| 1 |
NCT03481166 |
Not yet recruiting
New |
Women Empowered Through Education to Breastfeed |
|
- Other: Education on breastfeeding pain
|
Interventional |
Not Applicable |
- Western University, Canada
- Women's College Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Breastfeeding duration
- Breastfeeding exclusivity
- Pain severity
|
40 |
Female |
19 Years and older (Adult, Senior) |
NCT03481166 |
111412 |
|
May 2018 |
October 2018 |
October 2018 |
March 29, 2018 |
March 29, 2018 |
|
|
| 2 |
NCT03167073 |
Recruiting |
Impact of a Smartphone Application on Postpartum Weight Loss and Breastfeeding Rates Among Low-income, Urban Women |
|
- Other: BreastFeeding Friend (BFF)
- Other: dummy app
|
Interventional |
Not Applicable |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Rate of breastfeeding without formula supplementation
- Postpartum weight loss
- Rate of breastfeeding with or without formula supplementation
|
170 |
Female |
18 Years and older (Adult, Senior) |
NCT03167073 |
201704147 |
|
July 6, 2017 |
December 31, 2018 |
July 31, 2019 |
May 25, 2017 |
January 12, 2018 |
|
- Center for Outpatient Health
Saint Louis, Missouri, United States
|
| 3 |
NCT02523729 |
Completed |
Effects of Anke Malz on Women During Lactation |
- Non-alcoholic Malt Product in Lactation
|
- Dietary Supplement: Anke Malz
|
Interventional |
Not Applicable |
- China Medical University Hospital
- Lorillard Tobacco Company
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- The concentration of prolactin on lactational women
- Mean breast-feeding time
|
38 |
Female |
20 Years to 40 Years (Adult) |
NCT02523729 |
CMUH102-REC3-053 |
|
July 2013 |
September 2014 |
September 2014 |
August 14, 2015 |
August 14, 2015 |
|
|
| 4 |
NCT03480048 |
Recruiting
New |
Breastfeeding Support and Weight Management for Black Women |
|
- Behavioral: Breastfeeding and weight loss support
|
Interventional |
Not Applicable |
- Michigan State University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Henry Ford Health System
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Breastfeeding Duration
- Postpartum Weight Retention
|
60 |
Female |
18 Years and older (Adult, Senior) |
NCT03480048 |
RC105989
1R21HD085138-01A1 |
MamaBear |
March 22, 2017 |
November 30, 2018 |
November 30, 2018 |
March 27, 2018 |
April 5, 2018 |
|
- Henry Ford Health System, New Center One Women's Clinic
Detroit, Michigan, United States
|
| 5 |
NCT03178916 |
Recruiting |
Breast Feeding Practice in High Risk Pregnant Women |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The number of breast feeding women during pregnancy
|
140 |
Female |
20 Years to 45 Years (Adult) |
NCT03178916 |
BFHRP |
|
July 1, 2017 |
June 2018 |
October 2018 |
June 7, 2017 |
July 13, 2017 |
|
- Assiut Faculty of Medicine
Assiut, Egypt
|
| 6 |
NCT00619632 |
Completed |
Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT |
- Breastfeeding
- Breastfeeding, Exclusive
|
- Behavioral: Lactation Consultant
- Behavioral: Provider Prompt
- Behavioral: LC+ Provider Prompt
|
Interventional |
Not Applicable |
- Albert Einstein College of Medicine, Inc.
- Montefiore Medical Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Breastfeeding duration and intensity
- Infant health visits
- Patient and provider experiences of the interventions
|
666 |
Female |
18 Years and older (Adult, Senior) |
NCT00619632 |
06-08-364
NIH R01 HD04976301A2
Montefiore IRB= 06-08-364 |
BINGO |
February 2008 |
February 2013 |
February 2013 |
February 21, 2008 |
January 14, 2015 |
|
- Comprehensive Family Care Center
Bronx, New York, United States
|
| 7 |
NCT01338727 |
Completed |
Breastfeeding Education and Support Trial for Obese Women (BESTOW) |
- Exclusive Breastfeeding
- Breastfeeding Initiation
|
- Behavioral: Breastfeeding Peer Counseling
|
Interventional |
Not Applicable |
- University of Connecticut
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Exclusive Breastfeeding Rate
- Breastfeeding Rate
- Breastfeeding Initiation Rate
|
206 |
Female |
18 Years and older (Adult, Senior) |
NCT01338727 |
H06-009
DF05-015 |
BESTOW |
September 2006 |
March 2010 |
March 2010 |
April 19, 2011 |
April 19, 2011 |
|
- University of Connecticut
Storrs, Connecticut, United States
|
| 8 |
NCT03072758 |
Enrolling by invitation |
Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women |
- HIV Infections
- Breastfeeding, Exclusive
|
|
Interventional |
Not Applicable |
- University of Nevada, Las Vegas
- University Of Nigeria Teaching Hospital
- Catholic Caritas Foundation, Nigeria
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Initiation of breastfeeding
- Sustainment of exclusive breastfeeding
- Difference in rates of sustainment of exclusive breastfeeding
- (and 2 more...)
|
200 |
All |
Child, Adult, Senior |
NCT03072758 |
959559-3 |
|
March 30, 2017 |
March 15, 2018 |
March 31, 2018 |
March 7, 2017 |
October 26, 2017 |
|
- Catholic Caritas Foundation
Makurdi, Benue, Nigeria
|
| 9 |
NCT02639663 |
Unknown † |
Dental Support Device During Breastfeeding as a Mean for Pain Control |
|
|
Interventional |
Phase 3 |
- Tel-Aviv Sourasky Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of change in of the vas scores before and after using this device
- Duration of breastfeeding
- The rate of cessation of breastfeeding because of pain
|
700 |
Female |
18 Years to 45 Years (Adult) |
NCT02639663 |
559-15-TLV |
|
January 2016 |
January 2017 |
January 2018 |
December 24, 2015 |
December 24, 2015 |
|
|
| 10 |
NCT01630629 |
Completed |
Longitudinal Lactation Bone Density Study |
- Lactation
- Other Disorders of Bone Density and Structure
- Endocrine; Complications
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change from baseline in bone density measurements (BMD)
- Change from baseline of bone metabolism measurements
|
77 |
Female |
21 Years to 45 Years (Adult) |
NCT01630629 |
PRO12050600 |
|
August 2012 |
September 2015 |
September 2015 |
June 28, 2012 |
June 16, 2016 |
|
- University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
|
| 11 |
NCT02399774 |
Unknown † |
Dental Support Device During Breastfeeding as a Mean for Pain Control |
|
|
Interventional |
Phase 3 |
- Yariv yogev
- Rabin Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of change in of the vas scores before and after using this device
- Duration of breastfeeding
- The rate of cessation of breastfeeding because of pain
|
1500 |
Female |
18 Years to 45 Years (Adult) |
NCT02399774 |
0087-15-RMC |
|
May 2015 |
April 2017 |
April 2017 |
March 26, 2015 |
May 19, 2015 |
|
- Rabin Medical Center
Petah tikva, Israel
|
| 12 |
NCT02756169 |
Active, not recruiting |
Maternal Obesity and Breastfeeding Performance |
|
|
Interventional |
Not Applicable |
- Universidad Iberoamericana A.C., Mexico
- Mexican National Institute of Public Health
- National Council of Science and Technology, Mexico
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Predominant breastfeeding prevalence
- Exclusive breastfeeding prevalence
- Total duration of breastfeeding
- WHO Child Growth Standards
|
261 |
Female |
15 Years and older (Child, Adult, Senior) |
NCT02756169 |
SALUD-2014-01-234065
SSA.SEDESA:101/010/01/16 |
|
July 14, 2016 |
March 2018 |
April 2018 |
April 29, 2016 |
January 12, 2018 |
|
- Universidad Iberoamericana, A.C.
Mexico City, Mexico
|
| 13 |
NCT03069235 |
Completed |
Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program |
- HIV-infection/Aids
- Breast Feeding
|
- Behavioral: Family member / peer support
- Behavioral: Enhanced intervention with counselor support
- Behavioral: standard of care
|
Interventional |
Not Applicable |
- Johns Hopkins University
- MU-JHU CARE
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
|
218 |
Female |
18 Years to 50 Years (Adult) |
NCT03069235 |
NA_00050616 |
EBF |
February 8, 2012 |
November 30, 2013 |
November 30, 2013 |
March 3, 2017 |
March 3, 2017 |
|
|
| 14 |
NCT01459991 |
Completed |
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women |
|
- Other: Walnut
- Other: MyPyramid
|
Interventional |
Not Applicable |
- University of Arizona
- California Walnut Commission
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Estrogen associated hormones
- inflammatory and oxidative stress biomarkers
- body measurements
- diet adherence
|
138 |
Female |
18 Years to 40 Years (Adult) |
NCT01459991 |
Walnut Study |
|
October 2008 |
December 2010 |
October 2011 |
October 26, 2011 |
October 28, 2011 |
|
- Nutrition Research Clinic
Tucson, Arizona, United States
|
| 15 |
NCT02755194 |
Recruiting |
"Drugs in Lactation" Analysis Consortium |
|
|
Observational |
|
- The Hospital for Sick Children
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Drug levels in breast milk
|
300 |
Female |
18 Years and older (Adult, Senior) |
NCT02755194 |
1000036538 |
DLAC |
September 2014 |
September 2018 |
September 2018 |
April 28, 2016 |
April 25, 2017 |
|
- The Hospital for Sick Children
Toronto, Ontario, Canada
|
| 16 |
NCT00460018 |
Completed |
Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial) |
- Gestational Diabetes Mellitus
|
- Behavioral: Diet, Exercise, and Breastfeeding Intervention
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Postpartum weight retention
- reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)
- levels of plasma insulin
- (and 5 more...)
|
180 |
Female |
20 Years to 45 Years (Adult) |
NCT00460018 |
CN-04AFerr-04-H
CN-03AFerr-02 |
DEBI |
September 2005 |
|
|
April 13, 2007 |
June 19, 2009 |
|
- Kaiser Permanente Oakland
Oakland, California, United States - Kaiser Permanente Division of Research
Oakland, California, United States - Kaiser Permanente San Francisco
San Francisco, California, United States - (and 2 more...)
|
| 17 |
NCT01420419 |
Completed |
Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women |
|
- Other: Lanolin
- Other: Standard (usual) in-hospital and community postpartum care
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Nipple pain severity
- Breastfeeding duration
- Breastfeeding exclusivity
|
186 |
Female |
18 Years and older (Adult, Senior) |
NCT01420419 |
26044 |
LanP |
May 2011 |
February 2012 |
March 2012 |
August 19, 2011 |
January 16, 2013 |
|
- Postpartum Unit St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
|
| 18 |
NCT02325310 |
Active, not recruiting |
Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR |
|
- Biological: Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®
|
Interventional |
Phase 4 |
- Assistance Publique - Hôpitaux de Paris
- Service de Bactériologie-Virologie-Hygiène, CHU Limoge
- GO-CIC network (Réseau Gynéco-Obstetrical des Centres d’Investigation Clinique)
- REIVAC network (Réseau National d’Investigation Clinique en Vaccinologie)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Prevalence of the measles vaccine virus strain in breast milk.
- Number of infants with reported clinical symptoms of measles
- Number of women with reported clinical symptoms of measles
- (and 4 more...)
|
14 |
All |
18 Years to 36 Years (Adult) |
NCT02325310 |
2014-001538-28 |
BREMEAVAC |
February 2015 |
December 2016 |
June 2017 |
December 24, 2014 |
August 2, 2016 |
|
- Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur
Paris, France
|
| 19 |
NCT01352351 |
Completed |
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria |
- Breast Feeding Exclusive
- Initiation of Breastfeeding
|
- Behavioral: Breastfeeding promotion intervention
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- University of California, Davis
- Partners for Development
- The Alive & Thrive Small Grants
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of women who exclusively breastfeed to 6 months
- Proportion of women who exclusively breastfeed for 0-1 month
- Proportion of women who exclusively breastfeed for 2-3 months
- (and 2 more...)
|
485 |
Female |
15 Years to 45 Years (Child, Adult) |
NCT01352351 |
11-0534 |
|
May 2011 |
January 2013 |
January 2013 |
May 11, 2011 |
February 8, 2013 |
|
|
| 20 |
NCT03397108 |
Recruiting |
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease |
- Crohn's Disease
- Ulcerative Colitis
- Healthy Controls
|
|
Observational |
|
- The Hospital for Sick Children
- Mount Sinai Hospital, New York
- Crohn's and Colitis Foundation
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Levels of TNFα and its downstream chemokines (CCL2, CCL4, CCL7, and CXCL10) in breast milk of women with IBD and healthy controls by Multiplex assay
- Milk concentration of TNFα inhibitors (infliximab, adalimumab) at different time-points between two doses of medication, in lactating women with IBD by ELISA assay
- Scores on cognitive subset of Bayley Scales of Infant and Toddler development- Third Version (Bayley-III) in infants of healthy controls and women with IBD
- Simulated/predicted profiles of TNFα inhibitors (infliximab, adalimumab) in breast milk in a large population of lactating women with IBD by population pharmacokinetic modelling
|
160 |
Female |
18 Years and older (Adult, Senior) |
NCT03397108 |
1000056982 |
|
July 4, 2017 |
July 31, 2020 |
July 31, 2020 |
January 11, 2018 |
January 11, 2018 |
|
- Mount Sinai Hospital
Toronto, Ontario, Canada - The Hospital for Sick Children
Toronto, Ontario, Canada
|
| 21 |
NCT02106026 |
Completed |
Nursing Education Intervention for Maternal Breastfeeding |
- Breast Feeding
- Postpartum Breast Disorders
|
- Other: Preventive education
|
Interventional |
Not Applicable |
- Universidad Miguel Hernandez de Elche
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Breastfeeding duration
- Knowledge about breastfeeding and care of the breasts,
- Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis
|
314 |
Female |
Child, Adult, Senior |
NCT02106026 |
LACT-120413 |
|
December 2004 |
October 2006 |
October 2006 |
April 7, 2014 |
April 7, 2014 |
|
|
| 22 |
NCT02949713 |
Not yet recruiting |
Text Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected Women |
- HIV Infections
- Breast Feeding
|
- Behavioral: Text messaging-motivational interviewing
|
Interventional |
Not Applicable |
- University of Stellenbosch
- McMaster University
- University of British Columbia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Number of participants completing all study follow-up visits
- Number of participants consenting study participation
- Number of participants who are exclusively breastfeeding
- Number of participants who are breastfeeding
|
84 |
Female |
18 Years and older (Adult, Senior) |
NCT02949713 |
N16/09/11 |
|
June 2017 |
February 2018 |
February 2018 |
October 31, 2016 |
October 31, 2016 |
|
- Moleen Zunza
Cape Town, Western Cape, South Africa
|
| 23 |
NCT01463202 |
Completed
Has Results |
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression |
- Contraception
- Postpartum Depression
- Lactation
|
- Drug: Depot medroxyprogesterone acetate
|
Interventional |
Phase 4 |
- Beatrice Chen
- Society of Family Planning
- University of Pittsburgh
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
- Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
- Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
- Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
|
184 |
Female |
18 Years and older (Adult, Senior) |
NCT01463202 |
SFP5-1 |
DEPO-ABCD |
November 2011 |
February 13, 2017 |
October 16, 2017 |
November 1, 2011 |
March 13, 2018 |
March 13, 2018 |
- Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
|
| 24 |
NCT01806389 |
Completed
Has Results |
A Study of Breastfeeding in Buprenorphine Maintained Women |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Maternal Plasma Concentrations of Buprenorphine
- Maternal Breast Milk Concentrations of Buprenorphine
- Infant Plasma Concentrations of Buprenorphine
|
10 |
Female |
18 Years to 41 Years (Adult) |
NCT01806389 |
NA_00080884 |
|
February 2013 |
February 2016 |
February 2016 |
March 7, 2013 |
June 15, 2017 |
March 22, 2017 |
|
| 25 |
NCT02811172 |
Recruiting |
BEhavior of Biomarkers During pregnanCy and lactatiOn Through a Biological Multi-paradigm modEl. BECOME Study Protocol |
- Pregnancy
- Gestational Diabetes
- Hypertension
- Obesity
|
- Other: BEhavior of biomarkers during pregnanCy and lactatiOn
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Triglyceride levels
- prolactin levels
- glucose levels
- (and 6 more...)
|
224 |
Female |
Child, Adult, Senior |
NCT02811172 |
SPID201600X080546IV0 |
BECOME |
May 2016 |
August 2017 |
|
June 23, 2016 |
June 23, 2016 |
|
- Universidad de Granada
Granada, Spain
|
| 26 |
NCT00218010 |
Completed |
Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2 |
- Breast Feeding
- Opioid-Related Disorders
|
|
Observational |
|
- National Institute on Drug Abuse (NIDA)
- Johns Hopkins University
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- methadone concentrations in breast milk
- methadone concentrations in maternal plasma
- methadone concentrations in infant plasma
|
25 |
Female |
18 Years to 40 Years (Adult) |
NCT00218010 |
NIDA-00495-2 |
|
November 2000 |
August 2005 |
September 2005 |
September 22, 2005 |
January 12, 2017 |
|
- Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States
|
| 27 |
NCT01548313 |
Unknown † |
The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota |
|
|
Observational |
|
- University of Ljubljana
- University Medical Centre Ljubljana
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Effect of nutrition patterns of pregnant and lactating women on fatty acid composition of milk and plasma lipids, vitemine D in blood, bone density and composition of microbiota of colostrum, milk, meconium and child's faeces
- Health and development of a child
|
300 |
Female |
Child, Adult, Senior |
NCT01548313 |
J4 3606 BF-UL My milk |
MYMILK |
May 2010 |
May 2013 |
May 2015 |
March 8, 2012 |
February 2, 2015 |
|
- University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology
Ljubljana, Slovenia
|
| 28 |
NCT00785824 |
Completed |
African-American Bone Metabolism and Lactation Study |
- Lactation
- Bone Diseases, Endocrine
|
|
Observational |
|
- University of Pittsburgh
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Measurements 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 normal controls
- Measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover (i.e. NTX - N-telopepetide of collagen cross-links, CTX - C-telopepetide of collagen cross-links, BSAP - bone specific alkaline phosphatase and osteocalcin),
|
58 |
Female |
21 Years to 45 Years (Adult) |
NCT00785824 |
PRO08080129
R01DK073039 |
|
January 2009 |
November 2010 |
November 2010 |
November 5, 2008 |
October 31, 2013 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 29 |
NCT02621827 |
Completed |
Vitamin D Half-life in Pregnancy and Lactation |
|
- Other: Oral dose of stable isotope labeled 25(OH)D3
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Plasma concentration of stable isotope labeled 25(OH)D3
- Plasma concentration of vitamin D metabolites and related calciotropic hormones
- Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)
- Weighed dietary intake
|
49 |
Female |
18 Years to 45 Years (Adult) |
NCT02621827 |
MRC SCC1229 |
|
November 2011 |
October 2012 |
May 2013 |
December 4, 2015 |
December 4, 2015 |
|
|
| 30 |
NCT02220348 |
Recruiting |
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically |
- Breast Feeding
- Constipation
- Irritable Bowel Syndrome
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
|
8 |
Female |
18 Years to 45 Years (Adult) |
NCT02220348 |
LIN-PK-01 |
LIN-PK-01 |
July 2014 |
May 31, 2018 |
May 31, 2018 |
August 19, 2014 |
December 22, 2017 |
|
- University of Iowa
Iowa City, Iowa, United States - Forest Investigative Site 002
Philadelphia, Pennsylvania, United States
|
| 31 |
NCT02353806 |
Active, not recruiting |
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
- Chronic Hypertension in Pregnancy
|
- Drug: Amlodipine besylate
|
Interventional |
Phase 4 |
- University of Texas Southwestern Medical Center
- National Center for Advancing Translational Science (NCATS)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite of PK parameters in blood and breast milk (elimination half-life, time to peak serum concentration, maximal concentration, volume of distribution and area under the curve)
- Drug levels/concentration in cord blood (amlodipine levels/concentrations)
- Drug level/concentration in infant blood (amlodipine level/concentration)
- Neonatal clinical status (A range of clinical information will be collected including infant weight, Apgar scores, hemodynamic parameters such as blood pressure and heart rate as well as physical examination findings and hospital course)
|
16 |
Female |
18 Years to 50 Years (Adult) |
NCT02353806 |
042014-059
UL1TR001105 |
|
January 2015 |
July 2016 |
August 2016 |
February 3, 2015 |
May 12, 2016 |
|
- Parkland Health and Hospital System
Dallas, Texas, United States
|
| 32 |
NCT01181323 |
Completed
Has Results |
Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women |
|
- Other: Placebo
- Biological: Cold-adapted live attenuated influenza virus vaccine, trivalent
- Biological: Trivalent inactivated influenza vaccine
|
Interventional |
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Serious Adverse Events (SAEs)
- Number of Participants Reporting New Onset Chronic Medical Conditions
- Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination
- (and 19 more...)
|
240 |
Female |
18 Years to 49 Years (Adult) |
NCT01181323 |
09-0007
HHSN272200800006C |
|
September 2011 |
May 2013 |
May 2013 |
August 13, 2010 |
January 28, 2015 |
May 16, 2014 |
- Washington Hospital Center - Obstetrics and Gynecology
Washington, District of Columbia, United States - Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States - Saint Louis University - Center for Vaccine Development
Saint Louis, Missouri, United States - (and 3 more...)
|
| 33 |
NCT00643253 |
Completed |
Provider Approaches to Improved Rates of Infant Nutrition and Growth Study |
|
- Behavioral: LC and Electronic Prompt
|
Interventional |
Phase 3 |
- Albert Einstein College of Medicine, Inc.
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Breastfeeding intensity at 1,3, and 6 months
- Infant growth by treatment group and breastfeeding intensity
|
299 |
Female |
18 Years and older (Adult, Senior) |
NCT00643253 |
2007-490-000
1P60MD00516 |
PAIRINGS |
March 2008 |
September 2012 |
July 2013 |
March 26, 2008 |
July 11, 2013 |
|
- Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center
Bronx, New York, United States
|
| 34 |
NCT00994487 |
Completed |
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children |
- Childhood Obesity
- Breastfeeding
|
- Other: High Energy Density Preload
- Other: Low Energy Density Preload
|
Interventional |
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
- Compensation for high energy density and low energy density preloads
- Parental feeding style
|
7 |
Female |
3 Years to 5 Years (Child) |
NCT00994487 |
7828B |
|
June 2010 |
June 2010 |
July 2010 |
October 14, 2009 |
April 5, 2018 |
|
- University of Tennessee
Knoxville, Tennessee, United States
|
| 35 |
NCT00477776 |
Completed |
Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial |
|
- Drug: Metoclopramide (Maxolon)
- Drug: Placebo
|
Interventional |
Phase 3 |
- National University Hospital, Singapore
- The University of Western Australia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II
- amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months
|
160 |
Female |
15 Years to 50 Years (Child, Adult) |
NCT00477776 |
NHG SIG 06022 |
Maxalon |
April 2006 |
September 2008 |
March 2009 |
May 24, 2007 |
September 21, 2009 |
|
- National University Hospital
Singapore, Singapore
|
| 36 |
NCT01547533 |
Completed |
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease |
|
|
Observational |
|
- Hospital de Niños R. Gutierrez de Buenos Aires
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Benznidazole concentration in breastmilk and in plasma
- incidence of adverse drug reactions in women treated with benznidazole during lactation
|
10 |
Female |
18 Years to 40 Years (Adult) |
NCT01547533 |
LACT-BENZNIDAZOLE |
LACTBENZ |
August 2011 |
June 2013 |
December 2013 |
March 8, 2012 |
March 18, 2015 |
|
- Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Argentina
|
| 37 |
NCT01744405 |
Completed |
Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease |
|
|
Observational |
|
- Hospital de Niños R. Gutierrez de Buenos Aires
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Nifurtimox concentration in breastmilk and in plasma
- Incidence of adverse drug reactions in women treated with nifurtimox during lactation
|
12 |
Female |
18 Years to 40 Years (Adult) |
NCT01744405 |
LACT-NIFURTIMOX |
LACTNFX |
December 2012 |
December 2013 |
March 2015 |
December 6, 2012 |
March 18, 2015 |
|
- Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Argentina
|
| 38 |
NCT00608088 |
Completed |
Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer |
|
- Behavioral: Usual Care
- Behavioral: Community Health Nurse/Peer Councelor Team
|
Interventional |
Phase 3 |
- National Institute of Nursing Research (NINR)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Health Services Research
|
- Breastfeeding Rates
- Breastfeeding duration
- Cost Implications of a Nurse/Peer Councelor Program
- Infant indicies related to cost
|
328 |
Female |
12 Years to 44 Years (Child, Adult) |
NCT00608088 |
FWA 0006088
NIH/NINR - R01 RN007675 |
|
March 2003 |
August 2006 |
August 2006 |
February 6, 2008 |
February 6, 2008 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
| 39 |
NCT01136759 |
Completed |
Tenofovir Gel in Pregnancy and Lactation |
|
- Drug: Tenofovir 1% gel
- Other: Placebo gel
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- Safety and tolerability in pregnant women
- Safety and tolerability in infants, defined as no intensive care admission greater than 24 hours and no sepsis
- Safety and tolerability in lactating women, defined as specific Grade 2 or greater adverse events in laboratory abnormalities or genital/pelvic signs/symptoms
- (and 5 more...)
|
232 |
Female |
18 Years to 40 Years (Adult) |
NCT01136759 |
MTN-008
10805
MTN 008
5U01AI068633-04 |
|
March 2011 |
September 2013 |
September 2013 |
June 3, 2010 |
September 23, 2014 |
|
- Alabama CRS
Birmingham, Alabama, United States - University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States
|
| 40 |
NCT01130636 |
Completed |
Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation |
|
|
Interventional |
Phase 4 |
- Pharmahungary Group
- Hoffmann-La Roche
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Oseltamivir phosphate and oseltamivir carboxylate concentration in venous blood, breast milk/colostrums, and urine.
|
6 |
Female |
18 Years and older (Adult, Senior) |
NCT01130636 |
MV22970 |
|
June 2010 |
July 2012 |
July 2012 |
May 26, 2010 |
October 8, 2012 |
|
- DEOEC University of Debrecen, Clinic of Obstetrics and Gynecology
Debrecen, Hungary - Selye János Hospital, Department of Obstetrics and Gynecology
Komárom, Hungary
|
| 41 |
NCT02559713 |
Recruiting |
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease |
- Colitis, Ulcerative
- Crohn Disease
|
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Concentration of Vedolizumab in Breast Milk at Predose on Day 1
- Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1
- Concentration of Vedolizumab in Breast Milk on Day 4
- (and 4 more...)
|
12 |
Female |
18 Years and older (Adult, Senior) |
NCT02559713 |
Vedolizumab-4001
U1111-1171-5296 |
|
November 29, 2017 |
February 5, 2019 |
February 5, 2019 |
September 24, 2015 |
April 13, 2018 |
|
- University of Colorado
Aurora, Colorado, United States - Feinberg School of Medicine Northwestern University
Chicago, Illinois, United States - Carle Foundation Hospital
Urbana, Illinois, United States - (and 4 more...)
|
| 42 |
NCT00936195 |
Withdrawn |
Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial |
- HIV Infection
- Pregnancy
- Breastfeeding
- HIV Infections
|
- Drug: Efavirenz-Tenofovir-Emtricitabine
- Drug: Zidovudine-Lamivudine-Lopinavir/Ritonavir
|
Interventional |
Phase 3 |
- French National Agency for Research on AIDS and Viral Hepatitis
- Gilead Sciences
- Merck Sharp & Dohme Corp.
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- cumulative occurence of : -adverse pregnancy outcomes (spontaneous abortion, stillbirth, congenital abnormality requiring surgical correction in children < 1 yr of age); -paediatric HIV infection; -infant mortality
- occurence of grade 4 events in treated women, and of grade 3 or 4 events in ARV-exposed infants
- frequency of virological failure (>300 copies/mL) and viral resistance profile
- (and 3 more...)
|
0 |
Female |
18 Years and older (Adult, Senior) |
NCT00936195 |
ANRS 12200 UMA |
UMA |
January 2010 |
January 2013 |
June 2013 |
July 9, 2009 |
February 15, 2012 |
|
- Programme PAC-CI, site ANRS
Abidjan, Côte D'Ivoire - Center for Infectious Desease Reserach in Zambia
Lusaka, Zambia
|
| 43 |
NCT00418821 |
Recruiting |
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants |
- Mucopolysaccharidosis I
- Hurler's Syndrome
- Hurler-Scheie Syndrome
- Scheie
|
- Biological: Aldurazyme (laronidase)
|
Interventional |
Phase 4 |
- Genzyme, a Sanofi Company
- BioMarin/Genzyme LLC
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Breast milk samples for laronidase, Immunogenicity Testing, and Urinary glycosaminoglycans (uGAG).
|
10 |
Female |
Child, Adult, Senior |
NCT00418821 |
ALID01803
2007-007003-33 |
|
October 2010 |
January 2020 |
January 2020 |
January 5, 2007 |
August 22, 2017 |
|
- Dipartimento di Scienze Pediatriche Medico - Chirurgiche e Neuro Scienze dello Suiluppo
Rome, Italy
|
| 44 |
NCT02399956 |
Completed |
Lactation Outcomes Among Survivors of Pediatric Cancer |
|
|
Observational |
|
- St. Jude Children's Research Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Number of survivors who experience successful breastfeeding outcome by age at diagnosis
- Number of survivors who experience successful breastfeeding outcome by years since diagnosis
- Number of survivors who experience successful breastfeeding outcome by therapy with radiation
- (and 6 more...)
|
471 |
Female |
18 Years and older (Adult, Senior) |
NCT02399956 |
LACOUT |
|
March 2015 |
December 2015 |
December 2015 |
March 26, 2015 |
December 10, 2015 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
| 45 |
NCT02148237 |
Completed |
Increase Breastfeeding Duration Among Puerto Rican Mothers |
|
- Behavioral: Contingency Management
|
Interventional |
Not Applicable |
- Treatment Research Institute
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Duration of breastfeeding
- Infant weight
|
60 |
Female |
15 Years to 44 Years (Child, Adult) |
NCT02148237 |
R03HD077057
1R03HD077057-01A1 |
BFCM |
August 2014 |
April 2016 |
April 2016 |
May 28, 2014 |
May 23, 2016 |
|
- Special Supplemental Nutrition Program for Women, Infants, and Children
Philadelphia, Pennsylvania, United States
|
| 46 |
NCT01687634 |
Completed |
Home Visiting for Low Income, Pregnant Women |
- Pregnant Women
- Nutrition During Pregnancy
- Breast Feeding
- Newborns
|
- Behavioral: In-home Mentor Mother visits
- Behavioral: Health Information Mailings
|
Interventional |
Not Applicable |
- University of California, Los Angeles
- W.K. Kellogg Foundation
- Center for HIV Identification, Prevention, and Treatment Services
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Exclusive breastfeeding
- Maternal BMI
- Alcohol, tobacco, and drug use in pregnancy
- (and 3 more...)
|
203 |
Female |
18 Years and older (Adult, Senior) |
NCT01687634 |
P3018725 |
|
October 2012 |
July 2016 |
July 2016 |
September 19, 2012 |
May 16, 2017 |
|
- Robert F. Kennedy Schools
Los Angeles, California, United States
|
| 47 |
NCT02377544 |
Completed |
The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant |
|
- Dietary Supplement: Probiotic
- Other: Placebo
|
Interventional |
Not Applicable |
- Naomi Esthernita
- Indonesia University
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Gastrointestinal microbiota examination by DNA extraction and real time PCR
- Examination of IL-8 in breast milk
- Examination of urine IFABP
- (and 2 more...)
|
70 |
Female |
Child, Adult, Senior |
NCT02377544 |
FKUI-RSCM |
|
December 2014 |
December 2015 |
December 2015 |
March 3, 2015 |
February 25, 2016 |
|
- Budi Kemuliaan Women and Children Hospital
Jakarta, Central Jakarta, Indonesia
|
| 48 |
NCT01383070 |
Unknown † |
Evaluation of Effectiveness of Cell Phone Technology as Community Based Intervention to Improve Exclusive Breast Feeding |
- Malnutrition in Pregnancy
- Other Disorders of Breast and Lactation Associated With Childbirth
|
- Behavioral: Lactational Counseling by Cell phone
|
Interventional |
Not Applicable |
- Lata Medical Research Foundation, Nagpur
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.
- Growth through 6 months of age - weight, length and head circumference gains between birth and each immunization visit (at 6, 10 and 14 weeks), at 24 weeks and at 26 weeks for growth velocity.
|
1036 |
Female |
18 Years to 45 Years (Adult) |
NCT01383070 |
01_BFC |
BFC |
April 2010 |
September 2012 |
November 2012 |
June 28, 2011 |
June 28, 2011 |
|
- Lata Medical Research Foundation, Nagpur
Nagpur, India
|
| 49 |
NCT02776748 |
Completed |
PrEP in Breastfeeding Study |
- HIV Pre-exposure Prophylaxis During Breastfeeding
|
|
Interventional |
Phase 2
Phase 3 |
- University of Washington
- Bill and Melinda Gates Foundation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Steady state plasma concentrations of emtricitabine and tenofovir in the infants of breastfeeding women using PrEP: Quantity of PrEP medications in the infant plasma.
- Steady state plasma concentrations of emtricitabine and tenofovir in the infants of breastfeeding women using PrEP: Detectable and quantifiable concentrations of PrEP medications in the infant plasma.
- Steady state concentrations of emtricitabine and tenofovir in plasma of HIV-uninfected women using PrEP.
- (and 7 more...)
|
50 |
Female |
18 Years and older (Adult, Senior) |
NCT02776748 |
46363-IRB-D |
|
January 2015 |
May 2015 |
December 2015 |
May 18, 2016 |
May 18, 2016 |
|
- Partners in Prevention-Thika
Thika, Kenya - Partners in Prevention-Infectious Diseases Institute LTD
Kampala, Uganda
|
| 50 |
NCT03218956 |
Recruiting |
Protein Requirement During Lactation |
|
- Dietary Supplement: Dietary supplement: Protein intake
|
Interventional |
Not Applicable |
- University of British Columbia
- Canadian Institutes of Health Research (CIHR)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- 13C Phenylalanine Oxidation
|
10 |
Female |
20 Years to 45 Years (Adult) |
NCT03218956 |
H17-00079 |
|
September 30, 2017 |
May 15, 2019 |
May 30, 2019 |
July 17, 2017 |
October 26, 2017 |
|
- BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, Canada
|
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