Hyperemesis GravidarumDIMNCT00795561
Management of Nausea and Vomiting of Pregnancy
A study testing Day care and Inpatient in people with Hyperemesis Gravidarum and Nausea, run by University College Cork at 1 site in Ireland.
Trial summary
Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hyperemesis Gravidarum, Nausea, Vomiting
- What is being tested?
- Day care and Inpatient
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2009to Sep 2012
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women (no age limits) will be admitted to the study if they have two or more of the following criteria
- Ongoing viable intrauterine pregnancy/ pregnancies < 22 weeks gestation
- Persistent vomiting (>x3 episodes/ 24 hours) not attributable to other causes
- Severe nausea not attributable to other causes.
- Dehydration diagnosed by the presence of ketonuria.
- Electrolyte imbalance not attributable to other causes.
Who cannot join
- Women will not be admitted to the study if any of the following criteria are present.
- Women with a confirmed urinary tract infection (mid stream urine isolation of a single strain of uropathogen >105 bacteria/ml)
- Women with molar pregnancies
- Women with non viable pregnancies.
- Women who have already received treatment for NVP outside of this trial.
- Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland i.e. day care treatment is not an option.
- Women who do not have a good understanding of English.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Department of Obstetrics and Gynaecology, Cork University Maternity Hospital
Cork
About this study
Official title: Randomized Controlled Trial of Day Care Versus Inpatient Management of Nausea and Vomiting of Pregnancy
Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalization overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United States of America. The investigators aim to conduct a randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day and results in significantly greater patient satisfaction compared with standard inpatient management.
Read the detailed description
Upto 80% of all pregnant women experience some form of nausea and vomiting during their pregnancy (NVP). The International Statistical Classification of Disease and Related Health Problems ICD-10 defines hyperemesis gravidarum (HG) as persistent and excessive vomiting starting before the end of the 22nd week of gestation, and further subdivides the condition into mild and severe, severe being associated with metabolic disturbances such as carbohydrate depletion, dehydration or electrolyte imbalance. HG is a diagnosis of exclusion, characterized by prolonged and severe nausea and vomiting, dehydration, large ketonuria and > 5% bodyweight loss.
HG affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalisation overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United states. Taking into account other factors such as emergency room treatments, potential complications of severe HG and the fact that up to 35% of women with paid employment will lose time from work through nausea the actual cost of NVP to the economy is significantly higher.
NVP can be extremely debilitating for the patient and if inadequately managed can cause significant morbidities including malnutrition and electrolyte imbalances, thrombosis, Wernicke's encephalopathy, depressive illness and poor pregnancy outcomes such as prematurity and small for gestational age fetuses.
Day care has proven to be beneficial and safe mode of care for patients in other clinical settings. Studies have demonstrated that day care management of patients with NVP appears acceptable and feasible but no systematic reviews or randomized controlled trials have been performed which examine the effects of introducing day care on rates of hospital admission, duration of inpatient stay and patient satisfaction.
We aim to conduct a prospective open label randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day (28.6%) and results in significantly greater patient satisfaction compared with standard inpatient management.
The null hypothesis states there is no difference in the amount of inpatient hospital days when women with NVP are treated initially in day care or by standard inpatient admission.
All pregnant women under 22 weeks gestation, who have not already been treated for NVP in their current pregnancy, presenting with the diagnosis of NVP are eligible for inclusion in the trial. The treatment group will be day care treatment of NVP. The comparison group will be the inpatient treatment of NVP.
- Conditions
- Hyperemesis Gravidarum, Nausea, Vomiting, Pregnancy
- Being tested
- Day care, Inpatient
- Keywords
- Hyperemesis gravidarum, nausea, vomiting, pregnancy, day care, inpatient management, Nausea and vomiting of pregnancy
- Medical subject headings
- Hyperemesis Gravidarum, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day careProcedure or surgery
Also called day unit, day services
Patients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen.
InpatientProcedure or surgery
Also called admission
Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.
| Study group | Role | What they receive |
|---|---|---|
| Day care | Experimental | Patients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen. Receives: Procedure: Day care |
| Inpatient | Active comparator | Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen. Receives: Procedure: Inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the number of inpatient nights spent in hospital secondary to NVP from initial presentation until 22 weeks gestation. An inpatient night will be defined as requiring an inpatient bed between the hours of 20.00 and 08.00.
Measured: Following discharge
Secondary outcomes (9)
Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation.
Measured: 22 weeks gestation
Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation
Measured: 22 weeks gestation
Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.
Measured: 22 weeks gestation
Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation
Measured: 22 weeks gestation
Patient satisfaction will be measured by the Client Satisfaction Questionnaire.
Measured: Following first presentation
Incidence of miscarriage
Measured: 22 weeks gestation
Infant birth weight at delivery
Measured: Following delivery
Gestational age at delivery.
Measured: following delivery
Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation)
Measured: 16 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
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 Hyperemesis GravidarumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fergus McCarthy, University College Cork
- Investigators
- John R Higgins, MD, Principal investigator, Cork University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795561
- Sponsor's protocol ID
- ISRCTN05023126
- Other IDs
- ISRCTN05023126
- Acronym
- DIM
- Status last verified
- Jan 2014
- First submitted
- 20 Nov 2008
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gazmararian JA, Petersen R, Jamieson DJ, Schild L, Adams MM, Deshpande AD, Franks AL. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol. 2002 Jul;100(1):94-100. doi: 10.1016/s0029-7844(02)02024-0.
PubMed 12100809Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8.
PubMed 8373648World Health Organisation, International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Version for 2007.
Nelson-Piercy C. Treatment of nausea and vomiting in pregnancy. When should it be treated and what can be safely taken? Drug Saf. 1998 Aug;19(2):155-64. doi: 10.2165/00002018-199819020-00006.
PubMed 9704251Goodwin TM, Montoro M, Mestman JH. Transient hyperthyroidism and hyperemesis gravidarum: clinical aspects. Am J Obstet Gynecol. 1992 Sep;167(3):648-52. doi: 10.1016/s0002-9378(11)91565-8.
PubMed 1382389Hod M, Orvieto R, Kaplan B, Friedman S, Ovadia J. Hyperemesis gravidarum. A review. J Reprod Med. 1994 Aug;39(8):605-12.
PubMed 7996524Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.
PubMed 16150279Ismail SK, Kenny L. Review on hyperemesis gravidarum. Best Pract Res Clin Gastroenterol. 2007;21(5):755-69. doi: 10.1016/j.bpg.2007.05.008.
PubMed 17889806Sheehan P. Hyperemesis gravidarum--assessment and management. Aust Fam Physician. 2007 Sep;36(9):698-701.
PubMed 17885701Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005 Sep-Oct;11(5):527-39. doi: 10.1093/humupd/dmi021. Epub 2005 Jul 8.
PubMed 16006438Oates-Whitehead R. Nausea and vomiting in early pregnancy. Clin Evid. 2004 Jun;(11):1840-52. No abstract available.
PubMed 15652084Alalade AO, Khan R, Dawlatly B. Day-case management of hyperemesis gravidarum: Feasibility and clinical efficacy. J Obstet Gynaecol. 2007 May;27(4):363-4. doi: 10.1080/01443610701327396.
PubMed 17654186Attkisson, C.C., and Greenfield, T. K. (1995). The Client Satisfaction Questionnaire (CSQ) scales and the Service Satisfaction Scale- 30 (SSS-30). In L.I. Sederer & B. Dickey (Eds.) Outcomes assessment in clinical practice. (pp. 120-127) Baltimore, MD: Williams & Wilkins. (SSS-30 is reproduced in Appendix pp. 279-283).
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.
PubMed 11323066
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Day Care Versus Inpatient Management of Nausea and Vomiting of Pregnancy
- ClinicalTrials.gov ID
- NCT00795561
- Acronym / sponsor ID
- DIM / ISRCTN05023126
- Conditions
- Hyperemesis Gravidarum, Nausea, Vomiting, Pregnancy
- Keywords
- Hyperemesis gravidarum, nausea, vomiting, pregnancy, day care, inpatient management, Nausea and vomiting of pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Nov 2008 (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.
Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalization overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United States of America. The investigators aim to conduct a randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day and results in significantly greater patient satisfaction compared with standard inpatient management.
Detailed description
Upto 80% of all pregnant women experience some form of nausea and vomiting during their pregnancy (NVP). The International Statistical Classification of Disease and Related Health Problems ICD-10 defines hyperemesis gravidarum (HG) as persistent and excessive vomiting starting before the end of the 22nd week of gestation, and further subdivides the condition into mild and severe, severe being associated with metabolic disturbances such as carbohydrate depletion, dehydration or electrolyte imbalance. HG is a diagnosis of exclusion, characterized by prolonged and severe nausea and vomiting, dehydration, large ketonuria and > 5% bodyweight loss.
HG affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalisation overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United states. Taking into account other factors such as emergency room treatments, potential complications of severe HG and the fact that up to 35% of women with paid employment will lose time from work through nausea the actual cost of NVP to the economy is significantly higher.
NVP can be extremely debilitating for the patient and if inadequately managed can cause significant morbidities including malnutrition and electrolyte imbalances, thrombosis, Wernicke's encephalopathy, depressive illness and poor pregnancy outcomes such as prematurity and small for gestational age fetuses.
Day care has proven to be beneficial and safe mode of care for patients in other clinical settings. Studies have demonstrated that day care management of patients with NVP appears acceptable and feasible but no systematic reviews or randomized controlled trials have been performed which examine the effects of introducing day care on rates of hospital admission, duration of inpatient stay and patient satisfaction.
We aim to conduct a prospective open label randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day (28.6%) and results in significantly greater patient satisfaction compared with standard inpatient management.
The null hypothesis states there is no difference in the amount of inpatient hospital days when women with NVP are treated initially in day care or by standard inpatient admission.
All pregnant women under 22 weeks gestation, who have not already been treated for NVP in their current pregnancy, presenting with the diagnosis of NVP are eligible for inclusion in the trial. The treatment group will be day care treatment of NVP. The comparison group will be the inpatient treatment of NVP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day care | Experimental | Procedure: Day carePatients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen. |
| Inpatient | Active comparator | Procedure: InpatientPatients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women (no age limits) will be admitted to the study if they have two or more of the following criteria
- Ongoing viable intrauterine pregnancy/ pregnancies < 22 weeks gestation
- Persistent vomiting (>x3 episodes/ 24 hours) not attributable to other causes
- Severe nausea not attributable to other causes.
- Dehydration diagnosed by the presence of ketonuria.
Key exclusion criteria (7 listed)
- Women will not be admitted to the study if any of the following criteria are present.
- Women with a confirmed urinary tract infection (mid stream urine isolation of a single strain of uropathogen >105 bacteria/ml)
- Women with molar pregnancies
- Women with non viable pregnancies.
- Women who have already received treatment for NVP outside of this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day careAlso: day unit, day servicesPatients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen. | Procedure or surgery | Day care |
| InpatientAlso: admissionPatients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen. | Procedure or surgery | Inpatient |
Primary outcome
The primary outcome will be the number of inpatient nights spent in hospital secondary to NVP from initial presentation until 22 weeks gestation. An inpatient night will be defined as requiring an inpatient bed between the hours of 20.00 and 08.00.
Time frame: Following discharge
9 secondary outcomes
Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation.
Time frame: 22 weeks gestation
Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation
Time frame: 22 weeks gestation
Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.
Time frame: 22 weeks gestation
Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation
Time frame: 22 weeks gestation
Patient satisfaction will be measured by the Client Satisfaction Questionnaire.
Time frame: Following first presentation
Incidence of miscarriage
Time frame: 22 weeks gestation
Infant birth weight at delivery
Time frame: Following delivery
Gestational age at delivery.
Time frame: following delivery
Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation)
Time frame: 16 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Background: PubMed 12100809Gazmararian JA, Petersen R, Jamieson DJ, Schild L, Adams MM, Deshpande AD, Franks AL. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol. 2002 Jul;100(1):94-100. doi: 10.1016/s0029-7844(02)02024-0.
- Background: PubMed 8373648Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8.
- BackgroundWorld Health Organisation, International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Version for 2007.
- Background: PubMed 9704251Nelson-Piercy C. Treatment of nausea and vomiting in pregnancy. When should it be treated and what can be safely taken? Drug Saf. 1998 Aug;19(2):155-64. doi: 10.2165/00002018-199819020-00006.
- Background: PubMed 1382389Goodwin TM, Montoro M, Mestman JH. Transient hyperthyroidism and hyperemesis gravidarum: clinical aspects. Am J Obstet Gynecol. 1992 Sep;167(3):648-52. doi: 10.1016/s0002-9378(11)91565-8.
- Background: PubMed 7996524Hod M, Orvieto R, Kaplan B, Friedman S, Ovadia J. Hyperemesis gravidarum. A review. J Reprod Med. 1994 Aug;39(8):605-12.
- Background: PubMed 16150279Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.
- Background: PubMed 17889806Ismail SK, Kenny L. Review on hyperemesis gravidarum. Best Pract Res Clin Gastroenterol. 2007;21(5):755-69. doi: 10.1016/j.bpg.2007.05.008.
- Background: PubMed 17885701Sheehan P. Hyperemesis gravidarum--assessment and management. Aust Fam Physician. 2007 Sep;36(9):698-701.
- Background: PubMed 16006438Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005 Sep-Oct;11(5):527-39. doi: 10.1093/humupd/dmi021. Epub 2005 Jul 8.
- Background: PubMed 15652084Oates-Whitehead R. Nausea and vomiting in early pregnancy. Clin Evid. 2004 Jun;(11):1840-52. No abstract available.
- Background: PubMed 17654186Alalade AO, Khan R, Dawlatly B. Day-case management of hyperemesis gravidarum: Feasibility and clinical efficacy. J Obstet Gynaecol. 2007 May;27(4):363-4. doi: 10.1080/01443610701327396.
- Home page of Department of Obstetrics and Gynaecology, University College Cork, Cork University Maternity Hospital.Link provided by the sponsor.
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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.
John R Higgins, MD principal investigator
Cork University Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day care and Inpatient in people with Hyperemesis Gravidarum and Nausea, run by University College Cork at 1 site in Ireland.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 15 Jan 2014. 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 Ireland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome will be the number of inpatient nights spent in hospital secondary to NVP from initial presentation until 22 weeks gestation. An inpatient night will be defined as requiring an inpatient bed between the hours of 20.00 and 08.00. (time frame: Following discharge). 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 NCT00795561, 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 15 Jan 2014.