Short Cervix in Pregnancy MedDRA version: 17.1 Level: LLT Classification code 10021632 Term: Incompetent cervix System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Cyclogest
Pharmaceutical Form: Vaginal capsule
INN or Proposed INN: Progesterone PH Eur
CAS Number: 57-83-0
Other descriptive name: Progesterone pessaries
Concentration unit: mg milligram(
Sponsors
Kings College London
Guys and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with singleton pregnancies who are found to have cervical length =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For asymptomatic women at risk of preterm birth who develop a short cervix on transvaginal ultrasound scan, which is the optimal preventative strategy; cervical cerclage, arabin pessary or vaginal progesterone? ;Secondary Objective: Does the success of the intervention depend on early pregnancy biomarker expression?;Primary end point(s): Delivery < 37 completed weeks’ gestation (powered);Timepoint(s) of evaluation of this end point: Date of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) or one (or more) of intraventricular hemorrhage, periventricular leukomalacia, hypoxic ischemic encephalopathy, necrotizing enterocolitis, bronchopulmonary dysplasia and sepsiS. ii) Delivery <30 & 34 completed weeks’ gestation. iii) Gestation at delivery. iv) Time between intervention and delivery. v) Requirement for Rescue Cerclage (bulging fetal membranes). vi) Other maternal and fetal outcomes: clinical course, therapies administered, maternal and fetal morbidity and mortality data. vii) Participant and clinician’s perceptions of treatment: questionnaires with a selection of participants at 0-2 weeks post procedure. Questionnaires at one year are planned if funding is obtained Participant and clinician adherence to protocol i) Health costs at 28 days post-natal. ii) Biochemical end-points (if performed): endocervical swabs will be taken to determine the presence of cervico-vaginal infection and concentrations of biomarkers of preterm birth, infection and inflammation. Saliva samples will be collected for salivary hormone levels, and blood samples taken for inflammatory markers and genetic analysis. Results will be correlated with maternal and fetal outcomes. ;Timepoint(s) of evaluation of this end point: 14 weeks gestation - 28 days post delivery. | — |
Countries
United Kingdom
Contacts
Public ContactDr Natahsa Hezelgrave
Guys and St THomas' NHS FOundation Trust
Outcome results
None listed