Condition category
Pregnancy and Childbirth
Date applied
15/08/2015
Date assigned
22/08/2015
Last edited
18/09/2015
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 in a health facility, such as a hospital, with a skilled health-care professional can reduce the risk of complications, such as excessive bleeding (haemorrhage) which leads to death of mothers and their newborn babies. In Madagascar, only 44% give birth with a skilled birth attendant, such as a midwife or doctor, present and only 35% of these give birth in a health care facility.
mHealth is a system which uses mobile technology, such as mobile phones or personal digital assistants (PDAs) to support healthcare. The PANDA system is part of a mHealth system, which aims to provide complete antenatal care to pregnant women in the Ambanja region of Madagascar, and encourages women to give birth safely with a skilled birth attendant or in a healthcare facility. The aim of this study is to find out whether women who have taken part in the PANDA study have a better knowledge of the dangers of childbirth and if that makes them more likely to give birth in a healthcare facility.

Who can participate?
Women within a year of giving birth, who either have or have not taken part in the PANDA study.

What does the study involve?
Participants are given a questionnaire designed to test their knowledge of the dangers of pregnancy and childbirth, and to find out whether they gave birth in a healthcare facility or with the help of a birth attendant. The questionnaires for women who have taken part in the PANDA study are then compared to the questionnaires for women who have not.

What are the possible benefits and risks of participating?
All women will benefit from a individual educational session about obstetric danger signs for mother and child. There are no notable risks of taking part.

Where is the study run from?
Dispensaries served by the St. Damian Centre (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?
GRSSGO (Switzerland)

Who is the main contact?
Dr Nicole Schmidt

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicole Schmidt

ORCID ID

http://orcid.org/0000-0002-0428-0893

Contact details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Determinants of health service utilisation for delivery among women in Ambanja region, Madagascar

Acronym

RENY

Study hypothesis

Women knowing about obstetric danger signs are more likely to deliver in a health facility.

Ethics approval

Ethical Commission of the Canton of Geneva, 16/03/2015, ref: 15-023.

Study design

Prospective single-centre case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Place of delivery

Intervention

Exploring if women who participated in the PANDA study (study providing antenatal care using a m-Health device) will have an increased knowledge of obstetric danger signs. The PANDA study, approved by the ethical commission of Geneva (CER 14-217), and started in January 2015 at the CMC Saint Damian in the Ambanja region, aims to reach women in remote areas. The Pregnancy And Newborn Diagnostic Assessment (PANDA) is an mHealth system specifically designed for community-Health Workers (CHWs) to reach pregnant women in remote areas, collect information, conduct screening and provide health education. The system, as well as being a promising solution to increase access to antenatal care (ANC), also automatically generates enough data to evaluate its own performance. The main objective is to assess the functionality and acceptance of Panda system for providing ANC in hard to reach areas and to operationalize data monitoring for flagging of high-risk pregnancies.” (Extract from the approved protocol CER 14-217). Furthermore, the PANDA includes a short educational part for the women informing them about danger signs during pregnancy as well as for the newborn.
Using a prospective case-control design 136 women of all ages who have given birth in the last 12 months and having been included in the PANDA study will be compared with 136 women with the same criteria but having not participated in the PANDA study. In case of difficulties to recruit 136 women having participated in the PANDA study, it would be also possible to include 100 women as cases and 200 women as controls. Women will be recruited from April to October 2015 and be invited to answer a questionnaire taking approximately 30 minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Whether women who participated in the PANDA study are more likely to deliver in a health facility measured in the first year postpartum using a questionnaire.

Secondary outcome measures

1. Whether women having participated in the PANDA study have and increased knowledge of danger signs measured in the first year postpartum using a questionnaire.
2. Whether women with an increased knowledge of danger signs are more likely to give birth in a health facility measured in the first year postpartum using a questionnaire.

Overall trial start date

01/01/2015

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women within a year of giving birth
2. Women who have participated in the PANDA study (cases)
OR
3. Women who have not participated in the PANDA study (controls)

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

136 women of all ages who have given birth in the last 12 months and having been included in the PANDA study will be compared with 136 women with the same criteria but having not participated in the PANDA study. In case of difficulties to recruit 136 women having participated in the PANDA study, it would be also possible to include 100 women as cases and 200 women as controls.

Participant exclusion criteria

N/A

Recruitment start date

01/04/2015

Recruitment end date

31/10/2015

Locations

Countries of recruitment

Madagascar

Trial participating centre

Dispensaries served by the St. Damian Centre, Ambanja, Madagascar
Centre Medico-Chirurgical St-Damien
Ambanja
203
Madagascar

Sponsor information

Organisation

University Hospitals of Geneva, Department of Obstetric and Gynaecology

Sponsor details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch/gynecologie-obstetrique

Funders

Funder type

Research organisation

Funder name

GRSSGO (Gynaecology and Obstetric Society of the French Part of Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish the results (primary and secondary objective) of the study.

Intention to publish date

28/02/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes