Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery
Conditions
Interventions
This is a parallel cluster randomised control trial across 13 hospital sites. For the first 6 weeks all sites are continuing with their normal hospital routine management. For a nine month period, sev
Sponsors
Kings College London/ Guys and St Thomas’ Trust co-sponsorship
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who are pregnant 2. Any age range 3. With symptoms of threatened preterm labour (contractions or abdominal pain) 4. Between 23+0 and 34+6 weeks gestation If they are having the QUIPP App used in their care management: 5. Participants must have a quantitative fetal fibronectin assessment and/or a transvaginal ultrasound scan as part of their clinical care
Exclusion criteria
Exclusion criteria: 1. Definitive diagnosis of labour (i.e. regular painful contractions with cervical change > 3cm on speculum or digital examination) 2. Confirmed ruptured membranes (on speculum examination) 3. Significant vaginal bleeding Exclusion Criteria for Qualitative study 1. Unable or unwilling to give informed consent 2. Under 16 years of age 3. Unable to understand English language sufficiently to complete the questionnaire booklet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inappropriate management for threatened preterm labour is measured by number of inappropriate admission and in-utero transfer decisions: admitted to hospital/ transferred and delivery interval >7 days, or not admitted to hospital/ transferred and delivery interval <7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal clinical outcomes (e.g. new onset gestational diabetes) measured from the post-delivery outcome data 2. Neonatal clinical outcomes (e.g. gestational age at delivery) measured from the post-delivery outcome data 3. Process measures (e.g. days of maternal hospitalisation) measured from the post-delivery outcome data 4. Compliance to management recommendations measured from their visit to hospital data and post-delivery outcome data | — |
Countries
England, United Kingdom
Outcome results
None listed