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Prenatal Care Program in Dingyuan County (EPCP)

This study has been completed.
Sponsor:
Collaborator:
Shanghai Medical University, School of Public Health, China
Information provided by:
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01054235
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention
Prenatal Care
Behavioral: training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of Prenatal Care Program in Rural China

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • perinatal mortality [ Time Frame: Jan 1999-Dec 2003 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • timing and frequency of prenatal care and hospital delivery rate [ Time Frame: Jan 1999-Dec 2003 ] [ Designated as safety issue: Yes ]

Enrollment: 5000
Study Start Date: August 2000
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054235

Locations
China, Anhui
County Health Bureau, Ding Yuan County
Chuzhou, Anhui, China, 233200
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Shanghai Medical University, School of Public Health, China
Investigators
Principal Investigator: Elina Hemminki National Institute for Health and Welfare, Finland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elina Hemminki, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01054235     History of Changes
Other Study ID Numbers: 199901118
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: China: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
prenatal care
community-based randomized controlled trial
perinatal mortality
China

ClinicalTrials.gov processed this record on November 23, 2014