Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02613793
Status:
TERMINATED
Last Update Posted:
2019-06-03
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saccadic Reaction Time and Preterm Pre-eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'unable to recruit in suitable time frame', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-30', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-11-22', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saccadic reaction times in patients with preterm pre-eclampsia', 'timeFrame': 'Baseline (Day 0)', 'description': 'Attainment of 3000 saccades from women with preterm pre-eclampsia'}], 'secondaryOutcomes': [{'measure': 'Comparison of median latency of saccadic reaction time', 'timeFrame': 'Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum', 'description': 'Intra-individual and case control comparisons of saccadic reaction time median latency'}, {'measure': 'Comparison of standard deviation of saccadic reaction time median latency', 'timeFrame': 'Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum', 'description': 'Intra-individual and case control comparisons of standard deviation of saccadic reaction time median latency'}, {'measure': 'Comparison of standard deviation of early saccadic reaction time median latency', 'timeFrame': 'Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum', 'description': 'Intra-individual and case control comparisons of standard deviation of early saccadic reaction time median latency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm pre-eclampsia', 'Neurological dysfunction', 'Saccadic reaction time'], 'conditions': ['Pre-eclampsia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Tuffnell, DJ, Shennan, AH, Waugh, JJS, and Walker, JJ. The management of severe pre-eclampsia/eclampsia, guideline number 10(A). Royal College of Obstetricians and Gynaecologists, London; 2006'}, {'pmid': '18499505', 'type': 'BACKGROUND', 'citation': 'Irminger-Finger I, Jastrow N, Irion O. Preeclampsia: a danger growing in disguise. Int J Biochem Cell Biol. 2008;40(10):1979-83. doi: 10.1016/j.biocel.2008.04.006. Epub 2008 Apr 11.'}, {'pmid': '16332605', 'type': 'BACKGROUND', 'citation': 'Hogberg U. The World Health Report 2005: "make every mother and child count" - including Africans. Scand J Public Health. 2005;33(6):409-11. doi: 10.1080/14034940500217037. No abstract available.'}, {'pmid': '12044323', 'type': 'BACKGROUND', 'citation': 'Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available.'}, {'pmid': '12057549', 'type': 'BACKGROUND', 'citation': 'Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.'}, {'pmid': '21962629', 'type': 'BACKGROUND', 'citation': 'Sibai BM. Management of late preterm and early-term pregnancies complicated by mild gestational hypertension/pre-eclampsia. Semin Perinatol. 2011 Oct;35(5):292-6. doi: 10.1053/j.semperi.2011.05.010.'}, {'type': 'BACKGROUND', 'citation': 'Liddell E and Sherrington C, Reflexes in Response to Stretch (Myotatic Reflexes. Proceedings of the Royal Society of London. Series B, Containing Papers of a Biological Character, Vol. 96, No. 675 (May 1, 1924), pp. 212-242'}, {'type': 'BACKGROUND', 'citation': 'Carpenter RHS. The saccadic system: a neurological microcosm. Advances in Clinical Neuroscience and Rehabilitation. 2004;4:6-8'}, {'pmid': '6864248', 'type': 'BACKGROUND', 'citation': 'Hikosaka O, Wurtz RH. Visual and oculomotor functions of monkey substantia nigra pars reticulata. I. Relation of visual and auditory responses to saccades. J Neurophysiol. 1983 May;49(5):1230-53. doi: 10.1152/jn.1983.49.5.1230. No abstract available.'}, {'pmid': '17589313', 'type': 'BACKGROUND', 'citation': 'Antoniades CA, Altham PM, Mason SL, Barker RA, Carpenter R. Saccadometry: a new tool for evaluating presymptomatic Huntington patients. Neuroreport. 2007 Jul 16;18(11):1133-6. doi: 10.1097/WNR.0b013e32821c560d.'}, {'pmid': '16544135', 'type': 'BACKGROUND', 'citation': "Michell AW, Xu Z, Fritz D, Lewis SJ, Foltynie T, Williams-Gray CH, Robbins TW, Carpenter RH, Barker RA. Saccadic latency distributions in Parkinson's disease and the effects of L-dopa. Exp Brain Res. 2006 Sep;174(1):7-18. doi: 10.1007/s00221-006-0412-z. Epub 2006 Mar 17."}, {'pmid': '22492423', 'type': 'BACKGROUND', 'citation': 'Chandna A, Chandrasekharan DP, Ramesh AV, Carpenter RH. Altered interictal saccadic reaction time in migraine: a cross-sectional study. Cephalalgia. 2012 Apr;32(6):473-80. doi: 10.1177/0333102412441089. Epub 2012 Apr 5.'}, {'pmid': '17496064', 'type': 'BACKGROUND', 'citation': 'Pearson BC, Armitage KR, Horner CW, Carpenter RH. Saccadometry: the possible application of latency distribution measurement for monitoring concussion. Br J Sports Med. 2007 Sep;41(9):610-2. doi: 10.1136/bjsm.2007.036731. Epub 2007 May 11.'}, {'pmid': '26104417', 'type': 'BACKGROUND', 'citation': 'Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This study is recruiting two groups of women over the age of 18; those who are pregnant and who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to seizures in pregnancy (eclampsia) and may prove fatal for mother and child.\n\nCurrently the only effective treatment for pre-eclampsia is control of the mother's blood pressure until it is safe to deliver the baby. The timing of delivery is kept under constant review by the medical team, who must balance the risk to the mother of developing eclampsia against the risk to the baby of being born too early (premature).\n\nIf pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing this is not easy, so we want to assess whether measuring other reaction times might similarly help assess the risk of seizures. One possibility is by measuring the reaction time as we flick our eyes to follow a moving target, using an instrument called a saccadometer, which is worn on a head-band, a little like a head-torch.\n\nBy comparing the results between these groups and the non-pregnant women, we will be able to see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if so, whether saccadometry might be useful in helping doctors decide the best time for safe delivery.", 'detailedDescription': 'Prospective feasibility study with two arms; (i) case-control comparisons of saccadic reaction time distributions between patients with preterm pre-eclampsia, age- and gestation-matched pregnant controls and age-matched female non-pregnant controls \\[cross-sectional analysis\\]; (ii) intra-individual comparisons of antenatal and postnatal saccadic reaction time distributions of patients with preterm pre-eclampsia \\[longitudinal analysis\\].'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients with preterm pre-eclampsia diagnosed earlier than 35 weeks gestation (cases) and healthy age- and gestation-matched pregnant patients (controls)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for cases:\n\n1. Age ≥ 18 years\n2. Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)\n3. Gestational age \\< 35+0 weeks\n4. Participant is willing and able to give informed consent\n\nInclusion criteria for controls:\n\n1. Age ≥ 18 years\n2. Absence of essential hypertension and pre-eclampsia or pregnancy-induced hypertension in current and previous pregnancies\n3. Gestational age \\< 35+0 weeks\n4. Participant is willing and able to give informed consent\n\nExclusion Criteria:\n\n1. Maternal neurological or psychiatric disorder (e.g. epilepsy, migraine, multiple sclerosis, depression, etc.)\n2. Use of medication (other than vitamin supplements \\[cases and controls\\] and those for treatment or prevention of pre-eclampsia \\[cases\\]) during pregnancy'}, 'identificationModule': {'nctId': 'NCT02613793', 'briefTitle': 'Saccadic Reaction Time and Preterm Pre-eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'A Prospective Case Control Feasibility Study to Investigate the Utility of Saccadometry in the Diagnosis and Monitoring of Preterm Pre-eclampsia', 'orgStudyIdInfo': {'id': 'a11496'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm pre-eclampsia (cases)', 'description': 'Pregnant patients diagnosed with pre-eclampsia prior to 35 weeks gestation'}, {'label': 'Pregnant patients (controls)', 'description': 'Age- and gestation-matched pregnant patients who are not suffering with pre-eclampsia, hypertensive disease or any other neuropsychiatric condition'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Lucy Mackillop, BM BCh FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cambridge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Obstetric Physician', 'investigatorFullName': 'Lucy MacKillop', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}