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Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies (3DUT)

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ClinicalTrials.gov Identifier: NCT00919841
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment
Healthy Other: Ultrasound examination

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
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Postpartum women
Women who deliver a singleton vaginally
 Other: Ultrasound examination
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.
Other Names:
  • Three dimensional ultrasound
  • postpartum


Outcome Measures
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Primary Outcome Measures :
  1. To create the uterine involution curve after vaginal delivery [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery [ Time Frame: 7 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who deliver a singleton vaginally will be invited to participate the study.
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919841


Locations
Thailand
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Tuangsit Wataganara, MD Faculty of Medicine Siriraj Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tuangsit Wataganara, MD, Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00919841     History of Changes
Other Study ID Numbers: Si 059/2551(EC3)
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: May 2010

Keywords provided by Mahidol University:
postpartum
involution
three-dimension sonography
size of the uterus