BreastfeedingNCT05106634
Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
An observational study of Breastfeeding, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2019to 22 Oct 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Being aged >18 years old 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 early postpartum period (after 24 hours)
Who may be able to join
- being aged >18 years old;
- being literate;
- 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;
- not having a disease that prevents breastfeeding;
- having a full-term (37-42 weeks) VD or CS,
- agreeing to participate in the study
Who cannot join
- a history of psychological or mental health problems
- any condition in the mother or infant that was a barrier to breastfeeding
- baby's admission into the neonatal unit
- baby's separation from the mother for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Breastfeeding Success and Self-Efficacy Using LATCH in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section: Cross-sectional Study
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).
Read the detailed 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).
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding Success, breastfeeding Self-Efficacy, vaginal delivery, cesarean section, spinal anesthesia, general anesthesia, epidural anestezi
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding success observing
assessed using the LATCH Breastfeeding Assessment Tool
Measured: Postpartum 24 hours
Breastfeeding Self-Efficacy
assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Measured: Early postpartum period (after 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Sep 2019
- Primary completion4 Feb 2020
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Buran, Uludag University
- Investigators
- Gonca Buran, PhD, Principal investigator, Uludag Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106634
- Sponsor's protocol ID
- 2019-14/18
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24897921Maharlouei 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.
PubMed 30035142
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Breastfeeding Success and Self-Efficacy Using LATCH in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05106634
- Acronym / sponsor ID
- 2019-14/18
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding Success, breastfeeding Self-Efficacy, vaginal delivery, cesarean section, spinal anesthesia, general anesthesia, epidural anestezi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Being aged >18 years old 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 early postpartum period (after 24 hours)
Key inclusion criteria (6 listed)
- being aged >18 years old;
- being literate;
- 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;
- not having a disease that prevents breastfeeding;
- having a full-term (37-42 weeks) VD or CS,
Key exclusion criteria (4 listed)
- a history of psychological or mental health problems
- any condition in the mother or infant that was a barrier to breastfeeding
- baby's admission into the neonatal unit
- baby's separation from the mother for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breastfeeding success observing
Time frame: Postpartum 24 hours
assessed using the LATCH Breastfeeding Assessment Tool
Breastfeeding Self-Efficacy
Time frame: Early postpartum period (after 24 hours)
assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 24897921Alus 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.
- Background: PubMed 30035142Maharlouei 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.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonca Buran, PhD principal investigator
Uludag Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding success observing (time frame: Postpartum 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.