Status:
UNKNOWN
Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth
Lead Sponsor:
Asklepios proresearch
Collaborating Sponsors:
AG Pregnolia
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-50 years
Brief Summary
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and ...
Eligibility Criteria
Inclusion
- All participants must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study.
- Moreover both for a pessary cohort and for a normal cohort additional cohort-specific criteria for each group will need to be met. For the pessary cohort those shall consist of: suspected short cervix and confirmed on TVUS (CL \< 3rd percentile at gestational age at measurement) according to Salomon at al, whilst for the control (no-pessary) group: asymptomatic pregnant women with no risk factors for spontaneous preterm birth, respectively
Exclusion
- Any possible exclusion criteria will be evaluated for an ineligibility for the study on a first visit. Exclusion criteria for both pessary and control group will be: evidence of fetal anomaly or fetal chromosomal abnormality from fetal ultrasound, uterine malformations, a history of diethylstilboestrol (DES) use, (cases of so-called so called DES daughters, who were exposed to DES in utero), a cervical cerclage or pessary currently in place, a silicone allergy, painful regular contractions, abnormal placentation (previa, accrete), the rupture of membranes, a cervical dilation, any visible, symptomatic cervical or vaginal infections (this excludes treated, asymptomatic infections), a known HIV infection, cervical carcinoma, the presence on the cervix at the 12 o'clock position of any of the following conditions: Nabothian cyst, cervical myomas, cervical condylomas, cervical endometriosis, cervical tears, scar tissue, cervical ectopy, cervical scarring due to prior LLETZ, cervical squamous intraepithelial lesion, cervical dysplasia, cone biopsy, a vaginal bleeding evident on exam.
- The exclusion criteria about conditions on the cervix at 12 o'clock position cannot be checked without being enrolled in the study as it is an extra study assessment. Therefore, participants will be enrolled, the speculum assessment will be done after enrolment to clarify if any condition on the cervix at 12 o'clock position according to the exclusion criterion is present. If yes, the woman needs to be excluded from the study shortly after enrolment. These subjects will be replaced to reach the total number calculated.
- \-
Key Trial Info
Start Date :
November 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05267717
Start Date
November 23 2021
End Date
December 31 2022
Last Update
March 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ASKLEPIOS proresearch, Department of Pre-and Perinatal Medicine, Asklepios Barmbek, Hamburg-Barmbek, Germany.
Hamburg, Lohmühlenstraße 5/Haus J,, Germany, 20099