BreastfeedingPhase 3MaxalonNCT00477776
Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial
A Phase 3 study testing Metoclopramide (Maxolon) in people with Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries. Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for… Read more about this study
- Who is it for?
- Ages 15 to 50 years, 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
- Apr 2006to Mar 2009
- Phase
- Phase 3
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All pregnant women with pregestational or gestational diabetes under diet or insulin control
Who cannot join
- Patient 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
- Patient with known allergy or prior reaction to metoclopramide
- Patient 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 Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial
Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries.
Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.
Read the detailed description
The study aims to determine the breastfeeding initiation and duration rate of a cohort of pregnant women with gestational diabetes(diet-controlled) and insulin dependent and pre-existing diabetes, assess the impact of a post natally administered galactogogue, metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women on diet control and insulin and determine the prolactin response to lactation among diabetic women on diet control and insulin.
- Conditions
- Breastfeeding
- Being tested
- Metoclopramide (Maxolon), Placebo
- Keywords
- Beginning of 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
Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12
PlaceboDrug
Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12
| Study group | Role | What they receive |
|---|---|---|
| a | Active comparator | Mother with diet-controlled diabetes receive Metoclopramide 10 mg 3 times a day for the first 7 days, and 2 times a day for day 8 to 10, and once a day from day 11 to day 12 Receives: Drug: Metoclopramide (Maxolon) |
| b | Placebo comparator | Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day for day 11 to 12 Receives: Drug: Placebo |
| c | Active comparator | Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day from day 11 to 12 Receives: Drug: Metoclopramide (Maxolon) |
| d | Placebo comparator | Placebo 10 mg 3 times a day for 7 days, 2 times a day for day 8 to 10; and once a day from day 11 to 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II
Measured: within the first two weeks postpartum
Secondary outcomes (1)
amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months
Measured: within 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 posted24 May 2007 (estimated)
- Study startApr 2006
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 3
- 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
- Collaborators
- The University of Western Australia
- Investigators
- Chong Y S, MBBS,MRACOG, Principal investigator, National University Hospital and National University of SingaporeCitra Mattar, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477776
- Sponsor's protocol ID
- NHG SIG 06022
- Acronym
- Maxalon
- Status last verified
- Sep 2009
- First submitted
- 23 May 2007
- 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 12225305Hartmann PE, Cregan MD, Mitoulas LR. Maternal modulation of specific and non-specific immune components of colostrum and mature milk. Adv Nutr Res. 2001;10:365-87. doi: 10.1007/978-1-4615-0661-4_18. No abstract available.
PubMed 11795051Hartmann P, Cregan M. Lactogenesis and the effects of insulin-dependent diabetes mellitus and prematurity. J Nutr. 2001 Nov;131(11):3016S-20S. doi: 10.1093/jn/131.11.3016S.
PubMed 11694639Hansen WF, McAndrew S, Harris K, Zimmerman MB. Metoclopramide effect on breastfeeding the preterm infant: a randomized trial. Obstet Gynecol. 2005 Feb;105(2):383-9. doi: 10.1097/01.AOG.0000151113.33698.a8.
PubMed 15684169Foong 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 Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00477776
- Acronym / sponsor ID
- Maxalon / NHG SIG 06022
- Conditions
- Breastfeeding
- Keywords
- Beginning of breastfeeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- The University of Western Australia
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 May 2007 (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.
Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries.
Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.
Detailed description
The study aims to determine the breastfeeding initiation and duration rate of a cohort of pregnant women with gestational diabetes(diet-controlled) and insulin dependent and pre-existing diabetes, assess the impact of a post natally administered galactogogue, metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women on diet control and insulin and determine the prolactin response to lactation among diabetic women on diet control and insulin.
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)Mother with diet-controlled diabetes receive Metoclopramide 10 mg 3 times a day for the first 7 days, and 2 times a day for day 8 to 10, and once a day from day 11 to day 12 |
| b | Placebo comparator | Drug: PlaceboPlacebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day for day 11 to 12 |
| c | Active comparator | Drug: Metoclopramide (Maxolon)Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day from day 11 to 12 |
| d | Placebo comparator | Drug: PlaceboPlacebo 10 mg 3 times a day for 7 days, 2 times a day for day 8 to 10; and once a day from day 11 to 12 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pregnant women with pregestational or gestational diabetes under diet or insulin control
Key exclusion criteria (7 listed)
- Patient 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
- Patient with known allergy or prior reaction to 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: MaxalonMetoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12 | Drug | a, c |
| PlaceboPlacebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12 | Drug | b, d |
Primary outcome
a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II
Time frame: within the first two weeks postpartum
1 secondary outcome
amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months
Time frame: within 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.
- Background: 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.
- Background: PubMed 11795051Hartmann PE, Cregan MD, Mitoulas LR. Maternal modulation of specific and non-specific immune components of colostrum and mature milk. Adv Nutr Res. 2001;10:365-87. doi: 10.1007/978-1-4615-0661-4_18. No abstract available.
- Background: PubMed 11694639Hartmann P, Cregan M. Lactogenesis and the effects of insulin-dependent diabetes mellitus and prematurity. J Nutr. 2001 Nov;131(11):3016S-20S. doi: 10.1093/jn/131.11.3016S.
- Background: PubMed 15684169Hansen WF, McAndrew S, Harris K, Zimmerman MB. Metoclopramide effect on breastfeeding the preterm infant: a randomized trial. Obstet Gynecol. 2005 Feb;105(2):383-9. doi: 10.1097/01.AOG.0000151113.33698.a8.
- 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.
Chong Y S, MBBS,MRACOG principal investigator
National University Hospital and National University of Singapore
Citra Mattar, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II (time frame: within the first two weeks 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 NCT00477776, which also lists 5 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.