Cerclage After Full Dilatation Caesarean Section

NCT04110704 | Unknown DMC

• 2 other identifiers: 26129442833
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Preterm Premature Rupture of Membrane; Preterm Spontaneous Labor With Preterm Delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.

  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)

  Up to 48 weeks

• CRAFT-OBS: Number of participants who deliver <34 weeks gestation

  Up to 42 weeks

• CRAFT-OBS: Gestation at delivery

  Up to 42 weeks

• CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate

  Up to 42 weeks

Study Arms (2)

Transvaginal cerclage

ACTIVE COMPARATOR

Procedure: Insertion of transvaginal cerclage

Active monitoring

NO INTERVENTION

Interventions

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.

Transvaginal cerclage

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• Pregnant women up to 23+6 weeks gestation with a history of FDCS.
• Short cervix (\<=25mm) on transvaginal ultrasound scan.
• 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
• Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.
• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• University College, London: collaborator

Study Sites (1)

Guy's and St Thomas' Hospital NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Agnieszka Glazewska-Hallin

CONTACT

020 7188; agnieszka.glazewska-hallin@kcl.ac.uk

Michael Waring

CONTACT

michael.waring@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: October 2, 2019
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)