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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05106634
Other study ID # 2019-14/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date October 22, 2021

Study information

Verified date October 2021
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This cross-sectional observational study was conducted to compare breastfeeding success and breastfeeding self-efficacy levels of mothers who gave birth via vaginal delivery (spontaneous or via epidural analgesia) or cesarean section (under general or spinal anesthesia).


Description:

This study was conducted by including women, who gave birth via VD or CS in the gynecology clinics of a training and research hospital and a city hospital and were in the postpartum period (after 24 hours). It compared the breastfeeding self-efficacy and breastfeeding success of mothers who gave birth via CS (under spinal anesthesia or general anesthesia) with those of mothers who gave birth via vaginal delivery (under epidural analgesia or via spontaneous vaginal delivery).


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date October 22, 2021
Est. primary completion date February 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. being aged >18 years old; 2. being literate; 3. having a baby of weight between 2500-4000 g, with 5th minute APGAR score of =7, and without congenital diseases and sucking and swallowing problems; 4. not having a disease that prevents breastfeeding; 5. having a full-term (37-42 weeks) VD or CS, 6. agreeing to participate in the study Exclusion Criteria: 1. a history of psychological or mental health problems 2. any condition in the mother or infant that was a barrier to breastfeeding 3. baby's admission into the neonatal unit 4. baby's separation from the mother for any reason

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ul Bursa

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Alus Tokat M, Sercekus P, Yenal K, Okumus H. Early postpartum breast-feeding outcomes and breast-feeding self-efficacy in Turkish mothers undergoing vaginal birth or cesarean birth with different types of anesthesia. Int J Nurs Knowl. 2015 Apr;26(2):73-9. doi: 10.1111/2047-3095.12037. Epub 2014 Jun 5. — View Citation

Maharlouei N MD, Pourhaghighi A Medical student, Raeisi Shahraki H PhD, Zohoori D MD, Lankarani KB MD. Factors Affecting Exclusive Breastfeeding, Using Adaptive LASSO Regression. Int J Community Based Nurs Midwifery. 2018 Jul;6(3):260-271. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding success observing assessed using the LATCH Breastfeeding Assessment Tool Postpartum 24 hours
Primary Breastfeeding Self-Efficacy assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) Early postpartum period (after 24 hours)
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