Cerclage After Full Dilatation Caesarean Section

Last updated: July 27, 2021
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

N/A

Clinical Study ID

NCT04110704
261294
42833
  • Ages > 16
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion

CRAFT-OBS Inclusion Criteria:

  • Pregnant women under 23+6 weeks gestation with a history of previous caesarean sectionin labour.
  • Singleton pregnancy.
  • Willing and able to give informed consent (with or without interpreter).

Exclusion

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 arabinpessary 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 onultrasound scan.
  • Women with severe abdominal pain/evidence of sepsis (as judged by attendingclinician).
  • 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 technicallimitations of scanner) or a women with a non-MRI compatible metallic implant.

Study Design

Total Participants: 1000
Study Start date:
October 02, 2019
Estimated Completion Date:
October 01, 2022

Connect with a study center

  • Guy's and St Thomas' Hospital NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

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