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Drug use; Magnesium sulphate; Ras Desta Damtew memorial hospital

Introduction

Background

Hypertension is a common medical problem that complicates pregnancy. It may be, manifested as chronic hypertension, chronic hypertension with super imposed preeclampsia, Pregnancy induced hypertension, preeclampsia or eclampsia.

Hypertensive disorders in pregnancy can be manifested by increased blood pressure (BP) greater than or equal to 140/90 mmHg during pregnancy. Measured four hours apart and after 20 week of gestational age. The presence of the other clinical symptoms and signs of hypertension in pregnancy depends on the severity of the disease [1].

Pre-eclampsia (PE) is part of pregnancy induced hypertension (PIH) which is defined as a BP > 140/90mmHg in the presence of significant proteinuria of greater than 300 mg per 24 hours urine Specimen or, less accurately, more than 1+ protein (equivalent to Approximately 100mg/dl) on dipstick in at least two randomly collected Urine specimen at least 6 hours apart after the 20th week of gestation or up to 6 weeks postpartum.

Preeclampsia with severity features (Sever Preeclampsia) is the presence of Diastolic BP > 110 mmHg and the systolic BP ≥160mmHg measured twice at least six hours apart or a single measurement of >120mmHg, Hyperbilirubinemia, Hemolytic anemia, Thrombocytopenia (Less than 100,000/μL), Elevated Liver Enzymes (HELLP syndrome), Disseminated Intravascular Coagulation (DIC), Headache, visual disturbance and right upper abdominal pain, Oliguria ( less than 400ml in 24hours or 30ml/hour), Cardiac decompensation, pulmonary edema, cyanosis, Exaggerated Deep Tendon Reflexes (DTR).

Eclampsia is the occurrence of convulsions in woman who meets the diagnostic criteria for pre-eclampsia. Any convulsion occurring during pregnancy is eclampsia unless Proven otherwise. Anti-convulsants such as Magnesium Sulphate (MgSO₄), as well as antihypertensive medication, are rarely required for patients on conservative management (mild preeclampsia). Delivery is the definitive treatment for mother with sever preeclampsia. The primary objective is to prevent convulsion, intracranial bleeding and other vital organ damage.

MgSO₄ is one of the main interventions used to decrease the morbidity and mortality from preeclampsia/eclampsia. In 2011, MgSO₄ was been strongly suggested by the World Health Organization (WHO) to be the drug of choice for both treatment and prevention of eclampsia. Ethiopian Food and Drug Authority also recommends this; loading dose of 4gm as 20% solution IV over 10-15 minutes followed by 10gm as 50% IM injection divided on two sides of the buttock, followed by maintenance dose of 5gm every 4 hours as 50% concentration over 2minutes, 2gm IV as 50% solution over 2minutes if convulsion recurs. And, reduce the maintenance dose by half if there are signs of renal impairment during labor and for the first 24 hours postpartum [2].

Adverse Drug Effects associated with the use of MgSO₄ can be Respiratory Paralysis, pulmonary edema, depressed tendon reflexes, hypotension and hypocalcaemia. Therefore, renal function, BP, respiratory rate (RR), and DTR should be monitored when MgSO₄ is administered parenterally. Hypersensitivity, myocardial damage, diabetic coma, hypermagnesemia, hypercalcemia, and administration during 2 hours preceding delivery for mothers with toxemia of pregnancy. In patients with renal impairment it has to be ensured that renal excretory capacity is not exceeded by halving the recommended dose.

Significance of the study

The findings from this study could fill the gap in the obstetric use of MgSO₄ in the management of PE/E. This would identify problems in MgSO₄ use and suggest for further studies by researchers and healthcare facilities.

Methodology

Study area and study period

The study was conducted in Obstetrics wards of Ras Desta Damtew Memorial Hospital (RDDMH) from October 1 2022 to September 30, 2023 G.C. The hospital was established in 1924 E.C. RDDMH is located in Addis Ababa, Ethiopia. It has Medical, Surgical, Obstetrics and Gynecology, and Pediatrics services. In addition, there are ENT, Dental, Ophthalmology, ART, TB treatment and follow up services [3].

Study design

A retrospective cross-sectional study design was used.

Study population

All patients who received MgSO₄ for the management of PE/E.

Sampling technique and sample size determination

Purposive sampling technique was used and 240 patient charts were collected, organized and sorted based on their MRN and according to WHO recommended sample size (75-100) for performing hospital DUE,100 charts were selected by systematic random sampling technique. From the 100 charts, 13 were excluded because there was no documentation of MgSO₄.

Data collection procedures

Before commencing to data collection permission was received from the hospital Drug and Therapeutic Committee (DTC).  Data was collected by two DUE trained personnel. The tool was adopted from Ethiopian National Medicine Use Study Guideline, 2021.  And customized to our study objective. Data was directly filled on to MS-Excel data base.

Data processing and analysis

Data cleaning was performed after which it was imported to IBM SPSS Statistics Version 21.

Limitation of the study

The limitation of the study was that it did not address the frequency of MgSO₄ administration and control of seizure frequency. And it did not address the consumption of MgSO₄ vials [4].

Results

As shown in Figure 1, From 87 patient chart reviewed the minimum age of mothers was 17 and the maximum age was 40 years with median age of 27 years. And 26.5% of the mothers were within the range of 15-24 years of age, the majority of mothers were within the range of 25-34 years of age (61%) and the remaining 12.5% of mothers were within the range of 35-40 years of age (Figure 1).

Figure 1: Age of pregnant mothers for the study of drug use evaluation on magnesium sulphate use in obstetric wards: the case of Ras Desta Damtew memorial hospital 2023 GC.

From the total charts reviewed only 16.1% of the charts had a documentation of the mothers’ weight. When the pregnancies are classified based on gestational age; 13.8% were less than 28 weeks, 42.5% were in the range of 28-37 weeks of gestation, 37.9% were in the range of 37-42 weeks, and there were no pregnancies above 42 weeks of gestation. And 5.7% of the pregnancies were of unknown gestational age by date or estimation. 41.4% of the mothers in this study were primigravida while the rest 58.6% were multigravida (Figure 2). 

Figure 2: Gestational age distribution for the study of drug use evaluation on magnesium sulphate use in obstetric wards: the case of Ras Desta Damtew memorial hospital 2023 GC.

From the total charts reviewed 5.7% of the mothers had previous history of pre-eclampsia/eclampsia and 1.1% had concomitant disease which was Gestational Diabetes. The diagnosis of mothers in the study period were categorized in as mild pre-eclampsia, sever pre-eclampsia and eclampsia which were 9.2%, 83.9% and 6.9% respectively. There was no mother who developed eclampsia after admission. 80(92%) of the mothers had an indication. (5.7%) mothers were assessed to have pulmonary edema and all of them were given Furosemide injection [5].

As shown in figure 3 below, 21 (24.1%) of the mothers were Nifedipine co-administered with MgSO₄ from which none of them had developed a drug-drug interaction. This was assessed by BP monitoring of the patients obtained from the pre-eclampsia/eclampsia monitoring chart. There were 4(4.6%) patient with renal impairment were being administered MgSO₄. There was no record of adverse drug reaction/toxicity developed due to MgSO4. It was found that 49.4% of mothers had a documented dose of MgSO4 as per STG. From the total 87 mothers 81(93.1%) of them were given MgSO4 with the STG recommended duration (24-48hrs) (Figure 3).

Figure 3: Summary of study findings for the study of drug use evaluation on magnesium sulphate use in obstetric wards: the case of Ras Desta Damtew memorial hospital 2023 GC.

Urine output and DTR were monitored for 82(94.3%) and 37(42.5%) patients respectively. While Respiratory rate was monitored for all mothers. 85(97.7%) of the mothers were improved while 2(2.3%) got worsened and referred to a tertiary hospital.

The assessment of Prescriber’s information showed that prescribers full name and qualification were written in 86(98.9) and 85(97.7%) respectively. While signature and date of prescribing were recorded in all of the charts.

Discussion

Being pregnant at age 35 or more is one of the highest risks of developing PE/E. A study done at Omdurman Maternity Hospital at Sudan showed the 25-34 years of age was the largest age group of women with preeclampsia/eclampsia.  Our study result also showed that mothers between ages 25-34 were the largest group of women with PE/E which is 60.7% (Alsiddig Y et.al, 2019) [6]. 

Body weight is strongly correlated with progressively increased PE risk, ranging from 4.3% from women with body mass index(BMI) below 20 kg/m2 to 13.3% in those with a BMI over 35 kg/m2 (Knight et.al, 2010). In our study the weight of mother was recorded only for 16.1%. This shows that there is a gap in the identification of risk factors for Preeclampsia by healthcare providers during ANC.

The study finding revealed that only 5 of the mothers had previous history of PE/E which can be the risk factor for developing recurrent PE/E and on which magnesium sulphate can be administered as a preventive therapy and all of those mothers were given MgSO4. From the findings of the study it can be concluded that most of the mothers were diagnosed with severe PE (83.9), while only some of them were diagnosed with mild PE and E (9.2% and 6.9% respectively). From the total mothers 80 (92%) were found to have appropriate indication for MgSO₄. This finding is below our set threshold which was 95%. So 7 mothers took MgSO4 without indication, this includes those who were given MgSO₄ for mild PE which is not recommended and also it can be due to patients who were given MgSO₄ who did not fulfil the criteria for preventive therapy of PE/E [7].

Only 49.4% of the mothers took appropriate dose of MgSO₄ as recommended by the STG which is much deviated from the set threshold 95%. This does not mean that those mothers did not take the recommended dose because this study did not assess that, but on the patient charts physicians did not record the recommended dose correctly on the order sheet. They just order it ‘as per protocol’ which is not correct. Even if the dosing protocol is found in the obstetric wards of the hospital, it is mandatory to write the loading and maintenance of MgSO₄. This was a great obstacle which made it difficult for us to know the exact quantity of MgSO₄ the patient took.

Only 4(4.6%) of the mothers had renal impairment while 83 (95.4%) of them did not have renal impairment. This result is above the set criteria for contraindication of MgSO₄ administration which was 95%. MgSO₄ contraindication in pregnant mother not an absolute contraindication. There needs to be dose reduction by half. It was written on the order sheet as ‘reduce the recommended dose by half’ but we did not find the exact dose administered on the medication sheet.

The drug-drug interaction between MgSO₄ and Nifedipine is moderate (not significant). When Nifedipine is given with MgSO₄ has a synergistic physiologic effect which is hypotension which needs close monitoring of BP. The result of the study showed that 21 (24.1%) of the mothers were Nifedipine co-administered with MgSO₄.  They were assessed for reduced BP, from which none of them developed a drug-drug interaction. So the result is 100% which is greater than the set threshold which was 90% [8].

The outcome of treatment showed that 85 (97.7%) of the mothers were discharged improved. While only 2(2.3%) mothers got worsened and refereed to tertiary hospital. This finding is above the set threshold which was 95%. This result shows that MgSO₄ is an effective choice of medication for the control of seizures in PE/E.

Urine output and DTR were monitored for 82(94.3%) and 37(42.5%) patients respectively. While Respiratory rate was monitored for all mothers.  On this study we found that a significant drawback exists in the monitoring of patients taking MgSO₄. Mothers monitored for all the three parameters were 36(41.4%) which is below the set 100% threshold.  

The assessment of Prescriber’s information showed that prescribers full name and qualification were written in 86(98.9%) and 85(97.7%) respectively. While signature and date of prescribing were recorded in all of the charts. Orders with all the four parameters recorded were 96.5% which is below the set 100% threshold (Figure 4) [9].

Figure 4: Findings compared with thresholds’ for the study of drug use evaluation on magnesium sulphate use in obstetric wards: the case of Ras Desta Damtew memorial hospital 2023 GC 2023.

Conclusion and Recommendation

• The study findings revealed that documentation of mother’s weight was poor; where weight (BMI) increment is a significant risk factor for PE/E. there for we strongly recommend the measurement of pre pregnancy or first ANC weight (BMI).
• Indications for MgSO₄ administration was found appropriate for most of the mothers, but there were mothers found taking MgSO₄ against STG recommendations. However, it is ultimately the decision of the attending healthcare providers to start MgSO₄.
• The dose of MgSO₄ was not recorded correctly on order sheets, so we recommend physicians to write the full recommended loading and maintenance dose and also we recommend nurses to record each administered doses of MgSO₄ including the route.
• Overall the correct dose of Mgso₄ is not recorded obstetric order sheets.
• It is recommended that the duration of MgSO₄ to be 24-48 hours as per STG. We found some gaps only on some mothers who were given MgSO₄ below and above this duration, so it may be due to documentation gap, mothers response to treatment or duration of seizures. We strongly recommend for a complete documentation of MgSO₄ duration of administration.
• Since there is a gap in monitoring of patients and recording on PE/E follow up chart. We strongly recommend the maternity ward staff to monitor and record Urine output, DTR and RR.
• Prescribers name, qualification, signature and date of prescription must be written on all orders.
• We found that charts in the gynecology/obstetrics ward are disorganized which made it difficult for us to find the exact data we wanted. But now since electronic medical recording is started it may fill this gap.

Acknowledgement

We would like to we would like to thank our hospital DTC, Research and Training Department for the technical assistance and decisions passed on ethical procedures. We thank the Obstetrics and Gynecology Department, and Medical Record Room for their great cooperation in providing assistance and retrieval of patient charts. Our deepest gratitude also goes to Federal Ministry of Health of Ethiopia and World Health Organization for organizing the orientation and providing of the tools, technical assistance in data analysis and preparation of the final document.

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