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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05206552
Other study ID # 0514-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 25, 2022
Est. completion date July 25, 2023

Study information

Verified date September 2022
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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,


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 25, 2023
Est. primary completion date January 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Months and older
Eligibility Inclusion Criteria: *Women whom have given birth at rabin medical center with the ability to follow study requirements. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Maternal - Infant bonding questionnaire. EPDS - Postpartum depression questionnaire

Locations

Country Name City State
Israel Beilinson hospital Petach tikvah

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain verbal numerical score after labor and maternal infant bonding. pain levels graded from one to ten will be correlated with maternal infant bonding 24 hours after labor
Secondary 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 6 weeks after labor
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