rsz_logo_maia_18-01Advancing maternal and child health in Romania: an integrated assessment of the determinants of pregnancy outcomes

ROEN

About the MAIA study

Advancing Maternal and Child Health in Romania: an integrated assessment of the determinants of pregnancy outcomes initiative, also known as the MAIA Project, aims to explore and explain the impact of psychosocial stress and biological factors on pregnancy outcomes in Romania. The project is a 3 year study funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through Grant Number PN-II-ID-PCE-2011-3-0942.

The MAIA project pursues to answer complex questions on the prevalence and determinants of pregnancy outcomes, in a large cohort of pregnant women, recruited from five different clinical settings in Romania. The power of the study lays in its integrated approach which controls for the relation of inter-dependent pregnancy risk factors (medical history, social and living conditions, stress and depression, smoking and substance abuse) to explain birth outcomes. In addition, a cross-sectional component of the study will bring data on an extended sample in order to assess the prevalence of selected risk factors and their determinants in the Romanian context, where such population-based data is extremely limited.


Acknowledgement

The project is a 5 year study funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through Grant Number PN-II-ID-PCE-2011-3-0942, contract number 323/5.10.2011.

About MAIA

Infant mortality in Romania is higher than other countries in Central and Eastern Europe, with a majority of infant deaths being due to preterm delivery (PTD) or intrauterine growth restriction (IUGR). However, there is limited data on the determinants of pregnancy outcomes in Romania, with no prospective cohort studies exploring this relationship. Moreover, there is limited data on the prevalence of certain risk factors in larger samples of Romanian pregnant women. As a result, the MAIA Study will bring essential information for understanding the main issues needed to improve maternal and infant health in Romania.

The study is conducted in five clinical settings in Romania, across four phases. After screening 1750 pregnant women based on clinical enrollment, a cohort sample of 250 pregnant women (1st trimester of pregnancy) will be recruited. The cohort sample is assessed for allostatic load, and hair and blood samples are drawn for cortisol and cotinine measurements within the same phase. Phases II and III involve a second and third questionnaire with the cohort members, as well as biomarker measurement (cotinine and cortisol). Phase IV of the study consists of abstracting hospital birth records for all study participants. The cross-sectional data collected through the screening phase is used to assess risk factor prevalence and their determinants.


Aim and Objectives

The purpose of this research is to explore and explain psychosocial stress and its association with pregnancy outcomes in Romania. The study will provide prevalence data for pregnancy risk factors based on a clinical sample of Romanian pregnant women, as well as to test a novel methodology for research data collection in hospital settings in Romania. The specific objectives of the study are:

  1. to assess the prevalence of biologic and psychosocial risk factors for PTD and SGA, including maternal stress and depression, in a Romanian sample
  2. to study the association between specific biologic and psychosocial factors, particularly psychosocial stress and depression, and PTD and SGA
  3. to test a cost-effective methodology for pregnancy risk-factor screening within Romanian obstetrics and gynecology clinics

Study Design and Methods

The MAIA study employs a cohort design, with a quantitative strategy of inquiry, and explores the psycho-social stress, allostatic load, prenatal depression, pregnancy-specific anxiety, and tobacco, alcohol, and drug consumption in a sample of Romanian pregnant women seeking antenatal care in the clinics enrolled in the study. The study is conducted in four phases and implies filling in three questionnaires (HP1, HP2, and HP3), as well as collection of biomarkers, as follows:

Phase I: A cohort of 250 women in the first trimester of pregnancy is recruited based on a screening process undertaken on a sample of 1750 pregnant women. The cohort sample is subjected to allostatic load measurements (a measure of cumulative stress), a set of blood tests to determine their cortisol, total cholesterol, HDL cholesterol, glycated haemoglobin, metanephrines, and dehydroepiandrosterone sulfate glycolysis levels, as well as a test measuring their hair cotinine level. The HP1 questionnaire is completed using on-site computers with internet connection and placed in isolated locations of the clinics enrolled in the study. The women are enrolled by trained operators (resident doctors or nurses) who explain the details of the study, describe the method of data collection, and obtain subject’s informed consent.

Phase II and III: A second (HP2) and a third (HP3) questionnaire, as well as measurements of biomarkers (cortisol and cotinine) are given to the subjects included in the cohort, during the prenatal visits the pregnant women attend to in their second and third pregnancy trimester.

Phase IV: Consists of abstracting 1750 birth records to gather data on birth outcomes, including maternal complications, delivery method, gestational length, birth weight, and fetal/infant complications


Study Instruments

Operator Training Package

The operator training package is used to train program staff. The training package is only used during the initial training of data collectors. The package contains all the instrument needed for data collection, as well as the presentation and training materials used for this specific session (power-point presentations and hand-outs). Trainings consisted of half-day in class training, completed with a full-day on-site training and supervision of data collection.

Standard Operating Procedures (SOP)

The SOP is a complete protocol for the study, compiled in an easy-to-use manual. The aim of the manual is to ensure a standardized data collection procedure across clinics and data collectors. It contains information on the study design and phases, sample calculations for each setting, recruitment and enrollment procedures (including participant approach and consenting procedures), biological sample collection procedures, sample shipping and storage as well as reporting procedures. Each clinic has slightly different day-to-day procedures and has an adjusted SOP, based on the clinic flow.

Study Registry

The study registry is used for screening and enrollment of participants, as well as for documenting this process thoroughly. The registry contains a flowchart insuring that eligibility criteria are met (age 18+, medical conditions, medication), gestational age is recorded, refusals marked. The study registry also contains a form for documentation of procedures and phases the participant underwent.

Informed Consent Documents 

Informed consent is obtained from each individual in the study. An informed consent is obtained during the initial screening process for those enrolled in the cross-sectional study. Those individuals that are additionally enrolled in the cohort study completed a second informed consent. The document describes the study, its voluntary nature, as well as the rights of the participant as a human research subject.

Data Collection Instruments

The data collection instruments (questionnaires) are administered at enrollment for all individuals. The instrument collects demographic information, pregnancy experience, reproductive and medical history, and health and lifestyle. In addition, those that are enrolled in the cohort study are administered a similar survey in the second and third trimester of pregnancy.

Serum Collection Kit

Serum samples are collected from cohort participants to measure blood cortisol levels (1st, 2nd and 3rd trimester) as well as measures of allostatic load (1st trimester). When collecting the samples, the date and time of data collection, shipment and processing are recorded. The samples are entered in a laboratory circuit, ensuring a timely processing and optimum storage and transport conditions. Results are returned from the laboratory to the clinic, and entered in the study registry.

Hair Sample Collection Kit

A hair sample is taken in each of the three phases of the cohort to measure cotinine levels (indicators of both active as well as passive smoking). The hair collection kit consists of a pair of scissors, a sample string to measure the thickness of the hair sample, as well as a medium and associated envelope for keeping and transporting the samples.

Calendar – appointment instrument

Individuals involved in the cohort study are given a reminder card for their next visit, printed on the back of a personalized calendar. These cards include the date and location of the next visit.


Expected results

Mortality and morbidity due to preterm birth and low birth weight considerably burden individuals, families and the society as a whole in terms of increasing healthcare utilization and associated costs, increasing use of costly special education services, and increasing support from social services.

The proposed research is innovative and is projected to contribute to the existing body of knowledge in improving pregnancy outcomes, by understanding and reducing the burden of psychosocial pregnancy stress.

Drawing on an integrated assessment model, combining both extensive self-reported information with biomarker measurements for the phenomenon under investigation (psychosocial stress) as well as novel measurement techniques for the main confounding variables (smoking and secondhand tobacco smoke exposure), the results of the study will bring valuable empirical knowledge for improving perinatal health.

In addition, the large body of research conducted in the field typically pursued a prospective study design with one stress assessment during pregnancy and followed by a review of birth outcomes; however, our proposed design allows a rigorous monitoring of the pregnancy throughout all three trimesters. Because there is compelling evidence that stress during different stages of a pregnancy can have different impacts on birth outcomes, it is of the essence to assess psychosocial stress and associated risk factors at three distinct time points.

Furthermore, by developing the MAIA study in the socio-cultural context of an Eastern European Country, important insight can be brought for the Romanian public health scientific community on the prevalence of important pregnancy risk factors, as well on the relationships between them. Thus, there is great potential for derivative applied research initiatives, meant to explore alternative methods for reducing prenatal psychosocial stress, in the context of associated risk factors.


Acknowledgement

The project is a 5 year study funded by the Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI), through Grant Number PN-II-ID-PCE-2011-3-0942.

Anne Baber Wallis, PhD

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Dr. Wallis is the Principal Investigator of the MAIA study. Dr. Wallis was trained in maternal and child health at the Johns Hopkins University Bloomberg School of Public Health. Her current primary academic appointment is in the Department of Epidemiology and Population Health at the University of Louisville; she is a member of the Social and Behavioral Health research staff at the Cluj School of Public Health. At present, she is a Fulbright Fellow working with the Yerevan State Medical University in Armenia. From 2002-13, Dr Wallis was a professor in the Department of Epidemiology, College of Public Health, University of Iowa. Dr. Wallis’ primary area of research is in reproductive and social epidemiology; she has conducted research with collaborators in Armenia, Romania, Croatia, Serbia, the Gambia, and India. She has taught maternal and child health and epidemiology at the Babeș-Bolyai University Cluj-Napoca School of Public Health and she has spoken at conferences in the US, Romania, Serbia, Bosnia, and the UK.

Dr. Wallis has collaborated with Babeș-Bolyai University( Cluj-Napoca) since 2006; she has been PI on studies of infant feeding, perinatal depression, and pediatric injury. In 2011 Dr. Wallis became a researcher within Babes-Bolyai University, Centre for Health Policy and Public Health, Department of Social and Behavioral Health.


Răzvan Cherecheș, MD, PhD

razvan chereches

Dr. Razvan Chereches is currently the Executive Director of the Center for Health Policy and Public Health, Institute for Social Research, Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca. Since October 2007 Dr. Chereches is an Adjunct Assistant-Professor at the University of Iowa’s Department of Occupational and Environmental Health, being involved in both teaching and scientific research activities.

Dr Chereches has coordinated 13 research projects as a principle investigator, with a focus on health policy and health systems.

Dr. Chereches also has extensive experience on maternal and child health research in Romania, being involved in various research projects on perinatal depression, breastfeeding promotion and support as well as prevention of postnatal smoking relapse.

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Alexandra Brînzaniuc, PhD(c)

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Ms. Brinzaniuc is a Research Assistant with the Center for Health Policy and Public Health, Babeș-Bolyai University, Cluj-Napoca, Romania and has been working with the Community and Behavioral Health Department for 7 years. She has extensive experience in developing and implementing research projects focusing on maternal and child health.

Her research interests focus on health inequalities in maternal and child health, as well as specific topics such as perinatal depression, breastfeeding promotion, prevention of smoking during pregnancy and prevention of postnatal smoking relapse. Ms. Branzaniuc is enrolled in a part-time doctoral program within the Warwick Medical School, University of Warwick UK.

Ms. Brinzaniuc is currently a member of the European Public Health Association and was an affiliated researcher with the University of Iowa’s College of Public Health, between 2009 and 2011.

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Claudiu Mărginean, MD, PhD

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Dr. Marginean is a senior lecturer with the Department of Obstetrics and Gynecology, at the University of Medicine and Pharmacy, Tîrgu Mures, Romania. Dr. Marginean has a PhD in medicine and is a prolific scientific writer with over 50 published research articles and 8 books as author or co-author in the field of reproductive health.

Dr. Marginean’s main research interests focus on pregnancy health, specifically health related to the umbilical cord, improving quality care for pregnant women and infants, as well as standardization of pregnancy follow-up.

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Oana Blaga, PhD(c)

poza_Oana Pop

Ms. Pop is a Research Assistant and has been working with the Center for Health Policy and Public Health, Babeș-Bolyai University, Cluj-Napoca for six years. Ms. Pop is a young researcher with a strong interest in community and behavioral health issues.

She has experience in developing and implementing research projects focusing on maternal and child health, with a specific focus on intervention design and implementation. In 2012, Ms. Pop was trained at the University of Iowa’s College of Public Health in the prevention of non-communicable diseases, with a specific focus on tobacco control. In addition, Ms. Pop is a member of the European Social Marketing Association.

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Ioana Rus, PhD(c)

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Mrs. Rus is trained in human resources management and is currently working as a research assistant with the Center for Health Policy and Public Health, Babeș-Bolyai University, Cluj-Napoca focusing on project management. Mrs. Rus is involved in the implementation and design of several research projects within this research unit, ensuring their effective execution.

She has extensive experience in administering programs and projects in maternal and child health in Romania, especially in clinical settings. Mrs. Rus has managed the implementation of similar studies on prenatal smoking, breastfeeding practices and attitudes as well as perinatal depression, in clinical settings in large academic and smaller municipal hospitals. Mrs. Rus has experience in financial and technical reporting for research projects, being involved in the administration of over 15 national and international projects.

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Partners

The MAIA Project is implemented with the support of five clinical settings situated in four cities in Romania (Cluj-Napoca, Reghin, Sighişoara and Targu-Mureş). The sample is comprised of both small municipal and large academic hospitals, as well as state and private healthcare providers. Samples from each hospital are based on quotas, calculated using the number of yearly deliveries in each setting.

The five clinical settings were recruited in the study between 2011-2012 and are currently recruiting study participants and implementing the MAIA protocol. The study is administered in each clinic by a trained local coordinator and data collection team. This team works in close collaboration with the core project team from Babes-Bolyai University in order to maximize the reliability of the study’s results. The clinical partners of the MAIA Study are:

County Emergency Clinical Hospital Cluj-Napoca, Gynecology Clinic II

County Emergency Clinical Hospital Tîrgu Mureș, Gynecology Clinic

Reghin City Hospital

Nova Vita Hospital

Sighișoara City Hospital

Project Reports

2011 Scientific Report

In the first three months of the project (October-December 2011), the study team contacted the seven clinics to be included in the study and developed and pre-tested (on a sample of 50 pregnant women seeking antenatal care in one of the clinics enrolled in the study) the data collection instrument to be used in the process of data collection.

The quantifiable results of the project for the year of 2011 consisted of the partnerships established with the clinics and hospitals to be enrolled in the study, the submission of an article for publication, as well as the increase of the study’s visibility through the development of a website. All the contract objectives of the project for 2011 were met. A summary of the report in English can be found here. Download here

2012 Scientific Report

In the second year of the study, the project team developed all of the documents needed to assure a systematic data collection process in all of the clinics enrolled in the study, such as: the Standard Operating Procedure Manual, the Study Registry (a monitoring system for data collection and data linkage), and biological sample collection and shipment protocols. The team also recruited and trained one data collector from each clinic in the second year. The project team also installed and administered data collection points and initiated data collection in the seven locations (questionnaires for phases I, II, and III and associated biomarker collections for the cohort).

A poster presentation was submitted at the European Public Health Association Conference, organized in Malta in 7-10 November 2012. The abstract of the presentation was presented in a moderated poster session and published in the Supplement of the European Journal of Public Health. All contract objectives of the project for 2012 were met. A summary of the report in English can be found here. Download here.

2013 Scientific Report

In the third year of the study, the project team continued the data collection process and monitoring for both the screening and cohort samples, collected biological samples from the women enrolled in the cohort and analyzed them, conducted abstracting of birth certificates, and developed an analytical plan for the analyses to be conducted on the study datasets.

An oral presentation was held at the 6th European Public Health Association Conference, organized in Brussels, in November 2013. The abstract of the presentation was published in the Supplement of the European Journal of Public Health. Also, the project was disseminated by participating in the “Wring for maternity services, research, theory, policy, and practice: Integrating new theoretical insights from the iR4B COST Action” scientific writing workshop, organized by the Childbirth Cultures, Concerns, and Consequences: Creating a dynamic EU framework for optimal maternity care ISO907 COST Action and attended by more than 35 European researchers and editors activating the area of maternal and child health. All contracts objectives of the project for 2013 were met. A summary of the report in English can be found here. Download here.

2014 Scientific Report

In this year of the study, the project team continued the data collection process and monitoring for both the screening and cohort samples, collected biological samples from the women enrolled in the cohort and analyzed them, conducted abstracting of birth certificates, and developed an analytical plan for the analyses to be conducted on the study datasets.

Two manuscripts have been submitted for publication to international, peer-reviewed, ISI journals. Also, the website of the project was constantly updated with new information about the project.The dissemination of the project at the European level was conducted by two of the team members, who became members in the recently launched IS1405 COST Action – Building Intrapartum Research Through Health – an interdisciplinary whole system approach to understanding and contextualising physiological labour and birth (BIRTH). A summary of the report in Romanian can be found here. Download here.

2015 Scientific Report

In the fourth year of the project, the study team has finalized the data collection process for the screening and cohort samples, conducted semi-structured interviews with the data collectors in the clinics enrolled in the study, abstracted information from medical birth certificates for a part of the sample, and conducted preliminary analyses on the collected data.

The visibility of the project was ensured by maintaining and updating the project’s website and by participating in the 1st International Conference on Non-Communicable Diseases (19-20 May 2015) with an oral presentation. All contract objectives for 2015 were met. A summary of the report in Romanian can be found here. Download here.

2016 Scientific Report

In the last year of the project, the research team continued the abstracting of medical birth certificates for the babies of women enrolled in the study, conducted biomarker analyses for the women enrolled in the study’s cohort, finalized all project databases, and conducted data analyses. The dissemination of the project was conducted by publishing a manuscript in an ISI journal, by submitting a manuscript for publication to a scientific, ISI journal, by maintain and participating in two international conferences with one oral and one poster presentation, by publishing two press releases, and by maintaining and updating the project’s website.

All contract objectives of the project were met. A summary report in Romanian of all project activities conducted between 2011 and 2016 can be found here. Download here.


Scientific Conferences

Conference: 5th European Public Health Conference in Malta (7 – 10 November 2012)

Presentation Title: Maternal lifestyles and risk factors for adverse pregnancy outcomes: a pilot study in Cluj-Napoca, Romania

Type: Poster presentation

Authors: Negura D, Brinzaniuc A, Suciu AM, Pop OM, Vladut C, Chereches RM, Wallis A.

Published in conference proceedings: Yes (Supplement of the European Journal of Public Health 22:279)

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Conference: 6th European Public Health Conference in Brussels (13 – 16 November 2013)

Presentation Title: Prevalence and determinants of prenatal depression symptoms in a Romanian sample of pregnant women: a comparative analysis across socioeconomic groups

Type: Oral presentation

Authors: A Brinzaniuc, OM Pop, IA Rus, RM Chereches, A Baber-Wallis.

Published in conference proceedings: Yes (Supplement of the European Journal of Public Health)

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Conference: 1st International Conference on Non-Communicable Diseases (19-20 May 2015)

Presentation Title: Secondhand smoke exposure during pregnancy: what can we learn from self-reported exposure?

Type: Oral presentation

Authors: A Baber-Wallis, A Brinzaniuc.

Published in conference proceedings: No (the conference did not publish a conference proceeding)

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Conference: 9th National Congress on Perinatal Medicine (11-14 May 2016, Bucharest, Romania)

Presentation Title: Prevalence and patterns of self-reported tobacco consumption before and during pregnancy

Type: Poster presentation

Authors: Oana M. Blaga, Alexandra Brînzaniuc, Ioana A. Rus, Răzvan M. Cherecheș, Anne Baber Wallis

Published in conference proceedings: No (the conference did not publish a conference proceeding)

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Conference: The European Society for Nicotine and Tobacco Research Annual Meeting (9-11 September 2016, Prague, Czech Republic)

Presentation Title: Secondhand tobacco smoke exposure and depressive symptoms during pregnancy

Type: Oral presentation

Authors: Alexandra Brînzaniuc, Oana M. Blaga, Ioana A. Rus, Răzvan M. Cherecheș, Anne Baber Wallis

Published in conference proceedings: No (the conference did not publish a conference proceeding)


Scientific Publications

Within the fourth year of the project, the research team has developed a publication plan, focusing on both preliminary, as well as final results. The manuscripts which are currently in progress are:

Smoking and Quitting During Pregnancy: Analysis from a Hospital-Based Cohort of Pregnant Women in Romania

Key words: Tobacco, Smoking, Cessation, Pregnancy, Romania

Target Journal: Journal of Community Health (IF: 1.71)

Status: Published

Full citation: Blaga, O. M., Brînzaniuc, A., Rus, I. A., Cherecheș, R. M., & Wallis, A. B. (2016). Smoking and Smoking Cessation During Pregnancy. An Analysis of a Hospital Based Cohort of Women in Romania. Journal of Community Health, 1-11. DOI: 10.1007/s10900-016-0259-6

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The social patterning of prenatal depression: results from a hospital-based study in Eastern Europe

Key words: Pregnancy depression, socioeconomic position, EPDS, Eastern Europe

Target Journal: Archive of Women’s Mental Health (IF: 2.16)

Status: Submitted and under review

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Validity and Reliability of a Romanian version of the Pregnancy Experience Scale

Target Journal: Maternal and Child Health Journal (IF: 2.24)

Status: Work in progress

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Impact of prior pregnancy loss on depressive symptoms in a subsequent pregnancy

Target Journal: Women and Health (IF: 1.194)

Status: Work in progress

National available data


Above there are some key maternal and child health indicators collected by the World Health Organization (2015) and UNICEF (2013).

In addition to these resources, there are numerous agencies and organizations that collect health data on mothers, infants, and children in Romania. Some of the major data sources are listed below.

UNICEF’s Statistics for Romania

The State of the World’s Children 2015 Country Statistical tables report, among others, on basic indicators related to women’s, children’s, and infants’ health.

Peristat for Romania

AThis source monitors and reports on maternal and child health data in the perinatal period, across Europe. The last report was published in 2010.

Global Health Observatory Data Repository

Provides a summary of data collected by the World Health Organization’s European reports over a ten year period.

European Health for All Database

A database created by the World Health Organization Regional Office for Europe. Includes various information collected from regional World Health Organization Offices and other international organizations with the ability to display information in maps, graphs, and tables.

The World Bank DataBank

Similar to the European Health for All Databases, this resource uses a tool for data analysis and visualization of time series on topics such as population statistics, health nutrition, and poverty. The database was last updated in April 2015.

National Institute of Statistics

A national Romanian government center that collects various information on maternal and child health. Information is located on the website and requests can be made to the institute for more statistical data not found on the website.