Topic: Reproductive Health
Conditions
Interventions
Participants are randomly allocated to receive one of three treatments:
1. Arabin pessary: silicone cerclage pessary device sited around cervix in clinic
2. Cervical cerclage: Macdonald technique to s
Sponsors
University of Liverpool (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Singleton pregnancy 3. Between 16+0 – 24+6 weeks in current pregnancy 4. History of previous spontaneous preterm birth (sPTB) or premature rupture of membranes (PPROM) between 16-33+6 AND 5. Cervical length at least <3rd centile for gestational age OR 6. History of significant cervical surgery defined as two large loop excision of the transformation zone (LLETZ) procedures or a single knife cone biopsy (KCB) where a clinical decision is made to treat the short cervix 7. Clinical equipoise as to what is the best treatment
Exclusion criteria
Exclusion criteria: 1. Known or suspected structural or chromosomal fetal abnormality 2. Inability to give informed consent 3. Treatment with history indicated cerclage 4. Treatment with vaginal progesterone within two weeks of randomisation 5. All contraindications to use of progesterone (see protocol 6.2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility is measured at 12 months post recruitment, with follow up until final mother and baby discharge or 6 weeks postnatal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Economic analysis is completed at 12 months post recruitment 2. Patient and staff acceptability is measured 1-2 months post study completion | — |
Countries
United Kingdom
Contacts
Public ContactEdiri O'Brien
Outcome results
None listed