POPPIE: Pilot study Of midwifery Practice in Preterm birth Including women's Experiences

Not Applicable

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery; Pregnancy and Childbirth

• Registration Number: ISRCTN37733900
• Lead Sponsor: King's College London

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33022010/ Feasibility results (added 08/10/2020) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36634125/ Process evaluation (added 30/03/2023) Other publications in https://pubmed.ncbi.nlm.nih.gov/33882059/ Participants' experiences (added 05/05/2023) 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31088505/ (added 05/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-21
• Study Completion: 2019-05-30
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 334

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 (< 25mm)
5. Previous cerclage
6. Previous premature ruptured membranes (< 37 weeks)
7. One or more previous PTB (< 37 weeks)
8. Previous late miscarriage/abortion (>14 weeks)
9. Smoking at booking

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Recruitment and attrition rates and acceptability to women, healthcare professionals and stakeholders; Timepoints: at baseline/randomisation and in mid and post-implementation2. Health in pregnancy: other complications; Timepoint: following birth3. Labour and birth outcomes; Timepoint: following birth4. Maternal and neonatal postnatal outcomes; Timepoint: following birth5. Measure of implementation; Timepoints: early, mild and post-implementation6. Measure of quality of care; Timepoint: 4/6 weeks after birth7. Measure of women’s experience (trust, stress, system responsiveness, and safety); Timepoint: 4/6 weeks after birth8. Assessment of psycho-social health; Timepoints: at baseline/randomisation and 4/6 weeks after birth9. Health economic analysis of cost and resource use for mothers and infants; Timepoint: post-implementation