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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396509
Other study ID # mai-nsd-c/s
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date June 10, 2019

Study information

Verified date May 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 10, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Behavioral:
Maternal Attachment Inventory Score
three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.

Locations

Country Name City State
Turkey Pinar Yalcin Bahat Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups. 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 evaluate the correlations between the MIB scores and their sociodemographic data. 3 months
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