- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054235
Prenatal Care Program in Dingyuan County (EPCP)
January 20, 2010 updated by: Finnish Institute for Health and Welfare
Evaluation of Prenatal Care Program in Rural China
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
5000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Anhui
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Chuzhou, Anhui, China, 233200
- County Health Bureau, Ding Yuan County
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- pregnant woman in program area (in 20 townships) from August 2000 to March 2003
Exclusion Criteria:
- outsiders of program area
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
perinatal mortality
Time Frame: Jan 1999-Dec 2003
|
Jan 1999-Dec 2003
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
timing and frequency of prenatal care and hospital delivery rate
Time Frame: Jan 1999-Dec 2003
|
Jan 1999-Dec 2003
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elina Hemminki, Finnish Institute for Health and Welfare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hemminki E, Wu Z, Cao G, Viisainen K. Illegal births and legal abortions--the case of China. Reprod Health. 2005 Aug 11;2:5. doi: 10.1186/1742-4755-2-5.
- Wu Z, Viisainen K, Hemminki E. Determinants of high sex ratio among newborns: a cohort study from rural Anhui province, China. Reprod Health Matters. 2006 May;14(27):172-80. doi: 10.1016/S0968-8080(06)27222-7.
- Wu Z, Viisainen K, Li X, Hemminki E. Maternal care in rural China: a case study from Anhui province. BMC Health Serv Res. 2008 Mar 10;8:55. doi: 10.1186/1472-6963-8-55.
- Wu Z, Viisainen K, Wang Y, Hemminki E. Perinatal mortality in rural China: retrospective cohort study. BMJ. 2003 Dec 6;327(7427):1319. doi: 10.1136/bmj.327.7427.1319.
- Wu Z, Viisainen K, Wang Y, Hemminki E. Evaluation of a community-based randomized controlled prenatal care trial in rural China. BMC Health Serv Res. 2011 May 4;11:92. doi: 10.1186/1472-6963-11-92.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 22, 2010
Last Update Submitted That Met QC Criteria
January 20, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 199901118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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