Dietary fish oil supplementation in pregnant women with diabetes

Not Applicable

Completed

• Conditions: Diabetic pregnancy; Nutritional, Metabolic, Endocrine; Diabetes mellitus arising in pregnancy

• Registration Number: ISRCTN68997518
• Lead Sponsor: ewham University Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-30
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

Current inclusion criteria as of 14/02/2012:
1. Pregnant women aged 17-45 years old without any medical condition
2. Pregnant women aged 17-45 years old with diabetes (type 2 diabetes or gestational diabetes)

Previous inclusion criteria:
1. Pregnant women with or without diabetes (type 1, type 2, gestational diabetes)
2. Eligible age: 17 - 40 years
3. Control subjects without diabetes

Exclusion Criteria

Current exclusion criteria as of 21/06/2013:
1. Pregnancy with more than one foetus
2. Known major foetal anomaly
3. Current or planned corticosteroid therapy
4. Asthma requiring medication
5. Current or planned beta-adrenergic therapy
6. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
7. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
8. Previous or planned tocolytic therapy to induce labour or increase contraction strength

Previous exclusion criteria until 21/06/2013:
1. Smokers
2. History of stillbirth or foetal death
3. Pregnancy with more than one foetus
4. Known major foetal anomaly
5. Current or planned corticosteroid therapy
6. Asthma requiring medication
7. Current or planned beta-adrenergic therapy
8. Chronic hypertension requiring medication within 6 months of or during pregnancy
9. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
10. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
11.Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labour, or intrauterine growth retardation
12. Previous or planned tocolytic therapy to induce labour or increase contraction strength

Previous exclusion criteria until 14/02/2012:
1. Smokers
2. History of stillbirth or foetal death
3. Pregnancy with more than one foetus
4. Known major foetal anomaly
5. Asthma requiring medication
6. Current or planned beta-adrenergic therapy
7. Chronic hypertension requiring medication within 6 months of, or during, pregnancy
8. Chronic medical conditions such as HIV/AIDS, kidney disease or congenital heart disease
9. Haematologic or autoimmune disease such as sickle cell disease
10. Other haemoglobinopathies
11. Lupus or antiphospholipid syndrome
12. Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, or intrauterine growth retardation

Study & Design

• Study Type: Interventional
• Study Design: Not specified