Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk production in postpartum mothers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gadjah Mada University
• Treatments: Domperidone

Criteria

Inclusion Criteria:

• Mothers 20-35 years old.

• Gestational age at delivery 37-40 weeks.

• Vaginal delivery.

• Normal body mass index (BMI 18.5-24.9 kg/m2).

• Not taking drugs or breast milk enhancement supplements.

• Healthy mother's condition with normal nipples (protruding).

• Healthy baby condition with good suction reflex.

• The baby consumes only breast milk.

Exclusion Criteria:

• Allergy to ASI MOMMY® and Domperidon.

• The mother is taking medications that affect the effects of domperidone (such as antacids, cimetidine, ranitidine, famotidine and nizatidine) or medications that interact with domperidone (such as haloperidol, lithium).

• The mother is in a state of illness requiring hospitalization.

• Mother has HIV AIDS, heart problems, mastitis, and had undergone breast surgery.

• Underweight, overweight and obese mothers.

• Giving birth to twins.

• The baby has a congenital defect that affects the suctioning process of breast milk

• Infants and mothers who did not participate in the treatment until completion (day 7 of the intervention).