- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396509
Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
May 19, 2020 updated by: Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
To evaluate the effects of gestational age and other factors on maternal attachment relationship.
There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction.
The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The Maternal Attachment Inventory (MAI) measure maternal love attachment (9).
Muller tested the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never".
Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point.
The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İ̇stanbul
-
Istanbul, İ̇stanbul, Turkey, 34000
- Pinar Yalcin Bahat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Two hundred patients were divided into two groups.
100 women delivered vaginally and another 100 delivered with cesarean section.
They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Description
Inclusion Criteria:
- natural pregnancy (without any Assisted reproductive technology (ART) method)
- aged 18 to 45 years
- no adverse obstetric history
Exclusion Criteria:
- psychiatric diagnosis
- history of psychiatric drug use
- postpartum blues
- known complications during pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
women giving birth by normal vaginal delivery
100 women delivered vaginally. .
They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method),
|
three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
|
women giving birth by c-section
100 delivered with cesarean section.
They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
Women aged 18 to 45 years who delivered at term and had natural pregnancy (without any ART method),
|
three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups.
Time Frame: 3 months
|
They were examined three month after delivery using Maternal Attachment Inventory (MAI); Each item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never".
Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point.
The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluate the correlations between the MIB scores and their sociodemographic data.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 10, 2019
Study Registration Dates
First Submitted
May 16, 2020
First Submitted That Met QC Criteria
May 16, 2020
First Posted (Actual)
May 20, 2020
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mai-nsd-c/s
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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