NCT02901340

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 4, 2016

Last Update Submit

September 14, 2016

Conditions

Oligohydramnios

Keywords

Borderline idiopathic isolated oligohydramniosFetal renal artery doppler indicesneonatal outcomesMaternal hydration

Outcome Measures

Primary Outcomes (1)

  • Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios

    4 months

Study Arms (2)

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)

Interventions

one to two liters of water dailyDIETARY_SUPPLEMENT
Borderline isolated oligohydramnios

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • singleton pregnancies
  • between 34-37 gestational weeks
  • the age of them ranged from 18 to 35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Training and Research Hospital

Kayseri, 38000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Oligohydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Erdem SAHİN, Study Principal İnvestigator

CONTACT

+095321688683erdemsahin07@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 15, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

TU(1)