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Study of Antenatal Model to Prevent Preterm Delivery (AACP)

Primary Purpose

Preterm Delivery, Pregnant Women, Antenatal Care Model

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
antenatal model
Sponsored by
Showa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Delivery

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo National HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Antenatal model

Antenatal Model

Arm Description

Outcomes

Primary Outcome Measures

all preterm delivery

Secondary Outcome Measures

knowledge of midwife about preterm

Full Information

First Posted
November 1, 2010
Last Updated
November 1, 2010
Sponsor
Showa University
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT01232192
Brief Title
Study of Antenatal Model to Prevent Preterm Delivery
Acronym
AACP
Official Title
Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Showa University
Collaborators
Indonesia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Pregnant Women, Antenatal Care Model

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antenatal model
Arm Type
No Intervention
Arm Title
Antenatal Model
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
antenatal model
Other Intervention Name(s)
antenatal care model
Intervention Description
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
Primary Outcome Measure Information:
Title
all preterm delivery
Time Frame
37 weeks
Secondary Outcome Measure Information:
Title
knowledge of midwife about preterm
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Sungkar, MD, PhD
Organizational Affiliation
Dept Obstetrics Gynecology, Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
ZIP/Postal Code
13210
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Sungkar, MD, PhD
Email
alisungkar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yuditiya Purwosunu, MD
Email
yudi@med.showa-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Ali Sungkar, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22445423
Citation
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.
Results Reference
derived

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Study of Antenatal Model to Prevent Preterm Delivery

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