Clinical trial NCT01054235: Prenatal Care Program in Dingyuan County
Official title: Evaluation of Prenatal Care Program in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care
Keywords: prenatal care
community-based randomized controlled trial
perinatal mortality
China
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Medical University, School of Public Health, China
First posted: 2010-01-22
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* outsiders of program area

Primary outcomes:
measure: perinatal mortality
timeFrame: Jan 1999-Dec 2003
Secondary outcomes:
measure: timing and frequency of prenatal care and hospital delivery rate
timeFrame: Jan 1999-Dec 2003
Other outcomes:
Locations:
city: Chuzhou
country: China
facility: County Health Bureau, Ding Yuan County
state: Anhui
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Elina Hemminki
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/S0968-8080(06)27222-7.
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.
citation: 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.
citation: 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.