Official Title: “Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study

Study Primary Completion Date: May 2008

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.

Intervention(s) in this Clinical Trial

• 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
• Drug: placebo
  • placebo 10 mg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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
• Placebo Comparator: 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
• Active Comparator: 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
• Placebo Comparator: 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

Primary Measures

• successful initiation of lactation as determined by lactogenesis II markers
  • Time Frame: 7 days postpartum
    Safety Issue?: No

Secondary Measures

• weight change in baby 7 days after birth
  • Time Frame: 14 days postpartum
    Safety Issue?: No
• breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery
  • Time Frame: 6 months postpartum
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National University Hospital, Singapore

Overall Clinical Trial Officials and Contacts

Y S CHONG, MBBS Principal Investigator Dept. of O & G, National University Hospital  

Overall Contact: Doris LOH, B.A, IBCLC 96387660 dorisdeborah@yahoo.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264719

Study ID Number: NHG-SIG/05011

ClinicalTrials.gov Identifier: NCT00264719

Health Authority: Singapore: Domain Specific Review Boards