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

Not Applicable

Completed

• Conditions: Midtrimester miscarriage or preterm birth due to cervical incompetence; Pregnancy and Childbirth; Maternal care for cervical incompetence

• Registration Number: ISRCTN17866773
• Lead Sponsor: Birmingham Women's Hospital (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25348257

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-27
• Study Completion: 2014-02-08
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified