Healthy3DUTNCT00919841
Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies
An observational study of Healthy, run by Mahidol University at 1 site in Thailand.
Trial summary
Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ultrasound examination
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Dec 2009
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who deliver a singleton vaginally will be invited to participate the study.
Who may be able to join
- Women who deliver a singleton vaginally will be invited to participate the study.
Who cannot join
- Women who deliver multiple gestation.
- Women who deliver by Cesarean section
- Women who have puerperal complications eg. postpartum hemorrhage or infection
Trial locations and contacts
1 site in 1 country.
About this study
Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed.
Read the detailed description
Women who naturally deliver a singleton in the Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. Transabdominal or transvaginal approach will be at the examiner's discretion. Uterine volume will be measured with 3-dimensional sonographic technologies. Ovaries will also be assessed, along with Doppler flow in several vessels in the pelvis. The pattern of involution will be analyzed.
- Conditions
- Healthy
- Being tested
- Ultrasound examination
- Keywords
- postpartum, involution, three-dimension sonography, size of the uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Also called Three dimensional ultrasound, postpartum
Sequential three-dimension sonographic examination for the uterine size after vaginal delivery. The examination will be performed once a week, until the completion of 7 weeks after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum women | Women who deliver a singleton vaginally Receives: Other: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create the uterine involution curve after vaginal delivery
Measured: 7 weeks
Secondary outcomes (1)
To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
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 HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Tuangsit Wataganara, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919841
- Sponsor's protocol ID
- Si 059/2551(EC3)
- Acronym
- 3DUT
- Status last verified
- May 2010
- First submitted
- 11 Jun 2009
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wataganara T, Phithakwatchara N, Komoltri C, Tantisirin P, Pooliam J, Titapant V. Functional three-dimensional sonographic study of the postpartum uterus. J Matern Fetal Neonatal Med. 2015;28(18):2221-7. doi: 10.3109/14767058.2014.983063. Epub 2014 Nov 27.
PubMed 25363015
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies
- ClinicalTrials.gov ID
- NCT00919841
- Acronym / sponsor ID
- 3DUT / Si 059/2551(EC3)
- Conditions
- Healthy
- Keywords
- postpartum, involution, three-dimension sonography, size of the uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Jun 2009 (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.
Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed.
Detailed description
Women who naturally deliver a singleton in the Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. Transabdominal or transvaginal approach will be at the examiner's discretion. Uterine volume will be measured with 3-dimensional sonographic technologies. Ovaries will also be assessed, along with Doppler flow in several vessels in the pelvis. The pattern of involution will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum women | – | Other: Ultrasound examinationWomen who deliver a singleton vaginally |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who deliver a singleton vaginally will be invited to participate the study.
Key inclusion criteria (1 listed)
- Women who deliver a singleton vaginally will be invited to participate the study.
Key exclusion criteria (3 listed)
- Women who deliver multiple gestation.
- Women who deliver by Cesarean section
- Women who have puerperal complications eg. postpartum hemorrhage or infection
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 |
|---|---|---|
| Ultrasound examinationAlso: Three dimensional ultrasound, postpartumSequential three-dimension sonographic examination for the uterine size after vaginal delivery. The examination will be performed once a week, until the completion of 7 weeks after delivery. | Other | Postpartum women |
Primary outcome
To create the uterine involution curve after vaginal delivery
Time frame: 7 weeks
1 secondary outcome
To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
- Derived from this study: PubMed 25363015Wataganara T, Phithakwatchara N, Komoltri C, Tantisirin P, Pooliam J, Titapant V. Functional three-dimensional sonographic study of the postpartum uterus. J Matern Fetal Neonatal Med. 2015;28(18):2221-7. doi: 10.3109/14767058.2014.983063. Epub 2014 Nov 27.
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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.
Tuangsit Wataganara, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create the uterine involution curve after vaginal delivery (time frame: 7 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 NCT00919841, 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 4 May 2010.