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Effect of Omega-3 in Obese pregnant women on bad pregnancy outcomes

Effect of Omega-3 in Obese pregnant women on unfavorable pregnancy outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8nxwps
Enrollment
Unknown
Registered
2020-04-08
Start date
2019-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy, Pregnancy Complications

Interventions

This is a randomized clinical trial, using omega-3, which will be developed with obese pregnant women who will be randomized into 2 groups, a study group that will use omega-3 and standard monitoring,
Dietary supplement

Sponsors

Universidade da Região de Joinville - UNIVILLE
Lead Sponsor
Maternidade Darcy Vargas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women diagnosed with obesity will be selected according to World Health Organization criteria with a BMI greater than or equal to 30 kg / m2, aged 18 years or over, single pregnancy, with negative screening for gestational diabetes mellitus (GDM) at the beginning of pregnancy, gestational age less than 20 weeks, without pathology that interferes with glucose metabolism, coagulation disorder, systemic arterial hypertension (SAH), history or presence of liver, kidney or gastrointestinal disease or other condition that interferes with absorption, distribution and excretion of omega-3.

Exclusion criteria

Exclusion criteria: Pregnant women who wish to do so and those who are at risk for the fetus will be excluded.

Design outcomes

Primary

MeasureTime frame
Positive and significant effect of omega-3 in the prevention of Gestational Diabetes Mellitus in obese pregnant women, verified through the presence of difference in the incidence of Gestational Diabetes Mellitus between the groups, from the verification of a p value less than or equal to 0,05 in the comparison between groups for this outcome.;Positive and significant effect of omega-3 in the prevention of Specific Hypertensive Disease of Pregnancy in obese pregnant women, verified through the presence of difference in the incidence of Specific Hypertensive Disease of Pregnancy between the groups, from the verification of a value of p less or equal to 0.05 in the comparison between groups for this outcome.;Positive and significant effect of omega-3 on the lipid profile of obese pregnant women, verified through the presence of a difference in lipid profile between the groups, from the finding of a p value less than or equal to 0.05 in the comparison between the groups for this outcome.;Positive and significant effect of omega-3 on the cesarean section rate of obese pregnant women, verified through the presence of difference in the need for cesarean sections between the groups in absolute number and proportion, from the finding of a p value less than or equal to 0 , 05 in the comparison between groups for this outcome.;Positive and significant effect of omega-3 on the number of GIGs of obese pregnant women, verified through the presence of a difference in the incidence of newborns GIGs between the groups, from the finding of a p value less than or equal to 0.05 in the comparison between groups for this outcome.;Positive and significant effect of omega-3 on the platelet count of obese pregnant women verified by the presence of difference in the platelet count between the groups, from the finding of a p value less than or equal to 0.05 in the comparison between the groups for the east outcome.

Secondary

MeasureTime frame
There are no secondary outcomes

Countries

Brazil

Contacts

Public ContactGuilherme Dienstmann

Universidade da Região de Joinville - UNIVILLE

guidbio@gmail.com+554792300191

Outcome results

None listed

Source: REBEC (via WHO ICTRP)