Ob/Gyn 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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Included are postpartum women ages 15 to 43 who have given birth via cesarean section at Tulsa Regional Medical Center between January 1, 2003 and June 1, 2005. Postpartum follow up visit(s) must have occurred at the OSU Ob/Gyn Clinic in Tulsa, Oklahoma.
Key exclusion criteria (1 listed)
- 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.
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
Not reported in the source record.
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 4 Feb 2008.
- Background: PubMed 9351412Ryding EL, Wijma B, Wijma K. Posttraumatic stress reactions after emergency cesarean section. Acta Obstet Gynecol Scand. 1997 Oct;76(9):856-61. doi: 10.3109/00016349709024365.
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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.
John M. Beal, D.O. principal investigator
Oklahoma State University Center for Health Sciences
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 Postpartum Depression, run by Oklahoma State University Center for Health Sciences 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 1 inclusion and 1 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 4 Feb 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370903, which also lists 1 linked publication.
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 4 Feb 2008; AzTrials last refreshed its copy on 31 Oct 2026.