NCT05206552

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

January 12, 2022

Last Update Submit

September 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain verbal numerical score after labor and postpartum depression

    6 weeks after labor

Study Arms (1)

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

Other: Questionnaire

Interventions

Maternal - Infant bonding questionnaire. EPDS - Postpartum depression questionnaire

Parturients above the age of 18

Eligibility Criteria

Age18 Months+
Sexfemale(Gender-based eligibility)
Gender Eligibility Details\*Women will be elgible
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • \*Women whom have given birth at rabin medical center with the ability to follow study requirements.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • sharon orbach-zinger

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicipal investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 25, 2022

Study Start

January 25, 2022

Primary Completion

January 25, 2023

Study Completion

July 25, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations