Study of Antenatal Model to Prevent Preterm Delivery

NCT ID: NCT01232192

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery

Detailed Description

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The standard antenatal care nowadays can not answer for preterm delivery problems. Thus, comprehensive and proactive approach is needed for preventing preterm delivery. This antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered pH check

Conditions

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Preterm Delivery Pregnant Women Antenatal Care Model

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Antenatal model

Group Type NO_INTERVENTION

antenatal model

Intervention Type BEHAVIORAL

Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment:

* Midwife training
* Pregnant women campaigning
* Early detection with self pH detection
* Treatment of bacterial vaginosis

Antenatal Model

Group Type EXPERIMENTAL

antenatal model

Intervention Type BEHAVIORAL

Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment:

* Midwife training
* Pregnant women campaigning
* Early detection with self pH detection
* Treatment of bacterial vaginosis

Interventions

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antenatal model

Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment:

* Midwife training
* Pregnant women campaigning
* Early detection with self pH detection
* Treatment of bacterial vaginosis

Intervention Type BEHAVIORAL

Other Intervention Names

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antenatal care model

Eligibility Criteria

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Inclusion Criteria

* 14- 18 week gestation pregnant women with or without any vaginal discharge
* singleton pregnancy, without any fetal or uterine anomaly

Exclusion Criteria

* Any complication in pregnancy
* Any history of disease in pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role collaborator

Showa University

OTHER

Sponsor Role lead

Responsible Party

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Dept Obstetrics Gynecology, Indonesia University

Principal Investigators

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Ali Sungkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept Obstetrics Gynecology, Indonesia University

Locations

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Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Facility Contacts

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Ali Sungkar, MD, PhD

Role: primary

Yuditiya Purwosunu, MD

Role: backup

References

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Sungkar A, Purwosunu Y, Aziz MF, Pratomo H, Sutrisna B, Sekizawa A. Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate. Int J Gynaecol Obstet. 2012 Jun;117(3):264-7. doi: 10.1016/j.ijgo.2012.01.007. Epub 2012 Mar 23.

Reference Type DERIVED
PMID: 22445423 (View on PubMed)

Other Identifiers

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AACP09

Identifier Type: -

Identifier Source: org_study_id