Magnesium sulphate versus diazepam in the management of eclampsia: a randomized controlled trial

This randomized controlled trial compared the use of magnesium sulphate with diazepam as anticonvulsant in 51 eclamptic women. The use of magnesium sulphate was associated with less serious morbidity (in terms of recurrence of convulsions, cardiopulmonary problems, disseminated intravascular coagulopathy, and acute renal failure) but the difference was not statistically significant (relative risk 0.6; 95% CI 0.3 to 1.2). The one maternal death occurred in the magnesium sulphate group. Convulsions recurred in five (21%) women in the magnesium sulphate group and seven (26%) women in the diazepam group. Urine output poor enough to prompt diuretic stimulation was less frequent in the magnesium sulphate group than in the diazepam group (RR 0.3; 95% CI 0.1 to 0.9). Significantly fewer infants born in the magnesium sulphate group had low Apgar scores (less than 7 at 1 min) compared with those in the diazepam group (RR 0.6; 95% CI 0.4 to 0.9). There were two early neonatal deaths in the magnesium sulphate group, and three stillbirths in the diazepam group. This study suggests that magnesium sulphate has advantages over diazepam for the mother and the infant in the treatment of eclampsia, but the trial is small and should be replicated on a larger scale.     

Loading dose versus standard regime of magnesium sulfate in the management of eclampsia: a randomized trial

OBJECTIVE: To determine whether only loading dose of magnesium sulfate is effective in controlling convulsion in eclampsia. STUDY METHODS: This prospective study was conducted in Dhaka Medical College and Hospital, Bangladesh between July and November 1999. Eclamptic patients who were eligible for magnesium sulfate (MgSO4) therapy were randomly assigned by lottery to receive either only loading dose (n = 202) or standard regime (n = 199) of MgSO4. Besides the anticonvulsant, patients of both the groups were managed by same protocol for eclampsia management prepared by Eclampsia Working Group, Bangladesh. Efficacy of both the regimes was assessed by measuring the rate of recurrent convulsion. Results were expressed as mean +/- SD and a proportion. Statistical analysis was done using unpaired t-test, Z-test and chi2 test as appropriate. A P-value of < 0.05 was considered significant. RESULTS: At the time of randomization there were no significant differences between the two groups in terms of age (22.40 +/- 4.21 vs 22.49 +/- 4.67 years), parity (72.77% vs 70.35% primi), type of eclampsia (84.65% vs 85.42% antepartum eclampsia), number of convulsions (5.30 +/- 3.26 vs 5.48 +/- 3.32 times), gestational age (35.65 +/- 3.37 vs 35.13 +/- 3.26 weeks), systolic blood pressure (153.19 +/- 20.19 vs 154.17 +/- 22.32 mmHg), diastolic blood pressure (106.23 +/- 13.84 vs 105.60 +/- 12.88 mmHg), proteinuria (70.80% vs 72.36% had > + proteinuria) and Glasgow Coma Scale (GCS) (73.26% vs 75.88% > 8) for the loading and standard regime groups. There were also no differences between the two groups in mean fit and treatment interval (6.88 +/- 5.26 vs 7.12 +/- 4.29h), fit and delivery interval (11.35 +/- 10.22 vs 11 +/- 6.69h) and return of consciousness (10.94 +/- 8.29 vs 11.24 +/- 8.37h). The recurrent convulsion rate was almost the same in both the groups (3.96% in loading vs 3.51% in standard regime, P > 0.05). Case fatality rate was 4.45% and 5.02% in loading and standard regime groups, respectively (P > 0.05). CONCLUSION: Only loading dose of MgSO4 can control convulsion in eclampsia and it is as effective as standard regime.     

Magnesium sulphate for the prevention of eclampsia

The aim of this bi-monthly column is to highlight Cochrane Systematic Reviews of relevance to pregnancy and childbirth and to stimulate discussion on their implications for practice. The Cochrane Collaboration is an international organisation that prepares and maintains high quality systematic reviews to help people make well-informed decisions about healthcare and health policy. A systematic review searches, appraises and synthesises existing research to answer a specific research question. Residents in countries with a national license to The Cochrane Library, including the UK and Ireland, can access the Cochrane Library online free of charge through www.thecochranelibrary.com.     

Hospital, simulation center, and teamwork training for eclampsia management: a randomized controlled trial

OBJECTIVE: To compare the effectiveness of training for eclampsia in local hospitals and a regional simulation center, with and without teamwork theory. METHODS: This study is a randomized controlled trial of training in local hospitals and in a simulation center in the United Kingdom. Midwives and obstetricians working at participating hospitals were randomly assigned to 24 teams. Teams were randomly allocated to training in local hospitals or at a simulation center, and to teamwork theory or not. Performance was evaluated before and after training with a standardized eclampsia scenario captured on video. Outcome measures were completion of tasks, time to completion of tasks, administration of magnesium sulfate, and quality of teamwork. RESULTS: Training was associated with an increase in completion of basic tasks; 87% before training and 100% afterward. Basic tasks were completed more quickly; 55 seconds compared with 27 seconds, P=.012. The magnesium sulfate loading dose was administered by 61% of teams before training and by 92% afterward (P=.040). There was a shorter median time to administration (116 seconds less; P=.011). Training at the simulation center was not associated with additional improvement. Teamwork generally improved (median global score rose from 2.5 to 4.0; P<.001) but there was no additional benefit from teamwork training. CONCLUSION: Training resulted in enhanced performance with higher rates of completion for basic tasks, shorter times to administration of magnesium sulfate, and improved teamwork. There was no additional benefit from training in a simulation center, and none from teamwork theory. CLINICAL TRIAL REGISTRATION: ISRCTN, http://isrctn.org, ISRCTN67906788, reference number 0270030.     

Low-dose magnesium sulphate in the control of eclamptic fits: a randomized controlled trial

Context

Magnesium sulphate is now the gold standard for the control of eclamptic fits. The place of low-dose magnesium sulphate for the control of eclamptic seizures is yet to be determined.

Objectives

To determine the effectiveness of low-dose magnesium sulphate in controlling eclamptic fits.

Study design

Randomized controlled trial comparing low-dose with standardized dosing regimen.

Setting

Labour Unit of the department of Obstetrics and Gynecology Federal Medical Centre Azare, north-eastern Nigeria.

Protocol

Thirty-nine patients randomized into the low-dose regimen group received 9 g loading dose (4 g iv and 5 g im) and im maintenance of 2.5 g four hourly for 24 h post-delivery or post last fit, while the 33 patients in the standard dose regimen group received loading dose of 14 g followed by im maintenance dose of 5 g four hourly. In both study groups, 2 g iv of magnesium sulphate is given for breakthrough fits and 10 ml of 10 % calcium gluconate (slowly iv) was administered in the event of toxicity. Outcome measures include recurrent fits, mode of delivery, mean Apgar Score at 5 min, perinatal death, maternal complications including death.

Result

The mean age of the 72 patients was 22.3 ± 5.4 years and 60 % were primigravidas. Intrapartum eclampsia was encountered in 44 % of the patients followed by antepartum eclampsia (26 %). Overall 4.2 % recurrent convulsion rate was documented and it is not different among the study groups. There were also no differences in both foetal and maternal outcomes in the two study groups.

Conclusion

The effectiveness of low-dose regimen of magnesium sulphate appeared comparable to the ‘standard dose regimen’. Low-dose regimen may guarantee more safety and in an environment (such as ours) where cost is an important determinant of accessibility to qualitative health services, it is certainly attractive. More studies are needed to establish the place of low-dose regimen of magnesium sulphate in the management of eclampsia.     

Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide

Purpose

Primary objective was to assess whether oral analgesia with oxycodone offers superior pain relief after cesareans than patient controlled analgesia (PCA). Secondary outcomes were additional pain medication, time to first mobilization, therapeutic side effects, postoperative restrictions, overall satisfaction and costs.

Materials and methods

Randomized controlled trial at a University Hospital conduct between July 2009 and November 2009. Of the 1,112 patients, 257 met the inclusion criteria and 239 agreed to participate. Patients were randomly assigned to either receive intravenous piritramide PCA (2?mg piritramide/ml 0.9?% saline) or oral oxycodone (20?mg). Pain was assessed on a visual analog pain scale (VAS) at 2, 12, 24, 32, 40, 48 and 72?h after cesarean.

Results

No differences in VAS scores were observed within the general study population. Pain scores of oxycodone versus PCA were comparable at 24?h. Patients randomized to PCA demonstrated increased demand for rescue medication 48?h after cesarean (p?=?0.057). In the PCA group, patients with previous cesarean had increased operative times, a trend towards increased VAS scores after 48?h (p?=?0.081) and increased VAS scores in comparison to patients who did not have cesarean before (p?=?0.044). For this subgroup, no difference was seen in the oxycodone patients (p?=?0.883).

Conclusion

General satisfaction with both treatment regimes was high. The results support the potential use of oral pain regimes and emphasis the importance of a multimodal approach to treat post-cesarean pain. Oral oxycodone is a not expensive, convenient and comparable analgesic to PCA devices with opioids after cesarean. Trial registration at clinicaltrials.gov identifier: NCT 01115101.     

Magnesium supplementation during pregnancy: a double-blind randomized controlled clinical trial

Four hundred young normotensive primigravid women between 13 and 24 weeks' gestation were randomly allocated to one of two study groups. One group received placebo tablets and the other group received 365 mg of elemental magnesium daily (as magnesium aspartate hydrochloride). Three hundred seventy-four patients completed the study, 189 in the placebo group and 185 in the treatment group. There were no significant differences between the two groups regarding serum calcium, uric acid, or electrolyte levels. However, the magnesium-supplemented group had significantly higher magnesium levels at delivery (1.68 +/- 0.03 mg/dl vs. 1.56 +/- 0.03 mg/dl, p less than 0.01). There were no significant differences in either systolic or diastolic blood pressures between both groups either at time of enrollment or at subsequent gestational ages later during pregnancy. Analysis of variance for repeated measurements and Fisher's least significant difference testing indicated a significant increase (p less than 0.01) in blood pressure from the level at the time of enrollment to the level achieved at or beyond 37 weeks' gestation in each group. There were no significant differences between the two groups regarding any of the following parameters: incidences of preeclampsia, fetal growth retardation, preterm labor, birth weight, gestational age at delivery, or number of infants admitted to the special care unit. Magnesium supplementation during pregnancy did not improve pregnancy outcome in our population.     

Magnesium sulfate in women with mild preeclampsia: a randomized controlled trial

OBJECTIVE: To determine whether magnesium sulfate prevents disease progression in women with mild preeclampsia. METHODS: A total of 222 women with mild preeclampsia were randomized to receive intravenous magnesium sulfate (n = 109) or matched placebo (n = 113). Mild preeclampsia was defined as blood pressure of at least 140/90 mm Hg taken on two occasions in the presence of new-onset proteinuria. Patients with chronic hypertension or severe preeclampsia were excluded. Patients were considered to have disease progression if they developed signs or symptoms of severe preeclampsia, eclampsia, or laboratory abnormalities of full or partial HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome. RESULTS: The groups were similar with respect to maternal age, ethnicity, gestational age, parity, and maternal weight at enrollment. Fourteen women (12.8%) in the magnesium group and 19 (16.8%) in the placebo group developed severe preeclampsia after randomization (relative risk = 0.8, 95% confidence interval 0.4, 1.5, P =.41). None in either group developed eclampsia or thrombocytopenia. Women assigned magnesium had similar rates of cesarean delivery (30% versus 25%), chorioamnionitis (3% versus 2.7%), endometritis (5.3% versus 4.3%), and postpartum hemorrhage (1% versus 0.9%), compared to those assigned placebo. Neonates born to women assigned magnesium had similar mean Apgar scores at 1 and 5 minutes as those born to women assigned placebo (7.7 +/- 1.5 versus 7.8 +/- 1.6 and 8.7 +/- 0.7 versus 8.8 +/- 0.6, respectively). CONCLUSION: Magnesium sulfate does not have a major impact on disease progression in women with mild preeclampsia. Magnesium use does not seem to increase rates of cesarean delivery, infectious morbidity, obstetric hemorrhage, or neonatal depression.     

Microwave endometrial ablation versus endometrial resection: a randomized controlled trial

OBJECTIVE: To compare menstrual status, satisfaction, and acceptability of microwave endometrial ablation with transcervical endometrial resection for the treatment of heavy menstrual bleeding. METHODS: Women were randomized to either endometrial ablative method. Menstrual status, satisfaction, acceptability, and changes in health-related quality of life were obtained by a self-completed questionnaire. Case note review and personal communication identified further surgery rates at 2 years after each procedure. RESULTS: Among the original 263 women who underwent endometrial ablation, 249 (95%) returned questionnaires at 2 years. Menstrual status in both groups was similar, although the amenorrhea rate was higher after microwave endometrial ablation. Seventy-nine percent of women were either completely or generally satisfied after microwave ablation compared with 67% after transcervical endometrial resection. Health-related quality-of-life scores remained higher than at recruitment for both treatments. Hysterectomy rates were similar at 2 years (11.6% after microwave endometrial ablation and 12.7% after transcervical endometrial resection), and no repeat endometrial ablative procedures were required. CONCLUSION: Microwave endometrial ablation is an effective alternative to transcervical endometrial resection for dysfunctional uterine bleeding.     

Rectal versus oral misoprostol for active management of third stage of labor: a randomized controlled trial

Aim of the study  

To test that rectal misoprostol is effective for active management of third stage of labor, and probably with less side effects than oral misoprostol.     

Fluid supplementation in management of neonatal hyperbilirubinemia: a randomized controlled trial

Objective: To evaluate the efficacy of oral or intravenous fluid supplementation in accelerating the decline of serum bilirubin with intensive phototherapy among healthy term and late preterm neonates with hyperbilirubinemia.

Study design: This open-label randomized controlled trial randomized neonates with severe hyperbilirubinemia (serum total bilirubin ≥18?mg/dL or within 2?mg/dL of threshold for exchange transfusion) to receive 50?mL/kg of intravenous fluid over 8?h (IVF group, n?=?51), 50?mL of oral rehydration solution over 8?h (oral rehydration solution (ORS) group, n?=?50) or only standard therapy (control group, n?=?49). Intensive phototherapy was administered in all the three study groups.

Result: Over 8?h of intervention, serum bilirubin declined by 15.5% (95% CI: 11.7–19.4%) in IVF group, by 9.1% (95% CI: 7.3–10.9%) in ORS group and by 8.0% (95% CI: 6.2–9.7%) in control group (p?Conclusions: Intravenous fluid supplementation may result in a faster decline of STB in first few hours of treatment. However, with the use of intensive phototherapy, there was no effect on overall duration of phototherapy or need of exchange transfusion.

Clinical Trial Registration: Clinical trial registry of India: REF/2015/09/009775     

Early versus late amniotomy for labour induction: a randomized controlled trial

Objective: To evaluate the impact of early vs. late amniotomy on delivery mode in women undergoing induction of labor. Study design: 143 women admitted for induction were randomized to early amniotomy (EA, concomitant with the beginning of oxytocin infusion; n = 71) or to late amniotomy (LA, four hours after the beginning of oxytocin; n = 72). Randomization was stratified by parity. The primary outcome was the rate of cesarean. Secondary outcomes were duration of labor and intrapartum fever. Results: The cesarean rate was similar between groups (18% vs. 17% among nulliparous; and 3% vs. 0% among parous women, in EA and LA group, respectively). However, EA was associated with shorter oxytocin-to-delivery interval (12 vs. 15?h) and a non-significant decrease in intrapartum fever (3% vs. 25%) than LA in nulliparous women (p = 0.05). Conclusion: For women undergoing oxytocin induction, early amniotomy is associated with shorter labor in nulliparous women with no effect on the risk of cesarean section in both nulliparous and multiparous women.     

A randomised controlled trial of intravenous magnesium sulphate versus placebo in the management of women with severe pre-eclampsia

Objective To determine whether the administration of prophylactic intravenous magnesium sulphate reduces the occurrence of eclempsia in women with severe pre-eclampsia.
Design Randomised controlled trial.
Setting A tertiary referral obstetric unit.
Population Eight hundred and twenty-two women with severe pre-eclampsia requiring termination of pregnancy by induction of labour or caesarean section.
Methods The women were randomised to receive either placebo (saline) or magnesium sulphate intravenously. The investigators were blinded to the contents of the pre-mixed solutions.
Main outcome measure The occurrence of eclampsia in the two groups.
Results The data of 699 women were evaluated. Fourteen were withdrawn after randomisation. The overall incidence of eclampsia was 1.8%. Of 345 women who received magnesium sulphate, one developed eclampsia (0.3%); in the placebo group, 11/340 women (3.2%) developed eclampsia (relative risk 0.09; 95% confidence interval 0.01–0.69;   P = 0.003  ).
Conclusion The use of intravenous magnesium sulphate in the management of women with severe pre-eclampsia significantly reduced the development of eclampsia.     

A novel protocol for postpartum magnesium sulphate in severe pre-eclampsia: a randomized controlled pilot trial

Objective: Magnesium sulphate is the preferred anticonvulsant used to prevent the development of fits in severe pre-eclampsia; we aim to compare between three different protocols of postpartum magnesium sulphate in the effectiveness of preventing the development of fits in severe pre-eclampsia.

Methods: Double-blind randomized controlled pilot trial, done in Cairo university hospital, Cairo, Egypt during 2013–2014, on 240 women with severe pre-eclampsia. Magnesium sulphate intravenous infusion was given in the postpartum period to all the patients, women were randomly allocated to group I (Single loading dose only), group II (12?h abbreviated protocol) or group III (24?h standard protocol) (n?=?80 in each group).

Results: There were no significant difference between the three groups as regards the incidence of eclampsia, elevated liver enzymes and low platelets syndrome, maternal ICU admission and; however The incidence of flushing was significantly higher in group III than group II and I (24 [30%] versus 12 [15%] versus 4 [5%]; p?<?0.001) respectively.

Conclusion: The pilot study demonstrates that the single-loading dose of postpartum magnesium sulphate is a promising alternative to the standard and the abbreviated protocol in preventing eclampsia; however, a large clinical trial is necessary to prove this.     

Phenytoin sodium and magnesium sulphate in the management of eclampsia

Summary. Twenty-two patients with eclampsia were randomly allocated to receive either intravenous phenytoin sodium or intravenous magnesium sulphate. The groups were comparable. No side-effects occurred and therapeutic levels were obtained in both groups. While none of the 11 patients managed with magnesium sulphate had further convulsions, four of the 11 treated with phenytoin sodium did and were subsequently effectively treated with magnesium sulphate. These results suggest that phenytoin sodium is not as effective an anticonvulsant in eclampsia as is magnesium sulphate.     

Phenytoin sodium and magnesium sulphate in the management of eclampsia

Twenty-two patients with eclampsia were randomly allocated to receive either intravenous phenytoin sodium or intravenous magnesium sulphate. The groups were comparable. No side-effects occurred and therapeutic levels were obtained in both groups. While none of the 11 patients managed with magnesium sulphate had further convulsions, four of the 11 treated with phenytoin sodium did and were subsequently effectively treated with magnesium sulphate. These results suggest that phenytoin sodium is not as effective an anticonvulsant in eclampsia as is magnesium sulphate.