An interventional study of The PartoMa intervention in Obstetric Labor Complications, Stillbirth and Maternal Death, sponsored by Ib Christian Bygbjerg. Completed at 1 site in Tanzania. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Ib Christian Bygbjerg · Not applicable, Interventional, and Treatment
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 3,087 is above the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →This is the only study on the registry with Ib Christian Bygbjerg as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For the different substudies, sub-groups are selected (please see the secondary outcomes for a description).
All women in labour during the study period (4 months baseline and the 9th-12th month of the intervention) will be included for this pre- vs. post-study of the PartoMa intervention. The following subgroups will be studied in-depth: 1. All stillbirths 2. All maternal deaths 3. All women with severe hypertensive disorders 4. A randomized selected group of women delivering a the study site, approximately 300-600 each year.
Other: The PartoMa intervention
All health care providers (physicians and nurse-midwives) working at the Department of Obstetrics during the study period will be invited to participate in knowledge tests of obstetric care and qualitative participant observations as well as in-depth interviews regarding quality of care. This is a part of evaluating the use and effectiveness of the PartoMa intervention.
Other: The PartoMa intervention
WHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training
Composite outcome of stillbirths and birth asphyxia
Stillbirths (=late foetal deaths \>=1000g), subdivided into pre- and intra-hospital stillbirths (with/without positive foetal heart rate on admission). Birth asphyxia was defined as newborns with a 5-minutes Apgar score \< 6.
Time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Maternal death
Deaths of women at the study site while pregnant or within 42 days postpartum, from any cause related to or aggravated by pregnancy or its management.
Time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Cesarean sections and vacuum extractions
Time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Process indicators of quality of intrapartum labour care
This includes partogram use, timely surveillance (of foetal heart rate, labour progress, and maternal vital signs), and oxytocin use for labour augmentation. Management is compared to pre-selected audit criteria.
Time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Health providers' perception of their work situation in the labour and delivery rooms
Participant observations and in-depth interviews.
Time frame: This is assessed at multiple time points throughout the study period and more in-depth after 2 years of the intervention.
The women's experience of care received during delivery.
By focus group discussions.
Time frame: This is assessed through community visits in January - March 2016.
HALE
Cost of healthy life years gained /1,000 population /year
Time frame: This will be evaluated economically after finalizing the study period.
Plan to share: Undecided
Ran from Oct 2014 to primary completion in Mar 2016, 17 months.
Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Obstetric Labor Complications →