Influence of Diet on Pregnancy With Polyhydramnios

Polyhydramnios Clinical Trial

Official title:

The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04497532
• Other study ID #: 0152-19-WOMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2021
• Source: Wolfson Medical Center
• Contact: Liliya Tamayev, MD
• Phone: +972532343882
• Email: t_liki[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
• Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
• Without a medical indication for an immediate delivery

Exclusion Criteria:

• Medical recommendation for delivery within two weeks of diagnosis
• Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
• Premature rupture or membranes
• Twins pregnancy

Related Conditions & MeSH terms

• Polyhydramnios

Intervention

Other:
• Diet as suited for gestational diabetes mellitus
Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic fluid index (AFI) after 2 weeks	AFI as measured in ultrasound	Assess AFI two weeks after diet initiation