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

• ClinicalTrials.gov Identifier: NCT03536689
• Recruitment Status: Completed
• First Posted: May 25, 2018
• Last Update Posted: October 22, 2020
• Sponsor: Rajavithi Hospital
• Information provided by (Responsible Party): Rajavithi Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pregnancy Related	Diagnostic Test: Amniotic fluid index	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Factorial 2-by-2 open labeled randomised controlled trial
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Randomized Controlled Trial of Amniotic Fluid Index Compared Between After Upright and Left Lateral Decubitus Maternal Position Change
• Actual Study Start Date: February 20, 2018
• Actual Primary Completion Date: September 30, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Upright maternal position change; 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; 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; Other Name: AFI
Experimental: Left lateral decubitus maternal position change; 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; 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; Other Name: AFI

Outcome Measures

Primary Outcome Measures :

1. Amniotic fluid index change after maternal position change [ Time Frame: 15 minutes ]
   Amniotic fluid index before and after maternal position change

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 34 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Thailand

Rajavithi Hospital

Bangkok, Thailand, 10400

Sponsors and Collaborators

Rajavithi Hospital

Investigators

• Principal Investigator: Tirawat Chotkittikul, MD; Rajavithi Hospital

More Information

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT03536689
• Other Study ID Numbers: RAJAAFI001
• First Posted: May 25, 2018
• Last Update Posted: October 22, 2020
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rajavithi Hospital:

Amniotic fluid index

Additional relevant MeSH terms:

Pressure Ulcer; Skin Ulcer; Skin Diseases