NCT01232192

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 2, 2010

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

November 1, 2010

Last Update Submit

November 1, 2010

Conditions

Preterm DeliveryPregnant WomenAntenatal Care Model

Outcome Measures

Primary Outcomes (1)

  • all preterm delivery

    37 weeks

Secondary Outcomes (1)

  • knowledge of midwife about preterm

    one year

Study Arms (2)

Antenatal model

NO INTERVENTION
Behavioral: antenatal model

Antenatal Model

EXPERIMENTAL
Behavioral: antenatal model

Interventions

antenatal modelBEHAVIORAL

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

Also known as: antenatal care model
Antenatal ModelAntenatal model

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • week gestation pregnant women with or without any vaginal discharge
  • singleton pregnancy, without any fetal or uterine anomaly

You may not qualify if:

  • Any complication in pregnancy
  • Any history of disease in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, 13210, Indonesia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22445423DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ali Sungkar, MD, PhD

    Dept Obstetrics Gynecology, Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

November 2, 2010

Record last verified: 2009-03

Locations

ID(1)