REACH: Pregnancy circles pilot trial

Not Applicable

Completed

• Conditions: Pregnancy and Childbirth; Antenatal care; UKCRC code/ Disease: Reproductive Health and Childbirth/ Delivery; Specialty: Reproductive health and childbirth, Primary sub-specialty: Other

• Registration Number: ISRCTN66925258
• Lead Sponsor: niversity of East London

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30459959 protocol 2023 Results article in https://doi.org/10.1186/s40814-023-01238-w (added 20/03/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study Completion: 2019-10-12
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

1. Women aged 16 years of age and over at the time of recruitment
2. Currently pregnant and registering (or registered) for antenatal care at the participating NHS Trust maternity service, including both primiparous and multiparous women, and women deemed low” and high” risk
3. Live within the working areas of the local midwife group facilitators
4. Estimated delivery date that fits with those of a proposed group
4. Documented learning disability

Exclusion Criteria

1. Non-pregnant women
2. Women registered for antenatal care at other NHS services outside of Barts Health NHS Trust
3. Women who live away from the target areas
4. Women whose estimated delivery dates do not fit with the proposed group start date
5. Women who are under 16 years old
6. Women with a documented learning disability. When recruiting for specific groups, non-English speaking women who speak a language that is not a target language for that particular group.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment is measured using a proforma at recruitment and brief interviews with women, at recruitment, who decline participation2. Uptake of care is measured using monitoring forms completed by the facilitating midwives at the first 2 Pregnancy Circles3. Retention is measured using monitoring forms completed by the facilitating midwives4. Assessment response rates and completion is measured by response rates and completeness of data obtained at baseline, first follow up (35 weeks of pregnancy) and second follow up (4 months postnatal). Completeness of routine maternity data collected at 1 month postnatal from electronic compared with paper records will also be assessed.5. Language support is measured via questionnaires at first and second follow up time points; by postnatal interviews with participants and by observations during intervention delivery

Secondary Outcome Measures

Name	Time	Method
No secondary outcome measures