EUCTR2015-000456-15-GBActive, not recruitingNot 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 sitesStarted: March 11, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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.
Investigators
Similar Trials
Not yet recruiting
Unknown
Cervical Cerclage Pessary in Preventing Preterm BirthsCTRI/2023/07/054691Ziller Medical Inc.
Recruiting
Not Applicable
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesteronepregnant women at high risk of preterm birthJPRN-UMIN000023080Kyushu university hospital100
Active, not recruiting
Phase 1
Prevention of preterm birth in women at risk identified by ultrasound: evaluation of twotreatment strategies.EUCTR2012-000241-13-ESDra. Martinez Payo-Hospital Universitario Puerta de Hierro
Completed
Not Applicable
Stitch, progesterone or pessary: a randomised controlled trialPrevention of preterm birth in women with a short cervixPregnancy and ChildbirthISRCTN13364447Guy's and St. Thomas' NHS Foundation trust540
Recruiting
Not Applicable
Trial of prevention of preterm birth in pregnancy after abdominal trachelectomy by vaginal progesteronepregnancy after abdominal trachelectomyJPRN-UMIN000023161Kyushu university hospital30