Social risk in pregnancy Pregnancy and Childbirth Maternal care related to the fetus and amniotic cavity and possible delivery problems
Conditions
Interventions
The POW service is in addition to standard maternity care and will not be available to nulliparous women other than within the trial. Women assessed as having social risk and randomised to the interve
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Nulliparous women <28 weeks gestation 2. Assessed by the midwife as having specified social risk through systematic assessment. Nulliparous is defined as never having given birth to a child; this will include women who have had a miscarriage/s or termination/s of pregnancy. We have chosen under 28 weeks gestation as an inclusion criterion to give adequate time for the Pregnancy Outreach Worker (POW) service to impact on the outcomes.
Exclusion criteria
Exclusion criteria: 1. Those under 16 years of age due to the complexity of gaining informed consent from this group 2. Teenagers recruited to Family Nurse Partnership (FNP), but do not expect this to greatly affect recruitment to ELSIPS. One of the primary care trusts (PCTs) (South) participating in this trial is also involved in a national trial of additional support to pregnant teenagers, called the Family Nurse Partnership (FNP). The FNP intervention is health professionals providing intensive support throughout pregnancy up to 2 years after birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. 1.1. Engagement with antenatal care, assessed based on number of antenatal visits and 1.2. Maternal depression, assessed using the Edinburgh Postnatal Depression Scale (EPDS) at 8-12 weeks after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes will include: 1. Length of labour (first, second and third stages) 2. Mode of birth (spontaneous vaginal birth, instrumental birth or caesarean section) 3. Perineal trauma (episiotomy, degree of laceration) 4. Incidence of possible maternal morbidity (e.g., postpartum haemorrhage, shoulder dystocia, chorionamnioitis) 5. Length of stay in hospital 6. Engagement with other services, as required (e.g., smoking cessation service) Baby outcomes are mainly markers of poor perinatal outcome 1. Composite outcome of adverse perinatal outcome comprising: 1.1. Perinatal mortality 1.2. Preterm birth before 34 weeks 1.3. Birth weight 10th centile or below 1.4. Admission to neonatal unit 2. Apgar score at 5 minutes 2.1. Arterial cord blood gases, if taken 2.2. Breastfeeding initiation rate 2.3. Length of stay in hospital 2.4. Oxygen at 36 weeks post conceptual age, if applicable 2.5. Retinopathy of prematurity, if applicable 2.6. Abnormal cerebral ultrasound prior to discharge (e.g., intraparenchymal cerebral bleed, hydrocephalus, parenchymal cysts), if applicable 2.7. Necrotising enterocolitis (Bells Stage I, II or III), if applicable 2.8. Culture positive sepsis requiring greater than 5 days antibiotic treatment, if applicable Longer term infant outcomes Routine child health assessments, including immunisation uptake and breastfeeding continuation at 6 weeks Psychological outcomes 1. Self efficacy (using Pearlin and Schooler Mastery Scale) 2. Mother-to-infant bonding tool | — |
Countries
England, United Kingdom
Outcome results
None listed