Stillbirth Clinical Trial
Official title:
The PartoMa Project for Saving Lives at Birth - An Intervention Based Study to Strengthen the Quality of Monitoring, Action and Triage During Labour at an East African Referral Hospital
OVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of
locally agreed and achievable guidelines and a continual in-house training program for
strengthening partogram-based monitoring-to-action during labour.
INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the
PartoMa guidelines) and continual in-house education.
OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study).
SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.
POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and
their offspring, as well as health providers. Women and their offspring will be enrolled
at/after unset of labour and followed until discharge.
ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further
description and secondary outcomes, please see below.
STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit
collection of case file data from October 2016 - January 2017.
SPECIFIC OBJECTIVES
I (a) To analyze in depth current quality of intrapartum care by a mixed methods approach,
including exploration of underlying challenges in care delivery and an association between
suboptimal labour care and perinatal mortality. (b) To conduct a criterion-based audit of
stillbirths investigating direct and indirect causes and related maternal risks.
II. To develop locally achievable and agreed partogram-associated labour monitoring-to-action
guidelines (the PartoMa guidelines) for strengthening the partogram use as a decision support
tool, and study its acceptability by skilled birth attendants.
III. To implement the PartoMa guidelines and low cost, low dose, high frequency, in-house
training for strengthening the use of the partogram as a decision support tool, and study the
effect on knowledge, skills, quality of intrapartum care, record keeping, and perinatal
outcome.
IV. To conduct a post-exit 2 years evaluation of use and effect of the PartoMa guidelines and
recurring training.
V. To develop an electronic smartphone application (the PartoMa app), which includes the
PartoMa guidelines.
VI. To estimate the cost-effectiveness of the interventions studied (specific objectives
III-V).
SETTING
The East African Mnazi Mmoja Hospital (MMH) in Zanzibar is a governmental referral facility
serving the population of Zanzibar. As East Africa in general, the Zanzibarian archipelago
struggles with poverty and a resource constraint health system, and half of the population
live below the basic needs poverty line.
At the facility's Department of Obstetrics and Gynecology, the yearly number of deliveries is
approximately 12,000. Approximately 50 maternal deaths occur annually (420 deaths per 100 000
live births). While the facility-based neonatal death rate is unknown, our baseline study
revealed a stillbirth rate of 59 per 1000 total births, of which approximately half were
alive at the time of admission.
Prior to this study, maternal and perinatal death audits were not conducted routinely and
little is known about direct and indirect causes for the perinatal deaths.
METHODS
This study presents a quality improvement process of intrapartum monitoring, action and
triage. The overall study design is here presented in relation to the four specific
objectives:
I. The intervention-based study is based on an in-depth baseline quality of care assessment,
which includes criterion-based audit of intrapartum management in cases of stillbirths
compared to cases with Apgar scores of 7-10, and qualitative exploration of contributing
causes to substandard labour management (including participant observations and in depth
interviews).
II. Together with local doctors and nurse-midwives, international evidence-based guidelines
are adapted to be locally achievable (the PartoMa guidelines). Additionally, they are
internationally peer-reviewed with the aim of representing best possible care with the
limited resources available at the facility.
III. A concept for reoccurring in-house training in monitoring-to-action during labour is
developed, based on the PartoMa guidelines and implemented together with the guidelines. This
PartoMa intervention (guidelines and reoccurring in-house training) is evaluated by comparing
clinical practice and birth outcome (please see the specific outcome measures below) in the
baseline period (October 2014 - January 2015) with the 9th-12th month of the intervention
(October 2015 - January 2016).
IV. After the first intervention year (February 2016), a local steering group takes over the
continual implementation of the PartoMa guidelines. If the intervention is still running,
clinical practice and birth outcome will be analysed during the 21st - 24th month of the
intervention (October 2016 - January 2017) and compared with previous assessments.
V. If the PartoMa guidelines show to be accepted among birth attendants and effective in
improving quality of care, an electronic smartphone application (the PartoMa app) will be
developed, which includes the PartoMa guidelines.
VI. A cost-effectiveness analysis of the intervention steps is carried out.
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