NCT03935607

Brief Summary

The current study is based on the use of transvaginal sonography in the evaluation of oligohydramnios. Patients will be recruited after amniotic fluid index evaluation according to transabdominal sonography. After obtaining informed consent, transvaginal sonography will be used to evaluate and measure a possible amniotic fluid pocket that may precede the fetal presenting part.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

April 25, 2019

Last Update Submit

April 19, 2022

Conditions

Oligohydramnios

Outcome Measures

Primary Outcomes (1)

  • Amniotic Fluid Fore-Pocket

    Measurement of amniotic fluid pocket preceding fetal presenting part.

    Up to 30 minutes from the beginning of patient evaluation.

Secondary Outcomes (5)

  • Mode of delivery

    From time of induction up to 48 hours postpartum

  • pH level

    From the time of delivery up to 30 days postpartum

  • 1 minute Apgar score

    From the time of delivery up to 30 days postpartum

  • 5 minute Apgar score

    From the time of delivery up to 30 days postpartum

  • Neonatal intensive care unit admission

    From the time of delivery up to 30 days postpartum

Study Arms (2)

Normal amniotic fluid index

Patients with an amniotic fluid index of between 5-24 centimeters according to transabdominal sonography.

Diagnostic Test: Transvaginal sonography

Oligohydramnios

Patients with an amniotic fluid index of lss than 5 centimeters according to transabdominal sonography.

Diagnostic Test: Transvaginal sonography

Interventions

Transvaginal sonographyDIAGNOSTIC_TEST

Transvaginal sonography for the evaluation of an amniotic fluid pocket preceding the fetal presenting part.

Normal amniotic fluid indexOligohydramnios

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrgenancy
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who meet the above inclusion criteria will be asked to participate in the study and to provide a written informed consent. This study, under no circumstances, will alter the participants routine care.

You may qualify if:

  • Pregnant women at term beyond 37 weeks' gestation
  • Presented to our hospital for their routine care or prior to induction of labor
  • Singleton pregnancy
  • Planned for vaginal delivery
  • Non-laboring women with non-engaged fetal presenting part

You may not qualify if:

  • Pregnant women under 37 weeks' gestation
  • Planned cesarean deliveries
  • Laboring women with engaged fetal presenting part
  • Multiple gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Oligohydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 2, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2021

Study Completion

April 1, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

IL(1)