Clinical trials: Lactation
Postpartum Contraception, Family Planning
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis.
- Trial name
- LADII (NCT02866643)
- Testing
- Etonogestrel-Immediate, Etonogestrel-Delayed
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Stanford University
Breastfeeding
PRenatal Video-Based Education and PostPARtum Effects
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280…
- Trial name
- PREPARE (NCT04258709)
- Testing
- AME, Video-based infant care education
- Where
- United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Smoking, Cigarette, Breastfeeding
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors.
- Trial name
- NCT05123118
- Testing
- Integrated intervention of smoking cessation and breastfeeding
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Xiaozhong Wen
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)
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
Human Milk Microbiome, Bacterial Growth
Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions
The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life"…
- Trial name
- MiLC (NCT03123874)
- Testing
- Sterile pump set-up, Mother's Own pump set-up
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Cornell University
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)
Breastfeeding, Exclusive, Pain, Acute
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal and infant health, development, and well-being.
- Conditions
- Breastfeeding, Exclusive, Pain, Acute, Maternal Distress, Parent-Child Relations
- Trial name
- PROMPT (NCT05262920)
- Testing
- The BSM Intervention, Attention Control
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
Breastfeeding
Home-based Breastfeeding Peer Counselling Programme
A feasibility study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal breastfeeding support from peer counsellors at…
- Trial name
- NCT03705494
- Testing
- Home-based peer counselling (web-based) intervention
- Where
- Hong Kong
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
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
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
HIV Prevention
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use…
- Trial name
- NCT06394323
- Testing
- Behavioral: My Choice for HIV Prevention (MyChoice)
- Where
- Malawi
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV-1-infection, Antenatal Care
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV…
- Trial name
- NCT04330989
- Testing
- iNSC and Adherence supporter training
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Exclusive Breastfeeding, Co-production of Health in Communities
A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala
The purpose of this study was to determine whether exposure to m-health platforms promoting recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding message to participant mothers, and in…
- Trial name
- NCT02263118
- Testing
- Uni-directional SMS, Feature phone, Virtual communities
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Universidad Francisco Marroquín
Breast Feeding
A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
The purpose of this pilot randomized trial is to determine the effectiveness, feasibility, and acceptability of a mobile, semi-automated text message-based intervention (MILK) to prevent perceived low or insufficient milk supply…
- Trial name
- MILK (NCT02724969)
- Testing
- MILK or Text4Baby text message intervention
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Postpartum Period
Involving Men in Maternity Care in Burkina Faso
The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa.
- Trial name
- NCT02309489
- Testing
- Partner involvement
- Where
- Burkina Faso
- Volunteers
- 1,144 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
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
Breastfeeding
Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Aims and Objectives Aim To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of term neonates born by normal vaginal delivery at 36-48 hours.
- Trial name
- NCT00776789
- Testing
- skin to skin contact, Control group
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- All India Institute of Medical Sciences
Healthy Lactating Women
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily…
- Trial name
- NCT06021951
- Testing
- Bempedoic Acid 180 MG Oral Tablet, Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Esperion Therapeutics, Inc.
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