Cerclage After Full Dilatation Caesarean Section

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    1000
  • sponsor
    Guy's and St Thomas' NHS Foundation Trust
Updated on 23 January 2021
transvaginal ultrasound
fetal fibronectin

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.

Details
Condition Premature Birth, Premature, Preterm Premature Rupture of Membranes, Preterm Premature Rupture of Membrane, Pre-Term, Preterm Spontaneous Labor With Preterm Delivery, preterm delivery, preterm birth, premature delivery
Treatment Insertion of transvaginal cerclage
Clinical Study IdentifierNCT04110704
SponsorGuy's and St Thomas' NHS Foundation Trust
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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