BreastfeedingNCT05593536
Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status
A study testing Breastfeeding Education in people with Breastfeeding, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status. Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 Jul 2024
- Phase
- Interventional
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- GROUP 1:
- 18-35 age range
- Nulliparous Pregnancy
- Single Pregnancy
- Gestational week 34- 36
- Those who are literate
Show all 19Show fewer
- Those who have a smart phone and have the opportunity to benefit from teaching methods
- GROUP 2:
- 18-35 age range
- Nulliparous Pregnancy
- Single Pregnancy
- Gestational week 34-36
- Those who are literate
- GROUP 3:
- 18-35 age range
- Nulliparous Pregnancy
- Single Pregnancy
- Gestational week 34-36 gw
- Those who are literate
Who cannot join
- GROUP1:
- Presence of chronic disease
- Nipple problems
- Admission of the baby to the neonatal intensive care unit
- The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
- Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
Show all 25Show fewer
- The presence of a disease in the mother that will prevent breastfeeding
- Pregnant women with vision and hearing problems
- GROUP 2:
- Presence of chronic disease
- Nipple problems
- Admission of the baby to the neonatal intensive care unit
- The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
- Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
- The presence of a disease in the mother that will prevent breastfeeding
- Pregnant women with vision and hearing problems
- GROUP 3:
- Pregnant women who go to pregnancy school
- Presence of chronic disease
- Nipple problems
- Admission of the baby to the neonatal intensive care unit
- The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
- Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
- The presence of a disease in the mother that will prevent breastfeeding
- Pregnant women with vision and hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status.
Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital between October 2022 and August 2023. F test at 90% effect power 0.25 medium effect level on the sample of the study analyzed using the Gpower (3.1.9.2) Programe. As a result of the analyze, it was planned to recruit 207 nulliparous pregnant women. According to the calculation made, there should be at least 69 people in each groups. Accordingly, 69 people in the experimental 1 group (biological nurturing), 69 people in the experimental 2 group (classical breastfeeding), 69 people should be included in the control group. Experimental 1 group and experimental 2 group will be given breastfeeding training on their first visit and after two weeks. Breastfeeding success in the postpartum period will be compared in all groups.
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding Education
- Keywords
- biological nurturing, breastfeeding, education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding EducationBehavioural
Biological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (biological nurturing) | Experimental | In biological feeding, the mother takes a semi-sitting position and the baby lies face down on the mother's breast and belly, with every part of her body in contact with the mother. Receives: Behavioral: Breastfeeding Education |
| Group 2 (classic breastfeeding) | Experimental | In classical breastfeeding, the mother holds her baby in her arms and breastfeeds while she is in a sitting position. Receives: Behavioral: Breastfeeding Education |
| Group 3 (control) | No intervention | The mother will breastfeed her baby as she wishes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Measured: Two weeks after the first training
Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Measured: The first 24 hours of the postpartum period
Higher ''LATCH Scale'' score in the biological nurturing group
LATCH Scale is an assessment tool to evaluate the effectiveness of early breast-feeding. A numerical score of 0, 1, or 2 is assigned to the five letters of the acronym: Latching of infant onto the breast, Amount of audible swallowing, Type of nipple, Comfort of mother, Help needed by mother to hold baby to breast. Lower scores (< 5) can indicate the need for assistance for better success at breast-feeding.
Measured: The first 24 hours of the postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start15 Jul 2023
- Primary completion15 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dogan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593536
- Sponsor's protocol ID
- 2022/84
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen SS, Alexander DD, Krebs NF, Young BE, Cabana MD, Erdmann P, Hays NP, Bezold CP, Levin-Sparenberg E, Turini M, Saavedra JM. Factors Associated with Breastfeeding Initiation and Continuation: A Meta-Analysis. J Pediatr. 2018 Dec;203:190-196.e21. doi: 10.1016/j.jpeds.2018.08.008. Epub 2018 Oct 4.
PubMed 30293638Wang Y, Zhao T, Zhang Y, Li S, Cong X. Positive Effects of Kangaroo Mother Care on Long-Term Breastfeeding Rates, Growth, and Neurodevelopment in Preterm Infants. Breastfeed Med. 2021 Apr;16(4):282-291. doi: 10.1089/bfm.2020.0358. Epub 2021 Feb 2.
PubMed 33533688Omidi A, Rahmani S, Amini R, Karami M. The effect of a planned lactation education program on the mother's breastfeeding practice and weight gain in low birth weight infants: a randomized clinical trial study. BMC Pregnancy Childbirth. 2022 Jun 13;22(1):482. doi: 10.1186/s12884-022-04810-z.
PubMed 35698072von Salmuth V, Brennan E, Kerac M, McGrath M, Frison S, Lelijveld N. Maternal-focused interventions to improve infant growth and nutritional status in low-middle income countries: A systematic review of reviews. PLoS One. 2021 Aug 18;16(8):e0256188. doi: 10.1371/journal.pone.0256188. eCollection 2021.
PubMed 34407128Huda MH, Chipojola R, Lin YM, Lee GT, Shyu ML, Kuo SY. The Influence of Breastfeeding Educational Interventions on Breast Engorgement and Exclusive Breastfeeding: A Systematic Review and Meta-Analysis. J Hum Lact. 2022 Feb;38(1):156-170. doi: 10.1177/08903344211029279. Epub 2021 Jul 6.
PubMed 34229526Araban M, Karimian Z, Karimian Kakolaki Z, McQueen KA, Dennis CL. Randomized Controlled Trial of a Prenatal Breastfeeding Self-Efficacy Intervention in Primiparous Women in Iran. J Obstet Gynecol Neonatal Nurs. 2018 Mar;47(2):173-183. doi: 10.1016/j.jogn.2018.01.005. Epub 2018 Feb 3.
PubMed 29406289Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.
PubMed 31764775Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD006425. doi: 10.1002/14651858.CD006425.pub4.
PubMed 27922724Moraes GGW, Christoffel MM, Toso BRGO, Viera CS. Association between duration of exclusive breastfeeding and nursing mothers' self-efficacy for breastfeeding. Rev Esc Enferm USP. 2021 May 10;55:e03702. doi: 10.1590/S1980-220X2019038303702. eCollection 2021. English, Portuguese.
PubMed 33978141Parry KC, Tully KP, Hopper LN, Schildkamp PE, Labbok MH. Evaluation of Ready, Set, BABY: A prenatal breastfeeding education and counseling approach. Birth. 2019 Mar;46(1):113-120. doi: 10.1111/birt.12393. Epub 2018 Sep 6.
PubMed 30191591Sayres S, Visentin L. Breastfeeding: uncovering barriers and offering solutions. Curr Opin Pediatr. 2018 Aug;30(4):591-596. doi: 10.1097/MOP.0000000000000647.
PubMed 29782384Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
PubMed 32248838
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status
- ClinicalTrials.gov ID
- NCT05593536
- Acronym / sponsor ID
- 2022/84
- Conditions
- Breastfeeding
- Keywords
- biological nurturing, breastfeeding, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 25 Oct 2022 (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.
Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status.
Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital between October 2022 and August 2023. F test at 90% effect power 0.25 medium effect level on the sample of the study analyzed using the Gpower (3.1.9.2) Programe. As a result of the analyze, it was planned to recruit 207 nulliparous pregnant women. According to the calculation made, there should be at least 69 people in each groups. Accordingly, 69 people in the experimental 1 group (biological nurturing), 69 people in the experimental 2 group (classical breastfeeding), 69 people should be included in the control group. Experimental 1 group and experimental 2 group will be given breastfeeding training on their first visit and after two weeks. Breastfeeding success in the postpartum period will be compared in all groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (biological nurturing) | Experimental | Behavioral: Breastfeeding EducationIn biological feeding, the mother takes a semi-sitting position and the baby lies face down on the mother's breast and belly, with every part of her body in contact with the mother. |
| Group 2 (classic breastfeeding) | Experimental | Behavioral: Breastfeeding EducationIn classical breastfeeding, the mother holds her baby in her arms and breastfeeds while she is in a sitting position. |
| Group 3 (control) | No intervention | –The mother will breastfeed her baby as she wishes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 18-35 age range
- Nulliparous Pregnancy
- Single Pregnancy
- Gestational week 34- 36
- Those who are literate
Key exclusion criteria (25 listed)
- Presence of chronic disease
- Nipple problems
- Admission of the baby to the neonatal intensive care unit
- The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
- Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding EducationBiological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse. | Behavioural | Group 1 (biological nurturing), Group 2 (classic breastfeeding) |
Primary outcome
Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
Time frame: Two weeks after the first training
Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
Time frame: The first 24 hours of the postpartum period
Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Higher ''LATCH Scale'' score in the biological nurturing group
Time frame: The first 24 hours of the postpartum period
LATCH Scale is an assessment tool to evaluate the effectiveness of early breast-feeding. A numerical score of 0, 1, or 2 is assigned to the five letters of the acronym: Latching of infant onto the breast, Amount of audible swallowing, Type of nipple, Comfort of mother, Help needed by mother to hold baby to breast. Lower scores (< 5) can indicate the need for assistance for better success at breast-feeding.
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 18 Oct 2024.
- Background: PubMed 30293638Cohen SS, Alexander DD, Krebs NF, Young BE, Cabana MD, Erdmann P, Hays NP, Bezold CP, Levin-Sparenberg E, Turini M, Saavedra JM. Factors Associated with Breastfeeding Initiation and Continuation: A Meta-Analysis. J Pediatr. 2018 Dec;203:190-196.e21. doi: 10.1016/j.jpeds.2018.08.008. Epub 2018 Oct 4.
- Background: PubMed 33533688Wang Y, Zhao T, Zhang Y, Li S, Cong X. Positive Effects of Kangaroo Mother Care on Long-Term Breastfeeding Rates, Growth, and Neurodevelopment in Preterm Infants. Breastfeed Med. 2021 Apr;16(4):282-291. doi: 10.1089/bfm.2020.0358. Epub 2021 Feb 2.
- Background: PubMed 35698072Omidi A, Rahmani S, Amini R, Karami M. The effect of a planned lactation education program on the mother's breastfeeding practice and weight gain in low birth weight infants: a randomized clinical trial study. BMC Pregnancy Childbirth. 2022 Jun 13;22(1):482. doi: 10.1186/s12884-022-04810-z.
- Background: PubMed 34407128von Salmuth V, Brennan E, Kerac M, McGrath M, Frison S, Lelijveld N. Maternal-focused interventions to improve infant growth and nutritional status in low-middle income countries: A systematic review of reviews. PLoS One. 2021 Aug 18;16(8):e0256188. doi: 10.1371/journal.pone.0256188. eCollection 2021.
- Background: PubMed 34229526Huda MH, Chipojola R, Lin YM, Lee GT, Shyu ML, Kuo SY. The Influence of Breastfeeding Educational Interventions on Breast Engorgement and Exclusive Breastfeeding: A Systematic Review and Meta-Analysis. J Hum Lact. 2022 Feb;38(1):156-170. doi: 10.1177/08903344211029279. Epub 2021 Jul 6.
- Background: PubMed 29406289Araban M, Karimian Z, Karimian Kakolaki Z, McQueen KA, Dennis CL. Randomized Controlled Trial of a Prenatal Breastfeeding Self-Efficacy Intervention in Primiparous Women in Iran. J Obstet Gynecol Neonatal Nurs. 2018 Mar;47(2):173-183. doi: 10.1016/j.jogn.2018.01.005. Epub 2018 Feb 3.
- Background: PubMed 31764775Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.
- Background: PubMed 27922724Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD006425. doi: 10.1002/14651858.CD006425.pub4.
- Background: PubMed 33978141Moraes GGW, Christoffel MM, Toso BRGO, Viera CS. Association between duration of exclusive breastfeeding and nursing mothers' self-efficacy for breastfeeding. Rev Esc Enferm USP. 2021 May 10;55:e03702. doi: 10.1590/S1980-220X2019038303702. eCollection 2021. English, Portuguese.
- Background: PubMed 30191591Parry KC, Tully KP, Hopper LN, Schildkamp PE, Labbok MH. Evaluation of Ready, Set, BABY: A prenatal breastfeeding education and counseling approach. Birth. 2019 Mar;46(1):113-120. doi: 10.1111/birt.12393. Epub 2018 Sep 6.
- Background: PubMed 29782384Sayres S, Visentin L. Breastfeeding: uncovering barriers and offering solutions. Curr Opin Pediatr. 2018 Aug;30(4):591-596. doi: 10.1097/MOP.0000000000000647.
- Background: PubMed 32248838Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education in people with Breastfeeding, run by Istanbul University - Cerrahpasa 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 19 inclusion and 25 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 18 Oct 2024. 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?
Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group (time frame: Two weeks after the first training). The study lists 3 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 NCT05593536, which also lists 12 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 18 Oct 2024.