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Cerclage After Full Dilatation Caesarean Section

NCT04110704 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2021-07-28

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

Insertion of transvaginal cerclage

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.

Sponsors & Collaborators

  • King's College London

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2022-04-01
Completion
2022-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110704 on ClinicalTrials.gov