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The PartoMa Project: For Improving Monitoring, Action and Triage During Labour (PartoMa)

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ClinicalTrials.gov Identifier: NCT02318420
Recruitment Status : Unknown
Verified June 2017 by Ib Christian Bygbjerg, University of Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
University of Copenhagen
Rigshospitalet, Denmark
Free University Medical Center
Mnazi Mmoja Hospital
Lundbeck Foundation
Laerdal Foundation
Information provided by (Responsible Party):
Ib Christian Bygbjerg, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Obstetric Labor Complications Stillbirth Maternal Death Other: The PartoMa intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3087 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 1, 2014
Actual Primary Completion Date : March 1, 2016
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Women in labour

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
WHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training

Experimental: Health care providers
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Maternal death [ Time Frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16). ]
    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.

  2. 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). ]
  3. 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). ]
    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.

  4. 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. ]
    Participant observations and in-depth interviews.

  5. The women's experience of care received during delivery. [ Time Frame: This is assessed through community visits in January - March 2016. ]
    By focus group discussions.

  6. HALE [ Time Frame: This will be evaluated economically after finalizing the study period. ]
    Cost of healthy life years gained /1,000 population /year



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318420


Locations
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Tanzania
Dept. Obstetrics and Gynaecology, Mnazi Mmoja Hospital
Zanzibar City, Zanzibar, Tanzania
Sponsors and Collaborators
Ib Christian Bygbjerg
University of Copenhagen
Rigshospitalet, Denmark
Free University Medical Center
Mnazi Mmoja Hospital
Lundbeck Foundation
Laerdal Foundation
Investigators
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Study Director: Ib C Bygbjerg, Professor University of Copenhagen
Principal Investigator: Nanna Maaløe, MD University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ib Christian Bygbjerg, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02318420     History of Changes
Other Study ID Numbers: R164-2013-16038
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ib Christian Bygbjerg, University of Copenhagen:
Obstetrics
Partogram
ePartogram
eHealth
Low-income
Quality of care
Perinatal death
Maternal death
Cesarean section
Health information technology

Additional relevant MeSH terms:
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Stillbirth
Obstetric Labor Complications
Maternal Death
Death
Pathologic Processes
Fetal Death
Pregnancy Complications
Parental Death