P R E - E M P T N E W S L E T T E R : I S S U E 1 5 ; S E P , 2 0 1 3

PRE-EMPT News

Recent Activity

The PRE-EMPT newsletter is designed for those involved in this project. We hope this publication will keep you up to date on current and upcoming ac-tivities, important project changes and accomplishments by the team. The newsletter will be distributed bimonthly, with the next issue sched-uled for the end of November 2013. We welcome submissions of project updates by any team member for inclusion in the newsletter. Please submit by November 20th, 2013 for the next newsletter.

CLIP Nigeria Site visit,

Sagamu, Nigeria

August 27-30, 2013

CLIP Pakistan Site visit, Karachi, Pakistan

September 2-6, 2013

CLIP India Site visit, Belgaum, India

August 27-30, 2013

BMGF-UBC Interim report meeting and rounds with BMGF Family Health Unit

September 11, 2013

CLIP Pakistan Pilot Trial Launch, Karachi

and Hyderabad, Pakistan

September 16-18, 2013

The major recent activity of the Global Pregnancy CoLaboratory was the annual meeting on September 3 and 4 in Oxford. Highlights of the meeting included a review of the year's activity, which guided suggestions as to what might be done to improve the function of the group in the coming year. The year's activities included the application for two major grants, three white papers, 10 projects and the first publication credited to the CoLab.

Perhaps the most important function of meeting was to identify new projects for the coming year. This was accomplished by group by a very valuable brain-storming session led by Roberta Ness. Three projects were identified and several others are currently under consideration. One topic of discussion was the administrative barriers to research. It is very apparent that, although not intended to be an impediment, administrative hurdles have become a major problem in moving forward with collaborative research. There were many examples discussed ranging from long time delays for material transfer agreements to the very restrictive requirements for sharing of data internationally. Lucilla Poston and Roberta Ness agreed to prepare a letter or editorial for a high-impact journal to be presented from the CoLab on this topic.

As a second project, we agreed to explore the creation of an electronic database that could be made available to individuals who were performing, initially pre-eclampsia research and eventually any research on adverse pregnancy outcomes. The goal of this database would be to provide a standardised electronic format for the minimal and optimal data sets recommended by the harmonisation white paper and would eventually facili-tate data sharing. The standardised database would be likely to be housed at the setting of the individual investigator. However, a suggestion was raised that perhaps we could come up with a hybrid format that might allow us to work with industry such as MedSciNet to prepare something that could be used on a larger scale. Chris Redman is leading this effort.

The third project is very exciting, although in embryonic form. This project, which will be headed by Jenny Myers, will attempt to bring together known risk factors for adverse pregnancy outcomes and to analyze the data in an unbiased manner for clustering that might be associated with a specific risk factor. This approach, termed reverse phenotyping, has been championed by Les Myatt, who will be serving as part of the group working on this topic.

In an attempt to achieve sustainability we invited members of industry includ-ing Martin Hurd from Roche, Paul Sheard from Alere, and Laima Juodvirsiene from MedSciNet to discuss industry interactions. Each of these individuals presented what they thought CoLab could do for them and a useful discus-sion ensued that we hope will lead to collaboration with these and other groups.

The meeting was a very successful and a very good start for the next year of activities of the Global Pregnancy CoLaboratory.

Global Pregnancy CoLaboratory Meeting, Oxford

Top right: Oriel College, Oxford, UK, venue of the 3rd annual COLAB meeting

Bottom left: Laima Juodvirsiene from Med-SciNet presenting at the COLAB meeting.

P R E - E M P T N E W S L E T T E R : I S S U E 1 5 ; S E P , 2 0 1 3 P A G E 2

The PIERS on the Move (POM) study in South Africa is nearing completion. Data collection will finish as of November 1, 2013 and a final report will follow by the end of the year.

A publication describing the development of the POM ap-plications for both the South African study and CLIP was submitted with Dustin Dunsmuir as lead author earlier this month. We look forward to receiving feedback from re-viewers in due course. We are still awaiting word from PLOS Medicine after submitting revisions to the primary miniPIERS development and validation manuscript earlier this month.

Dietary calcium assessment

At the end of July/early August we were happy to receive another visit to South African sites from Gabriela Cor-mick’s team from the National University of LaMatanza in Argentina, to follow up on the training in dietary calcium assessment Gabriela conducted earlier this year.

Cochrane systematic reviews of calcium supplementation to prevent hypertensive disorders of pregnancy

We have updated our Cochrane review to include studies of lower-dose calcium supplementation (<1g daily) during pregnancy. We are also working on a new Cochrane re-view of pre-pregnancy calcium supplementation, to which the Calcium And Pre-eclampsia Trial will eventually con-tribute data. There remains considerable global interest in the potential for calcium supplementation to have a meaningful impact on morbidity and mortality from the hypertensive disorders of pregnancy, and the Calcium And Pre-eclampsia trial is to our knowledge the most ambi-tious and important on-going trial in this area.

Final revision and testing of the miniPIERS mHealth appli-cation (CLIP-POM) to be used in the CLIP study are now underway. Of note, further field testing was completed in Pakistan during the recent site visit by Beth Payne and

Dustin Dunsmuir. With the AKU team, Beth and Dustin were able to success-fully pilot data collection and synchro-nisation with the main AKU servers. All that remains now for this aspect of CLIP Pilot trial preparation in Paki-stan is receipt of the bulk shipment of

phones and training of the community health workers in their use. Upcoming site visits to both India and Nigeria are planned in order to complete similar field testing and finalise the community data collection and decision sup-port systems in those respective countries.

Recruitment

Our thanks to all the study site teams for maintaining recruit-ment – 500 women recruited on 25 Sep-tember 2013.

Recruitment in Harare

Thanks to Sarah Manyame for this photograph showing assessment of one of her clients in Harare. By 18 Sept the Harare site had recruited 135 women, of whom 62 have become pregnant. So far, this is the highest pregnancy rate among our sites.

miniPIERS Development & Validation (PI: Peter von Dadelszen)

CAP (Calcium And Pre-eclampsia) Trial (PI: Justus Hofmeyr)

Pictures from the CLIP Pilot Launch and CPD in Pakistan

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The Preeclampsia Registry™ The Preeclampsia Foundation announced on September 11th, the launch of The Preeclampsia Registry™, a patient and family database designed to aid and accelerate pre-eclampsia re-search. According to the Foundation’s news release, “ (t)he Preeclampsia Registry™ is the first of its kind to focus solely on hypertensive disorders of pregnancy to bring together survivors, family members, and researchers from all over the world with the purpose of developing a comprehensive picture of preeclampsia and discovering preventions and treatments, including ones that will reduce its long-term impact. The Preeclampsia Registry™ is a place to share your health and pregnancy history and even pose your own research questions, thus creating a significant resource for re-searchers to gather data and start new studies. Participation in any study is entirely optional.” For more information on how to enroll in the Preeclampsia Registry™ and what to expect following enrollment, please visit the Preeclampsia Foundation’s website: http://bit.ly/19iLbtb or please email Alina Brewer, at Registry@preeclampsia.org or call at 321-421-6957. Preeclampsia Foundation awards 2013 Vision Grants

On September 13, the Preeclampsia Foundation announced that it awarded two $ 25,000 research grants to two re-searchers to study the underlying mechanism s of pre-eclampsia; Vision Grants are awarded to the strongest scientific proposals recommended by the Foundation’s scientific review committee with a further review by a consumer advi-sory board. The Foundation’s Board of Directors renders the final decision based on those recommendations. For more information about the researchers’ grant proposals please visit: http://bit.ly/18Gyb4n.

CLIP Feasibility and Trial (PI: Peter von Dadelszen)

The past two months have seen great progress in Pilot Trial preparation activities in Pakistan, Nigeria and India and the start of the Feasibility Study in Mozambique. Highlights of each country’s progress are presented below.

Nigeria Sharla Drebit, Beth Payne and Larry Li visited Nigeria from August 26 – 30. Working with the Nigeria CLIP team during this visit we were able to: finalise surveillance forms and update the surveillance training manual accordingly; review data management requirements and install a testing server; discuss plans for community engagement in light of Feasibility findings; visit two Pilot clusters and engage local stakeholders to maintain support of the CLIP trial. Another exciting development for the CLIP Nigeria team is the successful recruitment of a Trial Manager, Dr. Ebun Jaiyesimi. We welcome her to the team and thank the entire CLIP Nigeria team for the hard work and hospitality!

Mozambique We are excited to report the start of the CLIP Feasibility Study in Mozambique. The contract is now signed and focus groups are underway. Work on the qualitative component of the Feasibility Study is expected to occur over the next four months with baseline surveillance scheduled to begin in January. We look forward to learning from the Feasibility Study how maternal health is organized and perceived, and how CLIP can be designed to have long-term, positive impact on the health of mothers and babies in Mozambique.

Pakistan Members of the UBC CLIP team were back in Pakistan earlier this month to continue working with the team to prepare for the Pilot Trial launch next month. During this visit Beth Payne and Dustin Dunsmuir spent time at AKU and the Matiari field office in order to field test the trial data collection and synchronisation processes. This involved some trouble shooting but in the end resulted in successful set-up of the trial databases and testing of phones to be used by the community health workers. Other accomplishments of note by the Pakistan team are completion of data collection for the baseline surveillance activities, the set-up of CLIP treatment packages for both methyldopa and MgSO4 and completion of Continuous Professional Development activities (See pg.3 and Page 4).

India A site visit was complete early this month to India. The bulk of this visit focussed on review of the Feasibility results in preparation of the final report. The ANM and staff nurse questionnaire was completed in both pilot intervention clusters this month. This survey provides further insight to the Feasibility Study results regarding the self-efficacy and preparedeness of ANMs in the management of pre-eclampsia and eclampsia. Data collection has begun for the maternal newborn health registry in all 12 clusters. Planning is ongoing for community engagement activities, health worker training and continuous professional development activities in preparation for the CLIP Trial.

Preeclampsia Foundation, Chair: Eleni Tsigas

UBC Department of Obstetrics & Gynaecology Room V3-341, 950 West 28th Ave Vancouver BC V5Z 4H4 Phone: 604-875-2424 ext 5545

PRE-EMPT Co-ordinating Centre

IMPACT 2025, Ottawa, Canada

October 3-4, 2013

CLIP Mozambique Site Visit

October 21-24, 2013

Third Annual PRE-EMPT Meeting, New Delhi, India

Novem-ber 11-14, 2013

Upcoming

Activities: 2013

On September 17th, and 18th, a series of events to mark the CLIP Pakistan Pilot Trial launch were conducted in Karachi and Hyderabad by the Aga Khan University Research team in Pakistan. On September 17th, Continuous Professional Development (CPD) activities were carried out to strengthen the evidence-based knowledge of pre-eclampsia and to sensitize the health services workforce to the CLIP protocol. It was a fantastic turnout of over 300 participants which included medical students, Lady Health Workers (LHWs), nurses, physi-cians, community health workers and health administrators. After participants registered and received their red CLIP bags with agenda, notebook and WHO guidelines, presentations were given on the topics of: (i) Maternal mortality and morbidity in Pakistan: causes and the burden of disease, (ii) CLIP project: translation research, (iii) Pre-eclampsia: diagnosis and management, and (iv) Eclampsia: diagnosis and management. On September 18, a stake-holders meeting was held to formally launch the CLIP Pilot Trial at AKU Karachi. The stake-holders included representatives from AKU research team, LHW programme (Matiari and Hyderabad), MNCH programme, and District Health Offer (DHO) office in Matiari. After a welcome address from Asghar Ali, Rahat Qureshi and Peter von Dadelszen presented on the current status of maternal mortality in Pakistan and benefits of proper management and the CLIP project. We would like to take this moment to congratulate and offer kudos to the CLIP Pakistan team for a successful Pilot Trial launch ceremony. For additional pictures, please re-fer to Page 3 of the newsletter.

http://pre-empt.cfri.ca/ ; Follow us on Twitter @UBC PRE_EMPT

CLIP Pilot Trial launches in Pakistan

Pictures from August 27-30 CLIP Site visit to Sagamu, Nigeria

Congratulations to Andrew Shennan (PI), Natasha Hezelgrave and the KCL team for receiving a grant from the Bill & Melinda Gates Foundation for CRADLE: Community blood pressure monitoring in rural Africa and Asia: detection of underlying pre-eclampsia. A component of the CRADLE project will be the development of a novel, low cost, accurate and easy to use BP monitor with traffic light warning system which will be used and evaluated for acceptability and usability in the CLIP Definitive Trial. The primary objective of the CRADLE project is to develop an accurate and tested low-cost solution to improve antenatal detection of pre-eclampsia, and hypotension associated with PPH and sepsis, by adapting existing tools for BP measurement for use by frontline health care providers working at a community level and in first-level clinics, who are best placed to both

access pregnant women and initiate life-saving interventions. Equipping frontline health workers with novel technology such as this, as well as provision of basic training in its use, enhances their capabilities and performance. Once widely implemented in LMICs, the availability of BP measurements will facilitate refer-rals of high-risk women to secondary level centres and thereby has potential to improve pregnancy out-come for both the mother and infant. We would also like to acknowledge the collaborators of the CRADLE Project: Annemarie de Greeff, South Africa; Suellen Miller, University of San Fransisco; and Gerhard Frick, Microlife™.

Note: Thank you to all the PRE-EMPT members for contributing content.

CRADLE receives funding from the Bill & Melinda Gates Foundation