Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443112
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-22
Brief Title:
Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Pregnancy Outcomes According To Cervical Cerclage Indications And Factors Affecting Pregnancy Duration And Outcomes A 2-Year Comparison Of Patients Who Underwent History-Based Ultrasound-Based or Rescue Cerclage
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCERCIAFAO
Brief Summary:
This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included The patients were divided into three subgroups for data analysis Groups included patients with respectively history-indicated cerclage group 1 ultrasound-indicated cerclage group 2 and rescue cerclage group 3 The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a good outcome was defined as delivery beyond 34 completed weeksFactors associated with successful cervical cerclage and perinatal outcomes after the procedure for all three groups were analyzed The investigators also calculated post-cerclage the cervical length cut-off value required to predict if birth could be postponed until after the 28th week of gestation in women with cervical insufficiency
Detailed Description:
This study retrospectively reviewed data from pregnant women who underwent cerclage from July 2021 to July 2023 in Çam and Sakura City Hospital which is a perinatal medical center in Istanbul Turkey The local ethics committee approved the study
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki
The patients were divided into three subgroups for data analysis Group 1 included patients with history-indicated cerclage who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption or previous cerclage due to painless cervical dilatation in the second trimester Group 2 comprised patients with ultrasound-indicated cerclage who had a history of spontaneous preterm birth before the 34th week previously and their cervical length CL was 25 mm before the 24th week of gestation in the current singleton pregnancy or who had 10 mm cervical length in the current singleton pregnancy without history Group 3 consisted of patients undergoing rescue cerclage who had premature cervical dilatation and exposure of fetal membranes in the vagina was detected in ultrasound or speculum examination of the cervix All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No1 proline The investigators collected the following data from medical records maternal age at cervical cerclage gravidity parity body mass index history of a cervical cone biopsy history of premature birth and cervical cerclage procalcitonin level C-reactive protein CRP level gestational age at cerclage pre-and post-cerclage CL week of birth pregnancy complications preterm premature rupture of the membranes PPROM abruptio placenta chorioamnionitis The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a good outcome was defined as delivery beyond 34 completed weeks The indications and the pregnancy outcomes miscarriage gestational age at delivery birth weight prolongation of pregnancy and rate of preterm birth before 34 weeks of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed
Moreover receiver operating characteristic ROC curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency CI Thus the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki
The patients were divided into three subgroups for data analysis Group 1 included patients with history-indicated cerclage who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption or previous cerclage due to painless cervical dilatation in the second trimester Group 2 comprised patients with ultrasound-indicated cerclage who had a history of spontaneous preterm birth before the 34th week previously and their cervical length CL was 25 mm before the 24th week of gestation in the current singleton pregnancy or who had 10 mm cervical length in the current singleton pregnancy without history Group 3 consisted of patients undergoing rescue cerclage who had premature cervical dilatation and exposure of fetal membranes in the vagina was detected in ultrasound or speculum examination of the cervix All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No1 proline The investigators collected the following data from medical records maternal age at cervical cerclage gravidity parity body mass index history of a cervical cone biopsy history of premature birth and cervical cerclage procalcitonin level C-reactive protein CRP level gestational age at cerclage pre-and post-cerclage CL week of birth pregnancy complications preterm premature rupture of the membranes PPROM abruptio placenta chorioamnionitis The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a good outcome was defined as delivery beyond 34 completed weeks The indications and the pregnancy outcomes miscarriage gestational age at delivery birth weight prolongation of pregnancy and rate of preterm birth before 34 weeks of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed
Moreover receiver operating characteristic ROC curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency CI Thus the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None