Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

Breastfeeding Clinical Trial

Official title:

Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05593536
• Other study ID #: 2022/84
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: August 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 207
• Est. completion date: July 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

GROUP 1:

• 18-35 age range

• Nulliparous Pregnancy

• Single Pregnancy

• Gestational week 34- 36

• Those who are literate

• 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

Exclusion Criteria:

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

• 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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Breastfeeding Education
Biological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Araban 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. — View Citation

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. — View Citation

Huang 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. — View Citation

Huda 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. — View Citation

Lumbiganon 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. — View Citation

Milinco 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. — View Citation

Moraes 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. — View Citation

Omidi 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. — View Citation

Parry 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. — View Citation

Sayres S, Visentin L. Breastfeeding: uncovering barriers and offering solutions. Curr Opin Pediatr. 2018 Aug;30(4):591-596. doi: 10.1097/MOP.0000000000000647. — View Citation

von 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. — View Citation

Wang 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks after the first training
Primary	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.	The first 24 hours of the postpartum period
Primary	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.	The first 24 hours of the postpartum period