Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

Healthy Clinical Trial

— 3DUT  

Official title:

Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919841
• Other study ID #: Si 059/2551(EC3)
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: May 1, 2010
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To create the uterine involution curve after vaginal delivery		7 weeks	No
Secondary	To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery		7 weeks	No