An investigation into the role of previous in-labour caesarean section in future preterm birth risk and potential management strategies

Not Applicable

• Conditions: Preterm birth risk following in labour Caesarean section when compared to women with term vaginal births; Pregnancy and Childbirth

• Registration Number: ISRCTN15068651
• Lead Sponsor: King's College London

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33198663/ (added 17/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-25
• Last Update Posted: 30 October 2023
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 6730

Inclusion Criteria

Current inclusion criteria as of 28/01/2020:
All CRAFT studies:
1. Pregnant women under 24+0 weeks’ gestation (or up to 36+6 weeks gestation for CRAFT-OBS) with a history of previous in-labour Caesarean section at term in any previous pregnancy
2. Ability to understand English (with or without interpreter)
3. Singleton pregnancy
4. Willing to give informed consent

CRAFT-OBS:
1. Pregnant women up until 36+6 weeks gestation who have had a previous emergency Caesarean section

CRAFT-RCT (discontinued August 2021):
1. Pregnant women between 14+0 and 23+6 weeks’ gestation with a history of FDCS
2. Short cervix (< = 25mm) on transvaginal ultrasound scan

CRAFT-IMG:
1. Pregnant women between 14+0 and 23+6 weeks’ gestation with a history of FDCS

Previous inclusion criteria:
All CRAFT studies:
1. Pregnant women under 24+0 weeks’ gestation with a history of previous caesarean section in labour
2. Ability to understand English (with or without interpreter)
3. Singleton pregnancy
4. Willing to give informed consent

CRAFT-OBS:
1. Pregnant women 14+0-23+6 weeks gestation who have had a previous emergency Caesarean section

CRAFT-RCT:
1. Pregnant women between 14+0 and 23+6 weeks’ gestation with a history of FDCS
2. Short cervix (< = 25mm) on transvaginal ultrasound scan

CRAFT-IMG:
1. Pregnant women between 14+0 and 23+6 weeks’ gestation with a history of FDCS

Exclusion Criteria

Current exclusion criteria as of 28/01/2020:
All CRAFT studies:
1. Under 16 years of age
2. Inability to give informed consent
3. Only previous caesarean section carried out before labour

CRAFT-RCT
1. Women with persistent fresh vaginal bleeding evident on speculum examination
2. Women with visible membranes evident on speculum examination or open cervix on ultrasound scan
3. Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician)
4. Known significant congenital or structural or chromosomal fetal abnormality
5. Suspected or proven rupture of the fetal membranes at the time of recruitment
6. Women who have any cerclage in situ

CRAFT-IMG:
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

Previous exclusion criteria:
All CRAFT studies:
1. Under 16 years of age
2. Inability to give informed consent
3. Previous caesarean section carried out before labour
4. Women recruited to studies with interventions of arabin pessary, progesterone, or cerclage, or if commenced on clinical grounds with management in the form of an arabin pessary, progesterone or cerclage will not be eligible

CRAFT-RCT
1. Women with persistent fresh vaginal bleeding evident on speculum examination
2. Women with visible membranes evident on speculum examination or open cervix on ultrasound scan
3. Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician)
4. Known significant congenital or structural or chromosomal fetal abnormality
5. Suspected or proven rupture of the fetal membranes at the time of recruitment

CRAFT-IMG:
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

Study & Design

• Study Type: Observational
• Study Design: Not specified