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Note: This record shows only 22 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:
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ISRCTN |
Last refreshed on:
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7 November 2022 |
Main ID: |
ISRCTN12397283 |
Date of registration:
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06/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safe motherhood in cultural safety: the impact of supporting traditional midwifery and intercultural dialogue in indigenous peoples in Guerrero State, Mexico
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Scientific title:
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Safe motherhood in cultural safety: the impact of supporting traditional midwifery and intercultural dialogue in indigenous peoples in Guerrero State, Mexico. A cluster-randomised controlled trial |
Date of first enrolment:
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01/02/2015 |
Target sample size:
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8000 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN12397283 |
Study type:
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Interventional |
Study design:
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Cluster-randomised controlled trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Canada
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Colombia
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Mexico
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Contacts
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Name:
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Ivan
Sarmiento |
Address:
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5858 Chemin de la Côte-des-Neiges
3rd Floor, Suite 300, QC
H3S 1Z1
Montréal
Canada |
Telephone:
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+1 (0)438 927 8710 |
Email:
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isarmiento@cemi.org.co |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Authentic traditional midwives identified by the community 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. Twenty intercultural brokers certified by the University of Guerrero
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Maternal and neonatal mortality, pregnancy and birth problems Pregnancy and Childbirth
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Intervention(s)
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The concern is the real-life effect of supporting authentic traditional midwives and fostering intercultural dialogue through a group of intercultural brokers in four indigenous groups of four municipalities in Guerrero State.
Among a sample of 80 clusters representative for the four municipalities, the intervention is assigned to 40 randomly selected clusters (10 clusters by each municipality), the remaining 40 clusters received usual care. Indigenous peoples and municipalities included are: Me pahaa and Náhua in Atlixtac, Na Savi in San Luis Acatlan, Me Pahaa in Acatepec, and Nancue Ñomndaa in Xichistlahuaca.
The intervention, based on discussions with traditional midwives, includes: 1. Supply basic material support for ATM in order to strength their practice and foster the relay of their profession (one ATM for each community) 2. Support for an apprentice for each midwife 3. Inform public health staff to improve understanding and attitudes toward midwives 4. Training and support a group of intercultural brokers to support the role of the midwives, and foster coordination between Western health services and communities
The training of intercultural brokers was concluded on June 2016, and support for traditional midwives started on 01/07/2015. The intervention will remain active until the end of the project. In February 2017 a final follow-up survey will be conducted.
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Primary Outcome(s)
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The 2017 follow-up survey will measure the following indicators from the 2015 baseline survey among women who gave birth during the past year: 1. Maternal deaths 2. Neonatal deaths 3. Number of times women seen by midwife during pregnancy 4. Proportion of births at home attended by midwives 5. Frequency of recourse to midwife in case of pregnancy complications 6. Frequency of recourse to midwife in case of complications with newborns 7. Proportion of women intending to have future births at home 8. Infection postpartum 9. Cost of birthing 10. 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
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Secondary Outcome(s)
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Secondary outcomes will also be measured in the 2017 follow-up survey: 1. From a survey of women who gave birth in previous year: 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 A mid-course evaluation using the technique of Most Significant Change with local stakeholders will inform about additional secondary outcomes regarding maternal health and cultural safety.
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Source(s) of Monetary Support
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Consejo Nacional de Ciencia y Tecnología
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Ethics review
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Status:
Approval date:
Contact:
1. Ethics Committee of the CIET Tropical Disease Research Centre (University of Guerrero), 22/10/2013, ref: 2013-014
2. The project was approved by community assemblies representing the indigenous peoples involved in the trial between January and February 2015
3. Research Ethics Office of McGill University, 12/06/2017, ref: A06-B28-17B
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/05/2017 |
URL:
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