Prenatal Care Program in Dingyuan County

Prenatal Care Clinical Trial

— EPCP  

Official title:

Evaluation of Prenatal Care Program in Rural China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054235
• Other study ID #: 199901118
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: January 20, 2010
• Start date: August 2000
• Est. completion date: March 2003

Study information

• Verified date: January 2010
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• outsiders of program area

Study Design

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

Related Conditions & MeSH terms

• Prenatal Care

Intervention

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).

Locations

Country	Name	City	State
China	County Health Bureau, Ding Yuan County	Chuzhou	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Shanghai Medical University, School of Public Health, China

Country where clinical trial is conducted

China, 

References & Publications (4)

Hemminki E, Wu Z, Cao G, Viisainen K. Illegal births and legal abortions--the case of China. Reprod Health. 2005 Aug 11;2:5. — View Citation

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. — View Citation

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. — View Citation

Wu Z, Viisainen K, Wang Y, Hemminki E. Perinatal mortality in rural China: retrospective cohort study. BMJ. 2003 Dec 6;327(7427):1319. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perinatal mortality		Jan 1999-Dec 2003	Yes
Secondary	timing and frequency of prenatal care and hospital delivery rate		Jan 1999-Dec 2003	Yes