Actively Recruiting
Lifestyle Intervention to Improve Twin Pregnancy Outcomes
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-16
81
Participants Needed
4
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The primary objective of the pilot study is to evaluate feasibility. If deemed feasible, the full study will be implemented, incorporating data from pilot study participants into the main study. Objective of the full study: To evaluate if a multi-component lifestyle extends gestational age at delivery by one week. Additional objective: to evaluate if the intervention positively influences multiple secondary outcomes including pregnancy complications, neonatal and maternal outcomes, and maternal quality of life.
CONDITIONS
Official Title
Lifestyle Intervention to Improve Twin Pregnancy Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided voluntary written informed consent prior to any randomization or intervention
- Diagnosed with dichorionic twin pregnancies according to acceptance criteria
- Recruited before the 14th week of gestation
- Proficient in Dutch, English, or French
You will not qualify if you...
- History of pre-existing diseases or conditions impacting diet, including pre-gestational diabetes, severe heart disease, chronic renal disease, celiac disease, inflammatory bowel disease, or post-bariatric surgery
- History of pre-existing diseases or conditions limiting physical activity, such as COPD, severe asthma, fibromyalgia, osteoarthritis, chronic pain syndromes, spinal cord injuries, multiple sclerosis, Parkinson's disease, history of stroke, or drug-resistant epilepsy
- Identified mental vulnerabilities requiring specific care pathways
- History of mental health disorders including PTSD, anxiety disorders, depressive disorders, bipolar disorder, obsessive-compulsive disorder, schizophrenia, or schizoaffective disorder
- Inability to give informed consent
- Lack of knowledge of Dutch, English, or French
- First trimester diagnosis of severe congenital anomaly in one or both twins
- First trimester fetal demise of one or both twins
- Rupture of membranes prior to recruitment
- Participation in any other interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU Brugmann
Brussels, Belgium, 1020
Not Yet Recruiting
2
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
3
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
4
Hôpital de la Citadelle
Liège, Belgium, 4000
Not Yet Recruiting
Research Team
P
Prof. Dr. Roland Devlieger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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