Umbilical DopplerNCT02842346
Correlation Between Umbilical Resistance Index and Fetal Growth
An observational study of Umbilical Doppler, run by University Tunis El Manar.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Doppler
- What is being tested?
- ultrasonography
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.
Who may be able to join
- Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.
Who cannot join
- -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.
About this study
Official title: Correlation Between Umbilical Resistance Index and Fetal Growth: a Pilot Study
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.
- Conditions
- Umbilical Doppler
- Being tested
- ultrasonography
- Keywords
- Ultrasound; umbilical Doppler; resistance index; fetal growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Umbilical DopplerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Kehila, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842346
- Sponsor's protocol ID
- CMNTIR
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
Publications
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.
PubMed 23096449Salavati 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.
PubMed 26907381
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Umbilical Resistance Index and Fetal Growth: a Pilot Study
- ClinicalTrials.gov ID
- NCT02842346
- Acronym / sponsor ID
- CMNTIR
- Conditions
- Umbilical Doppler
- Keywords
- Ultrasound; umbilical Doppler; resistance index; fetal growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.
Key inclusion criteria (1 listed)
- Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.
Key exclusion criteria (7 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonography | Other | – |
Primary outcome
fetal growth
Time frame: at birth
. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Background: PubMed 23096449Bolz 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.
- Background: PubMed 26907381Salavati 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Doppler, run by University Tunis El Manar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal growth (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.