Pregnancy, High Risk Clinical Trial
Official title:
The Effectiveness of MInding the Baby in a Danish Community Sample
Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.
Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old. The effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03651843 -
Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
|
||
Active, not recruiting |
NCT05656352 -
Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia
|
||
Not yet recruiting |
NCT06430853 -
Psychobiological Interventions in Pregnancy
|
N/A | |
Completed |
NCT05316415 -
The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
|
N/A | |
Not yet recruiting |
NCT03985618 -
The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity
|
N/A | |
Completed |
NCT02008097 -
Clinical Benefits of B-Flow Ultrasound
|
N/A | |
Recruiting |
NCT05922033 -
Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
|
Phase 4 | |
Completed |
NCT03413631 -
A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women
|
N/A | |
Not yet recruiting |
NCT05317585 -
Continuous Glucose Monitor Use in Pregnancy
|
N/A | |
Not yet recruiting |
NCT05388643 -
Early Detection of Gestational Diabetes Mellitus in Pregnancy
|
N/A | |
Recruiting |
NCT04861103 -
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
|
Phase 4 | |
Completed |
NCT03334149 -
Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
|
N/A | |
Completed |
NCT03646487 -
A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
|
N/A | |
Recruiting |
NCT05198206 -
Pregnant Women With Pulmonary Hypertension in China
|
||
Recruiting |
NCT05739123 -
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
|
||
Recruiting |
NCT05807256 -
Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
|
||
Completed |
NCT04874285 -
Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.
|
N/A | |
Not yet recruiting |
NCT05662462 -
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
|
N/A | |
Recruiting |
NCT03975894 -
TAPS2 Transfusion Antenatally in Pregnant Women With SCD
|
Phase 2 | |
Recruiting |
NCT05597943 -
mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
|
N/A |