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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

81 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Gestational age at delivery (main)

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.

Time frame

Delivery

Secondary outcomes

Birth weight (main)

Birth weight in grams and percentile.

Time frame

Delivery

Small for gestational age (main)

Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms

Time frame

Delivery

Offspring mortality (main)

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).

Time frame

24 weeks -28 days postpartum

Offspring infection (main)

Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery.

Time frame

within the first 72 hours of delivery

Other outcomes

Maternal mortality (main)

Maternal mortality- defined as death of the mother during pregnancy or within 42 days postpartum, due to any cause related to or aggravated by pregnancy or its management.

Time frame

within 42 days postpartum

Caesarean section delivery (main)

Time frame

delivery

Premature rupture of the membranes (main)

Time frame

before week 34

Maternal number of days in hospitalization after delivery (main)

Time frame

6 weeks postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov

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