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Cerclage Outcome by the Type of Suture material (COTS) study

A pilot/feasibility RCT comparing monofilament (intervention) versus multifilament (control) suture material for elective cervical cerclage in the management of suspected cervical incompetence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17866773
Enrollment
100
Registered
2013-03-27
Start date
2013-02-06
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Midtrimester miscarriage or preterm birth due to cervical incompetence Pregnancy and Childbirth Maternal care for cervical incompetence

Interventions

Cerclage can occur at any gestation between 14-20 weeks as long as it is performed as an elective procedure.The Monofilament non-braided suture used will be a looped Nylon and the Multifilament braide

Sponsors

Birmingham Women's Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. All women (>17 years) with a singleton pregnancy and a valid indication for cervical cerclage, as per Royal College of Obstetricians and Gynaecologists (RCOG) guidance, as follows: 1.1. History of three or more previous mid trimester losses or premature (<28 weeks) births. 1.2. Had cervical sutures in previous pregnancies 1.3. History of mid-trimester loss or premature delivery with a shortened cervix on ultrasound scan (<25mm) 1.4. Deemed at risk of preterm labour at the clinicians discretion (e.g. radical trachelectomy)

Exclusion criteria

Exclusion criteria: 1. Women who are unable or unwilling to give informed consent 2. Multiple pregnancy 3. Women under the age of 17 years

Design outcomes

Primary

MeasureTime frame
Live birth rate

Secondary

MeasureTime frame
1. Gestation at delivery 2. Mode of delivery 3. Length of stay in neonatal unit

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026