New treatment option for Twin Pregnancy, Dichorionic
Official title Lifestyle Intervention to Improve Twin Pregnancy Outcomes
ClinicalTrials.gov ID: NCT07270640
What this study is testing
- What it's testing
- The goal of this clinical trial to is assess the benefits of holistic lifestyle interventions, including nutrition, physical activities, and mindfulness, aiming to reduce preterm birth in twins, potentially revolutionizing twin care globally. An initial integrated pilot study is be conducted to assess and refine the intervention methods.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Prior to any randomization or intervention, participants must have provided voluntary written informed consent.
- Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria.
- Participants must be recruited before the 14th week of gestation.
- Proficiency in Dutch, English, or French is required.-
You likely can't join if
- Participant has a history of pre-existing diseases or condition impacting their diet:
- pre-gestational diabetes
- severe heart disease,
- chronic renal disease,
- celiac disease,
- inflammatory bowel disease,
See the full eligibility criteria
- Prior to any randomization or intervention, participants must have provided voluntary written informed consent.
- Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria.
- Participants must be recruited before the 14th week of gestation.
- Proficiency in Dutch, English, or French is required.-
- Participant has a history of pre-existing diseases or condition impacting their diet:
- pre-gestational diabetes
- severe heart disease,
- chronic renal disease,
- celiac disease,
- inflammatory bowel disease,
- post-bariatric surgery
- Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:
- Chronic Obstructive Pulmonary Disease (COPD)
- Severe Asthma.
- Fibromyalgia
- Osteoarthritis
- Chronic Pain Syndromes
- Spinal Cord Injuries.
- Multiple Sclerosis (MS)
- Parkinson's Disease
- History of a Stroke
- Drug resistance Epilepsy
- Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool.
- Participants with a History of Mental Health Disorders
- Post-Traumatic Stress Disorder (PTSD)
- Anxiety Disorders
- Depressive Disorders
- Bipolar Disorder
- Obsessive-Compulsive Disorder (OCD)
- Schizophrenia or schizoaffective disorder
- Inability to give informed consent
- No knowledge of Dutch, English or French
- First trimester diagnosis of severe congenital anomaly in one or both twins
- First trimester foetal demise of one or both twins
- Rupture of membranes prior to recruitment
- Participation in any other treatment Study
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Genk, Belgium
- Leuven, Belgium
- Liège, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Genk, Belgium; Leuven, Belgium; Liège, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.