Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Breastfeeding Clinical Trial

Official title:

Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264719
• Other study ID #: NHG-SIG/05011
• Status: Completed
• Phase: N/A
• First received: December 11, 2005
• Last updated: September 18, 2009
• Start date: January 2006
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Drug:
• 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
• placebo
placebo 10 mg

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful initiation of lactation as determined by lactogenesis II markers		7 days postpartum	No
Secondary	weight change in baby 7 days after birth		14 days postpartum	No
Secondary	breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery		6 months postpartum	No