Prenatal CareEPCPNCT01054235
Prenatal Care Program in Dingyuan County
A study testing training in people with Prenatal Care, run by Finnish Institute for Health and Welfare at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Prenatal Care
- What is being tested?
- training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2000to Mar 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant woman in program area (in 20 townships) from August 2000 to March 2003
Who cannot join
- outsiders of program area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prenatal Care
- Being tested
- training
- Keywords
- prenatal care, community-based randomized controlled trial, perinatal mortality, China
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: training |
What is being measured
The primary outcome is the main question the study is designed to answer.
perinatal mortality
Measured: Jan 1999-Dec 2003
Secondary outcomes (1)
timing and frequency of prenatal care and hospital delivery rate
Measured: Jan 1999-Dec 2003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startAug 2000
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prenatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Shanghai Medical University, School of Public Health, China
- Investigators
- Elina Hemminki, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054235
- Sponsor's protocol ID
- 199901118
- Acronym
- EPCP
- Status last verified
- Jan 2010
- First submitted
- 20 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16095526Wu 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.
PubMed 16713892Wu 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.
PubMed 18331626Wu 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.
PubMed 14656839Wu 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.
PubMed 21542939
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prenatal Care Program in Rural China
- ClinicalTrials.gov ID
- NCT01054235
- Acronym / sponsor ID
- EPCP / 199901118
- Conditions
- Prenatal Care
- Keywords
- prenatal care, community-based randomized controlled trial, perinatal mortality, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Shanghai Medical University, School of Public Health, China
- Study start
- Aug 2000
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: trainingThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant woman in program area (in 20 townships) from August 2000 to March 2003
Key exclusion criteria (1 listed)
- outsiders of program area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trainingThe 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). | Behavioural | experimental |
Primary outcome
perinatal mortality
Time frame: Jan 1999-Dec 2003
1 secondary outcome
timing and frequency of prenatal care and hospital delivery rate
Time frame: Jan 1999-Dec 2003
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
- Results publication: PubMed 16095526Hemminki 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.
- Results publication: PubMed 16713892Wu 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.
- Results publication: PubMed 18331626Wu 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.
- Results publication: PubMed 14656839Wu 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.
- Derived from this study: PubMed 21542939Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elina Hemminki principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Prenatal Care, run by Finnish Institute for Health and Welfare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perinatal mortality (time frame: Jan 1999-Dec 2003). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01054235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2010.