Comparison of Amniotic Fluid Index Between Before and After Maternal Position Change in Upright and Left Lateral Decubitus Position

Pregnancy Related Clinical Trial

Official title:

Randomized Controlled Trial of Amniotic Fluid Index Compared Between After Upright and Left Lateral Decubitus Maternal Position Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536689
• Other study ID #: RAJAAFI001
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: June 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Amniotic fluid has many important roles in fetal development such as the development of the digestive tract and respiratory system. The quantity of amniotic fluid can be measured by ultrasonography, measuring the deepest pocket in 4 quadrants of uterus then summarize as one value known as "amniotic fluid index"(AFI). The AFI has the normal range between 5-25 cm. The low AFI (< 5 cm) is associated with abnormal fetal heart rate, and the abnormal AFI does affect to the treatment during the antepartum and intrapartum phase. However , there is the study shown that when compared to the single deepest pocket (SDP) , AFI could detect the oligohydramnios more which might led to the unnecessary labor induction or operative delivery without the significant change of perinatal outcome. To increase the accuracy of AFI, we theorize that maternal position change might affect the amniotic fluid position which would increase the visual of the amniotic fluid as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 34 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pregnancy Related
• Pressure Ulcer

Intervention

Diagnostic Test:
• Amniotic fluid index
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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic fluid index change after maternal position change	Amniotic fluid index before and after maternal position change	15 minutes