Oral domperidone versus placebo for enhancing exclusive breastfeeding among post-lower segment cesarean section mothers – a double-blind randomized controlled trial

Abstract

Objective

To assess whether oral domperidone compared to placebo increases the rate of exclusive breastfeeding for 6 months among post-lower segment cesarean section (LSCS) mothers.

Methods

This double-blind Randomized Controlled Trial, conducted in a tertiary care teaching hospital in South India, included 366 post-LSCS mothers with delayed initiation of breastfeeding or with subjective feelings of not having enough milk. They were randomized to two groups - Group A: Standard lactation counseling and oral Domperidone and Group B: Standard lactation counseling and a placebo. The primary outcome was an exclusive breastfeeding rate at 6 months. Exclusive breastfeeding rates at 7 days and 3 months and serial weight gain of an infant were assessed in both groups.

Results

Exclusive breastfeeding rate at 7 days was statistically significant in the intervention arm. The exclusive breastfeeding rates at 3 months and 6 months were higher in the domperidone arm compared to placebo but not statistically significant.

Conclusion

Oral Domperidone along with effective breastfeeding counseling showed an increasing trend of exclusive breastfeeding rate at 7 days and at six months. Appropriate breastfeeding counseling and postnatal lactation support are important in enhancing exclusive breastfeeding.

Trial registration

The study was prospectively registered with CTRI – Reg no. CTRI/2020/06/026237

Keywords:

• Exclusive breastfeeding
• cesarean section
• lactation counseling
• galactagogues
• domperidone

Ethical approval

Obtained from JIPMER Institutional Ethics Committee for interventional studies JIP/IEC/2019/486 dated 10/2/2020.

Authors’ contributions

Arumugom Archana - collected and analyzed the data and drafted the manuscript, Bethou Adhisivam - conceptualized and designed the study, and edited manuscript. Chaturvedula Latha- clinical management of mothers, Sadhana Subramanian – statistical analysis.

Informed consent

Written informed consent was obtained from the participants.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

None