Progression of chronic kidney disease in pregnancy Urological and Genital Diseases
Conditions
Interventions
Eligible women will be identified from GP referral letters, antenatal or outpatient clinic visits and from health professionals on antenatal wards.
During pregnancy, a blood and urine test will be don
Sponsors
King’s College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: ORCHARD study: 1. Pregnant women with CKD Stages 2-5 including those with renal transplants i.e. pre-pregnancy eGFR 70 µmol/l (or > 80 µmol/l if Black) with no clinical suspicion of acute kidney injury 2. <24+6 weeks’ gestation 3. =18 years old 4. Willing and able to provide written informed consent Sub study (ORCHARD-BEET): 5. Consented to observational ORCHARD study 6. Agreed to be contacted about future research studies
Exclusion criteria
Exclusion criteria: ORCHARD study: 1. Already established on haemodialysis or peritoneal dialysis 2. Multifetal pregnancy 3. Major life-threatening congenital abnormality Sub study (ORCHARD-BEET): 4. Known allergy to beetroot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORCHARD: Recruitment per centre per month (determined from screening /enrolment logs) Sub-study (ORCHARD-BEET): Recruitment rate of pregnant women with CKD per site per month (determined from screening /enrolment logs) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORCHARD study: 1. Maternal factors will be measured using demographic and clinical data obtained from medical notes, patient interview, examination and blood/urine tests at baseline 2. Maternal renal function will be measured using serum creatinine and urine protein measurement (albumin creatinine ratio, protein creatinine ratio OR 24 hour urine protein) at baseline, each trimester, 6 weeks post-partum and 6 months post-partum 3. Maternal complications will be measured using maternal outcomes (mode, timing, indications for and complications of delivery) and adverse events as defined by the protocol and identified with medical notes and patient interview at each trimester visit, 6 weeks post-partum and 6 months post-partum 4. Neonatal adverse outcomes will be measured using review of medical notes at 6 weeks post-partum to assess mode and outcome of delivery, Apgar scores, measures of size and weight, admission to Neonatal ICU or Special Care Unit Sub study (ORCHARD-BEET): 5. Number of eligible women with CKD will be assessed from recruitment logs 6. Feasibility and acceptability of the intervention to clinicians and women (including reasons for declining, retention during study and participant attitudes) will be measured using by short semi-structured interviews of local principal investigators (face-to-face or by telephone) and acceptability of women will be assessed with “Survey Monkey” questionnaire sent 2-4 weeks after recruitment, 32+0-35+6 weeks’ gestation, 6-12 weeks after delivery asking whether they enjoyed taking their beetroot juice, whether they would be willing to take it in future pregnancies and whether they would recommend it to other pregnant women with chronic kidney disease 7. Adherence and reasons for non-adherence will be measured using daily diaries of participants which are reviewed and entered into an adherence log on the Orchard database at each trimester and 6 weeks post-partum 8. Mean and SD for primary outcome will be estimated to inform | — |
Countries
England, United Kingdom
Outcome results
None listed