Clinical trials: Lactation Disorders
Osteoporosis, Obesity
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42).
- Conditions
- Osteoporosis, Obesity, Weight Loss
- Trial name
- BEHIP (NCT00966381)
- Testing
- Exercise and weight loss intervention
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Greensboro
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
Hiv
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently…
- Trial name
- PANNA-B PK (NCT05648201)
- Testing
- Doravirine 100Mg Tab, Biktarvy 50/200/25 Tab
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Breast Feeding, Analgesia Obstetrical
Intravenous Dexmedetomidine for Cesarean Section
Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate…
- Conditions
- Breast Feeding, Analgesia Obstetrical, Postoperative Pain
- Trial name
- NCT03065530
- Testing
- Normal Saline, Dexmedetomidine 0.03ug/kg/h, Dexmedetomidine 0.05ug/kg/h
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
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
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
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
Healthy
The Safety and Efficacy of Recombinant Human Prolactin
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can…
- Trial name
- NCT00438490
- Testing
- Recombinant Human Prolactin
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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)
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
Norovirus Infections
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Preterm Birth, Breast Feeding
Prenatal Breast Pump Education of Mothers and Their Support Person
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to…
- Trial name
- NCT04006509
- Testing
- Prenatally Delivered Lactation Educational Program
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Florida
Insufficient Lactation
Improving Lactation Success in Black Mothers of Critically Ill Infants
Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce…
- Trial name
- NCT05147987
- Testing
- Hands free wearable breast pump
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Florida
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
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
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
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
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
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)