European Journal of Biomedical and Pharmaceutical Sciences

EFFECT OF ANTENATAL DOMPERIDONE VERSUS PLACEBO ON BREAST MILK PRODUCTION BETWEEN MOTHERS IN ACTIVE LABOR

Rauniyar H. K., MD, Sah R. P., MS, Singh A. K., MD and Sah R. G.*, PhD

ABSTRACT

This randomized double blind placebo controlled Phase II clinical trial study aims to determine the effectiveness of antenatal domperidone in increasing breast milk volume among thirty enrolled mothers in labor. The treatment group was given 10 mg domperidone tablets while the control group received identical placebo tablets to be taken thrice a day for three days postpartum. Mothers breastfed their infants per demand and also manually expressed their breast milk on the 18th, 36th and 72nd hours post-partum and milk volume was measured. The domperidone and the control groups were comparable with regards to demographic, socioeconomic and clinical profile. The mean volume of milk and (95% Confidence Interval of the Mean) at 18th hours was 1.61 ml (-2.14 ml to 5.36 ml) was increased to 6.46 ml (-4.3 ml to17 ml) at 36th hours was further increased to 12.39 (-10.99 ml to 35.77 ml) at 72 hours in domperidone group. Whereas, in the placebo group the mean volume of milk and (95% Confidence Interval of the Mean) at 18th hours was 0.26 ml (-0.56 ml to 1.10 ml); at 36th hours was 2.40 ml (-4.45 ml to 9.28 ml) and was 4.89 (-7.55 ml to 17.34 ml) at 72 hours. The volumes of breast milk on the 18th, 36th, and 72nd hours postpartum were significantly higher between the domperidone group compared to the control (p<0.05). In conclusion, antepartum domperidone is an effective drug in increasing breast milk production during active labor.

Keywords: Domperidone, Placebo, Breast milk, Active Labor, clinical trial.