The prevention of pre-term birth in women who develop a short cervix. A multicentre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal progesterone.

Guy's and St. Thomas' NHS Foundation trust0 个研究点目标入组 540 人开始时间: 2015年7月29日最近更新: 2024年7月29日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39012912/ (added 17/07/2024)

•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
•1. Written informed consent to participate
•2. History of:
•2.1. Previous preterm premature rupture of the fetal membranes (= 37 weeks’)
•2.2 History of previous PTB/second trimester loss (= 16 weeks’ or = 37 weeks’ gestation)
•2.3. Any cervical procedure to treat abnormal smears i.e. large loop excision, laser conisation, cold knife conisation or radical diathermy
•3. Incidental finding of a short cervix on ultrasound scan (e.g. at the time of anomaly scan)
•4. Women aged 18-50

•1. Women with persistent fresh vaginal bleeding evident on speculum examination.
•2. Women with visible membranes evident on speculum examination or open cervix on ultrasound scan.
•3. Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
•4. Known significant congenital or structural or chromosomal fetal abnormality.
•5. Suspected or proven rupture of the fetal membranes at the time of recruitment.
•6. Women currently using progesterone pessaries or who have taken progesterone beyond 18 weeks gestation.
•7. Women who have a cervical suture in situ.
•8. Women who already have a cervical pessary in situ.
•9. Insufficient understanding of the trial in the opinion of the Investigator
•10. If the attending clinician feels that an individual woman is more suited to one treatment modality over another
•11. Any contraindications or cautions to the investigational medicinal product including:
•11.1. Known allergy or hypersensitivity to progesterone
•11.2. Hepatic dysfunction
•11.3. Undiagnosed vaginal bleeding
•11.4. Mammary or genital tract carcinoma
•11.5. Thrombophlebitis
•11.6. Thromboembolic disorders
•11.7. Cerebral haemorrhage
•11.8. Porphyria

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