Understanding how, why, for whom, to what extent and in what contexts the Preterm Birth Surveillance Pathway is successfully (and unsuccessfully) implemented in England through a realist evaluation

IMplementation of the Preterm Birth Surveillance PAthway: a RealisT evaluation (including a realist literature scope)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57127874

Enrollment

Registered

2021-07-22

Start date

2021-12-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth Pregnancy and Childbirth

Interventions

Initial programme theories will be tested through interviews with women and staff, observational analysis and analysing routinely collected hospital and admin activity data. Staff members will be int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Staff: involved in the preterm birth pathway as staff 2. Women: involved in the preterm birth pathway as service users 3. Routine electronic hospital data and admin activity data: all service users at that hospital, collected for a period (e.g. 1 year) before preterm birth pathway implementation, and for a period (e.g. 1 year) after preterm birth pathway implementation

Exclusion criteria

Exclusion criteria: 1. Staff interviews: not involved in the preterm birth pathway as staff (either clinical or non-clinical), are under 18 years old, and not English speaking 2. Women interviews: not involved in the preterm birth pathway as service users, are under 18 years old, and not English speaking 3. Observations: not involved in the preterm birth pathway as service users or staff, or are under 18 years old 4. Anonymized routine electronic hospital data and admin activity data: women who have specifically requested to opt out of the study after seeing the posters in antenatal clinical areas

Design outcomes

Primary

Measure	Time frame
The contexts and mechanisms leading to both positive and negative outcomes in terms of implementation of the preterm birth pathway (PBP), assessed using interviews, observational analysis and routinely collected hospital and admin activity data for a period before and after implementation	—

Secondary

Measure	Time frame
The incidence of women having a singleton pregnancy having a preterm birth (liveborn and stillborn) as a % of all singleton births from 16+0 to 23+6 weeks' gestation, and from 24+0 to 36+6 weeks' gestation, assessed by analysing routinely collected hospital admin and activity data for a period before and after implementation	—

Countries

England, United Kingdom

Contacts

Public ContactNaomi Carlisle

naomi.h.carlisle@kcl.ac.uk+44 (0)20 7836 5454

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026