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Breastfeeding Education Through Clinical Demonstration for Primiparous Women to Prevent Sore Nipples and Engorgement

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 19, 2025 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Aug 15, 2025 to Mar 15, 2026
    • Start date: May 26, 2025 to Dec 26, 2025
    • Study completion date: Aug 31, 2025 to Mar 31, 2026
    v6
  2. Minor Study description shortened, about 30 wordsv5
  3. Minor Primary completion date: Jul 5, 2025 to Aug 15, 2025
    • Study completion date: Jul 31, 2025 to Aug 31, 2025
    v4
  4. Minor Enrollment target: 141 to 100
    • Start date: May 5, 2025 to May 26, 2025
    v3
  5. Notable Start date: Apr 5, 2025 to May 5, 2025
    • Study description shortened, about 90 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06770595
Lead Sponsor Gadjah Mada University
Conditions
(from sponsor)
Nipple Infection, Nipple Discharge, Engorgement
Related terms Breast Feeding, Galactorrhea, Hyperemia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov