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Lactation clinical trials

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NCT ID: NCT01191970 Withdrawn - Analgesia Clinical Trials

Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors

Start date: n/a
Phase:
Study type: Observational

Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum. One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease maternal endorphin production and result in the transmission of lower endorphin levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less likely to suckle optimally. Other studies have found that epidural analgesia does not significantly decrease lactation success when used during the vaginal delivery of a full-term, healthy neonate. Although most studies to date have compared the breast-feeding success of epidural recipients and non-recipients at various points postpartum, they do not specifically note whether deficient feeding behaviors on the part of the infant contribute to failed breast-feeding. The present study uses the LATCH assessment tool to score the infant's ability to latch onto the breast and the presence of audible swallowing, as well as the mother's level of physical comfort with breast feeding, whether she can successfully position the infant for feeding on her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment enables the separation of multiple factors that may contribute to breast-feeding failure. A multivariate regression analysis will determine how strongly the probability of breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and beta-endorphin concentrations in colostrum.

NCT ID: NCT01167517 Completed - Lactation Clinical Trials

Lactation Education Study in Mothers of Very Low Birth Weight Infants

Start date: July 2010
Phase: N/A
Study type: Interventional

This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. The investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via DVD will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.

NCT ID: NCT01127022 Completed - Pregnancy Clinical Trials

Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

NCT ID: NCT01025362 Completed - Lactation Clinical Trials

Baby-Friendly Community Health Services Evaluation

Start date: August 2009
Phase: N/A
Study type: Interventional

The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The initiative "Baby-Friendly Community Health Services (BFCHS)" is an initiative to reach this goal. BFCHS is developed from the concept "The Baby-Friendly Hospital Initiative" by WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at Norwegian well-baby clinics. The purpose of the study The study seeks to answer the following research questions: - What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed their children for 5 months? - What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed for 4 months? - What effect does the certification process have on the proportion of mothers who breastfeed at 11 months of age? - What effect does the certification process have on the differences in breastfeeding due to social inequality? - What effect does the certification process have on the mothers impression of the quality of the well-baby clinics lactation counseling? - What effect does the certification process have on mothers satisfaction with the breastfeeding experience? - What effect does the certification process have on perceived pressure to breastfeed? Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be the community health services. All community health services in six counties in Norway will be invited to participate. Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children. Data collection Respondents are identified through the National Population Register (DSF). The data collection takes place using a postal questionnaire. Baseline: Data collection before the intervention is implemented to assess breastfeeding prevalence and distribution of covariates in the two study arms. Post-survey: The post-survey to assess the effect, will take place about two years after baseline when the community health services have been certified. Sample size It is expected that the project could increase the breastfeeding prevalence with 5 percentage points. This assumption is the basis for the sample size. The initial aim is to recruit about 50 well-baby clinics.

NCT ID: NCT00851591 Terminated - Lactation Clinical Trials

Effect of Fenugreek on Milk Production

fenugreek
Start date: September 2008
Phase: N/A
Study type: Interventional

Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant. The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply. In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue. This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

NCT ID: NCT00785824 Completed - Lactation Clinical Trials

African-American Bone Metabolism and Lactation Study

Start date: January 2009
Phase: N/A
Study type: Observational

The primary aim of this study is to obtain measures of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these values to those of normal controls. The secondary aim is to obtain at the same time points, measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover [e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)], calcium and vitamin D metabolism in these subjects. These results will be compared with a non-African-American cohort of post-partum women and normal controls. The investigators hypothesize that African-American lactating women will have increased bone turnover when compared to non-lactating postpartum women and normal controls. The investigators further hypothesize that bone turnover is increased in lactating women independent of race.

NCT ID: NCT00672230 Completed - Lactation Clinical Trials

Dietary Lutein and the Retinopathy of Prematurity

Start date: August 2005
Phase: N/A
Study type: Interventional

The clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

NCT ID: NCT00374972 Withdrawn - Lactation Clinical Trials

Combined Hormonal Versus Progestin Only Contraception During Lactation

Start date: June 2006
Phase: N/A
Study type: Observational

Objective: To determine and compare the effect of low dose estrogen combined hormonal contraceptives and progestin-only contraceptives on lactation. The subjects will be drawn from a healthy obstetric population in each center, where possible preliminary contact during antenatal period. At the postpartum visit, subjects that express their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an informed consent the participants will be allocated according to their free wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to analysis. Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12 weeks post - partum. Instruction will be given as to recording information on intercurrent disease, frequency of nursing and use of complementary formula supplements. Maternal BMI calculation ( weight/height2) will be obtained at first visit. The objective is to compare the capacity of the breast to secrete milk under standard conditions and evaluate the influence of different hormonal contraception means. Thus samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding and multiplied by the number of feedings reported. Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk analysis : lipid, casein and carbohydrate content

NCT ID: NCT00181649 Withdrawn - Lactation Clinical Trials

Recombinant Human Prolactin for Lactation Induction

Start date: September 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).

NCT ID: NCT00181623 Completed - Lactation Clinical Trials

Recombinant Human Prolactin for Lactation Induction

Start date: January 2005
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).