- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901340
Fetal Renal Artery Doppler Indices in Borderline Isolated Oligohydramnios
Third Trimester Fetal Renal Artery Doppler Indices in Borderline Idiopathic Isolated Oligohydramnios and Relationship Between Neonatal Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During a routine pregnancy examination at 34-37 weeks gestation, the fetus was evaluated using ultrasound with the Toshiba Xario 200 3.5-megahertz probe. Fetal biometric measurements were obtained and placental structure and the amniotic fluid amount were evaluated in four quadrants. After detailed ultrasonography of the fetus, eligible pregnant women were included in the study.
Borderline idiopathic isolated oligohydramnios was defined according to the four quadrants technical with ultrasound examination and diagnosed with amniotic fluid index >5.0 and ≤8.0cm. After first ultrasound examination all patients in borderline isolated oligohydramnios group were hydrated with one to two liters of water daily. All patients monitored with non stress test and amniotic fluid index twice weekly until delivery after treatment with hydration.
For evaluating renal artery blood flow, an axial image of the fetal abdomen was obtained at the level of the fetal kidneys. Using color flow Doppler, the renal arteries were evaluated at the level of their origin from the abdominal aorta. The Doppler gate was placed within the lumen in a straight segment of the vessel. A minimum of three consecutive waveforms was used to calculate the PI. The umbilical artery Doppler measurements were studied in a free loop of cord, far from the fetus and placenta. pulsatile index and resistance index values were recorded.
The study consisted of two groups. The first group was formed of the patients who had normal amniotic volume and meets the inclusion criteria. In second group the investigators included patients who diagnosed borderline idiopathic isolated oligohydramnios. After delivery the investigators compared fetal renal artery doppler indices and neonatal outcomes between groups.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Kayseri, Turkey, 38000
- Recruiting
- Kayseri Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- singleton pregnancies
- between 34-37 gestational weeks
- the age of them ranged from 18 to 35 years
Exclusion Criteria:
- uteroplacental insufficiency
- preeclampsia
- chronic hypertension
- collagen vascular disease
- nephropathy
- chromosomal abnormalities
- congenital abnormalities, especially those associated with impaired urine production
- growth restriction
- ruptured fetal membranes
- twin pregnancies
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Borderline isolated oligohydramnios
Borderline idiopathic isolated oligohydramnios was defined according to the four quadrants technical with ultrasound examination and diagnosed with amniotic fluid index>5.0 and ≤8.0cm. The borderline idiopathic isolated oligohydramnios group was formed of the patients who meets the inclusion criteria and between 34-37 weeks gestation (n:40) |
|
|
Control group
The control group was formed of the patients who had normal amniotic volume and 34-37 weeks gestation who meets the inclusion criteria (n:100)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/474
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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