Development of Depression PostpartumNCT05595512
Postpartum Depression
An observational study of Development of Depression Postpartum, run by University of Jordan.
Trial summary
Postpartum depression (PPD) is one of the most common psychiatric complications of pregnancy and postpartum. It is often defined as an episode of depressive disorder that occurs in the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Development of Depression Postpartum
- What is being tested?
- Naser Al-Husban
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2014to 30 Apr 2021
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: patients were those diagnosed to have PPD within 6 months of delivery at Jordan University hospital (JUH) in the period 1st of January 2014 to the 1st of March 2021, Amman, Jordan. Data was collected retrospectively from the electronic files, from the departments of obstetrics and gynecology and psychiatry JUH in patients, outpatient clinics, inpatients' files delivery room records
Who may be able to join
- patients with confirmed diagnosis of PPD
- with complete clinical data
- have no other psychiatric diseases
Who cannot join
- patients with maternal blues
- patients with a diagnosis of any other psychiatric diseases
- cases of unconfirmed depression
- those with missing data.
About this study
Official title: Risk Factors for Developing Maternal Postpartum Depression; A Retrospective Cross-sectional Study
Postpartum depression (PPD) is one of the most common psychiatric complications of pregnancy and postpartum. It is often defined as an episode of depressive disorder that occurs in the postpartum period. Evidence suggests that PPD has serious consequences on the quality of life of all family members, increases the risk for familial conflicts, leaving great negative effects on maternal-infant interaction. The aim of our study was to investigate and shed the light on the determinants of development of PPD mainly maternal age among women in Jordan. We also aimed at examining additional factors on prevalence of PPD and providing more information on PPD among Jordanian mothers.
Read the detailed description
This was a retrospective descriptive cross-sectional study and included patients were those diagnosed to have PPD within 6 months of delivery at Jordan University hospital (JUH) in the period 1st of January 2014 to the 1st of March 2021, Amman, Jordan. Data was collected retrospectively from the electronic files, from the departments of obstetrics and gynecology and psychiatry JUH in patients, outpatient clinics, inpatients' files delivery room records. All data are electronic in the period of the study. Inclusion criteria; patients with confirmed diagnosis of PPD with complete clinical data and have no other psychiatric diseases. Exclusion criteria; patients with maternal blues, patients with a diagnosis of any other psychiatric diseases, cases of unconfirmed depression and those with missing data.
Main outcome measure was the number of patients who developed PPD within 6 months of childbirth in relation to age, parity and mode of delivery. We collected data of patients who were confirmed to have a diagnosis of postpartum depression by a consultant psychiatrist in the hospital who followed diagnostic criteria of the American psychiatric association11. Intellectual disability was not specifically assessed in our patients.
The variables and information collected for this study included age, parity, mode of delivery, body mass index (BMI) that was objectively measured routinely in our obstetric population. In addition, medications, chronic diseases, past history of depression, psychiatry, breast feeding, and any social or marital problems were also retrieved. Data related to antenatal complications like antepartum hemorrhage (APH), diabetes mellitus (DM), preeclampsia toxemia (PET), urinary tract infection (UTI)/pyelonephritis necessitated hospital admission, postpartum hemorrhage (PPH) with no need for blood transfusion, PPH with blood transfusion, emergency hysterectomy for bleeding, fetal outcome including nursery (good, term), neonatal intensive care unit (NICU) admission: preterm, hypoxemia/acidosis, birth trauma, congenital anomalies, fetal loss [Intrauterine Fetal Death (IUFD), stillborn, neonatal] were also obtained
- Conditions
- Development of Depression Postpartum
- Being tested
- Naser Al-Husban
- Keywords
- postpartum, depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naser Al-HusbanBehavioural
depressive symptoms within 6 months of delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression symptoms
symptoms related to depression that developed postpartum
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 Oct 2022
- Study start30 Jan 2014
- Primary completion30 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Depression PostpartumStudies 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595512
- Sponsor's protocol ID
- JUH obstetrics
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: available on reasonable request from the investigator
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Developing Maternal Postpartum Depression; A Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05595512
- Acronym / sponsor ID
- JUH obstetrics
- Conditions
- Development of Depression Postpartum
- Keywords
- postpartum, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 30 Jan 2014 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Oct 2022 (actual)
- 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.
Postpartum depression (PPD) is one of the most common psychiatric complications of pregnancy and postpartum. It is often defined as an episode of depressive disorder that occurs in the postpartum period. Evidence suggests that PPD has serious consequences on the quality of life of all family members, increases the risk for familial conflicts, leaving great negative effects on maternal-infant interaction. The aim of our study was to investigate and shed the light on the determinants of development of PPD mainly maternal age among women in Jordan. We also aimed at examining additional factors on prevalence of PPD and providing more information on PPD among Jordanian mothers.
Detailed description
This was a retrospective descriptive cross-sectional study and included patients were those diagnosed to have PPD within 6 months of delivery at Jordan University hospital (JUH) in the period 1st of January 2014 to the 1st of March 2021, Amman, Jordan. Data was collected retrospectively from the electronic files, from the departments of obstetrics and gynecology and psychiatry JUH in patients, outpatient clinics, inpatients' files delivery room records. All data are electronic in the period of the study. Inclusion criteria; patients with confirmed diagnosis of PPD with complete clinical data and have no other psychiatric diseases. Exclusion criteria; patients with maternal blues, patients with a diagnosis of any other psychiatric diseases, cases of unconfirmed depression and those with missing data.
Main outcome measure was the number of patients who developed PPD within 6 months of childbirth in relation to age, parity and mode of delivery. We collected data of patients who were confirmed to have a diagnosis of postpartum depression by a consultant psychiatrist in the hospital who followed diagnostic criteria of the American psychiatric association11. Intellectual disability was not specifically assessed in our patients.
The variables and information collected for this study included age, parity, mode of delivery, body mass index (BMI) that was objectively measured routinely in our obstetric population. In addition, medications, chronic diseases, past history of depression, psychiatry, breast feeding, and any social or marital problems were also retrieved. Data related to antenatal complications like antepartum hemorrhage (APH), diabetes mellitus (DM), preeclampsia toxemia (PET), urinary tract infection (UTI)/pyelonephritis necessitated hospital admission, postpartum hemorrhage (PPH) with no need for blood transfusion, PPH with blood transfusion, emergency hysterectomy for bleeding, fetal outcome including nursery (good, term), neonatal intensive care unit (NICU) admission: preterm, hypoxemia/acidosis, birth trauma, congenital anomalies, fetal loss [Intrauterine Fetal Death (IUFD), stillborn, neonatal] were also obtained
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients were those diagnosed to have PPD within 6 months of delivery at Jordan University hospital (JUH) in the period 1st of January 2014 to the 1st of March 2021, Amman, Jordan. Data was collected retrospectively from the electronic files, from the departments of obstetrics and gynecology and psychiatry JUH in patients, outpatient clinics, inpatients' files delivery room records
Key inclusion criteria (3 listed)
- patients with confirmed diagnosis of PPD
- with complete clinical data
- have no other psychiatric diseases
Key exclusion criteria (4 listed)
- patients with maternal blues
- patients with a diagnosis of any other psychiatric diseases
- cases of unconfirmed depression
- those with missing data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naser Al-Husbandepressive symptoms within 6 months of delivery | Behavioural | – |
Primary outcome
Postpartum depression symptoms
Time frame: 6 months
symptoms related to depression that developed postpartum
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 27 Oct 2022.
- Individual participant dataSharing planned: Undecided. available on reasonable request from the investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Development of Depression Postpartum, run by University of Jordan.
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 3 inclusion and 4 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Postpartum depression symptoms (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 27 Oct 2022.