Clinical trials: Perinatal Care, open to volunteers
Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)
Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
This feasibility pilot study aims to gather data that can guide the design of a larger, more comprehensive trial to establish the effects of myo-inositol supplementation on supporting healthy outcomes in pregnancies complicated…
- Trial name
- AMulet (NCT07241221)
- Testing
- Myo-inositol and folic acid supplement, Folic acid supplement
- Where
- Singapore
- Volunteers
- 182 people
- Sponsor
- National University Hospital, Singapore
Congenital Heart Disease, Fetal Heart Disorder
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on…
- Conditions
- Congenital Heart Disease, Fetal Heart Disorder, Neonatal Disease, Fetal Disease
- Trial name
- NCT07820163
- Volunteers
- 115 people
- Sponsor
- Assiut University
Perinatal Anxiety, Anxiety Sensitivity
Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders
The goal of this clinical trial is to find out if a digital program called Reaching Calm can help prevent anxiety in women who are pregnant.
- Conditions
- Perinatal Anxiety, Anxiety Sensitivity, Perinatal Depression
- Trial name
- NCT07458698
- Testing
- Digital mental health intervention
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Massachusetts, Worcester
Mother to Child Transmission, Breast Feeding
Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study
The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for…
- Conditions
- Mother to Child Transmission, Breast Feeding, Trauma
- Trial name
- NCT07195058
- Testing
- Trauma Informed Obstetric Care (TIOC)
- Where
- Argentina
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Columbia University
Perinatal Loss, Perinatal Grief
The Effect of Nursing Care With Peri-Natal Loss
This study was planned to evaluate the effect of standardised nursing care given to women with perinatal loss using the nursing process on perinatal grief, posttraumatic stress and postpartum depression.
- Trial name
- NCT06896214
- Testing
- Standardised nursing care intervention
- Volunteers
- 58 people
- Sponsor
- Gazi University
Maternal Care
Holistic Care Partner Program Feasibility and Acceptability
The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal…
- Trial name
- NCT06520566
- Testing
- Holistic care partner perinatal nurse navigation
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Perinatal Depression
Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression
The perinatal period (pregnancy and the first postnatal year) (O'Hara \& Wisner, 2014) involves important changes and considerable challenges for parents (Milgrom \& Gemmill, 2015).
- Trial name
- MaMHI (NCT07027761)
- Testing
- Online self-help, Maternal Mental Health Intervention (MaMHI), Usual Care
- Where
- Belgium
- Volunteers
- 210 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Depression, Anxiety, Antenatal Depression
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and…
- Conditions
- Depression, Anxiety, Antenatal Depression, Postnatal Depression
- Trial name
- IPMH (NCT06456307)
- Testing
- Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
- Where
- 2 sites in Kenya
- Volunteers
- 2,970 people, healthy volunteers welcome
- Sponsor
- Kenyatta National Hospital
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
Perinatal Substance Use
Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder
The goal of this pilot study is to learn if a digitally enhanced peer doula program for people with perinatal substance use disorders (PSUD) is feasible and acceptable to patients and staff at two clinics.
- Trial name
- EMBRACE (NCT07642947)
- Testing
- Digitally Enhanced Peer Doula Model of Care
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Trustees of Dartmouth College
Infant, Extremely Premature, Obstetric Labor, Premature
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to…
- Conditions
- Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal
- Trial name
- NCT05685745
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 5,000 people
- Sponsor
- The University of Texas Health Science Center, Houston
Perinatal Mental Health
Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change
The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings.
- Trial name
- COMPASS+ (NCT06849869)
- Testing
- COMPASS+
- Where
- United States
- Volunteers
- 14,820 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Anxiety Disorders, Stress Disorders, Post-Traumatic
MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients
Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited.
- Conditions
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Pregnancy, High Risk, Depressive Disorder, Major
- Trial name
- MOCHA (NCT07540585)
- Testing
- Collaborative Mental Health Care Program (CMHCP)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Indiana University
Perinatal Asphyxia
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care
The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.
- Trial name
- OptiNeoCare (NCT06322732)
- Where
- France
- Volunteers
- 336 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
Influenza, COVID-19
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur.
- Conditions
- Influenza, COVID-19, SARS-COV-2 Infection, Other Respiratory Viruses
- Trial name
- ICOPE (NCT06168019)
- Testing
- Exposures
- Where
- 2 sites in United States, India
- Volunteers
- 10,000 people
- Sponsor
- Boston University
Neonatal Death, Perinatal Death
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate…
- Trial name
- NCT05187897
- Testing
- CHV-NEO
- Where
- Kenya
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental…
- Conditions
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries, Perinatal Hypoxia
- Trial name
- RECOVER (NCT04913324)
- Testing
- Virtual Care
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- The Hospital for Sick Children
Persons With Psychiatric Disorders
Perinatal Peer Support for Veterans With Serious Mental Illness
Veterans with serious mental illness (SMI) are at high risk of exacerbation of mental illness in pregnancy and postpartum, with consequences including poor pregnancy outcomes, decreased functioning, and impaired child…
- Trial name
- NCT07362576
- Testing
- Perinatal peer support
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- VA Office of Research and Development
Pregnancy, Vbac
Effective Communication in Perinatal Care
ComPARE is a cross-sectional observational study investigating the effectiveness of communication during prenatal consultations concerning vaginal birth after caesarean (VBAC).
- Trial name
- ComPARE (NCT07919145)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele