BreastfeedingNCT00264719
Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial
A study testing Metoclopramide (Maxolon) in people with Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Metoclopramide (Maxolon)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria
Who cannot join
- Patients who have epilepsy or on anti-seizure medications,
- Patients who have a history of significant depression or are on antidepressant drugs
- Patients who have pheochromocytoma or uncontrolled hypertension
- Patients who have intestinal bleeding or obstruction
- Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
- Patients who have diabetes and hyperprolactinaemia
- Patients with HIV infection
- Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Metoclopramide (Maxolon), placebo
- Keywords
- A drug is administered to initiate breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide (Maxolon)Drug
Also called Maxalon
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
placeboDrug
placebo 10 mg
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 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 Receives: Drug: Metoclopramide (Maxolon) |
| B | Placebo comparator | 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 Receives: Drug: placebo |
| C | Active comparator | 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 Receives: Drug: Metoclopramide (Maxolon) |
| D | Placebo comparator | 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful initiation of lactation as determined by lactogenesis II markers
Measured: 7 days postpartum
Secondary outcomes (2)
weight change in baby 7 days after birth
Measured: 14 days postpartum
breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Y S CHONG, MBBS, Principal investigator, Dept. of O & G, National University HospitalY S CHAN, BSN, Principal investigator, DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264719
- Sponsor's protocol ID
- NHG-SIG/05011
- Status last verified
- Sep 2009
- First submitted
- 11 Dec 2005
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12225305Foong 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.
PubMed 32421208
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00264719
- Acronym / sponsor ID
- NHG-SIG/05011
- Conditions
- Breastfeeding
- Keywords
- A drug is administered to initiate breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Metoclopramide (Maxolon)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 |
| B | Placebo comparator | Drug: placeboMothers 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 |
| C | Active comparator | Drug: Metoclopramide (Maxolon)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 |
| D | Placebo comparator | Drug: placeboMothers 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria
Key exclusion criteria (8 listed)
- Patients who have epilepsy or on anti-seizure medications,
- Patients who have a history of significant depression or are on antidepressant drugs
- Patients who have pheochromocytoma or uncontrolled hypertension
- Patients who have intestinal bleeding or obstruction
- Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoclopramide (Maxolon)Also: MaxalonMothers 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 | A, C |
| placeboplacebo 10 mg | Drug | B, D |
Primary outcome
successful initiation of lactation as determined by lactogenesis II markers
Time frame: 7 days postpartum
2 secondary outcomes
weight change in baby 7 days after birth
Time frame: 14 days postpartum
breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery
Time frame: 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
- Results publication: PubMed 12225305Cregan 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.
- Derived from this study: PubMed 32421208Foong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y S CHONG, MBBS principal investigator
Dept. of O & G, National University Hospital
Y S CHAN, BSN principal investigator
DEPT OF O & G, NATIONAL UNIVERSITY HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoclopramide (Maxolon) in people with Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful initiation of lactation as determined by lactogenesis II markers (time frame: 7 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.