Condition category
Pregnancy and Childbirth
Date applied
28/04/2009
Date assigned
24/07/2009
Last edited
24/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Andersson

ORCID ID

Contact details

CIET Tropical Disease Research Centre
Calle Pino
Acapulco
80001
Mexico
neil@ciet.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Neonatal survival, cultural safety and traditional midwifery in indigenous communities of Guerrero State, Mexico: a cluster-randomised controlled trial

Acronym

BMx

Study hypothesis

1. Recovery and strengthening of traditional Amuzgo culture is important for the physical and mental health of Amuzgo people in the Mexican State of Guerrero
2. Recovery and strengthening of the traditional role of the midwife is a necessary condition for the safety of the Amuzgo birth culture
3. Traditional birth practices have some advantages over common biomedical practices for the physical and mental health of both the mother and the newborn
4. Birth attendant training conducted by biomedical practitioners, however respectful and sensitive, is inherently culturally unsafe
5. The transmission of traditional midwifery skills from generation to generation involves knowledge and practices that are sacred to the culture and best conveyed through a process of apprenticeship
6. Once their role and authority is stabilised, traditional midwives are more likely to adapt biomedical perspectives and technologies that they see, on the basis of evidence, to be helpful to the fulfilment of their roles

Ethics approval

1. Comisario Ejidal (representing the Amuzgo communities of Xochistlahuaca) approved on 5 March 2009
2. Ethics Committee of the CIET Tropical Disease Research Centre, University of Guerrero with indigenous participation, approved on 2 March 2009
3. CIETcanada Research Ethics Board approved on 7 December 2008

Study design

Single-centre cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Maternal, perinatal and neonatal health

Intervention

The following interventions to be carried out immediately in three randomly selected geographic areas of the municipality and, after the two-year trial period, in the remaining three areas:
1. Material support for each of the identified midwives in intervention areas to create or maintain a "school" of disciples or apprentices whom they will assist to pursue a vocation to midwifery
2. Support from indigenous health promoters in intervention areas to midwives, pregnant women and newborns consisting of:
2.1. Surveillance of pregnancies
2.2. Organisation of pregnant mothers' groups
2.3. Liaison with nearest health centre
2.4. Facilitation of contacts between pregnant women, midwives and health centres
2.5. Organisation of transport in obstetric and neonatal emergencies
2.6. Early postnatal visits to weigh newborns and check on their health status
3. Pregnant women's groups for mutual support in intervention areas
4. Organisation of existing public transport for response during obstetric and neonatal emergencies based on reimbursement for fuel costs through voucher provided by indigenous health promoter

The following interventions will be carried out immediately in the entire municipality and in the nearby regional hospital:
1. Updated training of hospital and health centre staff in obstetrics and neonatal care
2. Intercultural training of hospital and health centre staff
3. Training of translators at hospitals and health centres
4. Provision of residential space for family members who accompany indigenous mothers to regional hospital in Ometepec
5. Revision of norms and guidelines for responding to obstetric and neonatal emergencies among the indigenous population

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The 2011 follow-up survey will measure the following indicators from the 2008 baseline survey among women who gave birth during the previous three years:
1. Neonatal deaths
2. Number of times women seen by midwife during pregnancy
3. Proportion of births at home attended by midwives
4. Frequency of recourse to midwife in case of pregnancy complications
5. Frequency of recourse to midwife in case of complications with newborns
6. Proportion of women intending to have future births at home
7. Among women who gave birth in health institutions, questions about their treatment including birth position, availability of translators, presence of family members at birth, presence of midwife at birth, bathing in cold water, treatment of the placenta, retention of amulets and how respectful they considered their treatment to have been

Secondary outcome measures

1. From survey of women who gave birth in previous three years:
1.1. Prevalence of violent acts toward pregnant women
1.2. Proportion of births without external assistance

2. From survey of husbands, mothers and mothers-in-law:
2.1. Opinion as to whom the woman should consult first when she learns she is pregnant
2.2. Opinion as to who should attend the woman first if she has complications during pregnancy
2.3. Opinion as to who should decide whether to take the woman to the hospital if there are complications during childbirth
2.4. Perception of neighbours' preferences as to who should provide antenatal care
2.5. Perception of neighbours' preferences as to home vs institutional birth

3. From survey of health workers:
3.1. Consistency of criteria for classifying levels of pregnancy risk and referral of high risk pregnancies, complicated births and neonatal emergencies
3.2. Willingness to allow midwives to participate in institutional births and to charge for it
3.3. Proportion of workers who have received any intercultural training

All secondary outcomes will be followed-up for three years.

Overall trial start date

01/04/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

The following have been randomised into three geographic areas for immediate intervention and three for delayed intervention:
1. Twenty midwives identified by the baseline survey as having assisted at three or more births in the previous 3 years
2. All women in the baseline sample clusters who give birth or become pregnant during the trial period
3. All adult family members of the above
4. All families of the baseline sample communities where pregnancies or births occur during the trial period
5. Community health managers (gestores) certified by the Red de Promotores de Salud Indigenas Amuzgos, A.C. (Indigenous Amuzgo Health Promoters Network)
6. Medical personnel and support staff of health centres and hospitals serving the municipality of Xochistlahuaca

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20 midwives; 30 - 40 mothers; 1,500 community members

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Mexico

Trial participating centre

CIET Tropical Disease Research Centre
Acapulco
80001
Mexico

Sponsor information

Organisation

CIET Tropical Disease Research Centre (Mexico)

Sponsor details

Calle Pino
Acapulco
80001
Mexico

Sponsor type

Research organisation

Website

http://www.ciet.org

Funders

Funder type

Other

Funder name

Anonymous foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes