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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00919841
First received: June 11, 2009
Last updated: May 1, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Healthy
 Other: Ultrasound examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • To create the uterine involution curve after vaginal delivery [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: June 11, 2009
Last Updated: May 1, 2010
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on May 23, 2013