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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 12 February 2013
Main ID:  ISRCTN80090228
Date of registration: 24/07/2009
Primary sponsor: CIET Tropical Disease Research Centre (Mexico)
Public title: Neonatal survival, cultural safety and traditional midwifery in indigenous communities of Guerrero State, Mexico BMx
Scientific title: Neonatal survival, cultural safety and traditional midwifery in indigenous communities of Guerrero State, Mexico: a cluster-randomised controlled trial
Date of first enrolment: Apr 1 2009
Target sample size: 20 midwives; 30 - 40 mothers; 1,500 community members
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN80090228
Study type:  Interventional
Study design:  Single-centre cluster-randomised controlled trial  
Countries of recruitment
Mexico
Contacts
Name: Neil  Andersson
Address:  CIET Tropical Disease Research Centre Calle Pino 80001 Acapulco Mexico
Telephone:
Email: neil@ciet.org
Affiliation: 
Key inclusion & exclusion criteria
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

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Maternal, perinatal and neonatal health
Intervention(s)
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
Primary Outcome(s)
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(s)
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.
Secondary ID(s)
N/A
Source(s) of Monetary Support
Anonymous foundation (Switzerland)
Secondary Sponsor(s)
N/A
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