Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-07 @ 6:51 AM
Study NCT ID:
NCT02082795
Status:
UNKNOWN
Last Update Posted:
2014-03-10
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Women's Views on the Management of a Breech Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D001946', 'term': 'Breech Presentation'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-06', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mothers' opinions on anaesthesia for external cephalic version", 'timeFrame': 'Immediate', 'description': 'This is a qualitative study using information gathered during a semi-structured interview. All information will be gathered at the time of the interview. There will be no other followup.'}], 'secondaryOutcomes': [{'measure': "Mothers' opinions on management of breech presentation", 'timeFrame': 'Immediate', 'description': 'This is a qualitative study using information gathered during a semi-structured interview. All information will be gathered at the time of the interview. There will be no other followup.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breech presentation', 'External cephalic version', 'Anaesthesia', 'Qualitative', 'Pregnancy'], 'conditions': ['Presentation; Breech, Complicating Pregnancy']}, 'descriptionModule': {'briefSummary': 'The investigators aim to perform a qualitative study to explore the views of women with a breech presentation on their management in general, and the use of anaesthesia or analgesia for ECV in particular.', 'detailedDescription': 'Background\n\nWomen undergo external cephalic version (ECV) in order to turn a baby in a breech (bottom, or feet down) presentation to a head down position. The procedure traditionally has about a 40% success rate and may be painful, issues that recent literature suggests puts some women off.\n\nPain relief using a short acting morphine-like painkiller, called remifentanil, can significantly reduce the pain experienced but does not seem to improve ECV success rates. Alternatively, a spinal anaesthetic (similar to that used for a caesarean section) can be used. This increases success rates to around 60% and very effectively reduces pain; however, it is an invasive procedure with potential complications and requires a hospital stay of at least half a day.\n\nAims and objectives\n\nThe investigators aim to perform a qualitative study to explore the views of women with a breech presentation on their management in general, and the use of anaesthesia or analgesia for ECV in particular.\n\nMethods\n\nThe investigators will use a semi-structured interview to explore the views of 10-15 expectant mothers recruited from the Breech Clinic at Chelsea and Westminster Hospital. Interviews will be recorded and then transcribed for thematic analysis by two researchers.\n\nDissemination of output\n\nTo our knowledge, this will be the first report on how women view the use of regional anaesthesia and remifentanil analgesia for ECV. In addition, we will add the views of our patient population to the existing literature concerning the management of ECV in general. The investigators anticipate that this information will be used to plan services and to guide future research.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women found to have a fetus in a breech presentation at \\>34 weeks gestation following a presentation scan in Chelsea and Westminster Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breech presentation\n* eligible for an external cephalic version attempt\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Previous caesarean section\n* English not sufficient to carry out the interview'}, 'identificationModule': {'nctId': 'NCT02082795', 'briefTitle': "Investigating Women's Views on the Management of a Breech Pregnancy", 'organization': {'class': 'OTHER', 'fullName': 'Chelsea and Westminster NHS Foundation Trust'}, 'officialTitle': "Investigating Women's Views on the Management of a Breech Pregnancy", 'orgStudyIdInfo': {'id': 'breechqualyv1'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Angus Rivers, MBBS BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Angus Rivers, MBBS BSc', 'role': 'CONTACT', 'email': 'angusrivers@outlook.com'}], 'overallOfficials': [{'name': 'Steve Yentis, BSc MBBS MD MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea and Westminster Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}