Clinical trial NCT02901340: Fetal Renal Artery Doppler Indices in Borderline Isolated Oligohydramnios
Official title: Third Trimester Fetal Renal Artery Doppler Indices in Borderline Idiopathic Isolated Oligohydramnios and Relationship Between Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oligohydramnios
Keywords: Borderline idiopathic isolated oligohydramnios
Fetal renal artery doppler indices
neonatal outcomes
Maternal hydration
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was consisted of 2 groups and included pregnant women in between 34 and 37. weeks of gestation for both groups. The normal pregnancy group was consisted of 100 healthy pregnant women whom excluded borderline idiopathic isolated oligohydramniosis , the main group was consisted of 40 pregnant women with diagnosed borderline idiopathic isolated oligohydramniosis.

Brief summary: The purpose of the study is to investigate third trimester fetal renal artery doppler indices in borderline idiopathic isolated oligohydramnios and relationship between neonatal outcomes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Training and Research Hospital
Study officials:
References: