Not Yet RecruitingPhase 1ACTRN12622000314729

Receiving, Intravenous fluids for Moderate to Severe nausea and vomiting in pregnancy, at home, In the Community (IMSIC)

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.


Sponsor

Women's Health Initiative Translation Unit (WHITU)

Enrollment

150 participants

Start Date

Mar 4, 2022

Study Type

Interventional

Conditions

Summary

The aim of this project is to examine the implementation of a new model of care. This model of care will involve giving intravenous therapy (IVT) to women with nausea and vomiting of pregnancy in their home. We aim to assess if the number of times women present to emergency departments is reduced by receiving IVT at home and to explore the acceptability, sustainability and feasibility of this model of care with both women who participate in the project and with clinicians and managers involved in delivery of hospital in the home care, midwifery and obstetrics.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Inclusion Criteria1

  • Pregnant with moderate to severe nausea or vomiting of pregnancy (PUQE-24 score of equal to or greater than 7).

Exclusion Criteria6

  • 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

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Interventions

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

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.


Locations(1)

Liverpool Hospital - Liverpool

NSW, Australia

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ACTRN12622000314729