Prophylactic magnesium sulphate in prevention of eclampsia in women with severe preeclampsia: randomised controlled trial (PIPES trial)

Abstract

Optimum dose, route and duration of use of prophylactic magnesium sulphate in women with severe pre-eclampsia is still controversial. We compared the efficacy and safety of ‘low-dose Dhaka’ regime with ‘Loading dose only’ regime for seizure prophylaxis in severe preeclampsia using a randomised controlled trial in 402 women. The incidence of eclampsia in the ‘low-dose Dhaka’ regime group was 1.49% and that in the ‘Loading dose only regime’ was 2.98% (p = .321). In the low-dose Dhaka regime, injection site abscess and respiratory depression occurred in one woman each. Neonatal outcomes such as Apgar score at 5 minutes (5.0% vs. 8.05% p = .251) and perinatal mortality (20.4% vs. 21.9%, p = .724) were similar in both groups. Loading dose only regime may be considered an effective alternative regime for the prevention of eclampsia in women with severe preeclampsia.

Impact statement

• What is already known on this subject: Efficacy of therapeutic short regime magnesium sulphate in eclampsia has already been reported. Data regarding prophylactic short regime in women with preeclampsia is sparse.

• What the results of this study add: We have shown that short regime of magnesium sulphate using only the loading dose in the prevention of seizure in preeclampsia is an effective alternative to the low-dose Dhaka regime.

• What the implications are of these findings for clinical practice and/or further research: The short regime is less resource-intensive. Further larger studies are needed to confirm the efficacy of this short regime and to establish its cost-effectiveness.

Keywords:

• Dhaka regime
• magnesium sulphate
• severe preeclampsia
• loading dose only regime
• maternal medicine

Disclosure statement

The authors declare that they have no conflict of interest.

Ethical approval

The Institute Scientific Advisory committee and the Institute Ethics Committee approved the study (IEC/2011/5/22).

Informed consent

Informed consent was obtained from all individual participants included in the study.