Clinical trial NCT04110704: Cerclage After Full Dilatation Caesarean Section
Official title: An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Preterm Premature Rupture of Membrane
Preterm Spontaneous Labor With Preterm Delivery
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: University College, London
First posted: 2019-10-01
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Exclusion criteria:

* Women with persistent fresh vaginal bleeding evident on speculum examination.
* Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
* Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
* Known significant congenital or structural or chromosomal fetal abnormality.
* Suspected or proven rupture of the fetal membranes at the time of recruitment.

CRAFT-IMG

Inclusion criteria:

* Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.

Exclusion criteria:

* Contraindications to MRI, e.g. claustrophobia, BMI \>40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.

Primary outcomes:
measure: CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
timeFrame: Up to 42 weeks
measure: CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation
timeFrame: Up to 42 weeks
Secondary outcomes:
measure: CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
timeFrame: Up to 48 weeks
measure: 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)
timeFrame: Up to 48 weeks
measure: CRAFT-OBS: Number of participants who deliver <34 weeks gestation
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Gestation at delivery
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Any cervical length measurements taken antenatally
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Number of antenatal hospital appointments
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Number of hospital admissions
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Number of ultrasound indicated antenatal interventions
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks
timeFrame: Up to 42 weeks
measure: CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
timeFrame: Up to 48 weeks
measure: CRAFT-RCT: Number of participants with an adverse perinatal outcome
timeFrame: Up to 48 weeks
measure: CRAFT-RCT: Gestation at delivery
timeFrame: Up to 42 weeks
measure: CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
timeFrame: Up to 30 weeks
measure: CRAFT-RCT: Time between intervention and delivery.
timeFrame: Up to 42 weeks
measure: CRAFT-RCT - Health costs at 28 days post-delivery.
timeFrame: Up to 48 weeks
measure: CRAFT-IMG: Evidence of cervical injury
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital NHS Foundation Trust
Study officials:
References: