Insufficient cervix Pregnancy and Childbirth
Conditions
Interventions
Participants will be randomly allocated to receive either a monofilament suture or a braided suture to place a cervical cerclage. Apart from the type of thread used, participants will receive identica
Sponsors
Birmingham Women’s Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Singleton pregnancy 2. Indication for cervical cerclage (any of the below): 2.1. A history of three or more previous midterm losses or premature births (= 28 weeks) 2.2. Insertion of cervical sutures in previous pregnancies 2.3. A history of midtrimester loss or premature birth with a shortened (= 25 mm) cervix 2.4. Women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan and in whom the placement of a cervical cerclage is considered the most appropriate treatment 3. Aged 18 and over
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 07/06/2017: 1. Women who have taken part in C-STICH previously 2. Women aged less than 18 years old at the time of presentation 3. Those with a multiple pregnancy 4. Those requiring a rescue cerclage* 5. Women who are unwilling or unable to give informed consent 6. Those in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route) 7. Immediate need for insertion of a suture** 8. Women who have membranes that have ruptured or are surfacing*** * For study purposes, rescue cerclage is defined as: emergency cerclage where stitches are inserted in women who have had their preterm labours (e.g. uterine contractions, progressive cervical dilatation, bulging membranes) sufficiently halted by tocolysis or other means between 15 and 28 weeks. ** Immediate need for insertion of a suture should not be delayed by the trial (thus, if giving information about the trial and waiting for the participant to decide upon whether or not she wants to participate will delay the insertion of an urgently needed suture, then treatment should go ahead and the woman should be excluded from the trial). ***Woman with membranes that are ruptured or bulging through the external OS should have a rescue cerclage and be excluded from trial participation. Previous exclusion criteria: 1. Women aged less than 16 years old at the time of presentation 2. Those with a multiple pregnancy 3. Those requiring a rescue cerclage 4. Women who are unwilling or unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy loss rate (i.e. miscarriage and perinatal mortality, defined as any stillbirth or neonatal death in the first week of life), collected from the medical records at 7 days after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/09/2017: Maternal outcomes, collected at discharge from hospital or 7 days, whichever is sooner: 1. Time from conception to pregnancy end (any reason) 2. Miscarriage and pre viable neonatal death (defined as delivery =24 weeks) 4. Gestation at delivery (in live births >= 24 weeks) 5. Gestational age = 24 weeks) 6. Time from conception to onset of spontaneous vaginal delivery (in live births >= 24 weeks) 7. Sepsis (at any time in pregnancy and until 7 days postnatal) 8. Preterm pre labour rupture of membranes (PPROM) 9. Gestational age at PPROM 10. Mode of initiation of labour (spontaneous or induced) 11. Mode of delivery (vaginal or operative vaginal or caesarean) 12. Cerclage placement complications (cervical laceration/bleeding from cervix/ruptured membranes/bladder injury) 13. Cerclage removal complications (cervical tears/need for anaesthetic/difficult to remove) 14. Other maternal complications: vaginal bleeding/steroid use/chorioamnionitis/maternal pyrexia of 38°C (intrapartum/postnatal)/systemic infection requiring antibiotics (intrapartum/postnatal)/admission to HDU or ITU (pre/post-delivery) 15. Serious adverse events Neonatal outcomes, collected from the medical records at 28 days for babies born at term and at the estimated delivery date for babies born preterm: 1. Early neonatal death (defined as a death within 7 days after delivery) 2. Late neonatal death (defined as a death beyond 7 days and before 28 days after delivery) 3. Birth weight adjusted for gestational age and sex (in live births >= 24 weeks) 4. Small for gestational age and sex (= 24 weeks) 5. Resuscitation at birth/additional care required (SCBU/NICU/HDU/transitional)/length of stay in additional care 6. Antibiotics within 72 hours/sepsis (clinically diagnosed/proven) 7. Early neurodevelopmental morbidity (severe abnormality on cranial ultrasound scan) 8. Respiratory support (ventilation/CPAP)/days on respiratory support/supplementary oxygen r | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactMax Hughes
Outcome results
None listed