Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06059794
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety in Relation to Nausea and Vomiting in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2023-09-16', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy-Unique Quantification of Emesis (PUQE) score', 'timeFrame': 'Baseline', 'description': 'The Pregnancy-Unique Quantification of Emesis (PUQE) is a scoring system to quantify the severity of nausea and vomiting of pregnancy, based on quantification of the 3 physical symptoms of (nausea, vomiting and retching).'}, {'measure': 'Generalised Anxiety Disorder Assessment (GAD-7)', 'timeFrame': 'Baseline', 'description': 'The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day"'}], 'secondaryOutcomes': [{'measure': 'Disturbance in Sodium.', 'timeFrame': 'immediately after the intervention', 'description': 'assessed by serum levels of Sodium.'}, {'measure': 'Disturbance in Potassium', 'timeFrame': 'immediately after the intervention', 'description': 'assessed by serum levels of Potassium.'}, {'measure': 'Dehydration', 'timeFrame': 'immediately after the intervention', 'description': 'dehydration as detected clinically (like oliguria)'}, {'measure': 'Ketonuria', 'timeFrame': 'immediately after the intervention', 'description': 'acetone in urine assessed by urine dipstick'}, {'measure': 'Hospital admission', 'timeFrame': 'immediately after the intervention', 'description': 'Hospital admission'}, {'measure': 'Hospital stay', 'timeFrame': 'immediately after the intervention', 'description': 'Duration of hospital stay in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PUQE score', 'GAD-7 questionnaire'], 'conditions': ['Nausea Gravidarum', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn more about the relation between anxiety (assessed by GAD-7 questionnaire) and the nausea and vomiting in pregnancy (objectively measured by PUQE score).\n\nParticipants will answer 2 questionnaires: (GAD-7) for anxiety; and (PUQE score) for nausea and vomiting.', 'detailedDescription': 'Study Procedures:\n\n* Protocol approval will be sought from the ethical committee of the department of Obstetrics \\& Gynecology, Faculty of Medicine, Ain Shams University.\n* Recruitment of pregnant women complaining of nausea and vomiting in pregnancy (NVP) in first trimester will be done from the outpatient clinic and antenatal ward in Ain Shams University Maternity Hospital.\n* An informed written consent will be taken from all participants before enrollment in the study.\n* History taking, examination, and investigations (CBC, ultrasound, acetone in urine, serum sodium, potassium, alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine) will be done to identify eligible patients according to the inclusion and exclusion criteria.\n* PUQE score will be calculated for each patient. Patients will be classified into 3 groups (mild, moderate, severe) accordingly.\n* GAD-7 questionnaire will be calculated for each patient. Degree of anxiety will be classified into 4 groups (minimal, mild, moderate, severe) accordingly.\n* Data will be recorded in a case report form.\n* Statistical analysis will be done accordingly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study will include 105 pregnant women recruited from antenatal clinic and antenatal ward', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in first trimester complaining of NVP\n* Age (18-40) years\n\nExclusion Criteria:\n\n* History of known medical problem (e.g., endocrine abnormalities, gastrointestinal disease).\n* Known current or past psychiatric disorder (e.g., depression, anxiety, bipolar disorder, delirium, eating disorders, and psychotic disorder)\n* Multiple pregnancy\n* Known obstetric complications (non-viable pregnancy; either ectopic pregnancy; gestational trophoblastic disease, or miscarriage).\n* Medications (including antidepressant, anti-psychotic or other psychiatric drugs during the last 6 months) or illegal drug or narcotic use that would affect the test results\n* Current or past history of cognitive incompetence which can make it difficult to understand how to score GAD-7 questionnaire.'}, 'identificationModule': {'nctId': 'NCT06059794', 'briefTitle': 'Anxiety in Relation to Nausea and Vomiting in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Assessment of Anxiety Disorder in Relation to PUQE Score of Nausea and Vomiting in First Trimester Pregnancy', 'orgStudyIdInfo': {'id': 'FMASU MS 717/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PUQE score', 'type': 'OTHER', 'description': 'The Pregnancy-Unique Quantification of Emesis (PUQE) is a scoring system to quantify the severity of nausea and vomiting of pregnancy (NVP). Based on quantification of the 3 physical symptoms of NVP (nausea, vomiting and retching)'}, {'name': 'GAD-7', 'type': 'OTHER', 'description': 'The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day"'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khaled IA Abdalla, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Ebtihal M El Taieb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'For 2 years after completion and publication of the study', 'ipdSharing': 'YES', 'description': 'study protocol and analytic code will be shared after completion and publication of the study', 'accessCriteria': 'An email will be sent upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rania Hassan Mostafa', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}