Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery
Conditions
Brief summary
CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth \<34 weeks and \<37 weeks. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.
Interventions
PROCEDUREInsertion of transvaginal cerclage
Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.
Sponsors
King's College London
University College, London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
CRAFT-OBS Inclusion Criteria: * Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour. * Singleton pregnancy. * Willing and able to give informed consent (with or without interpreter).
Exclusion criteria
* Under 16 years of age. * Inability to give informed consent. * Previous caesarean section carried out before labour. * Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study CRAFT-RCT: Inclusion criteria: * Pregnant women up to 23+6 weeks gestation with a history of FDCS. * Short cervix (\<=25mm) on transvaginal ultrasound scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation | Up to 42 weeks |
| CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation | Up to 42 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRAFT-OBS: Number of participants who deliver <34 weeks gestation | Up to 42 weeks | — |
| CRAFT-OBS: Gestation at delivery | Up to 42 weeks | The proportion of participants who delivery at each gestation of completed weeks |
| CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate | Up to 42 weeks | — |
| CRAFT-OBS: Any cervical length measurements taken antenatally | Up to 42 weeks | — |
| CRAFT-OBS: Number of antenatal hospital appointments | Up to 42 weeks | — |
| CRAFT-OBS: Number of hospital admissions | Up to 42 weeks | — |
| CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken | Up to 42 weeks | — |
| CRAFT-OBS: Number of ultrasound indicated antenatal interventions | Up to 42 weeks | — |
| CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity. | Up to 48 weeks | We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services. |
| CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies | Up to 48 weeks | COPOP core outcomes |
| CRAFT-RCT: Number of participants with an adverse perinatal outcome | Up to 48 weeks | — |
| CRAFT-RCT: Gestation at delivery | Up to 42 weeks | Proportion of participants who deliver at each gestation of completed weeks |
| CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging) | Up to 30 weeks | — |
| CRAFT-RCT: Time between intervention and delivery. | Up to 42 weeks | — |
| CRAFT-RCT - Health costs at 28 days post-delivery. | Up to 48 weeks | — |
| CRAFT-IMG: Evidence of cervical injury | Up to 40 weeks | Size of any cervical lesion and its location seen on MRI or ultrasound scans |
| CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks | Up to 42 weeks | — |
| CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) | Up to 48 weeks | — |
Countries
United Kingdom
Contacts
Primary ContactAgnieszka Glazewska-Hallin
Backup ContactMichael Waring
Outcome results
None listed