Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol
Introduction Hypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dos...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-10-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e032799.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846123616292306944 |
|---|---|
| author | Titus Beyuo Emma Lawrence Elizabeth S Langen Samuel A Oppong |
| author_facet | Titus Beyuo Emma Lawrence Elizabeth S Langen Samuel A Oppong |
| author_sort | Titus Beyuo |
| collection | DOAJ |
| description | Introduction Hypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysis This study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and dissemination Ethical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration number Pan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983). |
| format | Article |
| id | doaj-art-2f6e3ccc3e214567831274a67ce78d61 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2f6e3ccc3e214567831274a67ce78d612024-12-13T23:15:12ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-032799Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocolTitus Beyuo0Emma Lawrence1Elizabeth S Langen2Samuel A Oppong31 Obstetrics and Gynaecology, University of Ghana School of Medicine and Dentistry, Accra, GhanaDivision of Surgery and Interventional Science, University College London, London, UK2 Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA1 Obstetrics and Gynaecology, University of Ghana School of Medicine and Dentistry, Accra, GhanaIntroduction Hypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysis This study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and dissemination Ethical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration number Pan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).https://bmjopen.bmj.com/content/9/10/e032799.full |
| spellingShingle | Titus Beyuo Emma Lawrence Elizabeth S Langen Samuel A Oppong Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol BMJ Open |
| title | Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol |
| title_full | Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol |
| title_fullStr | Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol |
| title_full_unstemmed | Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol |
| title_short | Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol |
| title_sort | open labelled randomised controlled trial of 12 hours versus 24 hours modified pritchard regimen in the management of eclampsia and pre eclampsia in ghana mopep study study protocol |
| url | https://bmjopen.bmj.com/content/9/10/e032799.full |
| work_keys_str_mv | AT titusbeyuo openlabelledrandomisedcontrolledtrialof12hoursversus24hoursmodifiedpritchardregimeninthemanagementofeclampsiaandpreeclampsiainghanamopepstudystudyprotocol AT emmalawrence openlabelledrandomisedcontrolledtrialof12hoursversus24hoursmodifiedpritchardregimeninthemanagementofeclampsiaandpreeclampsiainghanamopepstudystudyprotocol AT elizabethslangen openlabelledrandomisedcontrolledtrialof12hoursversus24hoursmodifiedpritchardregimeninthemanagementofeclampsiaandpreeclampsiainghanamopepstudystudyprotocol AT samuelaoppong openlabelledrandomisedcontrolledtrialof12hoursversus24hoursmodifiedpritchardregimeninthemanagementofeclampsiaandpreeclampsiainghanamopepstudystudyprotocol |