Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

NCT ID: NCT00264719

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-05-31

Brief Summary

Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.

Detailed Description

Hypothesis:

Early Use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

Metoclopramide(Maxolon) promotes lactation by antagonizing the release of dopamine in the central nervous system, thereby increasing prolactin levels, and thus inducing or augmenting breast milk levels. While Metoclopramide has commonly been used to augment breast milk production and relactation, its efficacy in helping to establish lactogenesis II has never been studied in a controlled clinical trial. If effective, it may become a valuable tool in aiding the successful establishment of breastfeeding, particularly in high risk groups such as mothers of preterm babies.

If shown to be an effective galactogogue, the use of metoclopramide provides an inexpensive and safe means of establishing and sustaining lactogenesis II, indirectly improving the degree and duration of breastfeeding practiced by mothers of both term and preterm infants.

The anticipated benefits are expected to be greatest for preterm infants and their mothers.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Mothers with pre-term deliveries will receive metoclopramide 10 mg three times a day for the first 7 days and 2 times a day for the 8th to 10th day, and once a day for the 11th to 12th day

Group Type: ACTIVE_COMPARATOR

Metoclopramide (Maxolon)

Intervention Type: DRUG

Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day

B

Mothers with pre-term deliveries will receive metoclopramide 10 mg 3 times a day, 2 times a day from 8th to 10th day and once a day from 11th to 12th day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo 10 mg

C

Mothers with full term deliveries will receive 10 mg metoclopramide, 3 times a day for the first 7 days, 2 times a day from 8th to 10th day, and once a day for day 11 to 12

Group Type: ACTIVE_COMPARATOR

Metoclopramide (Maxolon)

Intervention Type: DRUG

Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day

D

Mothers with full term deliveries will receive the placebo 10 mg three times a day, for 7 days, and two times a day from day 8 to day 10, and once a day from 11th to 12th day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo 10 mg

Interventions

Metoclopramide (Maxolon)

Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day

Intervention Type: DRUG

placebo

placebo 10 mg

Intervention Type: DRUG

Other Intervention Names

Maxalon

Eligibility Criteria

Exclusion Criteria

1. Patients who have epilepsy or on anti-seizure medications,

2. Patients who have a history of significant depression or are on antidepressant drugs

3. Patients who have pheochromocytoma or uncontrolled hypertension

4. Patients who have intestinal bleeding or obstruction

5. Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide

6. Patients who have diabetes and hyperprolactinaemia

7. Patients with HIV infection

8. Current pregnancy complicated by fetal congenital anomalies and multiple fetuses

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

National University Hospital

Principal Investigators

Y S CHONG, MBBS

Role: PRINCIPAL_INVESTIGATOR

Dept. of O & G, National University Hospital

Y S CHAN, BSN

Role: PRINCIPAL_INVESTIGATOR

DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

References

Cregan MD, De Mello TR, Kershaw D, McDougall K, Hartmann PE. Initiation of lactation in women after preterm delivery. Acta Obstet Gynecol Scand. 2002 Sep;81(9):870-7. doi: 10.1034/j.1600-0412.2002.810913.x.

Reference Type: RESULT

PMID: 12225305 (View on PubMed)

Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

Reference Type: DERIVED

PMID: 32421208 (View on PubMed)

Other Identifiers

NHG-SIG/05011

Identifier Type: -

Identifier Source: org_study_id