Effect of antenatal care on health of mothers and babies Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: 1. Currently pregnant. 2. Registering for antenatal care with one of the included maternity services. 3. Live within the working areas of the local midwife group facilitators. 4. Estimated delivery date (as per last menstrual period assessment) that fits with those of a proposed group. Midwife facilitators 1. Employed by the maternity services involved in the trial. 2. Attended study specific training provided by the research team or through a specialist MSc module at City, University of London (‘Leadership and innovation in maternity care: facilitating successful groups and teams’).
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/10/2020: Patients: 1. Under 16 years of age at the time of recruitment 2. Documented learning disability 3. Identified as being suitable for the ‘vulnerable women team’ - however services are configured differently in each trust so a decision about who is considered 'vulnerable' will be made locally. Women considered to be particularly vulnerable may include those with: current severe mental health concerns requiring specialist input/services/admission; substance misuse problems requiring specialist input/services; child protection concerns (including previous removal of children) _____ Previous exclusion criteria: Patients: 1. Under 16 years of age at the time of recruitment 2. Documented learning disability 3. Identified as being suitable for the ‘vulnerable women team’
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/12/2023: A ‘healthy baby’ composite will be measured using data from maternity records at 1 month postpartum. The ‘healthy baby’ composite will consist of the following: 1. Live baby (i.e. no pregnancy loss before 24 completed weeks, not stillborn and no neonatal death within 28 days of delivery) 2. Born at term (37 weeks and above) 3. Appropriate weight for gestational age (GROW centile >99.99 & 99.99 & 99.99 & <90.1) 4. Not admitted to a neonatal intensive care unit | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/06/2024: 1. Spontaneous vaginal delivery (SVD), defined as a woman who delivers vaginally measured using data collected postpartum from maternity records 2. Women’s empowerment measured using the Pregnancy-related empowerment scale (PRES) at 35 weeks of pregnancy (follow-up 1) 3. Women’s satisfaction with maternity care, measured using the NHS Friends and Families test, collected at 35 weeks pregnancy (follow-up 1) and at three months postpartum (follow-up 2) 4. Breastfeeding initiation measured using data collected postpartum from maternity records 5. Mental well-being measured using the Short Warwick-Edinburgh Mental Wellbeing Scale at 35 weeks (follow-up 1) and 3 months postpartum (follow-up 2) 6. Live baby (i.e. no pregnancy loss before 24 completed weeks, no stillbirth after 24 completed weeks of pregnancy and no neonatal death within 28 days of the birth), measured postpartum from maternity records 7. Born at term (37 weeks + 0 days and above) measured postpartum from maternity records 8. Appropriate weight for gestational age (GROW centile >9.99 & <90.01) measured postpartum from maternity records 9. Not admitted to a neonatal care unit (which includes Intensive Care Unit, SCBU and High Dependency Unit, but NOT transitional care) measured postpartum from maternity records Previous secondary outcome measures: 1. Women’s empowerment is measured using the Pregnancy-related empowerment scale (PRES) at 35 weeks pregnancy (follow-up 1). 2. Spontaneous vaginal delivery, defined as ‘Women whose labour starts spontaneously, progresses spontaneously without drugs, and who give birth spontaneously’ is measured data collected postpartum from maternity records. 3. Women’s satisfaction with maternity care is measured using the NHS Friends and Families test (follow up 1 and 2) and questions designed specifically for the study at three-months postpartum (follow-up 2) 4. Attendance at antenatal care is measured using data from mate | — |
Countries
England, United Kingdom