Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery
Conditions
Interventions
The allocation ratio of intervention to control will be 1:1. Randomisation will be managed via a secure web-based randomisation facility hosted by MedSciNet which will write the randomisation program
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Asymptomatic pregnant women with singleton pregnancy and = 24 weeks' gestation and identified at risk of PTB fulfilling one or more of the following criteria: 1. Cervical surgery (such as cone biopsy, LLETZ) 2. Uterine abnormality (such as bicornuate uterus) 3. Previous short cervix 4. Short cervix this pregnancy (14 weeks) 9. Smoking at booking
Exclusion criteria
Exclusion criteria: 1. > 24 weeks’ gestation 2. Aged < 19 years old at recruitment 3. Unable/unwilling to give informed consent 4. Multiple pregnancy 5. Resides outside the catchment area covered by Lewisham Hospital 6. Receiving care from an specialist team already (e.g., teenagers, women suffering severe mental health illness, domestic violence or human trafficking; women with pre-existing diabetes, HIV, hepatitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The initiation of the following interventions related to the prevention and/or management of preterm labour and birth: antibiotics for UTIs, smoking cessation and domestic violence referrals, transvaginal scan assessments of the cervix, fetal fibronectin assessments, cerclage insertion, progesterone administration, corticosteroid administration, magnesium sulphate administration, admission for observation or in utero transfer; Timepoint(s): following birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment and attrition rates and acceptability to women, healthcare professionals and stakeholders; Timepoints: at baseline/randomisation and in mid and post-implementation 2. Health in pregnancy: other complications; Timepoint: following birth 3. Labour and birth outcomes; Timepoint: following birth 4. Maternal and neonatal postnatal outcomes; Timepoint: following birth 5. Measure of implementation; Timepoints: early, mild and post-implementation 6. Measure of quality of care; Timepoint: 4/6 weeks after birth 7. Measure of women’s experience (trust, stress, system responsiveness, and safety); Timepoint: 4/6 weeks after birth 8. Assessment of psycho-social health; Timepoints: at baseline/randomisation and 4/6 weeks after birth 9. Health economic analysis of cost and resource use for mothers and infants; Timepoint: post-implementation | — |
Countries
England, United Kingdom
Outcome results
None listed