Obstetric Labor ComplicationsPartoMaNCT02318420
The PartoMa Project: For Improving Monitoring, Action and Triage During Labour
A study testing The PartoMa intervention in people with Obstetric Labor Complications and Stillbirth, run by Ib Christian Bygbjerg at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstetric Labor Complications, Stillbirth, Maternal Death
- What is being tested?
- The PartoMa intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,087 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Oct 2014to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women in labour delivering at the study site and their outcome, October 2014 - January 2015 and October 2015 - January 2016
- All health care providers at the department during the baseline and intervention period, October 2014 - January 2016
- For the different substudies, sub-groups are selected (please see the secondary outcomes for a description).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Dept. Obstetrics and Gynaecology, Mnazi Mmoja Hospital
Zanzibar, Zanzibar
About this study
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.
Read more
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.
Read the 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.
- 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:
- 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.
- 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.
- Conditions
- Obstetric Labor Complications, Stillbirth, Maternal Death
- Being tested
- The PartoMa intervention
- Keywords
- Obstetrics, Partogram, ePartogram, eHealth, Low-income, Quality of care, Perinatal death, Maternal death, Cesarean section, Health information technology
- Medical subject headings
- Obstetric Labor Complications, Stillbirth, Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PartoMa interventionOther
WHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training
| Study group | Role | What they receive |
|---|---|---|
| Women in labour | Experimental | 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. Receives: Other: The PartoMa intervention |
| Health care providers | Experimental | 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. Receives: Other: The PartoMa intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This is assessed through community visits in January - March 2016.
HALE
Cost of healthy life years gained /1,000 population /year
Measured: This will be evaluated economically after finalizing the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 Mar 2016
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ib Christian Bygbjerg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Universitair Ziekenhuis Brussel, Mnazi Mmoja Hospital, Lundbeck Foundation, Laerdal Foundation
- Responsible party
- Sponsor-investigator, Ib Christian Bygbjerg, University of Copenhagen
- Investigators
- Ib C Bygbjerg, Professor, Study director, University of CopenhagenNanna Maaløe, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318420
- Sponsor's protocol ID
- R164-2013-16038
- Acronym
- PartoMa
- Status last verified
- Sep 2019
- First submitted
- 4 Nov 2014
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Maaloe N, Andersen CB, Housseine N, Meguid T, Bygbjerg IC, van Roosmalen J. Effect of locally tailored clinical guidelines on intrapartum management of severe hypertensive disorders at Zanzibar's tertiary hospital (the PartoMa study). Int J Gynaecol Obstet. 2019 Jan;144(1):27-36. doi: 10.1002/ijgo.12692. Epub 2018 Oct 26.
PubMed 30307609Maaloe N, Housseine N, van Roosmalen J, Bygbjerg IC, Tersbol BP, Khamis RS, Nielsen BB, Meguid T. Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions. BMC Pregnancy Childbirth. 2017 Jun 7;17(1):175. doi: 10.1186/s12884-017-1360-2.
PubMed 28592237Maaloe N, Housseine N, Bygbjerg IC, Meguid T, Khamis RS, Mohamed AG, Nielsen BB, van Roosmalen J. Stillbirths and quality of care during labour at the low resource referral hospital of Zanzibar: a case-control study. BMC Pregnancy Childbirth. 2016 Nov 10;16(1):351. doi: 10.1186/s12884-016-1142-2.
PubMed 27832753
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02318420
- Acronym / sponsor ID
- PartoMa / R164-2013-16038
- Conditions
- Obstetric Labor Complications, Stillbirth, Maternal Death
- Keywords
- Obstetrics, Partogram, ePartogram, eHealth, Low-income, Quality of care, Perinatal death, Maternal death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- Ib Christian BygbjergUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Universitair Ziekenhuis Brussel, Mnazi Mmoja Hospital, Lundbeck Foundation, Laerdal Foundation
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women in labour | Experimental | Other: The PartoMa interventionAll 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. |
| Health care providers | Experimental | Other: The PartoMa interventionAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All women in labour delivering at the study site and their outcome, October 2014 - January 2015 and October 2015 - January 2016
- All health care providers at the department during the baseline and intervention period, October 2014 - January 2016
- For the different substudies, sub-groups are selected (please see the secondary outcomes for a description).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The PartoMa interventionWHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training | Other | Health care providers, Women in labour |
Primary outcome
Composite outcome of stillbirths and birth asphyxia
Time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).
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.
6 secondary outcomes
Maternal death
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
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
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.
Time frame: This is assessed through community visits in January - March 2016.
HALE
Time frame: This will be evaluated economically after finalizing the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 30307609Maaloe N, Andersen CB, Housseine N, Meguid T, Bygbjerg IC, van Roosmalen J. Effect of locally tailored clinical guidelines on intrapartum management of severe hypertensive disorders at Zanzibar's tertiary hospital (the PartoMa study). Int J Gynaecol Obstet. 2019 Jan;144(1):27-36. doi: 10.1002/ijgo.12692. Epub 2018 Oct 26.
- Derived from this study: PubMed 28592237Maaloe N, Housseine N, van Roosmalen J, Bygbjerg IC, Tersbol BP, Khamis RS, Nielsen BB, Meguid T. Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions. BMC Pregnancy Childbirth. 2017 Jun 7;17(1):175. doi: 10.1186/s12884-017-1360-2.
- Derived from this study: PubMed 27832753Maaloe N, Housseine N, Bygbjerg IC, Meguid T, Khamis RS, Mohamed AG, Nielsen BB, van Roosmalen J. Stillbirths and quality of care during labour at the low resource referral hospital of Zanzibar: a case-control study. BMC Pregnancy Childbirth. 2016 Nov 10;16(1):351. doi: 10.1186/s12884-016-1142-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ib C Bygbjerg, Professor study director
University of Copenhagen
Nanna Maaløe, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PartoMa intervention in people with Obstetric Labor Complications and Stillbirth, run by Ib Christian Bygbjerg at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of stillbirths and birth asphyxia (time frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.