Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 91540209 Date registered: 2016-04-14 Trial Status: Pending TRIAL DESCRIPTION Public title ASSESSING THE IMPACT OF AN INTERVENTION TO IMPROVE THE QUALITY OF EMERGENCY OBSTETRIC CARE ON MATERNAL AND PERINATAL MORTALITY Official scientific title ASSESSING THE IMPACT OF AN INTERVENTION TO IMPROVE THE QUALITY OF EMERGENCY OBSTETRIC CARE ON MATERNAL AND PERINATAL MORTALITY Brief summary describing the background and objectives of the trial Nigeria has some of the highest rates of maternal, stillbirth and neonatal mortality rates in the World. Institutional delays due to poorly responsive emergency obstetric care have been identified as being a key attributable factor in the high rates of mortality. We conducted this baseline formative research to provide the basis for designing cost-effective, realistic and do-able interventions for improving the quality of maternal health care Type of trial Prevention Acronym (If the trial has an acronym then please provide) ASSESSING THE IMPACT OF AN INTERVENTION TO IMPROVE THE QUALITY OF EMERGENCY OBSTETRIC CARE ON MATERNAL AND PERINATAL MORTALITY Disease(s) or condition(s) being studied Maternal Morbidity and mortality Purpose of the trial Anticipated trial start date 2016-08-01 Actual trial start date 2016-08-01 Anticipated date of last follow up 2018-11-30 Actual date of last follow up 2018-11-30 Anticipated target sample size (number of participants) 2334    Actual target sample size (number of participants) 2227    Recruitment status Not yet recruiting No Secondary ID Issuing authority/Trial register 1 H9-TSA-282 WHO ERC STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group Improved Data Collection system NA Simple and easy-to-use data collection system would be developed for this intervention 4 Active Experimental group Strategic Plan Development/Training of health managers NA Strategic deployment of resources and a timed action plan for reducing maternal mortality 4 Active Experimental group Implementing maternal and perinatal audits NA Implementation of the Maternal and perinatal audits and Surveillance (MDPR) as recommended by the Federal Ministry of Health 4 Active Experimental group Development and use of treatment protocols, algorithms and reminders NA Development of treatment protocols, algorithms and reminders; and training of staff to use them 4 Active Experimental group Advocacy for increased funding and resource allocation for maternal health NA Development of advocacy plan of action for intervention hospitals to leverage internal and external resources for maternal and child health 4 Active Experimental group Strategic action plans to reduce delays in hospitals NA Development of an electronic/computerised appointment system and training of staff to use it 4 Active Experimental group Staff training and re-training NA Staff training on new interventions for preventing maternal mortality 4 Active Experimental group Regular monitoring and evaluation, and reporting NA A simple M&E system will be developed both for this project as well as the hospital system overall 4 Active Experimental group Patients’ education and request for feedbacks NA Organise regular awareness creation sessions for patients attending the maternity sections of the intervention hospitals 4 Active Experimental group Branding hospitals as “Women-friendly” NA All intervention hospitals will be branded as “Women-friendly” and specific indicators of success will be identified for which each intervention hospital will be measured annually. 4 Active ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Primary Outcome Decrease in number of maternal and perinatal deaths At the end of the 24 months of intervention Secondary Outcome Increase in the number of women receiving antenatal, delivery and postnatal care At the end of the first 12 months of intervention and also after the last 12 months RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country Adeoyo Maternity Teaching Hospital Yemetu Ibadan 200001 Nigeria Ahamdu Bello University Teching Hospital Zaria Zaria 800001 Nigeria FUNDING SOURCES Name of source Street address City Postal code Country World Health Organization BLOCK 3510 JALAN TEKNOKRAT 6 CYBERJAYA 63000 Malaysia SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor COLLABORATORS Name Street address City Postal code Country CONTACT PEOPLE Role Name Email Phone Fax Principal Investigator Prof Friday Okonofua feokonofua@yahoo.co.uk 234 234 Street address City Postal code Country Position / Affiliation Km 11, Benin-Lagos Expressway, Igue-Iheya Benin City 300001 Nigeria Program Adviser, WHARC Scientific Enquiries Dr Rosemary Ogu rosemary.ogu@uniport.edu.ng 2147483647 2147483647 Street address City Postal code Country Position / Affiliation Km 11, Benin-Lagos Expressway, Igue-Iheya Benin City 300001 Nigeria Research Associate, WHARC Public Enquiries Dr Wilson Imongan drimongan@yahoo.com 2147483647 2147483647 Street address City Postal code Country Position / Affiliation Km 11, Benin-Lagos Expressway, Igue-Iheya Benin City 300001 Nigeria Executive Director, WHARC