Nipple InfectionNCT06770595
Breastfeeding Education Through Clinical Demonstration for Primiparous Women to Prevent Sore Nipples and Engorgement
A study testing breastfeeding positions and attachment practice. in people with Nipple Infection and Nipple Discharge, run by Gadjah Mada University at 6 sites in Indonesia.
Trial summary
Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nipple Infection, Nipple Discharge, Engorgement
- What is being tested?
- breastfeeding positions and attachment practice.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesIndonesia
- Study dates
- 26 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravida pregnant women who visited the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis health service centers
- Single pregnancy
- Mother has a mobile phone with internet access and can use WhatsApp Application
- Plans to stay for 6 months in the research area
- Willing to participate in the research by signing the informed consent
Who cannot join
- Presence of congenital orofacial abnormalities (labio-gntao-palatoschisis, etc) that make breastfeeding difficult
- Mother with breast problems (history of implant breast surgery)
- The mother or baby experiences problems during labor or postpartum that may lead to research dropouts
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Indonesia6 sites
Kasihan Community Health Centers
Bantul, Special Region of Yogyakarta, 55181
Arantika Meidya Pratiwi, M.Kes., +62 856-4751-9655, arantika.meidya@almaata.ac.id
Sewon Community health centers
Bantul, Special Region of Yogyakarta, 55185
Fatimatasarii, M. Keb., +62 821-3806-8823, fatimatasari@almaata.ac.id
Pajangan Community Health Centers
Bantul, Special Region of Yogyakarta, 55751
Annisa Nurmasari, Amd. Keb., ++62 853-2876-6419, annisa.nurmasari@almaata.ac.id
Jetis community health centers
Bantul, Special Region of Yogyakarta, 55781
Ratih Devi Alfiana, M.Keb., ++62 878-2554-9554, ratihdevi@almaata.ac.id
Pleret Community Health Centers
Bantul, Special Region of Yogyakarta, 55791
Isti Chana Zuliyati, M. Keb., +62 857-4358-7668, isti.chana@almaata.ac.id
Banguntapan community health centers
Bantul, Special Region of Yogyakarta, 55798
Lisana Shidiq Aliya, MPH, +62 882-2661-7158, lisanashidiqaliya@almaata.ac.id
About this study
Official title: The Effect of Prenatal Breastfeeding Education Through Clinical Demonstrations for Primiparous Women to Prevent Sore Nipples and Engorgement
Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples.
Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.
This research uses quasi-experiments. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups. breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group. The outcome of this research is position, attachment, effective sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups.
Read the detailed description
Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples. Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.
This research is an experimental study with a quasi-experimental design, the equivalent-time samples design. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The sampling method in this research used simple random sampling. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups.
breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group.
The selection of respondents was determined based on predetermined inclusion criteria. Next, respondents will be confirmed via WhatsApp so that the enumerator can meet with the respondent to provide an explanation regarding the progress of the research and ask for their willingness to participate in the research by signing an informed consent.
Respondents in the control group did not receive any special intervention. Furthermore, respondents were asked to confirm whether they had given birth in both the intervention group and the control group. A home visit will be carried out by a lactation counselor and enumerator one week postpartum. The first visit to the mother to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples, and swollen breasts. The second home visit was carried out at 14 days postpartum to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples and swollen breasts.
The outcome of this research is knowledge of breastfeeding techniques, position practice, and latching, evaluating the baby's sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups. Multiple logistic regression was used to analyze the impact of the intervention on tender nipples and swollen breasts to control confounding variables. The intervention effect is expressed as crude odds ratio and adjusted odds ratio, and the associated 95% CI will be obtained from the logistic regression model. The odds ratio was reported along with its 95% CI and was considered significantly significant statistics if the P value is <0.05.
- Conditions
- Nipple Infection, Nipple Discharge, Engorgement
- Being tested
- breastfeeding positions and attachment practice.
- Keywords
- Demonstration clinic, Education, Sore nipples, Engorgement, Breastfeeding
- Medical subject headings
- Galactorrhea, Hyperemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding positions and attachment practice.Behavioural
Breastfeeding clinical demonstration is a method of presentation of skills that shows how a particular procedure is performed in position and attachment breastfeeding. Respondents in this group will receive education provided face-to-face once with a duration of 40 minutes, with the following details: first, 25 minutes of education about breastfeeding position and attachment. In this case, the lactation counselor first explains the correct position and attachment for breastfeeding. Respondents were asked to carry out a practical simulation regarding the correct breastfeeding position and attachment using a doll, in this case, the lactation counselor will assess how the mother is positioned and attached. second, 10 minutes of education about swollen breasts and how to deal with them. third, a 10-minute question and answer session related to the educational material provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group is third-trimester pregnant women with 34-35 weeks of gestation who received clinical demonstration education breastfeeding about position and attachment. The clinical demonstration is provided by a lactation counselor.
Respondents in this group will receive education provided face-to-face with the clinical demonstration of breastfeeding positions and attachment. The education was given twice with a duration of 40 minutes to primigravida mothers aged 34-35 weeks gestation. For outcome measurement, A home visit will be carried out by a lactation counselor and enumerator 2 times, the first home visit in 7 days postpartum and the second home visit in 14 days postpartum, to assess breastfeeding positioning and latching practices, assess the baby's sucking, evaluate nipple pain, sore nipples, and engorgement. Receives: Behavioral: breastfeeding positions and attachment practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding positions practice
Mother's ability to practice breastfeeding positions, ordinal scale, measurement using observational checklist totalling 4 items. The value is the positions is not correct at all (if none of the criteria are met), not good positions (if 1 or 2 criteria fulfilled) and good positions (if 3 or 4 criteria fulfilled)
Measured: at birth to 14 days of postpartum
Breastfeeding attachment practice
Mother's ability to practice breastfeeding attachment, ordinal scale, measurement using observational checklist totalling 4 items. The value is the attachment is not correct at all (if none of the criteria are met), not good attachment (if 1 or 2 criteria fulfilled) and good attachment (if 3 or 4 criteria fulfilled)
Measured: at birth to 14 days of postpartum
Evaluate the baby's sucking while breastfeeding
Evaluation the baby's sucking, nominal scale, measurement using observational checklist. Correct sucking technique was defined as the infant having a wide-open mouth, with the tongue under the areola, and expressing milk from the breast by slow, deep sucks. Faulty technique was defined as superficial nipple sucking.
Measured: at birth to 14 days of postpartum
Evaluate of Sore nipples
Evaluation of sore nipples is measured by using Visuals Analog Score (VAS), ordinal scale. Scale 0 (no pain), scale 1-3 (mild), scale 4-6 (Moderate), scale 7-10 (Severe)
Measured: at birth to 14 days of postpartum
Evaluate Nipple pain
Evaluation of nipple pain is measured by Nipple Trauma Score (NTS), ordinal scale. Score 0 (no microscopically visible skin changes), score 1 (erythema or edema or combination of both), score 2 (superficial damage with or without scab formation on < 25% of the nipple surface), score 3 (superficial damage with or without scab formation on > 25% of the nipple surface), score 4 (partial-thickness wound with or without scab formation on < 25% of the nipple surface), score 5 (partial-thickness wound with or without scab formation on > 25% of the nipple surface).
Measured: at birth to 14 days of postpartum
Evaluate Engorgement
Evaluation engorgement is measured by engorgement scale, ordinal scale. Scale 1 (soft, no change), scale 2 (slight change), scale 3 (firm, non-tender), scale 4 (firm, beginning tenderness), scale 5 (firm, tender), scale 6 (very firm and very tender).
Measured: at birth to 14 days of postpartum
Secondary outcomes (1)
Change in knowledge breastfeed techniques
Ability to give precise answers to questions regarding breastfeeding, Ordinal scale, measurement using a questionnaire totalling 18 items.
The value is poor knowledge (0-6), enough knowledge (6-12), good knowledge (13-18). The higher score means a better knowledge about breastfeed techniques.
Measured: 36 weeks pregnancy to 38 weeks pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start26 Dec 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
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 Nipple InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eka Nurhayati, Gadjah Mada University
- Investigators
- Prasetya Lestari, M.Kes., Study director, Alma Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770595
- Sponsor's protocol ID
- GadjahMadaU03January2025
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weigert EM, Giugliani ER, Franca MC, Oliveira LD, Bonilha A, Espirito Santo LC, Kohler CV. [The influence of breastfeeding technique on the frequencies of exclusive breastfeeding and nipple trauma in the first month of lactation]. J Pediatr (Rio J). 2005 Jul-Aug;81(4):310-6. Portuguese.
PubMed 16106316Bergmann RL, Bergmann KE, von Weizsacker K, Berns M, Henrich W, Dudenhausen JW. Breastfeeding is natural but not always easy: intervention for common medical problems of breastfeeding mothers - a review of the scientific evidence. J Perinat Med. 2014 Jan;42(1):9-18. doi: 10.1515/jpm-2013-0095.
PubMed 24057589Bhandari N, Bahl R, Mazumdar S, Martines J, Black RE, Bhan MK; Infant Feeding Study Group. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial. Lancet. 2003 Apr 26;361(9367):1418-23. doi: 10.1016/S0140-6736(03)13134-0.
PubMed 12727395Blair A, Cadwell K, Turner-Maffei C, Brimdyr K. The relationship between positioning, the breastfeeding dynamic, the latching process and pain in breastfeeding mothers with sore nipples. Breastfeed Rev. 2003 Jul;11(2):5-10.
PubMed 14768311Degefa N, Tariku B, Bancha T, Amana G, Hajo A, Kusse Y, Zerihun E, Aschalew Z. Breast Feeding Practice: Positioning and Attachment during Breast Feeding among Lactating Mothers Visiting Health Facility in Areka Town, Southern Ethiopia. Int J Pediatr. 2019 Apr 7;2019:8969432. doi: 10.1155/2019/8969432. eCollection 2019.
PubMed 31080479Feenstra MM, Jorgine Kirkeby M, Thygesen M, Danbjorg DB, Kronborg H. Early breastfeeding problems: A mixed method study of mothers' experiences. Sex Reprod Healthc. 2018 Jun;16:167-174. doi: 10.1016/j.srhc.2018.04.003. Epub 2018 Apr 6.
PubMed 29804762Haggkvist AP, Brantsaeter AL, Grjibovski AM, Helsing E, Meltzer HM, Haugen M. Prevalence of breast-feeding in the Norwegian Mother and Child Cohort Study and health service-related correlates of cessation of full breast-feeding. Public Health Nutr. 2010 Dec;13(12):2076-86. doi: 10.1017/S1368980010001771. Epub 2010 Jun 25.
PubMed 20576199Kent JC, Ashton E, Hardwick CM, Rowan MK, Chia ES, Fairclough KA, Menon LL, Scott C, Mather-McCaw G, Navarro K, Geddes DT. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments. Int J Environ Res Public Health. 2015 Sep 29;12(10):12247-63. doi: 10.3390/ijerph121012247.
PubMed 26426034Safari JG, Kimambo SC, Lwelamira JE. Feeding practices and nutritional status of infants in Morogoro Municipality, Tanzania. Tanzan J Health Res. 2013 Jul;15(3):178-85. doi: 10.4314/thrb.v15i3.5.
PubMed 26591707Teich AS, Barnett J, Bonuck K. Women's perceptions of breastfeeding barriers in early postpartum period: a qualitative analysis nested in two randomized controlled trials. Breastfeed Med. 2014 Jan-Feb;9(1):9-15. doi: 10.1089/bfm.2013.0063. Epub 2013 Dec 4.
PubMed 24304033Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.
PubMed 24062375Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
PubMed 32944940
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prenatal Breastfeeding Education Through Clinical Demonstrations for Primiparous Women to Prevent Sore Nipples and Engorgement
- ClinicalTrials.gov ID
- NCT06770595
- Acronym / sponsor ID
- GadjahMadaU03January2025
- Conditions
- Nipple Infection, Nipple Discharge, Engorgement
- Keywords
- Demonstration clinic, Education, Sore nipples, Engorgement, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples.
Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.
This research uses quasi-experiments. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups. breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group. The outcome of this research is position, attachment, effective sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups.
Detailed description
Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples. Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.
This research is an experimental study with a quasi-experimental design, the equivalent-time samples design. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The sampling method in this research used simple random sampling. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups.
breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group.
The selection of respondents was determined based on predetermined inclusion criteria. Next, respondents will be confirmed via WhatsApp so that the enumerator can meet with the respondent to provide an explanation regarding the progress of the research and ask for their willingness to participate in the research by signing an informed consent.
Respondents in the control group did not receive any special intervention. Furthermore, respondents were asked to confirm whether they had given birth in both the intervention group and the control group. A home visit will be carried out by a lactation counselor and enumerator one week postpartum. The first visit to the mother to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples, and swollen breasts. The second home visit was carried out at 14 days postpartum to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples and swollen breasts.
The outcome of this research is knowledge of breastfeeding techniques, position practice, and latching, evaluating the baby's sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups. Multiple logistic regression was used to analyze the impact of the intervention on tender nipples and swollen breasts to control confounding variables. The intervention effect is expressed as crude odds ratio and adjusted odds ratio, and the associated 95% CI will be obtained from the logistic regression model. The odds ratio was reported along with its 95% CI and was considered significantly significant statistics if the P value is <0.05.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: breastfeeding positions and attachment practice.The intervention group is third-trimester pregnant women with 34-35 weeks of gestation who received clinical demonstration education breastfeeding about position and attachment. The clinical demonstration is provided by a lactation counselor. Respondents in this group will receive education provided face-to-face with the clinical demonstration of breastfeeding positions and attachment. The education was given twice with a duration of 40 minutes to primigravida mothers aged 34-35 weeks gestation. For outcome measurement, A home visit will be carried out by a lactation counselor and enumerator 2 times, the first home visit in 7 days postpartum and the second home visit in 14 days postpartum, to assess breastfeeding positioning and latching practices, assess the baby's sucking, evaluate nipple pain, sore nipples, and engorgement. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primigravida pregnant women who visited the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis health service centers
- Single pregnancy
- Mother has a mobile phone with internet access and can use WhatsApp Application
- Plans to stay for 6 months in the research area
- Willing to participate in the research by signing the informed consent
Key exclusion criteria (3 listed)
- Presence of congenital orofacial abnormalities (labio-gntao-palatoschisis, etc) that make breastfeeding difficult
- Mother with breast problems (history of implant breast surgery)
- The mother or baby experiences problems during labor or postpartum that may lead to research dropouts
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 positions and attachment practice.Breastfeeding clinical demonstration is a method of presentation of skills that shows how a particular procedure is performed in position and attachment breastfeeding. Respondents in this group will receive education provided face-to-face once with a duration of 40 minutes, with the following details: first, 25 minutes of education about breastfeeding position and attachment. In this case, the lactation counselor first explains the correct position and attachment for breastfeeding. Respondents were asked to carry out a practical simulation regarding the correct breastfeeding position and attachment using a doll, in this case, the lactation counselor will assess how the mother is positioned and attached. second, 10 minutes of education about swollen breasts and how to deal with them. third, a 10-minute question and answer session related to the educational material provided. | Behavioural | Intervention group |
Primary outcome
Breastfeeding positions practice
Time frame: at birth to 14 days of postpartum
Mother's ability to practice breastfeeding positions, ordinal scale, measurement using observational checklist totalling 4 items. The value is the positions is not correct at all (if none of the criteria are met), not good positions (if 1 or 2 criteria fulfilled) and good positions (if 3 or 4 criteria fulfilled)
Breastfeeding attachment practice
Time frame: at birth to 14 days of postpartum
Mother's ability to practice breastfeeding attachment, ordinal scale, measurement using observational checklist totalling 4 items. The value is the attachment is not correct at all (if none of the criteria are met), not good attachment (if 1 or 2 criteria fulfilled) and good attachment (if 3 or 4 criteria fulfilled)
Evaluate the baby's sucking while breastfeeding
Time frame: at birth to 14 days of postpartum
Evaluation the baby's sucking, nominal scale, measurement using observational checklist. Correct sucking technique was defined as the infant having a wide-open mouth, with the tongue under the areola, and expressing milk from the breast by slow, deep sucks. Faulty technique was defined as superficial nipple sucking.
Evaluate of Sore nipples
Time frame: at birth to 14 days of postpartum
Evaluation of sore nipples is measured by using Visuals Analog Score (VAS), ordinal scale. Scale 0 (no pain), scale 1-3 (mild), scale 4-6 (Moderate), scale 7-10 (Severe)
Evaluate Nipple pain
Time frame: at birth to 14 days of postpartum
Evaluation of nipple pain is measured by Nipple Trauma Score (NTS), ordinal scale. Score 0 (no microscopically visible skin changes), score 1 (erythema or edema or combination of both), score 2 (superficial damage with or without scab formation on < 25% of the nipple surface), score 3 (superficial damage with or without scab formation on > 25% of the nipple surface), score 4 (partial-thickness wound with or without scab formation on < 25% of the nipple surface), score 5 (partial-thickness wound with or without scab formation on > 25% of the nipple surface).
Evaluate Engorgement
Time frame: at birth to 14 days of postpartum
Evaluation engorgement is measured by engorgement scale, ordinal scale. Scale 1 (soft, no change), scale 2 (slight change), scale 3 (firm, non-tender), scale 4 (firm, beginning tenderness), scale 5 (firm, tender), scale 6 (very firm and very tender).
1 secondary outcome
Change in knowledge breastfeed techniques
Time frame: 36 weeks pregnancy to 38 weeks pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 16106316Weigert EM, Giugliani ER, Franca MC, Oliveira LD, Bonilha A, Espirito Santo LC, Kohler CV. [The influence of breastfeeding technique on the frequencies of exclusive breastfeeding and nipple trauma in the first month of lactation]. J Pediatr (Rio J). 2005 Jul-Aug;81(4):310-6. Portuguese.
- Results publication: PubMed 24057589Bergmann RL, Bergmann KE, von Weizsacker K, Berns M, Henrich W, Dudenhausen JW. Breastfeeding is natural but not always easy: intervention for common medical problems of breastfeeding mothers - a review of the scientific evidence. J Perinat Med. 2014 Jan;42(1):9-18. doi: 10.1515/jpm-2013-0095.
- Results publication: PubMed 12727395Bhandari N, Bahl R, Mazumdar S, Martines J, Black RE, Bhan MK; Infant Feeding Study Group. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial. Lancet. 2003 Apr 26;361(9367):1418-23. doi: 10.1016/S0140-6736(03)13134-0.
- Results publication: PubMed 14768311Blair A, Cadwell K, Turner-Maffei C, Brimdyr K. The relationship between positioning, the breastfeeding dynamic, the latching process and pain in breastfeeding mothers with sore nipples. Breastfeed Rev. 2003 Jul;11(2):5-10.
- Results publication: PubMed 31080479Degefa N, Tariku B, Bancha T, Amana G, Hajo A, Kusse Y, Zerihun E, Aschalew Z. Breast Feeding Practice: Positioning and Attachment during Breast Feeding among Lactating Mothers Visiting Health Facility in Areka Town, Southern Ethiopia. Int J Pediatr. 2019 Apr 7;2019:8969432. doi: 10.1155/2019/8969432. eCollection 2019.
- Results publication: PubMed 29804762Feenstra MM, Jorgine Kirkeby M, Thygesen M, Danbjorg DB, Kronborg H. Early breastfeeding problems: A mixed method study of mothers' experiences. Sex Reprod Healthc. 2018 Jun;16:167-174. doi: 10.1016/j.srhc.2018.04.003. Epub 2018 Apr 6.
- Results publication: PubMed 20576199Haggkvist AP, Brantsaeter AL, Grjibovski AM, Helsing E, Meltzer HM, Haugen M. Prevalence of breast-feeding in the Norwegian Mother and Child Cohort Study and health service-related correlates of cessation of full breast-feeding. Public Health Nutr. 2010 Dec;13(12):2076-86. doi: 10.1017/S1368980010001771. Epub 2010 Jun 25.
- Results publication: PubMed 26426034Kent JC, Ashton E, Hardwick CM, Rowan MK, Chia ES, Fairclough KA, Menon LL, Scott C, Mather-McCaw G, Navarro K, Geddes DT. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments. Int J Environ Res Public Health. 2015 Sep 29;12(10):12247-63. doi: 10.3390/ijerph121012247.
- Results publication: PubMed 26591707Safari JG, Kimambo SC, Lwelamira JE. Feeding practices and nutritional status of infants in Morogoro Municipality, Tanzania. Tanzan J Health Res. 2013 Jul;15(3):178-85. doi: 10.4314/thrb.v15i3.5.
- Results publication: PubMed 24304033Teich AS, Barnett J, Bonuck K. Women's perceptions of breastfeeding barriers in early postpartum period: a qualitative analysis nested in two randomized controlled trials. Breastfeed Med. 2014 Jan-Feb;9(1):9-15. doi: 10.1089/bfm.2013.0063. Epub 2013 Dec 4.
- Results publication: PubMed 24062375Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.
- Results publication: PubMed 32944940Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
- Individual participant dataSharing planned: No
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.
Prasetya Lestari, M.Kes. study director
Alma Ata University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding positions and attachment practice. in people with Nipple Infection and Nipple Discharge, run by Gadjah Mada University at 6 sites in Indonesia.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eka Nurhayati, Dr (+6285740022890, ekanhayati@almaata.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding positions practice (time frame: at birth to 14 days of postpartum). The study lists 6 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 NCT06770595, 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 19 Dec 2025.