Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
NCT ID: NCT06443112
Last Updated: 2024-06-05
Study Results
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Basic Information
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COMPLETED
129 participants
OBSERVATIONAL
2024-05-10
2024-05-10
Brief Summary
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Detailed Description
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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 No:1 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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history-indicated cerclage group (group1)
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.
transvaginal cervical cerclage by Mc Donald technique
In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
(Group 2) patients with ultrasound-indicated cerclage
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 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.
transvaginal cervical cerclage by Mc Donald technique
In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
Group 3 consisted of patients undergoing rescue cerclage
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.
transvaginal cervical cerclage by Mc Donald technique
In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
Interventions
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transvaginal cervical cerclage by Mc Donald technique
In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Multiple pregnancies
18 Years
45 Years
FEMALE
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Zeynep Kayaoglu yıldırım, MD
Role: STUDY_DIRECTOR
Başakşehir Çam ve Sakura City Hospital
Elif Sagban Gedik, MD
Role: PRINCIPAL_INVESTIGATOR
Başakşehir Çam ve Sakura City Hospital
Locations
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İstanbul Başakşehir Çam ve Sakura City Hospital
Istanbul, Basaksehir, Turkey (Türkiye)
Countries
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References
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Song RK, Cha HH, Shin MY, Choi SJ, Oh SY, Kim JH, Roh CR. Post-cerclage ultrasonographic cervical length can predict preterm delivery in elective cervical cerclage patients. Obstet Gynecol Sci. 2016 Jan;59(1):17-23. doi: 10.5468/ogs.2016.59.1.17. Epub 2016 Jan 15.
Chan LL, Leung TW, Lo TK, Lau WL, Leung WC. Indications for and pregnancy outcomes of cervical cerclage: 11-year comparison of patients undergoing history-indicated, ultrasound-indicated, or rescue cerclage. Hong Kong Med J. 2015 Aug;21(4):310-7. doi: 10.12809/hkmj144393. Epub 2015 Jul 17.
Cook JR, Chatfield S, Chandiramani M, Kindinger L, Cacciatore S, Sykes L, Teoh T, Shennan A, Terzidou V, Bennett PR. Cerclage position, cervical length and preterm delivery in women undergoing ultrasound indicated cervical cerclage: A retrospective cohort study. PLoS One. 2017 Jun 1;12(6):e0178072. doi: 10.1371/journal.pone.0178072. eCollection 2017.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BasaksehirCamveSakuraH
Identifier Type: -
Identifier Source: org_study_id
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