Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-11 @ 10:38 PM
Study NCT ID:
NCT02318420
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2014-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PartoMa Project: For Improving Monitoring, Action and Triage During Labour
Sponsor:
Ib Christian Bygbjerg
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PartoMa
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: