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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 11, 2005 | ||||||||
| Last Updated Date | September 18, 2009 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
successful initiation of lactation as determined by lactogenesis II markers [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00264719 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial | ||||||||
| Official Title ICMJE | Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study | ||||||||
| Condition ICMJE | Breastfeeding | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Completion Date | May 2009 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Singapore | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00264719 | ||||||||
| Responsible Party | Associate Professor Chong Yap Seng, National University Hospital | ||||||||
| Study ID Numbers ICMJE | NHG-SIG/05011 | ||||||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National University Hospital, Singapore | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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