Summary (Dutch or French)
Expecting twins is a novel and thrilling journey, nevertheless it additionally comes with larger dangers, together with early beginning (preterm supply) and infants being born too small. These challenges can affect the well being of each newborns and moms and improve the necessity for specialised medical care.
The LIFETWIN examine goals to discover whether or not a life-style intervention – together with tailor-made dietary recommendation, protected bodily exercise suggestions, and stress administration strategies – might help cut back the dangers of preterm beginning and enhance being pregnant outcomes for moms carrying twins.
Pregnant ladies anticipating dichorionic twins (twins with two separate placentas) can be invited to take part early of their being pregnant (earlier than week 14). Participants can be randomly assigned (which suggests they can’t select which group you’ll be in) to one in all two teams:
1. Lifestyle Intervention Group: Alongside their obstetrician appointments, all through being pregnant, ladies on this group will obtain eight periods performed by educated midwives (both face-to-face or by way of video convention for comfort), selling:
o Eating a well-balanced eating regimen with sensible recommendation.
o Engaging in protected and useful bodily actions.
o Using mindfulness and rest strategies to handle stress.
2. Standard Care Group: Women on this group will proceed to obtain the same old being pregnant care offered in Belgium, with normal way of life recommendation however with out the extra structured intervention.
All individuals could have three evaluation factors, the place they are going to be requested to reply questionnaires about their way of life.
This pilot examine goals to check whether or not it’s possible to efficiently recruit individuals and ship this intervention. If we are able to present that this strategy is efficient and possible, then a big randomised examine can be carried out in Belgium.
While some way of life interventions have been proven to enhance being pregnant outcomes for ladies carrying single infants, there may be little analysis on whether or not a structured way of life program can profit twin pregnancies. This examine may change the best way twin pregnancies are managed worldwide, serving to future moms and their twin infants thrive.
Trial Description
| Title | LIFETWIN: way of life intervention to enhance twin being pregnant end result: a multicentric randomized management trial – Pilot |
| Participants (P) | Women identified with a dichorionic twin being pregnant, recruited earlier than the 14th week of gestation |
| Intervention (I) | A posh way of life intervention delivered in eight structured 1h periods (roughly each 2-3 weeks) performed by a educated midwife, between weeks 16-36 of gestation. This is in further to any normal recommendation. Each session covers: • Dietary counselling: Adopting a Mediterranean-based eating regimen, adjusting for native meals availability and cultural preferences. Includes individualized eating regimen plan and a multivitamin supplementation program. • Physical exercise: Encouraging not less than 150 minutes of average cardio train per week, with a deal with personalised aim setting. • Mindfulness and stress discount: Introducing mindfulness-based stress discount (MBSR) and mindfulness-based childbirth and parenting (MBCP) strategies. Includes guided workouts akin to breath consciousness, physique scanning, and visualization. |
| Control (C) | Standard medical way of life recommendation for twin pregnancies for instance: General vitamin recommendation encouraging a balanced eating regimen wealthy in protein, iron, calcium, and folic acid. A each day prenatal vitamin pill is really useful (a prescription is offered however not reimbursed) together with further iron supplementation if wanted. Moderate bodily exercise, like strolling or swimming, is inspired within the absence of issues, whereas high-impact actions, extended standing, and heavy lifting ought to be prevented. Adequate relaxation and normal stress administration (with out particular packages) are additionally really useful to assist maternal well being and well-being all through the being pregnant. Smoking cessation and abstinence from alcohol are additionally suggested. |
| Outcome (O) | The main end result is a steady measure of gestational age at supply, recorded in days. For spontaneous pregnancies, gestational age is decided by ultrasound relationship earlier than 13 weeks and 6 days, whereas for IVF pregnancies, it’s based mostly on the embryo’s age on the time of switch. The design assumes a imply gestational age of 35.47 weeks with a regular deviation of two.81 weeks. To detect a distinction of 1 week in gestational age between the intervention and management teams with 80% energy and a two-tailed significance degree of 5%, the pattern dimension calculation indicated a necessity for 124 individuals in every group which has been improve to 137 to account for dropouts. |
| Trial Design | Parallel-group randomized managed trial containing an built-in feasibility pilot examine |
| Sample Size | For the pilot 81 individuals, a complete of 274 for the total examine |
| Trial period | Pilot 20 months |
| Budget | 668,000 € for the pilot in 4 websites |
Trial crew
| Sponsor | UZ Leuven |
| Chief Investigator | Prof, Dr Roland Devlieger |
| External companions | N/A |
| Number of taking part websites | Pilot examine 4 websites, full examine as much as 15 websites |