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Study of Antenatal Model to Prevent Preterm Delivery (AACP)

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ClinicalTrials.gov Identifier: NCT01232192
Recruitment Status : Unknown
Verified March 2009 by Showa University.
Recruitment status was:  Recruiting
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Sponsor:
Collaborator:
Indonesia University
Information provided by:
Showa University

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

Condition or disease Intervention/treatment Phase
Preterm Delivery Pregnant Women Antenatal Care Model Behavioral: antenatal model Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
No Intervention: Antenatal model Behavioral: 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
Other Name: antenatal care model

Experimental: Antenatal Model Behavioral: 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
Other Name: antenatal care model




Primary Outcome Measures :
  1. all preterm delivery [ Time Frame: 37 weeks ]

Secondary Outcome Measures :
  1. knowledge of midwife about preterm [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232192


Locations
Indonesia
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia, 13210
Contact: Ali Sungkar, MD, PhD       alisungkar@yahoo.com   
Contact: Yuditiya Purwosunu, MD       yudi@med.showa-u.ac.jp   
Principal Investigator: Ali Sungkar, MD, PhD         
Sponsors and Collaborators
Showa University
Indonesia University
Investigators
Principal Investigator: Ali Sungkar, MD, PhD Dept Obstetrics Gynecology, Indonesia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fetal Maternal Divsion, Dept Obstetrics Gynecology, Indonesia University
ClinicalTrials.gov Identifier: NCT01232192     History of Changes
Other Study ID Numbers: AACP09
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: March 2009

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications