Maternal Care PatternsNCT05206552
The Correlation Between Maternal Infant Bonding, Pain and Postpartum Depression
An observational study of Maternal Care Patterns, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The delivery process can be associated with significant maternal pain. which has many long and short term affects. The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 months and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Jan 2022to 25 Jul 2023
- 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 months and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women whom are the day after labor, who are above the age 18, have given birth to a healthy neonate from 37 weeks of gestation and are able to comply with study requirments
Who may be able to join
- Women whom have given birth at rabin medical center with the ability to follow study requirements.
Who cannot join
- Women given birth to twins
- Women who's baby was hospitalized
- Women who were treated with magnesium
- Women who's babies were born with congenital malformations
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Beilinson hospital
Petach Tikvah
Sharon Orbach, MD, 972-54-538-3093, sharonorbach@yahoo.com
Sharon Orbach-zinger
About this study
Official title: The Correlation Between Maternal Infant Bonding , Pain and Postpartum Depression a Prospective Observational Cohort Study
The delivery process can be associated with significant maternal pain. which has many long and short term affects.
The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.
Read the detailed description
Delivery is a process that is correlated with maternal pain. The maternal pain can have signifcant long term and short term maternal and neontal impact.
The most common method for pain reilef during delivery is epidural analgesia. Few studies have examined the assocaition between use of epidural analgesia and postpartum depression, with some studies showing a postive correlation and other condricting so.
Maternal bonding is defined as her's emotional state, including maternal feelings towards the infant, it has proven to be the basis for the child's later attachment and sense of self.
A stable and strong bond between mother and child is associated with positive parental behavior and of the child's cognitive and behavioral development, while a unstable maternal infant bond can may lead to long term matenal and infant complications.
The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.
In this study women the day after labor will be approched , following obtaining consent will be requested to fill out a the PBO vailadited maternal bonding questtionanire , the valadited EPDS (endinbough postpartum depression questionnaire) and a general questionnaire detailing their demographic , obstetric history and pain levels.
At six weeks postpartum a member of the research team will call the study participant and ask the PBO and EPDS questionnaires to asses the correlation between delivery pain , maternal bonding and postpartum depression,
- Conditions
- Maternal Care Patterns
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Maternal - Infant bonding questionnaire. EPDS - Postpartum depression questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Parturients above the age of 18 | Study participants will include women after labour whom gave birth to a healthy neonate at 37 weeks with the ability to comply with study requirments Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain verbal numerical score after labor and maternal infant bonding.
pain levels graded from one to ten will be correlated with maternal infant bonding
Measured: 24 hours after labor
Secondary outcomes (1)
Pain verbal numerical score after labor and postpartum depression
pain levels graded from one to ten will be correlated with postpartum depression defined as a score of above 10 on the edinbough postpartum depression score questionnaire
Measured: 6 weeks after labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start25 Jan 2022
- Primary completion25 Jan 2023 (estimated)
- Study completion25 Jul 2023 (estimated)
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 Maternal Care PatternsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharonorbach, Rabin Medical Center
- Investigators
- sharon orbach-zinger, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206552
- Sponsor's protocol ID
- 0514-21
- Status last verified
- Sep 2022
- First submitted
- 12 Jan 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shebelsky R, Sadi W, Heesen P, Aber RN, Fein S, Iluz-Freundlich D, Shmueli A, Azem K, Radyan Tamayev I, Binyamin Y, Orbach-Zinger S. The relationship between postpartum pain and mother-infant bonding: A prospective observational study. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101315. doi: 10.1016/j.accpm.2023.101315. Epub 2023 Oct 20.
PubMed 37865216
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Maternal Infant Bonding , Pain and Postpartum Depression a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05206552
- Acronym / sponsor ID
- 0514-21
- Conditions
- Maternal Care Patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 25 Jul 2023 (estimated)
- First posted
- 25 Jan 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.
The delivery process can be associated with significant maternal pain. which has many long and short term affects.
The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.
Detailed description
Delivery is a process that is correlated with maternal pain. The maternal pain can have signifcant long term and short term maternal and neontal impact.
The most common method for pain reilef during delivery is epidural analgesia. Few studies have examined the assocaition between use of epidural analgesia and postpartum depression, with some studies showing a postive correlation and other condricting so.
Maternal bonding is defined as her's emotional state, including maternal feelings towards the infant, it has proven to be the basis for the child's later attachment and sense of self.
A stable and strong bond between mother and child is associated with positive parental behavior and of the child's cognitive and behavioral development, while a unstable maternal infant bond can may lead to long term matenal and infant complications.
The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.
In this study women the day after labor will be approched , following obtaining consent will be requested to fill out a the PBO vailadited maternal bonding questtionanire , the valadited EPDS (endinbough postpartum depression questionnaire) and a general questionnaire detailing their demographic , obstetric history and pain levels.
At six weeks postpartum a member of the research team will call the study participant and ask the PBO and EPDS questionnaires to asses the correlation between delivery pain , maternal bonding and postpartum depression,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients above the age of 18 | – | Other: QuestionnaireStudy participants will include women after labour whom gave birth to a healthy neonate at 37 weeks with the ability to comply with study requirments |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women whom are the day after labor, who are above the age 18, have given birth to a healthy neonate from 37 weeks of gestation and are able to comply with study requirments
Key inclusion criteria (1 listed)
- Women whom have given birth at rabin medical center with the ability to follow study requirements.
Key exclusion criteria (4 listed)
- Women given birth to twins
- Women who's baby was hospitalized
- Women who were treated with magnesium
- Women who's babies were born with congenital malformations
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 |
|---|---|---|
| QuestionnaireMaternal - Infant bonding questionnaire. EPDS - Postpartum depression questionnaire | Other | Parturients above the age of 18 |
Primary outcome
Pain verbal numerical score after labor and maternal infant bonding.
Time frame: 24 hours after labor
pain levels graded from one to ten will be correlated with maternal infant bonding
1 secondary outcome
Pain verbal numerical score after labor and postpartum depression
Time frame: 6 weeks after labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 37865216Shebelsky R, Sadi W, Heesen P, Aber RN, Fein S, Iluz-Freundlich D, Shmueli A, Azem K, Radyan Tamayev I, Binyamin Y, Orbach-Zinger S. The relationship between postpartum pain and mother-infant bonding: A prospective observational study. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101315. doi: 10.1016/j.accpm.2023.101315. Epub 2023 Oct 20.
- Individual participant dataSharing planned: No
Related trials for Maternal Care Patterns
Active, not recruiting
Melanated Group Midwifery Care (MGMC)
Pregnancy Complications, Maternal Care Patterns
Active, not recruiting
An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Post-traumatic Stress Disorder, Dissociation
Active, not recruiting
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
Well-Being, Psychological, Dissociation
Active, not recruiting
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Active, not recruitingObservational study
Utilization of Maternal Healthcare Services and Infant Feeding Practices
Maternal Health, Prenatal Care
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.
sharon orbach-zinger principal investigator
Rabin Medical Center
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 Maternal Care Patterns, run by Rabin Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain verbal numerical score after labor and maternal infant bonding. (time frame: 24 hours after labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206552, 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 21 Sep 2022.