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Objective 3: CLIP Trial Updates (February - March 2016)

The CLIP Trial has enrolled 49,722 pregnancies to date including 15,580 pregnancies in India; 28,859 pregnancies in Pakistan; and 5,283 pregnancies in Mozambique. The first of the Feasibility supplement publications (9 articles) is in press and expected very soon in Reproductive Health BMC. The second Feasibility supplement (8 articles) has submitted at the end of this month to Reproductive Health BMC. Baseline census papers from India, Pakistan and Mozambique have been submitted for publication.

More than a year has passed since the official start date of the Mozambique Trial and nearly 8441 POM visits have been conducted to date. The Mozambique team started a third surveillance cycle in February 2016, and has recruited 5340 pregnancies to date.

A site visit to Mozambique was conducted in early March by CLIP UBC working group members Marianne Vidler, Sharla Drebit, and Larry Li, who were accompanied by Loki Jorgenson from LionsGate Technologies. During the site visit, in addition to routine monitoring, the team had the opportunity to interact with the health care workers (Agente Polivalente Elementars/APEs) and observe use of the pulse oximeter during the CLIP visits. In addition, much progress was made during the site visit in review of data management procedures, and queries. Data transfer between sites is an area of focus for both the teams at present. Furthermore, the Mozambique team has come up with innovative ways of co-ordination of information from community engagement, POM and surveillance to streamline mechanisms of data capture. The site is brainstorming ways to feedback stories from the CLIP intervention back to the communities to strengthen pre-eclampsia knowledge and awareness, and improve care seeking behavior. In addition, the site has come up with an innovative transportation plan to provide emergency obstetric care. We thank the Mozambique team for their kindness and hospitality for the site visit, and for their fantastic efforts!

In Pakistan, 31,636 POM visits have occurred and from the evaluation of SpO2 user and quality of recording reports, the lady health workers have shown excellent competence with the use of the pulse oximeter. Furthermore, overall acceptance of MgSO4 injections has increased since the start of the trial, which is a testament to the community engagement efforts by the team. By undertaking a robust review of outcome adjudication processes, the study team has created a ‘feedback mechanism’ for data cleaning and data collection. The team is now undertaking outcome adjudication, and data cleaning processes for the purpose of a planned interim analysis for end of May. A trial monitoring site visit will take place in early May, and a stakeholder engagement visit is planned for early June.

In India, as of earlier this month, 33,659 POM visits have taken place. The increased awareness in the community has led to early identification and reporting of pregnancies with women identifying and enrolling at as early as eight weeks of gestation. The number of postnatal care visits is also increasing and hypertension is being observed in women postpartum. A trial monitoring visit will take place at the end of April, and interim analysis is underway to share with the DSMB.

The UBC team in collaboration with the CLIP Nigeria team are working hard to publish the important POM and community engagement data in the form of a process evaluation study. Several new papers are planned to be completed in the next few months.