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NCT04110704: CRAFT
Cerclage After Full Dilatation Caesarean Section
NA trial testing Insertion of transvaginal cerclage in Preterm Birth in 1,000 participants. Status unknown.
1 April 2022
Quick facts
| Lead sponsor | Guy's and St Thomas' NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,000 |
| Start date | 2 October 2019 |
| Primary completion | 1 April 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Insertion of transvaginal cerclage
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Preterm Premature Rupture of Membrane — all drugs for Preterm Premature Rupture of Membrane →
- Preterm Spontaneous Labor With Preterm Delivery — all drugs for Preterm Spontaneous Labor With Preterm Delivery →
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Who can join
16 and older, female only, with Preterm Birth or Preterm Premature Rupture of Membrane. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04110704
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Guy's and St Thomas' NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04110704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guy's and St Thomas' NHS Foundation Trust
- Last refreshed: 28 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04110704.
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