Clinical trial NCT06443112: Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Incompetence (Complicating Pregnancy)
Keywords: cervical cerclage indications
cervical insufficiency
post-cerclage cervical length
Pregnancy outcomes
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-05
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-45 aged Pregnant women who underwent cerclage at 12-25 weeks gestation from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey.

Brief summary: This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 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 weeks.Factors 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 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.

Eligibility criteria: Inclusion Criteria:

* Pregnants that underwent cervical cerclage between July 2021 and July 2023 with singleton pregnancies

Exclusion Criteria:

* Pregnant women without follow-up whose post-procedure data cannot be accessed
* Multiple pregnancies

Primary outcomes:
measure: Latency from the time of cerclage procedure to delivery
timeFrame: time from cerclage procedure to birth
measure: pre-cerclage and post-cerclage cervical length cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency.
timeFrame: time from diagnosis to birth
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Başakşehir Çam ve Sakura City Hospital
state: Basaksehir
Study officials:
affiliation: Başakşehir Çam ve Sakura City Hospital
name: Zeynep Kayaoglu yıldırım, MD
role: STUDY_DIRECTOR
affiliation: Başakşehir Çam ve Sakura City Hospital
name: Elif Sagban Gedik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.