Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia

NCT03549767 | Unknown

• 1 other identifier: REC 2018-015
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium Sulphate is the drug of choice for prevention and treatment of seizures in preeclampsia and eclampsia. It is administered parenterally by intravenous (IV) and or intramuscular (IM) routes. The IM regimen requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.

Conditions

Preeclampsia and Eclampsia

Outcome Measures

Primary Outcomes (1)

• Acceptability of Springfusor

  Acceptability of Springfusor for administration of magnesium sulphate will be assessed using a Likert scale ranging from one (very acceptable) to five (very unacceptable).

  At 24 hours after loading dose

Secondary Outcomes (3)

• Discontinuation

  24 hour after the loading dose

• Level of pain

  At 24 hours after loading dose

• Safety of springfusor

  within 24 hours

Study Arms (2)

Springfusor

EXPERIMENTAL

Women in this group will have their loading dose (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 20 minutes) and maintenance therapy (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 4 hours through an IV infusion administered using a Springfusor pump.. The 4 gm maintenance dose will be repeated every 4 hours for 24 hours.

Device: Springfusor

Standard of care

ACTIVE COMPARATOR

The control group will have Magnesium sulphate administered using the Pritchard regimen, which involves administration of loading dose of 4 gm of 20% Magnesium sulphate IV over 15-20 minutes, immediately followed by 10 gm of 50% Magnesium sulphate IM (5gm on each buttock). The maintenance dose of 5 gm of 50% Magnesium sulphate IM every 4 hourly in alternate buttocks continued for 24 hours

Procedure: Standard of care

Interventions

Springfusor DEVICE

Springfusor for administration of magnesium sulphate

Springfusor

Standard of care PROCEDURE

Pritchard regimen. Magnesium sulphate is administered using hospital practice

Standard of care

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include pregnant women with age of 15 years and above
• Pregnancy of 20+ weeks of gestation or delivered within 24 hours,
• Presenting with preeclampsia and eclampsia i.e. have a raised blood pressure (systolic of \>140 mmHg and diastolic \> 90mmHg), proteinuria \>1+.
• Presenting within the study period
• Consent to participate in the study.

You may not qualify if:

• Pregnant women or delivered within 24 hours who admitted with had received magnesium sulphate 24 hours prior to admission,
• Has known allergy to magnesium sulphate and
• Has elevated serum creatinine (\>1.2 mg/dl). However the participants may be enrolled prior to the knowledge of serum creatinine, but withdrawn if the level is \>1.2 mg/dl.

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mualgo Hospital

Kampala, Central Region, +256, Uganda

Location

Related Publications (1)

• Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

  PMID: 37815037 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sam Ononge, PhD

  Makerere University College of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Ononge, PhD

CONTACT

+256772486301; ononge2006@yahoo.com

Annettee Nakimuli, PhD

CONTACT

+256772471618; annettee.nakimuli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is testing the acceptability of the device (springfusor) in the administration of magnesium suphate

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)