Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062470) titled 'Implementation of a Gentle Nipple Stimulation Program Using a Breast Pump shortly After Delivery' on Aug. 4.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - St Luke's International University

Condition: Condition - Mothers of infants who have difficulty breastfeeding frequently following a cesarean section or a epidural anethtesia delivery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - If a mother is unable to breastfeed sufficiently on the day of delivery following a cesarean section or an epidural, milk production may be delayed. In this study, we will evaluate the feasibility of implementing a program in clinical settings that involves gentle nipple stimulation using a breast pump shortly after delivery. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In this study, we will implement a program in clinical settings that involves gentle nipple stimulation using a breast pump shortly after delivery, and evaluate its implementability.

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - mothers 1) Mothers who undergo a cesarean section (scheduled or emergency) at 37 weeks or later at a participating facility 2) Mothers whose breastfeeding is delayed on the day of delivery due to neonatal factors (such as early vomiting, week sucking, or hypoglycemia), even after an anesthetized delivery 3) Mother-infant pairs for whom direct breastfeeding is not scheduled from the day of delivery until the following morning due to reasons related to the mother 4) Mothers of preterm infants or those requiring medical treatment, resulting in a period of separation between mother and infant 5) Prefer to breastfeed 6) Aged 20 years or older but under 44 years at the time consent is obtained. 7) Participants for whom written informed consent has been obtained regarding participation in this study

Midwives none Key exclusion criteria - 1) Individuals whose ability to breastfeed is limited due to a pre-existing condition or complications 2) Individuals whose newborn has a serious medical condition 3) Other individuals deemed unsuitable by the principal investigator (or co-investigator). (e.g., severe fatigue) Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 26 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071341

Disclaimer: Curated by HT Syndication.