Preterm DeliveryAACPNCT01232192
Study of Antenatal Model to Prevent Preterm Delivery
A study testing antenatal model in people with Preterm Delivery and Pregnant Women, run by Showa University at 1 site in Indonesia.
Trial summary
The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery, Pregnant Women, Antenatal Care Model
- What is being tested?
- antenatal model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 14- 18 week gestation pregnant women with or without any vaginal discharge
- singleton pregnancy, without any fetal or uterine anomaly
Who cannot join
- Any complication in pregnancy
- Any history of disease in pregnancy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Special Capital Region, 13210
Ali Sungkar, MD, PhD, alisungkar@yahoo.com
Yuditiya Purwosunu, MD, yudi@med.showa-u.ac.jp
About this study
Official title: Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis
The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery
Read the 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
- Conditions
- Preterm Delivery, Pregnant Women, Antenatal Care Model
- Being tested
- antenatal model
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antenatal modelBehavioural
Also called antenatal care 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
| Study group | Role | What they receive |
|---|---|---|
| Antenatal model | No intervention | Not described Receives: Behavioral: antenatal model |
| Antenatal Model | Experimental | Not described Receives: Behavioral: antenatal model |
What is being measured
The primary outcome is the main question the study is designed to answer.
all preterm delivery
Measured: 37 weeks
Secondary outcomes (1)
knowledge of midwife about preterm
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Investigators
- Ali Sungkar, MD, PhD, Principal investigator, Dept Obstetrics Gynecology, Indonesia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232192
- Sponsor's protocol ID
- AACP09
- Acronym
- AACP
- Status last verified
- Mar 2009
- First submitted
- 1 Nov 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22445423
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01232192
- Acronym / sponsor ID
- AACP / AACP09
- Conditions
- Preterm Delivery, Pregnant Women, Antenatal Care Model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal model | No intervention | Behavioral: antenatal model |
| Antenatal Model | Experimental | Behavioral: antenatal model |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 14- 18 week gestation pregnant women with or without any vaginal discharge
- singleton pregnancy, without any fetal or uterine anomaly
Key exclusion criteria (2 listed)
- Any complication in pregnancy
- Any history of disease in pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antenatal modelAlso: antenatal care modelAntenatal 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 | Behavioural | Antenatal Model, Antenatal model |
Primary outcome
all preterm delivery
Time frame: 37 weeks
1 secondary outcome
knowledge of midwife about preterm
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Derived from this study: PubMed 22445423Sungkar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Sungkar, MD, PhD principal investigator
Dept Obstetrics Gynecology, Indonesia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antenatal model in people with Preterm Delivery and Pregnant Women, run by Showa University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all preterm delivery (time frame: 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2010.