Study of Antenatal Model to Prevent Preterm Delivery (AACP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Showa University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Indonesia University
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT01232192
First received: November 1, 2010
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention
Preterm Delivery
Pregnant Women
Antenatal Care Model
Behavioral: antenatal model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis

Resource links provided by NLM:


Further study details as provided by Showa University:

Primary Outcome Measures:
  • all preterm delivery [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knowledge of midwife about preterm [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: January 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Showa University

Additional 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
Study First Received: November 1, 2010
Last Updated: November 1, 2010
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Vaginosis, Bacterial
Premature Birth
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014