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Prenatal Care Program in Dingyuan County (EPCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01054235
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Sponsor:
Collaborator:
Shanghai Medical University, School of Public Health, China
Information provided by:
Finnish Institute for Health and Welfare

Brief Summary:
The general objective of this study is to evaluate prenatal care in the specific context of rural China. It also aims to define the optimal content of prenatal care for the context of rural China, to evaluate the effect of such prenatal care on infant and maternal outcomes, using a community based, well designed controlled trial in rural counties. Finally, it aims to describe the process of conducting a controlled study using community resources.

Condition or disease Intervention/treatment Phase
Prenatal Care Behavioral: training Not Applicable

Detailed Description:
The study was conducted in a rural county of 900,000 people in Anhui province, in eastern China. The total area of the county is almost 3,000 square kilometres. The majority of the population of the county is engaged in farming. In terms of national GDP rankings, the study county is typical of less developed rural areas in China. Twenty townships (10 interventions and 10 control) out of a total of 55 were selected - on the basis of having sufficient health facilities and staff - for a controlled trial on the introduction of systematic prenatal care in the area.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Prenatal Care Program in Rural China
Study Start Date : August 2000
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Arm Intervention/treatment
Experimental: experimental
The intervention consisted of 1) training township midwives, 2) informing women and men in the community of the importance of prenatal care, 3) providing intervention township hospitals with basic medical instruments used in prenatal care (i.e. blood pressure monitors, weighing scales for mothers and newborns, stethoscopes). For control ,none of the intervention will be given.
Behavioral: training
The intervention consisted of 1) training township midwives, 2) informing women and men in the community of the importance of prenatal care, 3) providing intervention township hospitals with basic medical instruments used in prenatal care (i.e. blood pressure monitors, weighing scales for mothers and newborns, stethoscopes).




Primary Outcome Measures :
  1. perinatal mortality [ Time Frame: Jan 1999-Dec 2003 ]

Secondary Outcome Measures :
  1. timing and frequency of prenatal care and hospital delivery rate [ Time Frame: Jan 1999-Dec 2003 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant woman in program area (in 20 townships) from August 2000 to March 2003

Exclusion Criteria:

  • outsiders of program area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054235


Locations
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China, Anhui
County Health Bureau, Ding Yuan County
Chuzhou, Anhui, China, 233200
Sponsors and Collaborators
Finnish Institute for Health and Welfare
Shanghai Medical University, School of Public Health, China
Investigators
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Principal Investigator: Elina Hemminki Finnish Institute for Health and Welfare
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elina Hemminki, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01054235    
Other Study ID Numbers: 199901118
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010
Keywords provided by Finnish Institute for Health and Welfare:
prenatal care
community-based randomized controlled trial
perinatal mortality
China