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

CRAFT: Cerclarge after full dilatation caesarean section; an investigation into the role of previous in labour caesarean section in future preterm birth risk and potential management strategies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15068651

Enrollment

4400

Registered

2019-09-25

Start date

2019-10-02

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Current interventions as of 14/12/2021: CRAFT-OBS: This is a multicentre prospective cohort observational study of 4400 pregnant women with a previous history of CS in labour who will be recruited fol

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 14/12/2021: CRAFT-OBS: Incidence of delivery <37+0 completed weeks gestation in women with a previous caesarean section in labour CRAFT control group: Incidence of delivery <37+0 completed weeks gestation in women with a previous term vaginal birth CRAFT-IMG: Incidence of cervical abnormalities on MRI and/or ultrasound in women who have a spontaneous preterm birth or late miscarriage with a history of a previous full dilatation caesarean section Previous primary outcome measures: CRAFT-OBS: Incidence of delivery <37+0 completed weeks gestation in women with a previous caesarean section in labour CRAFT-RCT: The spontaneous preterm birth rate <34 weeks gestation between women with and women without an ultrasound indicated cerclage with a history of a full dilatation caesarean section CRAFT-IMG: Incidence of cervical abnormalities on MRI and/or ultrasound in women who have a spontaneous preterm birth or late miscarriage with a history of a previous full dilatation caesarean section	—

Measure

Time frame

Current primary outcome measures as of 14/12/2021: CRAFT-OBS: Incidence of delivery <37+0 completed weeks gestation in women with a previous caesarean section in labour CRAFT control group: Incidence of delivery <37+0 completed weeks gestation in women with a previous term vaginal birth CRAFT-IMG: Incidence of cervical abnormalities on MRI and/or ultrasound in women who have a spontaneous preterm birth or late miscarriage with a history of a previous full dilatation caesarean section Previous primary outcome measures: CRAFT-OBS: Incidence of delivery <37+0 completed weeks gestation in women with a previous caesarean section in labour CRAFT-RCT: The spontaneous preterm birth rate <34 weeks gestation between women with and women without an ultrasound indicated cerclage with a history of a full dilatation caesarean section CRAFT-IMG: Incidence of cervical abnormalities on MRI and/or ultrasound in women who have a spontaneous preterm birth or late miscarriage with a history of a previous full dilatation caesarean section

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Secondary

Measure	Time frame
Current secondary outcome measures as of 14/12/2021: CRAFT-OBS: 1. Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) 2. Incidence of preterm birth <34 week gestation in women with a previous caesarean section in labour 3. Gestation at delivery stratified by the cervical dilatation at the time of previous caesarean in labour 4. Incidence of late miscarriage (14+0-23+6 weeks) in women with a previous caesarean section in labour 5. Healthcare use, e.g. the number of antenatal appointments, number of days as inpatient, cervical length, cervicovaginal fetal fibronectin levels, and number of interventions 6. Other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies: 6.1. Maternal set of outcomes: 6.1.1. Maternal mortality 6.1.2. Maternal infection or inflammation 6.1.3. Prelabor rupture of membranes 6.1.4. Harm to mother from intervention 6.2. Neonatal set of outcomes: 6.2.1. Offspring mortality 6.2.2. Offspring infection 6.2.3. Gestational age at birth 6.2.4. Harm to offspring from intervention 6.2.5. Birth weight 6.2.6. Early neurodevelopmental morbidity 6.2.7. Late neurodevelopmental morbidity 6.2.8. Gastrointestinal morbidity 6.2.9. Respiratory morbidity CRAFT-IMG: No secondary outcome measures Previous secondary outcome measures as above plus: CRAFT-RCT: 1. Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) or one/more of intraventricular haemorrhage, periventricular leukomalacia, hypoxic ischaemic encephalopathy, necrotizing enterocolitis, bronchopulmonary dysplasia and sepsis. 2. Gestation at delivery 3. Late miscarriage (14+0-23+6 weeks) 4. Requirement for rescue cerclage (when fetal membranes are exposed) 5. Time between randomised intervention and delivery 6. Health costs at 28 days	—

Measure

Time frame

Current secondary outcome measures as of 14/12/2021: CRAFT-OBS: 1. Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) 2. Incidence of preterm birth <34 week gestation in women with a previous caesarean section in labour 3. Gestation at delivery stratified by the cervical dilatation at the time of previous caesarean in labour 4. Incidence of late miscarriage (14+0-23+6 weeks) in women with a previous caesarean section in labour 5. Healthcare use, e.g. the number of antenatal appointments, number of days as inpatient, cervical length, cervicovaginal fetal fibronectin levels, and number of interventions 6. Other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies: 6.1. Maternal set of outcomes: 6.1.1. Maternal mortality 6.1.2. Maternal infection or inflammation 6.1.3. Prelabor rupture of membranes 6.1.4. Harm to mother from intervention 6.2. Neonatal set of outcomes: 6.2.1. Offspring mortality 6.2.2. Offspring infection 6.2.3. Gestational age at birth 6.2.4. Harm to offspring from intervention 6.2.5. Birth weight 6.2.6. Early neurodevelopmental morbidity 6.2.7. Late neurodevelopmental morbidity 6.2.8. Gastrointestinal morbidity 6.2.9. Respiratory morbidity CRAFT-IMG: No secondary outcome measures Previous secondary outcome measures as above plus: CRAFT-RCT: 1. Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) or one/more of intraventricular haemorrhage, periventricular leukomalacia, hypoxic ischaemic encephalopathy, necrotizing enterocolitis, bronchopulmonary dysplasia and sepsis. 2. Gestation at delivery 3. Late miscarriage (14+0-23+6 weeks) 4. Requirement for rescue cerclage (when fetal membranes are exposed) 5. Time between randomised intervention and delivery 6. Health costs at 28 days

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026