Clinical trials: Lactation Disorders
Low Birth Weight
DarDar Nutrition Study in HIV Breastfeeding Women
This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their…
- Trial name
- DarDar2B (NCT01461863)
- Testing
- Porridge protein calorie supplement, multivitamin
- Where
- Tanzania
- Volunteers
- 96 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Vitamin D Deficiency
Establishing the Vitamin D Requirements During Lactation
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding…
- Trial name
- NCT00412074
- Testing
- 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol), 6400 IU Vitamin D3 (cholecalciferol)
- Where
- 2 sites in United States
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Breast Discharge Infected, Intraductal Papilloma of Breast
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
In this prospective clinical trial, patients who sign an approved informed consent for ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the study.
- Trial name
- NCT01901562
- Testing
- Ductoscopic papillectomy
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Montefiore Medical Center
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)
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
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
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Obstetric Pain, Postpartum Depression
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic…
- Conditions
- Obstetric Pain, Postpartum Depression, Breastfeeding, Pain, Acute
- Trial name
- KINETIC (NCT04037085)
- Testing
- Ketamine
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
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
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
Contraception, Postpartum Depression
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
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)…
- Conditions
- Contraception, Postpartum Depression, Lactation
- Trial name
- DEPO-ABCD (NCT01463202)
- Testing
- Depot medroxyprogesterone acetate
- Where
- United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Beatrice Chen
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)
Lactation
Recombinant Human Prolactin for Lactation Induction
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
- Trial name
- NCT00181610
- Testing
- Recombinant Human Prolactin, Normal Saline
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital
Smoking, Cigarette, Breastfeeding
Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months…
- Trial name
- NCT04670822
- Testing
- Breastfeeding promotion
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Pregnancy, Overweight and Obesity
Diabetes Prevention Program Feasibility Study of Breastfeeding
The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood…
- Trial name
- NCT04021602
- Testing
- Diabetes Prevention Program, Breastfeeding Education, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- University of Kansas Medical Center
Lactation Suppressed
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress.
- Trial name
- eLISTA (NCT06029673)
- Testing
- Cabergoline 1 MG
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Stanford University
Influenza
Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune…
- Trial name
- NCT01181323
- Testing
- Cold-adapted live attenuated influenza virus vaccine, trivalent, Trivalent inactivated influenza vaccine
- Where
- 6 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Low Milk Supply, Pre-diabetes
Metformin to Augment Low Milk Supply (MALMS) Study
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply.
- Conditions
- Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation
- Trial name
- MALMS (NCT02179788)
- Testing
- Standard care, Metformin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Osteoporosis
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly.
- Trial name
- NCT00903344
- Testing
- Vitamin D3, Multivitamin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Leigh Eck, MD