Lifestyle Intervention to Improve Twin Pregnancy Outcomes
ConditionTwin Pregnancy, Dichorionic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
Qualifiers
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.-
Disqualifiers
pre-gestational diabetes
severe heart disease,
chronic renal disease,
celiac disease,
Trial design
Treatments tested in this trial
- LIFETWIN
Treatment groups
81 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov