Medical condition: Miscarriage Medical condition in lay language: Miscarriage Therapeutic areas: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] Pregnancy and Childbirth
Conditions
Interventions
Randomisation will be conducted by a computer algorithm in a 1:1:1 (control:intervention:intervention) ratio to either the control arm, omega-3 intervention low-dose arm (750mg) or the high-dose arm (
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent to receive DHA (omega-3) supplements 2. Patient confirmation of positive pregnancy test 3. Fish consumption - 0, 1 or 2 portions per week (1 portion defined as 140g or 4.9oz when cooked)
Exclusion criteria
Exclusion criteria: 1. Currently taking omega-3 supplementation with DHA concentration >300mg and unwilling to stop 2. Sensitive or allergic to fish or seafood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definitive (D) primary outcome: Live births = 34 weeks of gestation as a proportion of all women randomised measured using data collected from medical records at one timepoint at the pregnancy end;Intermediate (I) primary outcome: Ongoing pregnancies at 11 – 14 weeks of gestation as a proportion of all women randomised measured using data collected from medical records at one timepoint at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be collected using a questionnaire at one timepoint: 1. Miscarriage rate (defined as delivery before 24 weeks of gestation) 2. Live birth <34 weeks 3. Ectopic pregnancy 4. Termination 5. Stillbirth 6. Molar pregnancy 7. Multiple pregnancy 8. Gestational age at miscarriage 9. Gestational age at live birth 10. First-trimester miscarriage, defined as loss of pregnancy up to 13 weeks and 6 days 11. Early first-trimester miscarriage, defined as loss of pregnancy up to 7 weeks and 6 days 12. Late first-trimester miscarriage, defined as loss of pregnancy between 8 weeks and 0 days and up to 13 weeks and 6 days 13. Second-trimester miscarriage, defined as loss of pregnancy between 14 weeks and 0 days and up to 23 weeks and 6 days 14. Where live birth =24 weeks: gestational age <28/<32/<37 weeks 15. Mode of delivery (unassisted vaginal, instrumental vaginal, elective caesarean section, emergency caesarean section, vaginal breech delivery, other) 16. Birth weight 17. Antenatal complications: antepartum haemorrhage, pregnancy-induced hypertension, pre-eclampsia, obstetric cholestasis, cervical cerclage, preterm (<37 weeks) pre-labour rupture of membranes, gestational diabetes, fetal growth restriction, small for gestational age, macrosomia. Other complications will be tabulated but not formally analysed. 18. Post-partum complications: haemorrhage (other complications will be tabulated but not formally analysed) 19. Maternal complications: admission to high dependency unit (HDU) or intensive therapy unit (ITU) (other complications will be tabulated but not formally analysed) 20. Maternal mental health: confirmed diagnosis or sought medical support for a psychological disorder related to miscarriage 21. Neonatal complications: admission to neonatal care unit (neonatal intensive care unit [NICU] or Special Care Baby Unit [SCBU]) (other complications will be tabulated but not formally analysed); congenital and chromosomal abnormalities | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLee Priest
Outcome results
None listed