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| ID | Type | Description | Link |
|---|---|---|---|
| 42833 | Other Identifier | CPMS |
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| Name | Class |
|---|---|
| King's College London | OTHER |
| University College, London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal cerclage | Active Comparator |
| |
| Active monitoring | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of transvaginal cerclage | Procedure | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity. | We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services. | Up to 48 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) |
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CRAFT-OBS
Inclusion Criteria:
Exclusion Criteria:
CRAFT-RCT:
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Exclusion criteria:
CRAFT-IMG
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka Glazewska-Hallin | Contact | 020 7188 | 8151 | agnieszka.glazewska-hallin@kcl.ac.uk |
| Michael Waring | Contact | michael.waring@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' Hospital NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
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| ID | Type | URL | Comment |
|---|---|---|---|
| IRAS 261294 | Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2019 | Oct 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| C563032 | Preterm Premature Rupture of the Membranes |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Up to 48 weeks |
| CRAFT-OBS: Number of participants who deliver <34 weeks gestation | Up to 42 weeks |
| CRAFT-OBS: Gestation at delivery | The proportion of participants who delivery at each gestation of completed weeks | Up to 42 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: 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 other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies | COPOP core outcomes | Up to 48 weeks |
| CRAFT-RCT: Number of participants with an adverse perinatal outcome | Up to 48 weeks |
| CRAFT-RCT: Gestation at delivery | Proportion of participants who deliver at each gestation of completed weeks | Up to 42 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 | Size of any cervical lesion and its location seen on MRI or ultrasound scans | Up to 40 weeks |
| D000091642 | Urogenital Diseases |