Condition category
Pregnancy and Childbirth
Date applied
03/08/2020
Date assigned
14/08/2020
Last edited
14/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Along with India, Nigeria currently accounts for one-third of the annual maternal deaths in the world. Among several other factors, poor quality of care and the inadequate use of skilled care for pregnant women are the key determinants of the high rate of maternal deaths in Nigeria.
The intervention was designed to improve the quality of care, and patient satisfaction and to reduce deaths of mothers and children during pregnancy and childbirth in Nigeria.

Who can participate?
Pregnant women who access maternal care in participating centers and their health care givers

What does the study involve?
Of the 8 hospitals involved in the study, the intervention was carried out in 4. The intervention activities include structured training in improving maternal outcomes, strategic planning and monitoring, and gathering patient feedback. During the study period data was collected from all 8 hospitals on maternal outcomes to compare between the hospitals that received the intervention and those that did not.

What are the possible benefits and risks of participating?
None

Where is the study run from?
The Women’s Health and Research Centre, Bénin City (Nigeria)

When is the study starting and how long is it expected to run for?
July 2017 to July 2019

Who is funding the study?
World Health Organisation (Switzerland)

Who is the main contact?
Prof. Friday Okonofua, feokonofua@yahoo.co.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Friday Okonofua

ORCID ID

http://orcid.org/0000-0002-8777-2606

Contact details

KM 11
Lagos-Benin Expressway
Igue-Iheya
Benin City
301000
Nigeria
+234 8023347828
feokonofua@wharc-online.org

Type

Scientific

Additional contact

Prof Rosemary Ogu

ORCID ID

http://orcid.org/0000-0002-5467-302X

Contact details

University of Port Harcourt
Port Harcourt
500272
Nigeria
+234 8033129937
rosemary.ogu@uniport.edu.ng

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

A65869

Study information

Scientific title

Intervention to improve the quality of emergency obstetric care for preventing maternal and perinatal mortality in referral hospitals in Nigeria: a quasi-experimental research study

Acronym

Study hypothesis

1.There is no significant difference in the policies and patterns of emergency obstetric care and practices between intervention and control health facilities
2. There is no significant difference in the clinical management of the complications that lead to maternal/perinatal deaths between the intervention and control health facilities
3. There is no significant difference in the assessments of the quality of clinical care between intervention and control sites
4. There is no significant difference in case-fatality rates due to leading obstetric complications between intervention and control sites
5. There is no significant difference in the indicators of maternal and newborn outcomes (maternal, stillbirth, and neonatal death ratios) between the intervention and control health facilities

Ethics approval

1. Approved 25/06/204, WHO Research Ethics Review Committee (20 Avenue Appia-CH-1211 Geneva 27, Switzerland; no telephone number provided; ercsec@who.int), ref: A65869.
2. Approved 16/07/2014, National Health Research Ethics Committee (NHREC) of Nigeria (Federal Ministry of Health, Federal Secretariat, Abuja, Nigeria; +234-9-523-8367; info@nhrec.net), ref: NHREC/01/01/2007 – renewed in 2015, ref: NHREC 01/01/20047-12/12/2015b

Study design

Multi-centre interventional quasi-experimental mixed-methods study

Primary study design

Interventional

Secondary study design

Quasi-experimental mixed-methods study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Emergency obstetric care

Intervention

All the women who presented for antenatal, delivery and postnatal care within the period were eligible for inclusion in the study. Recruitment and informed consent were obtained at the time the women registered in the hospitals for antenatal care, or during admission for management of complications, or at the time of delivery. Informed consent was obtained from those presenting with pregnancy related complications when they have been clinically stabilized. For women presenting at the hospital for the first time in labour, consent is obtained after they delivered their babies. The monitoring/evaluation officer collects and enters the data into the computer system daily. Sources of data collection were hospital records, clinical case records, maternal/perinatal deaths clinical audit records, maternal/perinatal death reviews, client flow analysis, focus group discussion, in-depth interview, and exit interviews. Total duration of observation is the total time the woman spends at the facility.

Six public secondary care hospitals and two public tertiary care hospitals in both north and south of Nigeria were selected randomly for the formative phase. Thereafter the intervention was carried out in four of the initial eight hospitals, with two hospitals as intervention and two as control sites. At baseline, we assessed the providers’ and facilities’ readiness to provide care, patients' satisfaction and experience while accessing obstetric care, using a mixed-method which included a questionnaire on knowledge and management of obstetric complications, site inventory assessment, client flow analysis, focus group discussion and in-depth interviews.
The intervention activities which were developed based on the results in the formative research include
1. Development of a strategic plan for preventing maternal and perinatal deaths
2. Staff Training/Capacity building for healthcare providers in the facilities
3. Establishing a maternal and perinatal death surveillance and response system (MPDSR) in the health facilities
4. Development of protocols, guidelines, algorithm and reminders for clinical Emergency Obstetric Care EmOC
5. Advocacy activities for increased funding and resource mobilization
6. Computerized appointment scheduling system to reducing delays in service delivery
7. Patients education and feedback- Involving men in maternal and child health care through monthly health talk

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Measured at baseline, monthly during the intervention, and at endline using patient records:
1. Number of women attending antenatal, delivery and post-natal clinics
2. Women with moderate to severe PPH, eclampsia, and obstructed labour
3. Number of cases with PPH, eclampsia and obstructed labour where internationally accepted protocols are adhered to or breeched
4. Number of clinically managed cases of PPH, eclampsia and obstructed that died
5. Number of maternal deaths
6. Number of stillbirths and early neonatal deaths occurring in the hospitals

Secondary outcome measures

Client perception of quality and satisfaction with care measured using client flow analysis (patient records) at baseline, monthly during the intervention, and at endline and also by an exit interview questionnaire

Overall trial start date

01/07/2017

Overall trial end date

30/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pregnant women that present during the intervention period
2. All the healthcare givers in the obstetric units

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

18,000 patient records reviewed and 2,400 interviewed

Total final enrolment

20439

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Nigeria

Trial participating centre

Central Hospital Benin City
Benin City
301000
Nigeria

Trial participating centre

Central Hospital Warri
Warri
-
Nigeria

Trial participating centre

General Hospital Minna
Minna
-
Nigeria

Trial participating centre

General Hospital Suleja
Suleja
-
Nigeria

Sponsor information

Organisation

World Health Organization

Sponsor details

20 Avenue Appia-CH-1211
Geneva
CH1211
Switzerland
+41 22 791 3791
ercsec@who.int

Sponsor type

Research council

Website

https://www.WHO.INT.RPC/Research_Ethics

Funders

Funder type

Research organisation

Funder name

World Health Organization

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

Switzerland

Results and Publications

Publication and dissemination plan

Data repository
Publication in high impact journals
Policy document

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
The datasets generated during the formative phase of this study is stored on Zenodo (http://doi.org/10.5281/zenodo.161549). Users are expected to request for access from the Principal Investigator, Professor Friday Okonofua Email feokonofua@yahoo.co.uk. The intervention datasets will also be stored on Zenodo and will be available on request from the principal Investigator. The qualitative data are outputs generated from a computer-assisted qualitative data analysis software, Atlas.ti version 6.25, whereas the quantitative data are all stored in SPSS format. There are no legal issues, and no consent to share is required from the participants.

Intention to publish date

30/10/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/08/2020: Internal review. 12/08/2020: Trial’s existence confirmed by the World Health Organization.