Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03818867
Eligibility Criteria:
Inclusion Criteria:
* Twin pregnancies presenting with an open cervix between 14 and 26 weeks of gestation, OR
* Twin pregnancies complicated by TTTS treated by Laser surgery between 16+0 and 26+0 weeks' gestation in whom a short cervix (\<15mm) is identified.
* Age \>18 years
* Informed consent
Exclusion Criteria:
* Cervical dilatation ≥5cm
* Amniotic membranes prolapsed beyond external os into the vagina, unable to visualise cervical tissue
* Preterm premature rupture of the membranes (PPROM) at the time of diagnosis of dilated cervix
* Major fetal malformations unrelated to TTTS
* Intrauterine death of one or both fetuses
* Symptoms or signs of threatened imminent delivery, e.g. painful regular uterine contractions, active vaginal bleeding, history of ruptured membranes
* Suspected chorioamnionitis \[based on maternal uterine tenderness, a temperature of 38°C or greater, significant leucocytosis (\>15,000 x 106/L) or elevated C-reactive protein (\>15 mg/L), or maternal tachycardia\].
* Placenta praevia
* Monochorionic monoamniotic twin pregnancies
* Prophylactic cervical cerclage
* Women who are not able to give valid consent, e.g. unconscious or severely ill
* Mental health disorder which impairs the ability to give fully informed consent
* Women under the age of 18 years
* Higher order multiple pregnancies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03818867
Study Brief:
Protocol Section:
NCT03818867