Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT01013558
Status:
COMPLETED
Last Update Posted:
2009-12-08
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Options for Preoperative Anesthesia in Intrauterine Needling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-07', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2009-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol', 'timeFrame': '15-60 minutes'}], 'secondaryOutcomes': [{'measure': 'influence of analgesics (remifentanil) on the fetal stress response', 'timeFrame': '15-60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fetal pain', 'intrauterine', 'needling'], 'conditions': ['Stress', 'Pain']}, 'referencesModule': {'references': [{'pmid': '35553414', 'type': 'DERIVED', 'citation': 'Andrewartha K, Grivell RM. Perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures. Cochrane Database Syst Rev. 2022 May 13;5(5):CD011068. doi: 10.1002/14651858.CD011068.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy\n* clinically indicated intrauterine transfusion\n* red cell alloimmunisation\n\nExclusion Criteria:\n\n* severe adipositas\n* suspicion of structural anomalies\n* fetal hydrops\n* contraindication for remifentanil'}, 'identificationModule': {'nctId': 'NCT01013558', 'acronym': 'NO PAIN', 'briefTitle': 'New Options for Preoperative Anesthesia in Intrauterine Needling', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling', 'orgStudyIdInfo': {'id': 'P04.014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': '0.15 microgram/kg/min continuous infusion.', 'armGroupLabels': ['remifentanil']}, {'name': 'saline', 'type': 'DRUG', 'description': 'continuous infusion', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Frank P.H.A. Vandenbussche, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leuven University Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'F.P.H.A. Vandenbussche, MD PhD', 'oldOrganization': 'Leiden University Medical Center'}}}}