Recurrent miscarriage Pregnancy and Childbirth Recurrent miscarriage
Conditions
Interventions
Low Molecular Weight Heparin, aspirin and intense surveillance versus intense surveillance only.
Medications given as follows: enoxaparin 40 mg subcutaneously, once per day by self injection and 75
Sponsors
Greater Glasgow Health Board (North Glasgow University Hospitals Division) and Glasgow University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Have a history of a minimum of two consecutive early pregnancy losses (defined as at/or before 24 weeks gestation) 2. Present at less than or equal to 7 weeks gestation with a positive pregnancy test and confirmatory ultrasound 3. Give written informed consent
Exclusion criteria
Exclusion criteria: 1. A previous foetal loss has been associated with an anatomical, chromosomal,(maternal/paternal) endocrine or immunological cause 2. They have a previous history of venous or arterial thrombosis 3. They are already known to have antiphospholipid syndrome (as defined by the presence of an antiphospholipid antibody and three consecutive early pregnancy failures) 4. At enrolment are already known to have a thrombophilic disorder 5. They have a history of three or more pregnancy losses and are found or are already known to have a positive lupus inhibitor screen or Immunoglobulin G (IgG)/Immunoglobulin M (IgM) anticardiolipin antibodies above the local reference range 6. Are found to have an excluding condition on booking for the current pregnancy such as anaemia requiring therapy, platelets less than 150 x 10^12/l, abnormal thyroid function, multiple or rare red cell alloantibodies or auto-antibodies 7. Known hypersensitivity to the active substance or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate (delivery of a live infant beyond 37 weeks of gestation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Preterm delivery of a live infant (between 28 and 37 weeks of gestation) 2. Obstetric complications (pregnancy associated hypertension, pre-eclampsia, intrauterine growth retardation) 3. Congenital malformations 4. Admission to special care 5. Side-effects of the drug used, both for the mother and the baby 6. Thromboembolic complications | — |
Countries
United Kingdom
Outcome results
None listed