Twin Pregnancy, Dichorionic
Conditions
Keywords
twin pregnancy, dichorionic, lifestyle interventions
Brief summary
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. For the pilot study, we aim to include 81 pregnant women across 4 sites. This sample size is based on pragmatic considerations, while ensuring diverse representation, including individuals from low socioeconomic status backgrounds and high-risk groups. For the full trial, in total 274 women are needed to detect a clinically meaningful difference in gestational age at delivery, the primary outcome.
Interventions
BEHAVIORALLIFETWIN
The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
First, a pilot phase (n = 81) is installed to evaluate feasibility. After evaluation and if necessary protocol amendments, a full trial will be rolled out (n = 274)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. pre-gestational diabetes 2. severe heart disease, 3. chronic renal disease, 4. celiac disease, 5. inflammatory bowel disease, 6. post-bariatric surgery * Participant has a history of pre-existing diseases or conditions impacting their physical activity ability: 1. Chronic Obstructive Pulmonary Disease (COPD) 2. Severe Asthma. 3. Fibromyalgia 4. Osteoarthritis 5. Chronic Pain Syndromes 6. Spinal Cord Injuries. 7. Multiple Sclerosis (MS) 8. Parkinson's Disease 9. History of a Stroke 10. 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 1. Post-Traumatic Stress Disorder (PTSD) 2. Anxiety Disorders 3. Depressive Disorders 4. Bipolar Disorder 5. Obsessive-Compulsive Disorder (OCD) 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery (main) | Delivery | The primary outcome is gestational age at delivery, measured in weeks and days. This is calculated based on the last menstrual period and confirmed via early ultrasound dating (before 13 weeks and 6 days) for spontaneous pregnancies or based on embryo age at transfer for IVF patients. The study aims to evaluate whether a multi-component lifestyle intervention can delay delivery by at least one week, thereby enhancing pregnancy outcomes. Gestational age data will be collected from medical records to ensure accuracy and consistency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight (main) | Delivery | Birth weight in grams and percentile. |
| Small for gestational age (main) | Delivery | Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms |
| Offspring mortality (main) | 24 weeks -28 days postpartum | Offspring mortality- defined as the death of one or both twins occurring at any time from foetal viability (24 weeks' gestation) until 28 days postpartum (neonatal period). |
| Offspring infection (main) | within the first 72 hours of delivery | Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery. |
| Early neurodevelopmental morbidity (main) | 6 weeks postpartum | Early neurodevelopmental morbidity- defined as diagnosis of Intraventricular haemorrhage (IVH) Grade III-IV, periventricular leukomalacia (PVL), hypoxic-ischemic encephalopathy (HIE), and neonatal seizures. |
| Gastrointestinal morbidity (main) | 6 weeks postpartum | Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation. |
| Respiratory morbidity (main) | 6 weeks postpartum | Respiratory morbidity- defined as diagnosis of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), transient tachypnoea of the newborn (TTN) or persistent pulmonary hypertension of the newborn (PPHN) |
| NICU admission (main) | within 72 hours of delivery | Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery. |
| Number of days in the NICU (main) | 6 weeks postpartum | Number of days in the NICU |
| Gestational weight gain (main) | from 14 weeks pregnancy to delivery | Gestational Weight Gain (GWG) corrected to pregnancy duration. |
| Maternal quality of life (main) | Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum | Maternal quality of Life based on questionnaire EQ-5D-5L. |
| Postpartum weight (main) | 6 weeks postpartum | Postpartum weight recorded 6 weeks postpartum |
Countries
Belgium
Contacts
CONTACTProf. Dr. Roland Devlieger
Outcome results
None listed