Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-06-06 @ 7:58 PM
Study NCT ID:
NCT01846156
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Magnesium Sulphate Protocol for Pre-eclampsia
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 52013 | REGISTRY | Kasr Aliny | View |