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Recruiting NCT07270640

Lifestyle Intervention to Improve Twin Pregnancy Outcomes

No phase Interventional Twin Pregnancy, Dichorionic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIFETWIN.
Who it may be relevant to
Registry conditions: Twin Pregnancy, Dichorionic. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral LIFETWIN
    The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.

Primary outcome measures

  • Gestational age at delivery (main) [Time frame: Delivery]
Secondary outcome measures (12)
  • Birth weight (main) [Time frame: Delivery]
  • Small for gestational age (main) [Time frame: Delivery]
  • Offspring mortality (main) [Time frame: 24 weeks -28 days postpartum]
  • Offspring infection (main) [Time frame: within the first 72 hours of delivery]
  • Early neurodevelopmental morbidity (main) [Time frame: 6 weeks postpartum]
  • Gastrointestinal morbidity (main) [Time frame: 6 weeks postpartum]
  • Respiratory morbidity (main) [Time frame: 6 weeks postpartum]
  • NICU admission (main) [Time frame: within 72 hours of delivery]
  • Number of days in the NICU (main) [Time frame: 6 weeks postpartum]
  • Gestational weight gain (main) [Time frame: from 14 weeks pregnancy to delivery]
  • Maternal quality of life (main) [Time frame: Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum]
  • Postpartum weight (main) [Time frame: 6 weeks postpartum]

Eligibility criteria

Inclusion 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.-

Exclusion criteria

  • 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 interventional Study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Belgium · 4 centers
  • CHU Brugmann — Brussels
  • Ziekenhuis Oost-Limburg — Genk
  • UZ Leuven — Leuven
  • Hôpital de la Citadelle — Liège

Identifiers

NCT: NCT07270640 · S68251

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗