Sequential Volume Measurement of Postpartum Uterus Using... | NCT00919841

Studies
Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

NCT00919841

Sponsor

Mahidol University

Status

Completed

Last Update Posted

May 4, 2010Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Healthy

Interventions

Ultrasound examination

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 11, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2010

Last Update Posted Date

May 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postpartum women		Women who deliver a singleton vaginally	Other: Ultrasound examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound examination	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To create the uterine involution curve after vaginal delivery		7 weeks

Secondary Outcomes

Measure	Description	Time Frame
To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery		7 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who deliver a singleton vaginally will be invited to participate the study.

Exclusion Criteria:

Women who deliver multiple gestation.
Women who deliver by Cesarean section
Women who have puerperal complications eg. postpartum hemorrhage or infection

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women who deliver a singleton vaginally will be invited to participate the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tuangsit Wataganara, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital		Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25363015	Derived	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.

ID	Term
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena