Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Gestational age at delivery (main)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.-
排除标准
- •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
研究组 & 干预措施
Intervention
Lifestyle coaching sessions
干预措施: LIFETWIN (Behavioral)
Control
Standard of care
结局指标
主要结局
Gestational age at delivery (main)
时间窗: 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.
Gestational age at delivery
时间窗: 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.
次要结局
- Birth weight (main)(Delivery)
- Small for gestational age (main)(Delivery)
- Offspring mortality (main)(24 weeks -28 days postpartum)
- Offspring infection (main)(within the first 72 hours of delivery)
- Early neurodevelopmental morbidity (main)(6 weeks postpartum)
- Gastrointestinal morbidity (main)(6 weeks postpartum)
- Respiratory morbidity (main)(6 weeks postpartum)
- NICU admission (main)(within 72 hours of delivery)
- Number of days in the NICU (main)(6 weeks postpartum)
- Gestational weight gain (main)(from 14 weeks pregnancy to delivery)
- Maternal quality of life (main)(Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum)
- Postpartum weight (main)(6 weeks postpartum)
- Gastrointestinal morbidity(6 weeks postpartum)
- Birth weight(Delivery)
- Small for gestational age(Delivery)
- Early neurodevelopmental morbidity(6 weeks postpartum)
- Offspring mortality(24 weeks -28 days postpartum)
- Offspring infection(within the first 72 hours of delivery)
- Respiratory morbidity(6 weeks postpartum)
- NICU admission(within 72 hours of delivery)
- Number of days in the NICU(6 weeks postpartum)
- Gestational weight gain(from 14 weeks pregnancy to delivery)
- Maternal quality of life(Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum)
- Postpartum weignt(6 weeks postpartum)