New Magnesium Sulphate Protocol for Pre-eclampsia

NCT ID: NCT01846156

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-04-30

Brief Summary

there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

Detailed Description

The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.

The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-

• Systolic blood pressure ≥ 160.
• Diastolic blood pressure ≥ 110.
• Proteinuria > +2 by dip stick.
• Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
• Fetal growth restriction (IUGR).

After obtaining an informed consent the patients will be subjected to the following:

• Careful history taking including age, parity, gestational age.
• Complete physical examination and assessment of the blood pressure.
• Urine analysis by dipstick.
• All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .

Using Random Number Table, the sample size will be divided into three categories:-

• Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
• Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
• Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.

Inclusion criteria:

• Pregnant females ≥20 weeks of gestation.
• Pregnant females with criteria of severe pre-eclampsia.
• Single or multi-fetal pregnancy.
• Primigravida or Multigravida.

Exclusion criteria:

• Pregnant females < 20 weeks gestation.
• Pregnant females with history of epilepsy.
• Pregnant females with diabetes.
• Pregnant females with chronic hypertension.
• Pregnant females with renal disease.

Conditions

Pre-eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Abrreviated MgSO4 protocol

\- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.

Group Type: EXPERIMENTAL

MgSO4

Intervention Type: DRUG

A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University

No maintenance protocol

\- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate

Group Type: EXPERIMENTAL

MgSO4

Intervention Type: DRUG

A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University

standard MgSO4 protocol

\- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.

Group Type: ACTIVE_COMPARATOR

MgSO4

Intervention Type: DRUG

A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University

Interventions

MgSO4

A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant females ≥20 weeks of gestation.
• Pregnant females with criteria of severe pre-eclampsia.
• Single or multi-fetal pregnancy.
• Primigravida or Multigravida.

Exclusion Criteria

• Pregnant females < 20 weeks gestation.
• Pregnant females with history of epilepsy.
• Pregnant females with diabetes.
• Pregnant females with chronic hypertension.
• Pregnant females with renal disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Waleed El-khayat

Assistant Professor of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed El-khayat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 37815037 (View on PubMed)

Other Identifiers

52013

Identifier Type: REGISTRY

Identifier Source: secondary_id

52103

Identifier Type: -

Identifier Source: org_study_id