NCT00919841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 4, 2010

Status Verified

May 1, 2010

Enrollment Period

5 months

First QC Date

June 11, 2009

Last Update Submit

May 1, 2010

Conditions

Healthy

Keywords

postpartuminvolutionthree-dimension sonographysize of the uterus

Outcome Measures

Primary Outcomes (1)

  • To create the uterine involution curve after vaginal delivery

    7 weeks

Secondary Outcomes (1)

  • To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery

    7 weeks

Study Arms (1)

Postpartum women

Women who deliver a singleton vaginally

Other: Ultrasound examination

Interventions

Ultrasound examinationOTHER

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.

Also known as: Three dimensional ultrasound, postpartum
Postpartum women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 25363015DERIVED

MeSH Terms

Interventions

Postpartum Period

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Tuangsit Wataganara, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 4, 2010

Record last verified: 2010-05

Locations

TH(1)