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

Phase 1

• Conditions: Reproductive Health and Childbirth - Antenatal care; Moderate to severe nausea or vomiting of pregnancy and hyperemesis gravidarum (NVPHG).

• Registration Number: ACTRN12622000314729
• Lead Sponsor: Women's Health Initiative Translation Unit (WHITU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-21
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>[End of therapy and completion of trial participation];Acceptable level of symptom management using the PUQE-24 [At Study entry, daily over the three days of IVT at home and on study exit.]