PregnancyNCT01477541
Cluster-randomized Trial Measuring Integration of Professional Midwives and Obstetric Nurses in Rural Clinics in Mexico
A study testing PM/ON integration in people with Pregnancy, run by Instituto Nacional de Salud Publica, Mexico.
Trial summary
Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy
- What is being tested?
- PM/ON integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinics containing one medical team only (1 doctor and accompanying staff)
- Clinics less than 2 hours away from a referral hospital
- Clinics where at least 25 deliveries took place in the previous year
Who cannot join
- Clinics inaccessible by car
- Clinics undergoing remodeling
About this study
Official title: Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics.
Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. This project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and puerperium care. The goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. We posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.
- Conditions
- Pregnancy
- Being tested
- PM/ON integration
- Keywords
- Prenatal care, Maternal mortality, Perinatal mortality, Perinatal, Puerperium, Puerperium care, Midwives, Midwife, Obstetric, Nurse, Integration, Alternative personnel, Skilled attendant, Birth attendant, Delivery, Delivery services, Best practices, Rural
- Medical subject headings
- Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM/ON integrationOther
Professional midwives or obstetric nurses are integrated into clinic staff and delivering services.
| Study group | Role | What they receive |
|---|---|---|
| PM/ON integration arm | Experimental | Health centers where professional midwives or obstetric nurses are integrated into clinic staff and delivering services. Receives: Other: PM/ON integration |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of evidence-based practices during labor, delivery, and postpartum care
Will collect data on deliveries ocurring in sites over 21 month period.
Measured: 21 months
volume of prenatal visits, deliveries
We will Assess overall number of first and follow up prenatal visits and deliveries in intervention and control sites
Measured: 21 months
Use of harmful or unnecessary practices during labor and delivery
We will assess use of harmful or unnecessary practices during labor and delivery
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2007
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary of Health, Guerrero state, Secretary of Health, Oaxaca state
- Responsible party
- Principal investigator, Dilys Walker, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Dilys Walker, MD, Principal investigator, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477541
- Sponsor's protocol ID
- 104-6466
- Status last verified
- Nov 2011
- First submitted
- 18 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Alternative Providers for Care During Pregnancy, Delivery and Postpartum in Rural Public Health Clinics.
- ClinicalTrials.gov ID
- NCT01477541
- Acronym / sponsor ID
- 104-6466
- Conditions
- Pregnancy
- Keywords
- Prenatal care, Maternal mortality, Perinatal mortality, Perinatal, Puerperium, Puerperium care, Midwives, Midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary of Health, Guerrero state, Secretary of Health, Oaxaca state
- Study start
- Nov 2007
- Primary completion
- Mar 2010 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. This project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and puerperium care. The goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. We posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PM/ON integration arm | Experimental | Other: PM/ON integrationHealth centers where professional midwives or obstetric nurses are integrated into clinic staff and delivering services. |
| Control | No intervention | – |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinics containing one medical team only (1 doctor and accompanying staff)
- Clinics less than 2 hours away from a referral hospital
- Clinics where at least 25 deliveries took place in the previous year
Key exclusion criteria (2 listed)
- Clinics inaccessible by car
- Clinics undergoing remodeling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM/ON integrationProfessional midwives or obstetric nurses are integrated into clinic staff and delivering services. | Other | PM/ON integration arm |
Primary outcome
Use of evidence-based practices during labor, delivery, and postpartum care
Time frame: 21 months
Will collect data on deliveries ocurring in sites over 21 month period.
volume of prenatal visits, deliveries
Time frame: 21 months
We will Assess overall number of first and follow up prenatal visits and deliveries in intervention and control sites
Use of harmful or unnecessary practices during labor and delivery
Time frame: 21 months
We will assess use of harmful or unnecessary practices during labor and delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilys Walker, MD principal investigator
Instituto Nacional de Salud Publica, Mexico
Questions about this trial
What is this clinical trial studying?
A study testing PM/ON integration in people with Pregnancy, run by Instituto Nacional de Salud Publica, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of evidence-based practices during labor, delivery, and postpartum care (time frame: 21 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.