Infant development and maternal wellbeing Pregnancy and Childbirth Infant development
Conditions
Interventions
Participant calculation:
Our randomised study with 250 in each group of the trial will be capable (80% power
alpha 0.05) of detecting an improvement of Bayley score at one year of 5 points.
Intervention group:
The intervention will be carried out by specially trained peer group mentors from the same geogr
Sponsors
The Royal Group of Hospitals Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: We intend to recruit first time mothers aged 30 years or less from the antenatal clinics at Royal Maternity Hospital, Belfast at first booking (approximately 10 - 12 weeks). Women will be selected from small areas (electoral district equivalents) that are within the most deprived fifth of the Northern Ireland population. These women will be identified from postcodes on their hospital referral letter and when they attend the hospital booking clinic they will be invited to participate in the study. MOMENTS Qualitative Study: Purposive samples were selected for invitation to participate. Mentors were selected to include a range of age, locality, work experience, family composition and mentor experience.
Exclusion criteria
Exclusion criteria: 1. Women who had been pregnant previously (including miscarriage, termination, stillbirth, live birth) 2. Women with any significant ongoing medical condition which requires regular attendance with a health professional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in Bayley scores in infants and in maternal physical and mental well-being at one year between the intervention and non-intervention group. This assessment, in hospital, will take approximately 90 minutes. The Bayley Scales of Infant Development II assess performance on mental, motor and behavioural rating scales; raw scores will be converted to normalised scores representing the Mental Development Index and Psychomotor Development Index. The 36-item short form health survey (SF-36) will also be used to assess maternal physical and mental health. MOMENTS Follow-up Study: 1. Bayley's Scales of Infant Development III at age 2.5 years and 4 years 2. Maternal quality of life by SF-36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At booking (10 - 12 weeks): basic demographic data, mother's knowledge of pregnancy and infant development, current dietary habits, feeding intentions, lifestyle factors (smoking, alcohol and drugs), physical and mental health (SF-36) 2. At 22 weeks (when women attend hospital for an anomaly scan): foetal growth (biparietal diameter, femur length and abdominal circumference) and a short questionnaire on stress levels (Speilberger State Trait Anxiety Questionnaire) and maternal feelings for the pregnancy 3. At 29 - 30 weeks: foetal growth and foetal behaviour. During a 45 minute ultrasound, the frequency and duration of movement and the foetus's startle reaction. A two-second vibroacoustic stimulus (Corometrics) will be presented to the foetus and the response noted in the following 10 seconds (whether the foetus responded and the strength of the foetus) scored on a 10 point scale. Both measures are useful indicators of neurological well-being. Maternal self-report of anxiety levels will be obtained. 4. At birth: Apgar scores at 1 and 5 minutes, growth measurements (birth weight, length and head circumference) in relation to gestation, Brazelton Neonatal Behavioural Assessment Scale at 24 - 72 hours, method of infant feeding 5. At 6 - 8 weeks: infant growth measurements by health visitors during routine visits in the community, details of method and amount of feeding will be noted 6. At 7 - 8 months: infant growth and feeding data will be recorded by health visitors at routine visits and infant temperament using the Revised Infant Temperament Questionnaire (RITQ). Temperament is considered to represent constitutionally based individual differences in reactivity and self-regulation which represent the core of developing personality. The RITQ involves questionnaire responses from the infant's mother which measure dimensions of activity, rhythmicity, approach, adaptability, threshold, mood, intensity, persistence and distractibility. The Parenting Stress Index short | — |
Countries
United Kingdom
Outcome results
None listed