Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000314729p
Ethics application status
Submitted, not yet approved
Date submitted
24/01/2022
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Receiving, Intravenous fluids for Moderate to Severe nausea and vomiting in pregnancy, at home, In the Community (IMSIC)
Scientific title
Assessing dissemination and feasibility of the Implementation of a new model of care, in the community, for women with moderate to severe nausea or vomiting of pregnancy.
Secondary ID [1] 306220 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMSIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe nausea or vomiting of pregnancy and hyperemesis gravidarum (NVPHG). 324942 0
Condition category
Condition code
Reproductive Health and Childbirth 322372 322372 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivery of intravenous fluid therapy (Hartmans Fluid 3 L/24hrs per day) at home for women presenting to hospital emergency department (ED) with NVPHG who have a PUQE-24 score of greater than or equal to seven.

Women who have consented to receive intravenous fluid therapy at home will be provided with a fact/information sheet about NVPHG. Women will receive usual care in the ED going home with an intravenous cannula (IVC) in place to received further intravenous fluid therapy (IVT) in their home. IVT at home will be administered over three consecutive days by a home visiting community midwife or nurse.

This three day management of NVPHG at home will follow existing local health district (LHD) ambulatory care guidelines for women with NVPHG. Women will be asked to complete a Nausea and vomiting of pregnancy quality of life questionnaire (NVPQOL), the Productivity Cost Questionnaire (iPCQ) and the EQ-5D-3L survey at study entry and on completion of the three days of IVT. Participants will be asked to complete a 24hour Pregnancy unique quantifier of emesis (PUQE-24) daily over the three days of treatment then at study follow up phone call, along with a satisfaction survey. The community midwife or nurse will complete a Visual infusion Phlebitis score (VIP) score daily of the IVC site.

The PUQE-24 score will assist the home visiting midwife or nurse to assess effectiveness of IVT for each women and arrange appropriate medical review. Women will receive two to three litres of IVT each day, delivered at 500 ml to one litre per hour. The three day IVT management plan can be re commenced as many times as a women requires for the duration of her NVPHG.

Strategies to monitor adherence include: measurement of fluid left each day by visiting staff, interrogation of pump for running times and errors and daily assessment by visiting staff to assess if any other medications taken

Qualitative interviews will be conducted with 10 to 15 participants in the intervention and analysed thematically. Clinicians and managers (6 to 10) involved in the care of women with hyperemesis gravidarum will be sought to participate in qualitative interviews that will be analysed using content analysis to assess fidelity. Every woman sequentially will be invited to partake in the qualitative interviews. We expect to require about 6-10 women to reach saturation.
Intervention code [1] 322623 0
Treatment: Drugs
Comparator / control treatment
Retrospective/historical data analysis of ED presentations and admission for NVPHG over Jan 2021 and Dec 2021 within the LHD. The time to be covered retrospectively will match the time the study is to be undertaken. eg we expect it to take 12 months to recruit and hence the 12months retrospective data collection. If the study takes 18 months, we will retrospectively collect 18 months. ie it will be matched.
Control group
Historical

Outcomes
Primary outcome [1] 330137 0
Primary outcome 1: Acceptability, feasibility and sustainability will be assessed through semi-structured interviews of intervention participants (10 to 15) at completion of their treatment and 6 to 10 clinicians or managers involved in the delivery of care to women with NVPHG, these will be analysed thematically.

Timepoint [1] 330137 0
End of therapy and completion of trial participation
Primary outcome [2] 330138 0
Acceptable level of symptom management using the PUQE-24
Timepoint [2] 330138 0
At Study entry, daily over the three days of IVT at home and on study exit.
Secondary outcome [1] 405010 0
Avoidable emergency presentations. This will be assessed by checking their electronic medical records to assess for any re-presentations to the hospitals in the district. We are also going to undertake a linkage analysis with the admitted patient database to ensure we have not missed any admission in other local health districts.

Avoidable presentations are illnesses of low acuity eg Triage category 3-5 that do not require admission.
Timepoint [1] 405010 0
During remainder of pregnancy. This will be assessed every week.
Secondary outcome [2] 405011 0
Avoidable emergency presentations. This will be assessed by checking their electronic medical records to assess for any re-presentations to the hospitals in the district. We are also going to undertake a linkage analysis with the admitted patient database to ensure we have not missed any admission in other local health districts.

Avoidable presentations are illnesses of low acuity eg Triage category 3-5 that do not require admission.
Timepoint [2] 405011 0
Within the next 12 weeks from recruitment
Secondary outcome [3] 405012 0
Service utilization / encounters. This will be assessed by checking their electronic medical records to assess for any encounters within the health district. We are also going to undertake a linkage analysis with the non-admitted patient database as well as the MBS (Medicine Benefits scheme) to ensure we have also assessed encounters with primary health.
Timepoint [3] 405012 0
Remainder of pregnancy. The data for the LHD will be assessed every week and the MBS data will be collected at the end of the study.
Secondary outcome [4] 405013 0
Service utilization / encounters. This will be assessed by checking their electronic medical records to assess for any encounters within the health district. We are also going to undertake a linkage analysis with the non-admitted patient database as well as the MBS (Medicine Benefits scheme) to ensure we have also assessed encounters with primary health.
Timepoint [4] 405013 0
Within the next 12 weeks from recruitment
Secondary outcome [5] 405014 0
NVPQOL - Nausea vomitting of Pregnancy quality of life assessment (covers 4 domains: physical symptoms and aggravating factors, fatigue, emotions and limitations).
Timepoint [5] 405014 0
at study exit
Secondary outcome [6] 405015 0
iPCQ- productivity questionnaire
Timepoint [6] 405015 0
At study exit
Secondary outcome [7] 405016 0
EQ-5D-3L - more general quality of life assessment
Timepoint [7] 405016 0
At study exit
Secondary outcome [8] 405017 0
Miscarriage. This will be assessed from medical records and by asking the women on follow up phone call.
Timepoint [8] 405017 0
Remainder of the pregnancy. This will be assessed 6-8 weeks after trial inclusion and at the expected delivery date.
Secondary outcome [9] 405018 0
Hypertensive disorder of pregnancy. This will be assessed from medical records and by asking the women on follow up phone call. The Society of Obstetric Medicine Australia and New Zealand (SOMANZ) criteria will be used for the definitions of the hypertensive disorders.
Timepoint [9] 405018 0
At end of the pregnancy
Secondary outcome [10] 405019 0
Gestational diabetes (GDM). This will be assessed from medical records and by asking the women on follow up phone call. The Australian Diabetes in Pregnancy Society (ADIPS) criteria will be used for this definition of GDM
Timepoint [10] 405019 0
At end of the Pregnancy
Secondary outcome [11] 405020 0
Deep venous thrombosis (DVT) or venous thromboembolism (VTE). This will be assessed from medical records and by asking the women on follow up phone call.
Timepoint [11] 405020 0
Till the end of the pregnancy. This will be assessed at the 6-8 week post trial follow up call and at the end of the pregnancy follow up.
Secondary outcome [12] 405335 0
Cannula site infections. This will be assessed from medical records, but mainly by visual inspection. The staff will undertake a Visual Infusion Phlebitis Score (as per local health district policy)
Timepoint [12] 405335 0
During the study (daily) and within 1 week of end of participation in study.
Secondary outcome [13] 405336 0
Intrauterine growth restriction. This will be assessed from medical records and by asking the women on follow up phone call.. IUGR will be considered if the baby is less than the 5th or the 10th centile.
Timepoint [13] 405336 0
Diagnosed during any time during pregnancy on fetal ultrasound. The frequency of scans will be based on routine clinical practice- this is at the discretion of the treating clinicians. This will be assessed at the end of the pregnancy.
Secondary outcome [14] 405337 0
Number of medications given for hyperemesis. This will be assessed by the daily visiting research midwife.
Timepoint [14] 405337 0
End of trial participation. This will be assessed daily over the three days of the therapy at home.
Secondary outcome [15] 405338 0
Number of medications given for hyperemesis. This will be assessed by asking the women on the telephone as well as by collecting the MBS and PBS data.
Timepoint [15] 405338 0
Within 12 weeks of trial completion
Secondary outcome [16] 405339 0
Pregnancies terminated. This will be assessed by asking the women on the telephone as well as by collecting the MBS and PBS data.
Timepoint [16] 405339 0
End of pregnancy
Secondary outcome [17] 405340 0
Baby Birth weight. This will be extracted from the medical record which is the weight measured by the birthing midwife on electronic scales.
Timepoint [17] 405340 0
At delivery
Secondary outcome [18] 405341 0
Gestation at delivery. This will be calculated from the agreed date of delivery based on the initial dating ultrasound.
Timepoint [18] 405341 0
At delivery
Secondary outcome [19] 405342 0
Presence of any congenital abnormalities. This will be assessed at delivery when the babies have a physical examination by the pediatrician as well as if any congenital abnormalities are noted during fetal ultrasounds that may occur as part of clinic practice during the pregnancy.
Timepoint [19] 405342 0
Determined at delivery and during delivery admission
Secondary outcome [20] 405343 0
Neonatal morbidity (admission to NICU, sepsis, hypoglycaemia or other neonatal intervention not considered routine care) . This will be extracted from the neonatal discharge summary
Timepoint [20] 405343 0
6 weeks after delivery
Secondary outcome [21] 405344 0
Neonatal mortality. This will be assessed by examining the baby's medical record.
Timepoint [21] 405344 0
6 weeks from delivery

Eligibility
Key inclusion criteria
Pregnant with moderate to severe nausea or vomiting of pregnancy (PUQE-24 score of equal to or greater than 7).
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Not pregnant
Unwilling or unable to receive IVT at home
Patients with a condition that interferes with their ability to understand the study’s requirements.
Patients with an underlying health condition including Type 1 diabetes, renal or cardiac disease, epilepsy, short bowel syndrome or bariatric surgery that is likely to interfere with the evaluation of patient safety or the study outcome.
Severe electrolyte disturbance or a creatinine of >90umol/L
Other diagnosis that is contributing to NVPHG: thyrotoxicosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Comparison of the enrolled women with a 3:1 ratio comparison with historical controls (allowing for 80% power). By planning this analysis this will allow adequate power to assess for a reduced effect size to 30% (compared to the 50%reduction in the rate of admission or representations) between the control and the intervention group. Any differences in baseline data between the two groups will be adjusted for by using regression as appropriate. Data distribution assessed and appropriate test used to determine differences between groups for continuous and categorical data.
Thematic analysis of semi structured in-depth interviews

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2022
Actual
Date of last participant enrolment
Anticipated
6/03/2023
Actual
Date of last data collection
Anticipated
6/11/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21543 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 36450 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 310569 0
Hospital
Name [1] 310569 0
South West Sydney Local Health District
Country [1] 310569 0
Australia
Primary sponsor type
Hospital
Name
Women's Health Initiative Translation Unit (WHITU)
Address
1 Campbell Street, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 311813 0
None
Name [1] 311813 0
Address [1] 311813 0
Country [1] 311813 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310176 0
SWSLHD HREC
Ethics committee address [1] 310176 0
Ethics committee country [1] 310176 0
Australia
Date submitted for ethics approval [1] 310176 0
30/11/2021
Approval date [1] 310176 0
Ethics approval number [1] 310176 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116758 0
Prof Angela Makris
Address 116758 0
WHITU, 1 Campbell St Liverpool, NSW 2170.
Country 116758 0
Australia
Phone 116758 0
+61 2 87383788
Fax 116758 0
+61 2 8738 3718
Email 116758 0
[email protected]
Contact person for public queries
Name 116759 0
Angela Makris
Address 116759 0
WHITU, 1 Campbell St Liverpool, NSW 2170.
Country 116759 0
Australia
Phone 116759 0
+61 2 87383788
Fax 116759 0
+61 2 8738 3718
Email 116759 0
[email protected]
Contact person for scientific queries
Name 116760 0
Angela Makris
Address 116760 0
WHITU, 1 Campbell St Liverpool, NSW 2170.
Country 116760 0
Australia
Phone 116760 0
+61 2 87383788
Fax 116760 0
+61 2 8738 3718
Email 116760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Will need ethical approval to access the IPD and enter into a collaborators agreement (CTRA) + confidentiality- IPD not generally available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.