Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04370769
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy intention', 'timeFrame': 'Baseline (Pre-pregnancy)', 'description': "Measuring women's pregnancy intention using standardised measure (Desire to Avoid Pregnancy Questionnaire)"}, {'measure': 'Risk perception of pregnancy risk (Perception of Pregnancy Risk Questionnaire)', 'timeFrame': 'Baseline (Pre-pregnancy)', 'description': "Measuring women's perception of pregnancy risk."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risk perception'], 'conditions': ['Chronic Kidney Diseases', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '36971978', 'type': 'DERIVED', 'citation': 'Ralston ER, Smith P, Clark K, Wiles K; RaDaR CKD Pregnancy Group; Chilcot J, Bramham K. Exploring biopsychosocial correlates of pregnancy risk and pregnancy intention in women with chronic kidney disease. J Nephrol. 2023 Jun;36(5):1361-1372. doi: 10.1007/s40620-023-01610-2. Epub 2023 Mar 27.'}]}, 'descriptionModule': {'briefSummary': "Currently, there is no robust evidence about how women with Chronic Kidney Disease (CKD) perceive pregnancy risk. The aims of this research are to understand women with CKD's perception of risk in pregnancy. In order to provide appropriate pre-pregnancy and antenatal counselling including accurate presentation of risk of pregnancy outcomes, it is important to establish how do women with CKD perceive their risk in pregnancy. In addition, to facilitate discussion about pregnancy for women with CKD, it is critical to understand key psychosocial factors influencing their risk perceptions.\n\nThis study will be conducted in two phases. In phase one, risk perceptions in women with CKD who are contemplating pregnancy will be quantitatively measured with potential influencing psychosocial factors including their illness perceptions, quality of life, anxiety, depression and perceived social support. Demographic, pregnancy-intentions, medical and pregnancy histories will also be collected. Phase one findings will establish to what extent do women with CKD perceive their pregnancy risk.\n\nIn phase two, perception of risk, pregnancy intention and behaviour, will be qualitatively explored in women with CKD who perceive high and low degrees of risk. This sub-study will facilitate understanding about which factors and experiences impact risk perception and their relationship with pregnancy intentions and behaviour.", 'detailedDescription': "The objectives for this research are:\n\n1. To understand how women with CKD perceive their pregnancy risk.\n2. To examine the associations between biopsychosocial factors (demographics, psychosocial factors, renal and pregnancy history) and women with CKD's perception of risk in pregnancy.\n3. To examine the relationship between pregnancy-related intention and perception of pregnancy risk in women with CKD.\n4. To gain an in-depth understanding of the biopsychosocial factors which influence risk perception and pregnancy-related behaviour, in women with CKD who perceive high and low risk perceptions.\n\nTo achieve these objectives this study is divided into two phases:\n\nPhase 1: Quantitative assessment of risk perception and biopsychosocial factors in women with CKD Phase 2: Qualitative exploration of risk perception in women with CKD with high and low risk perception scores"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with CKD who are planning a pregnancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with CKD stages 1-5 according to KDOQI guidelines)\n\n * ≥18 years old\n * Planning a pregnancy\n * Adults who have the capacity/capability to provide fully informed consent for the study\n\nExclusion Criteria:\n\n* Already established on haemodialysis or peritoneal dialysis\n* Women \\< 18 years old or \\>50 years old\n* Inability or unwilling to give informed consent\n* Does not speak English'}, 'identificationModule': {'nctId': 'NCT04370769', 'acronym': 'PREDICT_RP', 'briefTitle': 'PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Understanding Perception of Risk in Pregnancy Associated Progression of Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'PREDICT_RP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Kidney Disease', 'description': 'Women with kidney disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'state': 'Greater London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elizabeth R Ralston', 'role': 'CONTACT', 'email': 'elizabeth.ralston@kcl.ac.uk', 'phone': '07713730377'}], 'facility': 'Elizabeth Ralston', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}