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

NCT02318420 | Completed

• 1 other identifier: R164-2013-16038
• Study Type: interventional
• Target: 3,087
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications; Stillbirth; Maternal Death

Keywords

Obstetrics; Partogram; ePartogram; eHealth; Low-income; Quality of care; Perinatal death; Maternal death; Cesarean section; Health information technology

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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.

  This is assessed through community visits in January - March 2016.

Study Arms (2)

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.

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.

Other: The PartoMa intervention

Interventions

The PartoMa intervention OTHER

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

Health care providers; Women in labour

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Ib Christian Bygbjerg: lead
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Free University Medical Center: collaborator
• Mnazi Mmoja Hospital: collaborator
• Lundbeck Foundation: collaborator
• Laerdal Foundation: collaborator

Study Sites (1)

Dept. Obstetrics and Gynaecology, Mnazi Mmoja Hospital

Zanzibar, Zanzibar, Tanzania

Location

Related Publications (3)

• 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.

  PMID: 30307609 DERIVED

• Maaloe 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.

  PMID: 28592237 DERIVED

• Maaloe 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.

  PMID: 27832753 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications; Stillbirth; Maternal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parental Death

Study Officials

• Ib C Bygbjerg, Professor

  University of Copenhagen

  STUDY DIRECTOR

• Nanna Maaløe, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: December 17, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

TA (1)