NCT03536689

Brief Summary

Comparison of amniotic fluid index between before and after maternal position change in Upright and left lateral decubitus maternal position

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 22, 2020

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

May 14, 2018

Last Update Submit

October 20, 2020

Conditions

Pregnancy Related

Keywords

Amniotic fluid index

Outcome Measures

Primary Outcomes (1)

  • Amniotic fluid index change after maternal position change

    Amniotic fluid index before and after maternal position change

    15 minutes

Study Arms (2)

Upright maternal position change

EXPERIMENTAL

The participant will be measured by ultrasonograhy for amniotic fluid index in supine position before maternal position change, then she will do the upright position for 5 minute. After 5 minute of upright position , she will lie down in supine position and she will be measured by ultrasonograhy for amniotic fluid index after upright position.

Diagnostic Test: Amniotic fluid index

Left lateral decubitus maternal position change

EXPERIMENTAL

the participant will be measured by ultrasonograhy for amniotic fluid index in supine position before maternal position change, then she will do the left lateral decubitus position for 5 minutes. After 5 minutes of left lateral decubitus position , she will lie down in supine position and she will be measured by ultrasonograhy for amniotic fluid index after left lateral decubitus position.

Diagnostic Test: Amniotic fluid index

Interventions

Amniotic fluid indexDIAGNOSTIC_TEST

Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index

Also known as: AFI
Left lateral decubitus maternal position changeUpright maternal position change

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women age 20-34 years whose gestational age was confirmed by ultrasonography before 24 weeks of gestation

You may not qualify if:

  • Pregnant women with multifetal pregnancy
  • Pregnant women who have underlying disease
  • Pregnant women who have the history of premature rupture of amniotic membrane
  • Pregnant women who have amniotic fluid index below 5 cm (oligohydramnios)
  • Pregnant women who have amniotic fluid index more than 25 cm (polyhydramnios)
  • Pregnant women whose her baby has the fetal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Study Officials

  • Tirawat Chotkittikul, MD

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: Factorial 2-by-2 open labeled randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 25, 2018

Study Start

February 20, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 22, 2020

Record last verified: 2018-06

Locations

TH(1)