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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014