Study of Antenatal Model to Prevent Preterm Delivery

Pregnant Women Clinical Trial

— AACP  

Official title:

Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01232192
• Other study ID #: AACP09
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2010
• Last updated: November 1, 2010
• Start date: January 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2009
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antenatal Care Model
• Pregnant Women
• Premature Birth
• Preterm Delivery

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Showa University	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all preterm delivery		37 weeks	No
Secondary	knowledge of midwife about preterm		one year	No