Intervention on Maternal Health Care in Rural China

Maternal Health Clinical Trial

— CHIMACA  

Official title:

Structural Hinders to and Promoters of Good Maternal Care in Rural China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006317
• Other study ID #: 015396
• Status: Completed
• Phase: N/A
• First received: October 30, 2009
• Last updated: August 20, 2015
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2015
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeUnited Kingdom: Research Ethics CommitteeBelgium: Institutional Review BoardSweden: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical 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). 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.

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:

1. 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.

2. 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:

1. 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).

2. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• townships with certain population size and distance to health care facilities

Exclusion Criteria:

• townships having another intervention in health care facilities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Maternal Health

Intervention

Behavioral:
• clinical skills training
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 education
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).

Other:
• financial
In addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui
China	Xian Jiaotong University, No.28	Xi'an	Shaanxi
China	Chongqing Medical University, No.1	Yurzhong	Chongqing

Sponsors (10)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Anhui Medical University, Center for Health Statistics and Information, Chongqing Medical University, Fudan University, Karolinska Institutet, Liverpool School of Tropical Medicine, Peking University, University Ghent, Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access to maternal health care		Up to 33 months	No