NCT02842346

Brief Summary

The aim of our study was to investigate the correlation between the umbilical resistance index and weight gain during the third trimester of low-risk pregnancies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 20, 2016

Last Update Submit

July 21, 2016

Conditions

Keywords

Ultrasound; umbilical Doppler; resistance index; fetal growth

Outcome Measures

Primary Outcomes (1)

  • fetal growth

    . During routine prenatal third trimester ultrasonography patients had a fetal weight estimation and measurement of the umbilical resistance index. After delivery we took note of the weight at birth, the term of the delivery, and the time interval between the ultrasound and the delivery, and then we calculated the weight gain on a weekly basis.

    at birth

Interventions

Eligibility Criteria

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

Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.

You may qualify if:

  • Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.

You may not qualify if:

  • The lack of an ultrasound carried out during the first trimester to confirm the term of the pregnancy.
  • A medical condition in the mother: diabetes, high blood pressure or a known chronic illness.
  • A medical condition in the fetus: suspicion of fetal hypotrophy (fetal biometrics lower than the 10th percentile), a birth defect (a chromosomal abnormality) during the pregnancy.
  • Patients with tobacco addiction.
  • A body mass index (BMI) ≥ 30 before the pregnancy.
  • Multiple pregnancies
  • A gap of less than 4 weeks between the date of the ultrasound and the date of delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bolz N, Kalache KD, Proquitte H, Slowinski T, Hartung JP, Henrich W, Bamberg C. Value of Doppler sonography near term: can umbilical and uterine artery indices in low-risk pregnancies predict perinatal outcome? J Perinat Med. 2013 Mar;41(2):165-70. doi: 10.1515/jpm-2012-0042.

    PMID: 23096449BACKGROUND
  • Salavati N, Sovio U, Mayo RP, Charnock-Jones DS, Smith GC. The relationship between human placental morphometry and ultrasonic measurements of utero-placental blood flow and fetal growth. Placenta. 2016 Feb;38:41-8. doi: 10.1016/j.placenta.2015.12.003. Epub 2015 Dec 12.

    PMID: 26907381BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 22, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07