EUCTR2015-000456-15-GB
Active, not recruiting
Not Applicable
The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal progesterone. - SuPPoRT: Stitch,Progesterone or Pessary: a randomised controlled trial
Kings College London0 sitesMarch 11, 2015
ConditionsShort Cervix in PregnancyMedDRA version: 17.1Level: LLTClassification code 10021632Term: Incompetent cervixSystem Organ Class: 100000004868Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
DrugsCyclogest
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Short Cervix in Pregnancy
- Sponsor
- Kings College London
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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:
Outcomes
Primary Outcomes
Not specified
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