Effect of Domperidone tablets in increasing the percentage of cesarean section mothers who give only breast milk to babies during the first 6 months after delivery

Effect of oral Domperidone versus placebo in enhancing exclusive breastfeeding among post natal mothers who underwent lower segment cesarean sectionâ?? A double blind randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026237

Enrollment

366

Registered

2020-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O927- Other and unspecified disorders oflactation

Interventions

Intervention1: Domperidone: Post natal mothers who will receive Tab domperidone 10 mg tds for 3 days (DOMSTAL manufactured by Torrent pharmaceuticals Ltd.)in addition to counselling Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: Post LSCS mothers (i) Who have initiated breastfeeding after 1 hour of delivery (Delayed initiation of breastfeeding) (or) (ii) Subjective feeling of not having enough milk by the mother within 48 hours of delivery

Exclusion criteria

Exclusion criteria: (i) Either mother or neonate is acutely ill (ii) Mothers under General anaesthesia (iii) Infants born at less than 34 weeks of gestation

Design outcomes

Primary

Measure	Time frame
Exclusive breastfeeding rateTimepoint: Exclusive breastfeeding rate at 6 months of age	—

Secondary

Measure	Time frame
a)Exclusive breastfeeding rate b)weight gain of the infant c)usage of donor human milk d)rate of exclusive breastfeeding between gestational age of 34-37 wks and 37 weeks e)adverse effects associated with domperidone useTimepoint: a)Exclusive breastfeeding rate at 7 days and 3 months b)weight gain of the infant on day 7, at 6 wks, 10 wks, 14 wks and 6 months c)usage of donor human milk till 6 months d)rate of exclusive breastfeeding between gestational age of 34-37 wks and 37 weeks e)adverse effects associated with domperidone use	—

Measure

Time frame

a)Exclusive breastfeeding rate b)weight gain of the infant c)usage of donor human milk d)rate of exclusive breastfeeding between gestational age of 34-37 wks and 37 weeks e)adverse effects associated with domperidone useTimepoint: a)Exclusive breastfeeding rate at 7 days and 3 months b)weight gain of the infant on day 7, at 6 wks, 10 wks, 14 wks and 6 months c)usage of donor human milk till 6 months d)rate of exclusive breastfeeding between gestational age of 34-37 wks and 37 weeks e)adverse effects associated with domperidone use

—

Countries

India

Contacts

Public ContactDr Adhisivam B

JIPMER

adhisivam1975@yahoo.co.uk9488822113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026