Condition category
Pregnancy and Childbirth
Date applied
18/09/2015
Date assigned
14/10/2015
Last edited
01/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Madagascar has a high rate of deaths among women giving birth. It has been shown that giving birth with the help of a skilled birth attendant, such as a doctor or midwife, can reduce the risk of complications, such as excessive bleeding (haemorrhage) that lead to death of mothers and their newborn babies. In Madagascar, only 44% of women give birth in the presence of a skilled birth attendant and so many women do not have access to life saving treatment. mHealth is a system which uses mobile technology, such as mobile phones or personal digital assistants (PDAs) to support healthcare. The pregnancy and newborn diagnostic assessment (PANDA) system is a mHealth system which has been specifically designed for community-Health Workers (CHWs) to reach pregnant women in remote areas. It allows them to carry out screening, collect information and provide education about healthcare. The aim of this study is to evaluate how effective the PANDA system is for providing antenatal care to women in remote areas.

Who can participate?
Pregnant women living in Madagascar.

What does the study involve?
Women attend an antenatal care visit and their medical history is taken by a healthcare worker. This information is then linked to a random ID number for each woman. At this visit, the women also are tested for HIV, syphilis and malaria, as well as having standard measurements taken to assess their general health. If any women have abnormal results to these tests, their results are sent to them immediately by smartphone and they receive a follow up appointment at the local hospital. For the rest of the study, test results and information are sent to the medical centre everyday via smartphone so that they are away of any potential risks during the pregnancy and can intervene if necessary.

What are the possible benefits and risks of participating?
The main benefits of taking part in the study are that the women involved will have access to high quality antenatal care, including screening for diseases. There are no risks of taking part in the study.

Where is the study run from?
Centre Médico Chirurgical Saint Damien (Madagascar)

When is the study starting and how long is it expected to run for?
January 2015 to October 2015

Who is funding the study?
1. Commission of Humanitarian Affairs, Geneva (Switzerland)
2. Romand Group of the Swiss Society of Gynecology (Switzerland)
3. Valdese Church (Italy)

Who is the main contact?
Mrs Anne Caroline Benski
Anne-Caroline.Benski@hcuge.ch

Trial website

Contact information

Type

Public

Primary contact

Mrs Anne Caroline Benski

ORCID ID

http://orcid.org/0000-0002-1184-882X

Contact details

Boulevard Saint Georges 66
Geneva
1205
Switzerland
+41 787 397 261
Anne-Caroline.Benski@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Usability and feasibility of a mobile health system to provide comprehensive antenatal care in low-income countries: PANDA mHealth pilot study in Madagascar

Acronym

PANDA

Study hypothesis

To assess the usability and feasibility of a mobile health system (mHealth) to provide high quality antenatal care according to World Health Organization (WHO) recommendations.

Ethics approval

1. Ethical Cantonal Board of Geneva (Commission cantonale d'éthique et de la recherche), 12/01/2015, ref: CER 14-217
2. Ethical Committee of Madagascar (Comite national d'êthique de Madagascar), 12/01/2015

Study design

Cross-sectional pilot feasibility study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Most maternal and newborn deaths are related to direct complications during pregnancy and childbirth and could be reduced by providing comprehensive antenatal care

Intervention

The women enrolled will attend a number of ANC visits along the pregancy according with WHO recomandations and the stage of pregnancy at the time of the enrollment. A random ID number will be assigned to each women, to which their clinical data and test results will be linked. ANC visits will start with the collection of social/personal data and medical history and then screening tests (HIV, HPV syphilis, malaria, haemoglobin, glucose) as well as other measurements (temperature, weight, height, blood pressure, uterine height) will be conducted. All results will be available at the end of the visits except for the HPV where the self-sampling of the women will be collected and sent to the virology laboratory in Geneva and destroyed after one year. Abnormal results will be signalised immediately by the smartphone and the woman will be referred to the hospital. Once the screening is completed, the PANDA team will proceed to health education, focusing on maternal and newborn care and birth preparedness as well as family planning. On a daily basis, data and test results will be sent via the mobile phone to the medical unit, for data verification and personalised intervention plans in order to optimise the management of pregnancies and childbirths, and to ensure appropriate care for high risk pregnancies.

Intervention type

Other

Phase

Drug names

Primary outcome measures

PANDA system feasibility using the Redmine tool an open source flexible project management web application with a ticket tracking system collecting all the items in real time during the ANC visits.

Secondary outcome measures

1. The capacity of PANDA system to provide standardised and high quality ANC, measured using the percentage of missing data and deviations from the WHO guidelines of the ANC visits. Data verification done at the end of each day of antenatal visits
2. The capacity of the system to map the pregnancies in order to help health personnel for a better management of the resources, measured using the number of women referred to the hospital for treatment and follow-up. Data is verified daily by the hospital obstetric team

Overall trial start date

13/01/2015

Overall trial end date

30/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women

Participant type

Patient

Age group

All

Gender

Female

Target number of participants

300 pregnant women

Participant exclusion criteria

Patients who are not able to comply with the protocol

Recruitment start date

13/01/2015

Recruitment end date

20/05/2015

Locations

Countries of recruitment

Madagascar

Trial participating centre

Centre Médico Chirurgical Saint Damien
Ambanja
103
Madagascar

Sponsor information

Organisation

Hôpitaux Universitaires de Genève

Sponsor details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Commission of Humanitarian Affairs, Geneva

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Romand Group of the Swiss Society of Gynecology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Valdese Church

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

September 2015: submission for publication regarding usability and feasibility test regarding the first 100 patients
November 2015: Oral presentation at the "Congrès du Groupement Romand de la Société Suisse de Gynécologie"
January 2016: submission for publication for the results of 300 patients

Intention to publish date

31/01/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes