Clinical trials: Lactation Disorders
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Mucopolysaccharidosis I, Hurler's Syndrome
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic…
- Conditions
- Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie
- Trial name
- NCT00418821
- Testing
- Laronidase
- Where
- Italy
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Breast Feeding, Infant Nutrition
Feeding My Baby - A National WIC Study
The goal of the study is to be a current examination of infant and toddler feeding practices among families receiving WIC services.
- Conditions
- Breast Feeding, Infant Nutrition, Childhood Obesity, Infant Feeding Patterns
- Trial name
- NCT02031978
- Volunteers
- 4,367 people
- Sponsor
- USDA Food and Nutrition Service
HIV Infections
Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.
- Trial name
- NCT04140266
- Testing
- Dapivirine (DPV) Vaginal Ring (VR)-004, Truvada Tablet
- Where
- 4 sites in Malawi, South Africa and 2 more
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy Related, Burnout, Professional
The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care.
- Conditions
- Pregnancy Related, Burnout, Professional, Wellness, Psychological
- Trial name
- NCT06014892
- Testing
- Snoo smart bassinet, Willow wearable breast pump, Maven Clinic on-demand perinatal consultation
- Where
- 7 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries.
- Trial name
- NCT00270296
- Testing
- Trizivir, Lamivudine/Zidovudine, Lopinavir/Ritonavir
- Where
- 4 sites in Botswana
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice…
- Trial name
- NCT00074412
- Testing
- Nevirapine
- Where
- 5 sites in South Africa, Tanzania and 2 more
- Volunteers
- 2,026 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Feeding and Eating Disorders of Childhood
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.
- Trial name
- NCT00635453
- Testing
- Dietary Advice
- Where
- Brazil
- Volunteers
- 715 people
- Sponsor
- Federal University of Health Science of Porto Alegre
Malnutrition, Wasting
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or…
- Conditions
- Malnutrition, Wasting, Growth Failure
- Trial name
- NCT04587271
- Testing
- Moringa oleifera (high dose), Moringa oleifera (low dose)
- Where
- 2 sites in Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Suzanna L Attia
Fabry Disease, Alpha Galactosidase A Deficiency
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full…
- Trial name
- NCT00230607
- Testing
- agalsidase beta
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Viral Hepatitis B, Contraception
Blood-borne Infection Screening in an Afghan Antenatal Population
Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan.
- Conditions
- Viral Hepatitis B, Contraception, Breast Feeding, Exclusive, Effects of; Lack of Care of Infants
- Trial name
- NCT01199601
- Testing
- Concentrated postpartum counseling
- Where
- Afghanistan
- Volunteers
- 1,291 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV/AIDS
VITAL Start: Brief Facility-based Video Intervention
This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize…
- Trial name
- VITAL (NCT03654898)
- Testing
- VITAL Start: Video-based pre-ART counseling, Standard of Care
- Where
- Malawi
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham