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Fetal Renal Artery Doppler Indices in Borderline Isolated Oligohydramnios

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ClinicalTrials.gov Identifier: NCT02901340
Recruitment Status : Unknown
Verified September 2016 by Erdem Sahin, Kayseri Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Erdem Sahin, Kayseri Education and Research Hospital

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.

Condition or disease Intervention/treatment
Oligohydramnios Dietary Supplement: one to two liters of water daily

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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Third Trimester Fetal Renal Artery Doppler Indices in Borderline Idiopathic Isolated Oligohydramnios and Relationship Between Neonatal Outcomes
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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)

Dietary Supplement: one to two liters of water daily
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)



Primary Outcome Measures :
  1. Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901340


Contacts
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Contact: Erdem SAHİN, Study Principal İnvestigator +095321688683 erdemsahin07@hotmail.com

Locations
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Turkey
Kayseri Training and Research Hospital Recruiting
Kayseri, Turkey, 38000
Sponsors and Collaborators
Kayseri Education and Research Hospital

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Responsible Party: Erdem Sahin, Principal Investigator, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02901340     History of Changes
Other Study ID Numbers: 2016/474
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Keywords provided by Erdem Sahin, Kayseri Education and Research Hospital:
Borderline idiopathic isolated oligohydramnios
Fetal renal artery doppler indices
neonatal outcomes
Maternal hydration
Additional relevant MeSH terms:
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Oligohydramnios
Pregnancy Complications