Clinical trials: Maternal
mHealth, PMTCT
Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs.
- Conditions
- mHealth, PMTCT, Adherence, Medication, SMS
- Trial name
- Mobile WAChx (NCT02400671)
- Testing
- SMS messaging
- Where
- 6 sites in Kenya
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- University of Washington
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery
Pulse Pressure and Post-epidural Fetal Heart Rate Changes
Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes.
- Trial name
- NCT02565485
- Testing
- Lactated Ringer's
- Where
- United States
- Volunteers
- 276 people
- Sponsor
- MetroHealth Medical Center
Sepsis
Zambia Chlorhexidine Application Trial
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry…
- Trial name
- ZamCAT (NCT01241318)
- Testing
- Chlorhexidine gluconate (4%), Dry cord care
- Where
- Zambia
- Volunteers
- 77,535 people, healthy volunteers welcome
- Sponsor
- Boston University
Pregnancy
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects.
- Trial name
- NCT02159807
- Testing
- Bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Depression
Maternal Depression Treatment in HIV
Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8…
- Trial name
- M-DEPTH (NCT03892915)
- Testing
- evidence-based depression treatment
- Where
- Uganda
- Volunteers
- 391 people
- Sponsor
- RAND
Adolescents, 18 and Under When Child Was Born for Mothers
Young Parents Program, Project Connect
1. Specific Aims 1. To evaluate the effects of life skills/parenting groups that are embedded within a comprehensive multidisciplinary clinic for adolescent parents (the Young Parents Program), using a randomized control design.
- Conditions
- Adolescents, 18 and Under When Child Was Born for Mothers, 25 and Under When Child Was Born for Fathers
- Trial name
- YPPProCon (NCT01379924)
- Testing
- Parenting/Life Skills Intervention, Teen-tot medical home
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Exercise, Women
Conmigo: A Mother-daughter Intervention to Promote Physical Activity
Regular physical activity (PA) contributes to reduced risk of obesity, chronic disease, cardiovascular disease, and cancer, and can improve emotional and mental health, learning, productivity, and social skills.
- Conditions
- Exercise, Women, Hispanic Americans, Child
- Trial name
- Conmigo (NCT04736030)
- Testing
- Intervention
- Where
- United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- San Diego State University
Congenital Heart Disease, Periventricular Leucomalacia
Randomized Trial of Maternal Progesterone Therapy
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a…
- Conditions
- Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery
- Trial name
- NCT02133573
- Testing
- Progesterone, Vaginal lubricant
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Children's Hospital of Philadelphia
Obstetric Pain
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.
- Trial name
- NCT00361712
- Testing
- Preemptive epidural analgesia, Standard of care
- Where
- Israel
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
HIV, Pregnancy
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different…
- Trial name
- PregnantHIV (NCT01854762)
- Testing
- Raltegravir, Lopinavir/Ritonavir
- Where
- Brazil
- Volunteers
- 33 people
- Sponsor
- Fundação Bahiana de Infectologia
Opaque Bottles, Conventional, Clear Bottles
Opaque Bottle Study
The proposed research aimed to conduct an intervention study assessing the effect of feeding mode (clear versus opaque bottle) on the quality and outcome of infant feeding interactions.
- Trial name
- NCT03711370
- Testing
- Clear Bottle, Opaque Bottle
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- California Polytechnic State University-San Luis Obispo
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
HIV, Pregnancy
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study
Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women Rationale: In developing countries many women present with a new HIV diagnosis in late pregnancy, and are at high risk of transmitting infection…
- Trial name
- DolPHIN1 (NCT02245022)
- Testing
- Dolutegravir 50mg od, Standard of Care
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 60 people
- Sponsor
- University of Liverpool
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Postpartum Depression, Postpartum Anxiety
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary…
- Trial name
- NCT05423093
- Testing
- Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infants of Diabetic Mothers
Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States. Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is also increasing, mainly due to an increase in the…
- Trial name
- FAEE-IDM (NCT02308735)
- Testing
- N/A - No intervention
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig