Maternal HealthCHIMACANCT01006317
Intervention on Maternal Health Care in Rural China
A study testing clinical skills training, health education and financial in people with Maternal Health, run by Finnish Institute for Health and Welfare at 3 sites in China.
Trial summary
This project aims to strengthen and improve the performance of health care system in rural China in order to improve maternal and child health. It also provides policy-makers and health service managers with evidence for the development of informed policy on maternal and child health (MCH). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Health
- What is being tested?
- clinical skills training, health education and financial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2008to Jun 2009
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- townships with certain population size and distance to health care facilities
Who cannot join
- townships having another intervention in health care facilities
Trial locations and contacts
3 sites in 1 country.
China3 sites
Anhui Medical University
Hefei, Anhui, 230032
Xian Jiaotong University, No.28
Xi'an, Shaanxi, 710049
Chongqing Medical University, No.1
Yurzhong, Chongqing Municipality, 400016
About this study
Official title: Structural Hinders to and Promoters of Good Maternal Care in Rural China
This project aims to strengthen and improve the performance of health care system in rural China in order to improve maternal and child health. It also provides policy-makers and health service managers with evidence for the development of informed policy on maternal and child health (MCH). The research focuses on women of reproductive age in rural areas of China as well as on their antenatal and obstetric care service providers, both clinicians and policy makers. For the Member States and China, as well as other countries it will provide a comprehensive analysis and synthesis of current state of affairs, provider and user perspectives, of antenatal and obstetric care in rural China at national and local level. This study seeks to assess whether improving financial accessibility to and quality of maternal health care increase use of and impact of maternity services. This project is implemented in 3 provinces: Anhui, Shaan'xi and Chongqing. This project will provide a practical example and information on impact of abolishing user fees on MCH service utilisation and develop and disseminate evidence-based policy recommendations on how to improve access to and quality of antenatal and obstetrical care for local and central government and international organisations, and thus serve as a step toward reaching such important goals.
CHIMACA includes 3 types of interventions, two behavioural interventions and financial intervention. Behavioural interventions are training for clinical skills and training health education.
Read the detailed description
Province of Chongqing:
Basic design: randomized townships (3 groups) comparing 2 different interventions to one randomised internal control group and one non-randomized external control group. In service-training:
- in service-training of clinical skills: Yes. In non-randomized setting, comparing in-service training to the external control group without training, and in randomized setting comparing in-service training to the internal control group without in-service training.
- in service-training of health education: Yes. In non-randomized setting, comparing in-service training to the external control group without training, and in randomized setting comparing in-service training to the internal control group without in-service training.
- Control groups: one randomized internal control group and one external non-randomised control group.
- 20 townships in Rongchang County are divided into 2 intervention groups and one internal control group (7 clusters)
- 6 townships in Tongliang County are randomly selected for an external control group
Province of Shaan'xi:
Basic design: Randomized townships, 5 groups (in two counties) comparing 2 different interventions to the randomized control group (Figure 2)
- Financial intervention: Yes. In randomized setting, comparing coverage of ante- and postnatal care to in service-training of clinical skills, in non-randomized setting comparing coverage of ante- and postnatal care to normal local coverage system (control group of matched pairs).
- In service-training:
- Clinical skills: Yes. In randomized setting, comparing in service-training of clinical skills to coverage of ante- and postnatal care, in non-randomized setting comparing in service-training of clinical skills to normal local coverage system (control group of matched pairs).
- Health education: Yes. In randomized setting, comparing in service training of health education to normal local system, control group (in one county) and to group of clinical skills and control group (in one county).
- Control group: randomized townships. - 25 townships in Zhen'an County are divided into 2 groups (12 clusters): one intervention and one control group
- 29 townships in Lantian County are divided into three groups (10 clusters): two intervention groups and one control group.
Province of Anhui Basic design: randomized townships, 3 groups (in two counties), comparing 4 different interventions to randomized control groups (Figure 3)
- Financial intervention: Yes, in a randomized setting, comparing coverage of antenatal and postnatal care to the control and in-service training groups.
- In service-training of clinical skills: Yes, in a randomized setting, comparing the in-service training group to the control group and to the group of antenatal and postnatal care.
- In service-training of health education: Yes, in a randomized setting, comparing two different types of health education to the control group.
- Control groups: randomized townships
- 18 townships in Fanchang county are divided into 2 intervention groups (Group 1 and Group 2) and one control group (Group 3)
- 12 townships in Xuancheng county are divided into two intervention groups (Group 4 and Group 5) and one control group (Group 6).
- Conditions
- Maternal Health
- Being tested
- clinical skills training, health education, financial
- Keywords
- Maternal health services, utilization, education, randomized controlled trial, cost, clinical skills, rural China
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical skills trainingBehavioural
Also called training intervention
In addition to financial coverage (CMS) extensive in-service training of clinical skills (CS) to all doctors and MCH workers at the village and township level.
health educationBehavioural
Also called training intervention
In addition to financial coverage extensive in-service training of health education (HE) to all doctors and MCH workers at the village and township level(Anhui, Chongqing and Shaan'xi provinces); In addition to financial coverage extensive in-service training of health education (HE) for Family planning (FP) staff at village level (Anhui).
financialOther
Also called funding
In addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Financial coverage of MCH care within the local reimbursement system (CMS). |
| Clinical skills training | Experimental | In addition to financial coverage (CMS) extensive in-service training of clinical skills (CS) to all doctors and MCH workers at the village and township level. Receives: Behavioral: clinical skills training |
| health education | Experimental | In addition to financial coverage extensive in-service training of health education (HE) to all doctors and MCH workers at the village and township level(Anhui, Chongqing and Shaan'xi provinces); In addition to financial coverage extensive in-service training of health education (HE) for Family planning (FP) staff at village level (Anhui). Receives: Behavioral: health education |
| Financial | Experimental | In addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care. Receives: Other: financial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to maternal health care
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Liverpool School of Tropical Medicine, Karolinska Institutet, University Ghent, Fudan University, Center for Health Statistics and Information, Anhui Medical University, Chongqing Medical University, Xi'an Jiaotong University, Peking University
- Responsible party
- Sponsor
- Investigators
- Elina Hemminki, MD, DrPH, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006317
- Sponsor's protocol ID
- 015396
- Acronym
- CHIMACA
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2009
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Hinders to and Promoters of Good Maternal Care in Rural China
- ClinicalTrials.gov ID
- NCT01006317
- Acronym / sponsor ID
- CHIMACA / 015396
- Conditions
- Maternal Health
- Keywords
- Maternal health services, utilization, education, randomized controlled trial, cost, clinical skills, rural China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Liverpool School of Tropical Medicine, Karolinska Institutet, University Ghent, Fudan University, Center for Health Statistics and Information, Anhui Medical University, Chongqing Medical University, Xi'an Jiaotong University, Peking University
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Nov 2009 (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.
This project aims to strengthen and improve the performance of health care system in rural China in order to improve maternal and child health. It also provides policy-makers and health service managers with evidence for the development of informed policy on maternal and child health (MCH). The research focuses on women of reproductive age in rural areas of China as well as on their antenatal and obstetric care service providers, both clinicians and policy makers. For the Member States and China, as well as other countries it will provide a comprehensive analysis and synthesis of current state of affairs, provider and user perspectives, of antenatal and obstetric care in rural China at national and local level. This study seeks to assess whether improving financial accessibility to and quality of maternal health care increase use of and impact of maternity services. This project is implemented in 3 provinces: Anhui, Shaan'xi and Chongqing. This project will provide a practical example and information on impact of abolishing user fees on MCH service utilisation and develop and disseminate evidence-based policy recommendations on how to improve access to and quality of antenatal and obstetrical care for local and central government and international organisations, and thus serve as a step toward reaching such important goals.
CHIMACA includes 3 types of interventions, two behavioural interventions and financial intervention. Behavioural interventions are training for clinical skills and training health education.
Detailed description
Province of Chongqing:
Basic design: randomized townships (3 groups) comparing 2 different interventions to one randomised internal control group and one non-randomized external control group. In service-training:
- in service-training of clinical skills: Yes. In non-randomized setting, comparing in-service training to the external control group without training, and in randomized setting comparing in-service training to the internal control group without in-service training.
- in service-training of health education: Yes. In non-randomized setting, comparing in-service training to the external control group without training, and in randomized setting comparing in-service training to the internal control group without in-service training.
- Control groups: one randomized internal control group and one external non-randomised control group.
- 20 townships in Rongchang County are divided into 2 intervention groups and one internal control group (7 clusters)
- 6 townships in Tongliang County are randomly selected for an external control group
Province of Shaan'xi:
Basic design: Randomized townships, 5 groups (in two counties) comparing 2 different interventions to the randomized control group (Figure 2)
- Financial intervention: Yes. In randomized setting, comparing coverage of ante- and postnatal care to in service-training of clinical skills, in non-randomized setting comparing coverage of ante- and postnatal care to normal local coverage system (control group of matched pairs).
- In service-training:
- Clinical skills: Yes. In randomized setting, comparing in service-training of clinical skills to coverage of ante- and postnatal care, in non-randomized setting comparing in service-training of clinical skills to normal local coverage system (control group of matched pairs).
- Health education: Yes. In randomized setting, comparing in service training of health education to normal local system, control group (in one county) and to group of clinical skills and control group (in one county).
- Control group: randomized townships. - 25 townships in Zhen'an County are divided into 2 groups (12 clusters): one intervention and one control group
- 29 townships in Lantian County are divided into three groups (10 clusters): two intervention groups and one control group.
Province of Anhui Basic design: randomized townships, 3 groups (in two counties), comparing 4 different interventions to randomized control groups (Figure 3)
- Financial intervention: Yes, in a randomized setting, comparing coverage of antenatal and postnatal care to the control and in-service training groups.
- In service-training of clinical skills: Yes, in a randomized setting, comparing the in-service training group to the control group and to the group of antenatal and postnatal care.
- In service-training of health education: Yes, in a randomized setting, comparing two different types of health education to the control group.
- Control groups: randomized townships
- 18 townships in Fanchang county are divided into 2 intervention groups (Group 1 and Group 2) and one control group (Group 3)
- 12 townships in Xuancheng county are divided into two intervention groups (Group 4 and Group 5) and one control group (Group 6).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Financial coverage of MCH care within the local reimbursement system (CMS). |
| Clinical skills training | Experimental | Behavioral: clinical skills trainingIn addition to financial coverage (CMS) extensive in-service training of clinical skills (CS) to all doctors and MCH workers at the village and township level. |
| health education | Experimental | Behavioral: health educationIn addition to financial coverage extensive in-service training of health education (HE) to all doctors and MCH workers at the village and township level(Anhui, Chongqing and Shaan'xi provinces); In addition to financial coverage extensive in-service training of health education (HE) for Family planning (FP) staff at village level (Anhui). |
| Financial | Experimental | Other: financialIn addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- townships with certain population size and distance to health care facilities
Key exclusion criteria (1 listed)
- townships having another intervention in health care facilities
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 |
|---|---|---|
| clinical skills trainingAlso: training interventionIn addition to financial coverage (CMS) extensive in-service training of clinical skills (CS) to all doctors and MCH workers at the village and township level. | Behavioural | Clinical skills training |
| health educationAlso: training interventionIn addition to financial coverage extensive in-service training of health education (HE) to all doctors and MCH workers at the village and township level(Anhui, Chongqing and Shaan'xi provinces); In addition to financial coverage extensive in-service training of health education (HE) for Family planning (FP) staff at village level (Anhui). | Behavioural | health education |
| financialAlso: fundingIn addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care. | Other | Financial |
Primary outcome
Access to maternal health care
Time frame: Up to 33 months
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 21 Aug 2015.
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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.
Elina Hemminki, MD, DrPH principal investigator
Finnish Institute for Health and Welfare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical skills training, health education and financial in people with Maternal Health, run by Finnish Institute for Health and Welfare at 3 sites in China.
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 1 inclusion and 1 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 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Access to maternal health care (time frame: Up to 33 months). 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 21 Aug 2015.