Viewing Study NCT05310929



Ignite Creation Date: 2024-05-06 @ 5:27 PM
Last Modification Date: 2024-10-26 @ 2:29 PM
Study NCT ID: NCT05310929
Status: COMPLETED
Last Update Posted: 2022-04-05
First Post: 2022-03-27

Brief Title: Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia
Sponsor: Ain Shams University
Organization: Ain Shams University

Study Overview

Official Title: Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia
Status: COMPLETED
Status Verified Date: 2022-03
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: Two hundred patients with severe PE were admitted prepartum to the ICU to stabilize blood pressure They were randomly assigned to one of two groups 100 in each group Group N received nitroglycerine intravenous infusion in a concentration of 1 mgml thus 1µgKgmin equals to 48 mlhr for an 80 Kg patient Group L received labetalol intravenous infusion in a concentration of 10 mg ml thus 50 mgml equals to 5 mlhr The starting infusion rate of the antihypertensive medication was 5 mlhr The infusion rate was titrated to stabilize systolic blood pressure SBP at 130-140 mmHg and diastolic blood pressure DBP at 80-90 mmHg study end point by adjusting the infusion rate as required either by maintaining the same infusion rate or by changing its infusion rate by 1 mlhr up or down according to the clinical condition every 10 minutes On any abrupt reduction in blood pressure below 120 mmHg for SBP or 80 mmHg for DBP the infusion was immediately discontinued and a bolus of 150 ml lactate ringer was given
Detailed Description: Patients and Methods The study was conducted in the intensive care unit ICU of the Obstetrics and Gynaecology Hospital of Ain-Shams University as a randomized double-blind and placebo-controlled study on patients diagnosed with severe PE from July 2016 to June 2018 The study was approved by Ethical Research Committee at Ain Shams University ethical number FMASU R 472019 and all participants provided written informed consent

Woman eligible for this study were aged between 18-40 years old at greater than 34 weeks of gestation having severe PE without severe features without imminence of eclampsia or clinical manifestations of target organ damage as per the ACOG criteria 7 Severe PE was diagnosed by severe hypertension systolic blood pressure 160 mmHg or diastolic blood pressure 110 mmHg repeated measurement should be taken for confirmation no more than 15 minutes later presence of clinically significant proteinuria 03 grams or more of protein in 24-hour urine collection or urinary proteincreatinine ratio of 30 or more8

Exclusion criteria were patients with chronic hypertension imminence of eclampsia target organ damage active asthma and congestive heart failure Patients with any known allergy to one of the study drugs are also excluded

Two hundred patients with severe PE were admitted prepartum to the ICU to stabilize blood pressure They were randomly assigned to one of two groups 100 in each group Group N received nitroglycerine intravenous infusion in a concentration of 1 mgml thus 1µgKgmin equals to 48 mlhr for an 80 Kg patient Group L received labetalol intravenous infusion in a concentration of 10 mg ml thus 50 mgml equals to 5 mlhr The starting infusion rate of the antihypertensive medication was 5 mlhr The infusion rate was titrated to stabilize systolic blood pressure SBP at 130-140 mmHg and diastolic blood pressure DBP at 80-90 mmHg study end point by adjusting the infusion rate as required either by maintaining the same infusion rate or by changing its infusion rate by 1 mlhr up or down according to the clinical condition every 10 minutes On any abrupt reduction in blood pressure below 120 mmHg for SBP or 80 mmHg for DBP the infusion was immediately discontinued and a bolus of 150 ml lactate ringer was given

Randomization was attained by using orderly numbered opaque sealed envelopes containing computer-generated random allocations

Patients received full intensive care treatment for PE according to the standard protocol of the obstetric ICU of Ain-Shams University All treatments were provided by physicians who were not involved in the study including infusion of lactated Ringer solution at a starting rate of 75 mlhr and then adjusted according to the fluid balance magnesium sulfate 4 gm IV loading dose over a period of 10 minutes and 1 gmhr IV infusion until 24 hours after delivery as seizure prophylaxis its dose was adjusted according to renal function in addition to antihypertensive medications according to the assigned group The study solution was stopped if maternal pulse reached less than 60 bpm or increased more than 110 bpm

Vital signs were monitored at admission and until patients were discharged from the ICU using ECG pulse oximetry continuous invasive arterial blood pressure monitoring through radial artery and an indwelling catheter for urine output assessment

Assessment of fetal well-being was done before starting of the study in the form of cardiotocography CTG modified biophysical profile doppler US on umbilical artery and growth scan In addition continuous fetal heart rate monitoring was done by CTG during the study time

Severe persistent hypertension was considered when SBP was greater than 160 mmHg or DBP was greater than 110 mmHg after the administration of maximum dose of allocated drug treatment 20 mlhr Hence patient was shifted to sodium nitroprusside infusion after 2 hours of starting treatment with assigned drugs

After stabilization of the patient and once the target BP was achieved induction of labor was started using 3 mg prostaglandin E2 PGE2 vaginal tablet It was to be repeated after 6 hours if needed In case oxytocin was to be used it was administered at least 6 hours apart from PGE2 last dose

If the patient was not eligible for induction of labor as in case of previous cesarean delivery CS transverse lie of the fetus and other standard obstetrical indications CS was done at once CS was also performed in case of failed induction of labor no uterine contractions nor cervical changes after 6mg of PGE2 fetal compromise arrest of progress of labor arrest of cervical dilatation arrest of fetal descent and in case of moderate or severe accidental hemorrhage

The following data were recorded and included demographic characteristics the time taken to control blood pressure time from starting infusion till reaching study end point and number of sudden attacks of hypotension BP values below the desired level In addition side effects of drugs such as tachycardia HR100 bpm bradycardia HR60 bpm headache nauseavomiting hypotension flushing dizziness were recorded The mode of delivery either vaginal or caesarean section was also recorded Fetal outcome regarding stillbirths death in utero at or after 20 weeks gestation and suspected fetal compromise by abnormal CTG continuous or progressive fetal bradycardia 100 bpm reduced fetal heart rate variability 5 bpm that last more than 90 minutes atypical variable decelerations with over 50 of contractions late decelerations for 30 minutes single prolonged decelerations for more than 3 minutes or sinusoidal pattern more than 10 minutes 1 min Apgar score less than 7- and 5-minutes Apgar score less than 7 were also recorded

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None