Condition category
Pregnancy and Childbirth
Date applied
24/09/2016
Date assigned
13/10/2016
Last edited
13/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Every year, one and a half million deaths can be avoided if safe essential and emergency surgical care is available. Shortage of health care staff is considered the main reason for the extensive unmet need for surgery. Sierra Leone has one of the highest maternal mortality ratios in the world, with 11 mothers dying of pregnancy-related complications for every 1000 live born babies. Access to affordable and quality surgical services is limited. One possibility to improve access to essential obstetric and surgical care is to train non-physician clinicians (NPCs). Since 2011, NPCs have been trained to perform essential obstetric and surgical care, based upon the example from East Africa. To date, there are few studies that have examined the safety of surgical task-sharing. The aim of this study is to assess the quality of surgical care in Sierra Leone and examine differences in morbidity (disease) and mortality (deaths) after caesarean sections performed by medical doctors and NPCs.

Who can participate?
Women who undergo a caesarean section in hospitals where both medical doctors and NPCs are working

What does the study involve?
Information is collected during and after the caesarean section operation, at discharge and during home visits after 30 days, 1 year and 5 years. During these visits, the research nurse checks the mother’s wound, does a simple examination of the baby, and collects data on following pregnancies and health expenditure.

What are the possible benefits and risks of participating?
Participants receive an incentive in the form of a health promotion package during the home visits. The study will not delay or interfere with treatment. There are no specific risks related to participation in this study.

Where is the study run from?
The study is organized by the Norwegian University of Science and Technology, Trondheim (Norway) in cooperation with the Ministry of Health and Sanitation of Sierra Leone. Other partners: Lund University (Sweden), King’s College London (UK), College of Medicine and Allied Health Sciences, Freetown (Sierra Leone), United Nations Population Fund, Freetown (Sierra Leone).

When is the study starting and how long is it expected to run for?
October 2016 to October 2022

Who is funding the study?
The study is funded by Liaison Committee between the Central Norway Regional Health Authority (RHA) and the Norwegian University of Science and Technology (NTNU) with additional support from United Nations Population Fund.

Who is the main contact?
Alex van Duinen

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alex van Duinen

ORCID ID

Contact details

Masanga Hospital
Masanga
Tonkolili
N/A
Sierra Leone

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Maternal and perinatal outcomes after caesarean section performed by medical doctors and non-physician clinicians in Sierra Leone: a prospective observational study

Acronym

Study hypothesis

The outcome after cesarean section performed by non-physician clinicians is not inferior compared to cesarean sections performed by medical doctors.

Ethics approval

1. Office of the Sierra Leone Ethics and Scientific Review Committee, 19/05/2016
2. Norwegian Regional Central Committee for Medical and Health Research Ethics, 08/09/2016, ref: 2016/1163/REK Midt

Study design

Multicentre prospective observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Caesarean section or laparotomy for uterus rupture

Intervention

Inclusion and first data collection will be done by trained anaesthesia team members which are working in the study facilities. Data collected during the first data collection is categorized in: informed consent, inclusion/exclusion criteria, patient details, pregnancy-related information and obstetric history, onset of labour, perioperative information.

Routinely, the research nurse will visit the hospital to collect and confirm the data and will add discharge data. After confirmation, the data are sent to the central collection point. After entering the data into the database follow-up visits are planned after 30 days (with a window period of +14 days), 1 year and 5 years. During these visits, the research nurse will collect data on maternal and perinatal outcome, following pregnancies, health expenditure and socioeconomic status. The research nurse will check the wound of the mother and do a simple examination of the baby.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Maternal and neonatal survival, measured by research nurse before discharge and at 30-day follow-up visit

Secondary outcome measures

1. Infection, including wound infection, treated with antibiotics before discharge
2. Reoperation for wound dehiscence before discharge
3. New pregnancy within the first year
4. Development of vesicovaginal fistula (VVF) within the first year
5. Uterus rupture within 5 years after caesarean section
All outcomes measured by research nurse at discharge and follow-up visits

Overall trial start date

01/10/2016

Overall trial end date

01/10/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women who undergo a caesarean section (including laparotomy for uterine rupture)
2. The foetus is over 500 grams
3. The procedure is performed by a Medical Doctor or a Non-Physician Clinician

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1200

Participant exclusion criteria

1. Caesarean section performed by a student (for example medical student) as first surgeon
2. Patients who have undergone laparotomy for uterine rupture where the foetus is already delivered vaginally

Recruitment start date

01/10/2016

Recruitment end date

01/10/2017

Locations

Countries of recruitment

Sierra Leone

Trial participating centre

Lion Heart Medical Center
Yele
-
Sierra Leone

Trial participating centre

Magbenteh Community Hospital
Makeni
-
Sierra Leone

Trial participating centre

Serabu Mission Hospital
Serabu
-
Sierra Leone

Trial participating centre

Magburaka Governmental Hospital
Magburaka
-
Sierra Leone

Trial participating centre

Princess Christian Maternity Hospital (PCMH)
Freetown
-
Sierra Leone

Trial participating centre

Kabala Governmental Hospital
Kabala
-
Sierra Leone

Trial participating centre

Kenema Governmental Hospital
Kenema
-
Sierra Leone

Trial participating centre

Kambia Governmental Hospital
Kambia
-
Sierra Leone

Trial participating centre

Port Loko Governmental Hospital
Port Loko
-
Sierra Leone

Sponsor information

Organisation

Institute of Cancer Research and Molecular Medicine of the Norwegian University of Science and Technology

Sponsor details

Olav Kyrres gt 9
Trondheim
N-7491
Norway

Sponsor type

University/education

Website

http://www.ntnu.no/dmf/

Funders

Funder type

Other

Funder name

Liaison Committee between the Central Norway Regional Health Authority and the Norwegian University of Science and Technology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the study will be published in international peer-reviewed journals and at national and international conferences. The aim is to have the first results and research protocol published within one year after finalizing the data collection.

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Alex van Duinen on reasonable request.

Intention to publish date

01/10/2023

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes