SuPPoRT: Stitch, Progesterone or Pessary: a Randomised Trial

• Conditions: Short Cervix in Pregnancy; MedDRA version: 17.1Level: LLTClassification code 10021632Term: Incompetent cervixSystem Organ Class: 100000004868; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-000456-15-GB
• Lead Sponsor: Kings College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women with singleton pregnancies who are found to have cervical length <25 mm on transvaginal ultrasound between 14+0 weeks’ gestation (dated by ultrasound or LMP and adjusted for ultrasound estimated date of delivery once ultrasound performed if no miscarriage prior to dating ultrasound) until 23+6 weeks’ gestation and one or more of the following risk factors;

•Written informed consent to participate
•History of
oPrevious preterm premature rupture of the fetal membranes (= 37 weeks’)
oHistory of previous PTB/second trimester loss (= 16 weeks’ or = 37 weeks’ gestation).
oAny cervical procedure to treat abnormal smears i.e. large loop excision, laser conisation, cold knife conisation or radical diathermy.

•Incidental finding of a short cervix on ultrasound scan (e.g. at the time of anomaly scan).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Women with persistent fresh vaginal bleeding evident on speculum examination.
•Women with visible membranes evident on speculum examination or open cervix on ultrasound scan.
•Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
•Known significant congenital or structural or chromosomal fetal abnormality.
•Suspected or proven rupture of the fetal membranes at the time of recruitment.
•Women currently using progesterone pessaries or who have taken progesterone beyond 18 weeks gestation.
•Women who have a cervical suture in situ.
•Women who already have a cervical pessary in situ.
•Insufficiuent uUnderstanding of the tTrial in the opinion of the Investigator
•Any contraindications or cautions to the investigational medicinal product including:
• known allergy or hypersensitivity to progesterone.
• hepatic dysfunction,
• undiagnosed vaginal bleeding,
• mammary or genital tract carcinoma,
• thrombophlebitis,
• thromboembolic disorders,
• cerebral haemorrhage,
•• porphyria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified