Pre-eclampsiaNCT02613793
Saccadic Reaction Time and Preterm Pre-eclampsia
An observational study of Pre-eclampsia, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant patients with preterm pre-eclampsia diagnosed earlier than 35 weeks gestation (cases) and healthy age- and gestation-matched pregnant patients (controls)
Who may be able to join
- Age ≥ 18 years
- Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
- Gestational age < 35+0 weeks
- Participant is willing and able to give informed consent
- Age ≥ 18 years
- Absence of essential hypertension and pre-eclampsia or pregnancy-induced hypertension in current and previous pregnancies
- Gestational age < 35+0 weeks
- Participant is willing and able to give informed consent
Who cannot join
- Maternal neurological or psychiatric disorder (e.g. epilepsy, migraine, multiple sclerosis, depression, etc.)
- Use of medication (other than vitamin supplements [cases and controls] and those for treatment or prevention of pre-eclampsia [cases]) during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Case Control Feasibility Study to Investigate the Utility of Saccadometry in the Diagnosis and Monitoring of Preterm Pre-eclampsia
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.
Currently 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).
Read more
If 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.
By 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.
Read the detailed description
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].
- Conditions
- Pre-eclampsia
- Keywords
- Preterm pre-eclampsia, Neurological dysfunction, Saccadic reaction time
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm pre-eclampsia (cases) | Pregnant patients diagnosed with pre-eclampsia prior to 35 weeks gestation | |
| Pregnant patients (controls) | Age- and gestation-matched pregnant patients who are not suffering with pre-eclampsia, hypertensive disease or any other neuropsychiatric condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccadic reaction times in patients with preterm pre-eclampsia
Attainment of 3000 saccades from women with preterm pre-eclampsia
Measured: Baseline (Day 0)
Secondary outcomes (3)
Comparison of median latency of saccadic reaction time
Intra-individual and case control comparisons of saccadic reaction time median latency
Measured: 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
Comparison of standard deviation of saccadic reaction time median latency
Intra-individual and case control comparisons of standard deviation of saccadic reaction time median latency
Measured: 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
Comparison of standard deviation of early saccadic reaction time median latency
Intra-individual and case control comparisons of standard deviation of early saccadic reaction time median latency
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion30 May 2019
- Study completion30 May 2019
Why it stopped: unable to recruit in suitable time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Lucy MacKillop, Oxford University Hospitals NHS Trust
- Investigators
- Lucy Mackillop, BM BCh FRCP, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613793
- Sponsor's protocol ID
- a11496
- Status last verified
- May 2019
- First submitted
- 2 Sep 2015
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 18499505Hogberg 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.
PubMed 16332605Brown 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.
PubMed 12044323Altman 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.
PubMed 12057549Sibai 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.
PubMed 21962629Liddell 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
Carpenter RHS. The saccadic system: a neurological microcosm. Advances in Clinical Neuroscience and Rehabilitation. 2004;4:6-8
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.
PubMed 6864248Antoniades 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.
PubMed 17589313Michell 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.
PubMed 16544135Chandna 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.
PubMed 22492423Pearson 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.
PubMed 17496064Tranquilli 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.
PubMed 26104417
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Control Feasibility Study to Investigate the Utility of Saccadometry in the Diagnosis and Monitoring of Preterm Pre-eclampsia
- ClinicalTrials.gov ID
- NCT02613793
- Acronym / sponsor ID
- a11496
- Conditions
- Pre-eclampsia
- Keywords
- Preterm pre-eclampsia, Neurological dysfunction, Saccadic reaction time
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: unable to recruit in suitable time frame
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Jan 2016
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Currently 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).
If 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.
By 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.
Detailed description
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].
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm pre-eclampsia (cases) | – | –Pregnant patients diagnosed with pre-eclampsia prior to 35 weeks gestation |
| Pregnant patients (controls) | – | –Age- and gestation-matched pregnant patients who are not suffering with pre-eclampsia, hypertensive disease or any other neuropsychiatric condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients with preterm pre-eclampsia diagnosed earlier than 35 weeks gestation (cases) and healthy age- and gestation-matched pregnant patients (controls)
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
- Gestational age < 35+0 weeks
- Participant is willing and able to give informed consent
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Maternal neurological or psychiatric disorder (e.g. epilepsy, migraine, multiple sclerosis, depression, etc.)
- Use of medication (other than vitamin supplements [cases and controls] and those for treatment or prevention of pre-eclampsia [cases]) during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saccadic reaction times in patients with preterm pre-eclampsia
Time frame: Baseline (Day 0)
Attainment of 3000 saccades from women with preterm pre-eclampsia
3 secondary outcomes
Comparison of median latency of saccadic reaction time
Time frame: 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
Comparison of standard deviation of saccadic reaction time median latency
Time frame: 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
Comparison of standard deviation of early saccadic reaction time median latency
Time frame: 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
Results and safety
The study was stopped early (reason given: unable to recruit in suitable time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- BackgroundTuffnell, 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
- Background: PubMed 18499505Irminger-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.
- Background: PubMed 16332605Hogberg 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.
- Background: PubMed 12044323Brown 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.
- Background: PubMed 12057549Altman 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.
- Background: PubMed 21962629Sibai 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.
- BackgroundLiddell 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
- BackgroundCarpenter RHS. The saccadic system: a neurological microcosm. Advances in Clinical Neuroscience and Rehabilitation. 2004;4:6-8
- Background: PubMed 6864248Hikosaka 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.
- Background: PubMed 17589313Antoniades 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.
- Background: PubMed 16544135Michell 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.
- Background: PubMed 22492423Chandna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Mackillop, BM BCh FRCP principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unable to recruit in suitable time frame). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saccadic reaction times in patients with preterm pre-eclampsia (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613793, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.