Influence of Diet on Pregnancy With Polyhydramnios

Wolfson Medical Center (WMC)

Status: Unknown

Conditions: Polyhydramnios

Treatments: Other: Diet as suited for gestational diabetes mellitus

Study type: Interventional

Funder types: Other

Identifiers

NCT04497532

0152-19-WOMC

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control

No Intervention group

Diet

Experimental group

Treatment:

Other: Diet as suited for gestational diabetes mellitus