Study of Antenatal Model to Prevent Preterm Delivery

Not Applicable

• Conditions: Preterm Delivery; Pregnant Women; Antenatal Care Model
• Interventions: Behavioral: antenatal model

• Registration Number: NCT01232192
• Lead Sponsor: 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

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 Timeline

• Study Start: 2009-01
• Status Verified: 2009-03
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Last Update Submitted: 2010-11-01
• Study First Posted: 2010-11-02
• Last Update Posted: 2010-11-02
• Primary Completion: 2011-01
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antenatal model	antenatal model	-
Antenatal Model	antenatal model	-

Primary Outcome Measures

Name	Time	Method
all preterm delivery	37 weeks

Secondary Outcome Measures

Name	Time	Method
knowledge of midwife about preterm	one year

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia