NCT01054235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

2.6 years

First QC Date

January 20, 2010

Last Update Submit

January 20, 2010

Conditions

Prenatal Care

Keywords

prenatal carecommunity-based randomized controlled trialperinatal mortalityChina

Outcome Measures

Primary Outcomes (1)

  • perinatal mortality

    Jan 1999-Dec 2003

Secondary Outcomes (1)

  • timing and frequency of prenatal care and hospital delivery rate

    Jan 1999-Dec 2003

Study Arms (1)

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

Interventions

trainingBEHAVIORAL

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).

experimental

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • outsiders of program area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County Health Bureau, Ding Yuan County

Chuzhou, Anhui, 233200, China

Location

Related Publications (5)

  • 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.

    PMID: 16095526RESULT

  • 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.

    PMID: 16713892RESULT

  • 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.

    PMID: 18331626RESULT

  • 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.

    PMID: 14656839RESULT

  • 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.

    PMID: 21542939DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elina Hemminki

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

August 1, 2000

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

CN(1)