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Lactation clinical trials

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NCT ID: NCT01630629 Completed - Lactation Clinical Trials

Longitudinal Lactation Bone Density Study

Start date: August 2012
Phase: N/A
Study type: Observational

Changes in maternal calcium metabolism are necessary during lactation to provide adequate calcium in breast milk for development of the newborn skeleton. The calcium in milk is derived from the maternal skeleton, resulting in significant bone loss, a process thought to be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination with a decreased estrogen levels. After weaning, bone lost during lactation is rapidly regained. Differences between African-American and Caucasian bone metabolism are well documented and include higher bone mineral density (BMD), lower risk of fragility fracture, lower 25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians. Most studies of bone metabolism in lactating women have been done in Caucasians. Because of differences in bone metabolism between African-Americans and Caucasians, we do not know whether African-Americans will have similar findings. The primary aim of this study is to compare the changes in bone mineral density (BMD) during lactation in African-Americans with those in Caucasians. It is not known whether the loss in BMD during lactation will be the same for both races. African-Americans display skeletal resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and lower fracture risk than Caucasians. A recent study by our group indicated that lactating African-American mothers had slightly lower bone resorption but quantitatively similar bone formation compared to Caucasians. However, there was a significant increase of 2-3 fold in markers of bone formation and resorption in both groups. Therefore, it is currently not known whether the loss in BMD during lactation will be the same for both races. Primary outcome measures in this study will include spine, hip and radius BMD by Dual X-Ray Absorbiometry (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24 weeks postpartum, and six months after weaning (+1 week). This longitudinal protocol will distinguish between two hypotheses. Either: a) as measured by BMD, bone loss in African-Americans during lactation will be equal to that in Caucasians, and skeletal recovery will be the same or possibly accelerated compared to Caucasians; or, b) African-Americans will be resistant to bone loss during lactation compared to Caucasians because of resistance to Parathyroid Hormone-related Protein (PTHrP).

NCT ID: NCT01563094 Completed - Lactation Clinical Trials

Bone Accrual and Hormones in Response to Lactation

Start date: January 2003
Phase:
Study type: Observational

This is a prospective observational trial of healthy postpartum women to investigate changes in bone density and markers of bone turnover during lactation. The study hypothesis is that women who breast-feed 5 months or more will lose bone density and subsequently regain the bone density after weaning. This study seeks to define determinants of the regain in bone density.

NCT ID: NCT01548313 Completed - Pregnancy Clinical Trials

The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota

MYMILK
Start date: May 2010
Phase:
Study type: Observational

The ideal food for normal infants is human milk. In addition, breast milk has been shown to be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they play a key role in the initiation and development of the gut microbiota. Intestinal colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and the homeostasis of the intestinal epithelium. Colonization begins immediately after birth, while later the composition of the gut microbiota is affected by feeding practices. Results of some studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the adhesion of probiotics to mucosal surfaces and along with probiotic bacteria contribute to the regulation of innate and adaptive immune responses and present a link among mother's diet, and microbes. The main purpose of the proposed research is to establish the link among mothers' nutrition, human milk LCPUFAs composition and microbiota and their potential influence on child's gut microbiota development. Pregnant women from three different regions of Slovenia will be involved into the study. Dietary intakes will be assessed during pregnancy, at the beginning of the 3rd trimester of pregnancy, and during lactation, at 4 weeks post partum, by 7-day weighed dietary protocol (7DP). Human milk (colostrum, and mature human milk) and infant's faeces will be sampled twice: at 2 or 3rd day post partum (meconium) and at 4 weeks post partum for the determination of human milk LCPUFAs composition and the assessment of human milk (colostrum und mature) and faeces microbiota. The fatty acid composition of human milk will be analysed by capillary gas-liquid chromatography (GC). Microbiota of milk and faeces will be studied using conventional microbiological and modern molecular approach such as qualitative and quantitative PCR amplification of informative genomic regions, DGGE/TGGE and/or t-RFLP and sequencing. Regular monthly meetings with the researchers will be organised for discussion and advising. Basic health parameters of infants will be followed. Data will be gathered from maternity department medical charts, from regular paediatric health care visits and from especially designed health care diary each mother will keep until the end of her child's first year.

NCT ID: NCT01547533 Completed - Chagas Disease Clinical Trials

Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease

LACTBENZ
Start date: August 2011
Phase: N/A
Study type: Observational

The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.

NCT ID: NCT01543477 Completed - Pregnancy Clinical Trials

Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

PASCO II
Start date: July 7, 2010
Phase:
Study type: Observational

The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

NCT ID: NCT01463202 Completed - Contraception Clinical Trials

Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

DEPO-ABCD
Start date: November 2011
Phase: Phase 4
Study type: Interventional

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

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: 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.