Objective
To evaluate perioperative complications of history- and ultrasound-indicated cerclage.
Methods
We performed a retrospective observational study of a cohort of patients who underwent history- (n = 198) or ultrasound-indicated (n = 89) cerclage procedures. We evaluated the rates of perioperative complications based on indication for cerclage. The χ 2 was used for categorical variables and Student t test for continuous data.
Results
One patient (0.35%) had an intraoperative complication (unsuccessful regional anesthesia) and 1 patient (0.35%) had a postoperative complication (contractions and bleeding 2 weeks after cerclage placement, delivered a nonviable infant). Peripartum complications included chorioamnionitis (6.2%), preterm premature rupture of membranes (11%), preterm delivery (20%), and delivery before 32 weeks’ gestational age (8%), and they were similar in the history-indicated and ultrasound-indicated groups.
Conclusion
History- and ultrasound-indicated cerclages are associated with a 0.6%; 95% confidence interval, −0.26 to 1.66 risk of perioperative complications. There was no difference in perioperative complications or outcome between the 2 groups.
Cervical insufficiency is described as the inability of the cervix to retain a pregnancy in the absence of contractions or labor. It affects approximately 1% of women and presents clinically as painless cervical dilation. In the 1950s, Shirodkar and McDonald introduced cervical cerclage procedures as a treatment for cervical insufficiency. Current evidence from randomized clinical trials has demonstrated that cerclage placement in women with a history of preterm birth or second trimester loss and cervical shortening below 25 mm at a transvaginal sonogram can reduce the risk of preterm birth by 39-43%. Approximately 40,000 cerclage procedures are performed in the United States annually despite limited published data pertaining to perioperative surgical complications.
Commonly quoted complications of cervical cerclage include preterm premature rupture of membranes (PPROM), chorioamnionitis, preterm labor, cervical trauma, suture displacement, and bleeding. Rates of PPROM have been reported to be 0.8-18% after a history-indicated and 3-65.2% after an ultrasound-indicated cerclage; chorioamnionitis rates are reported to be 1-6.2% and 30-35%, respectively. Though studies focus on the overall outcome and efficacy of cerclages, there is limited information available on the perioperative complications and safety of history- or ultrasound-indicated cervical cerclage.
The main objective of this study was to determine the rate of perioperative complications of history- and ultrasound-indicated cerclage. Secondary objectives were to determine whether there were differences in perioperative complications and outcome based on indication for cerclage placement.
Materials and Methods
In this retrospective analysis of a prospectively gathered cohort of patients undergoing cerclage placement, we obtained institutional review board approval and reviewed the medical records of 309 patients with singleton pregnancies who underwent history- or ultrasound-indicated cervical cerclage at Georgetown University Hospital, MedStar Health, Washington, DC, and Inova Alexandria Hospital, Alexandria, VA, between January 2005 and December 2009.
The indications for history-indicated cerclage were as follows: 3 or more unexplained spontaneous second-trimester losses or preterm deliveries; a single documented second-trimester loss or preterm delivery characterized by painless cervical dilation suggestive of cervical insufficiency; or prior pregnancy complicated by a physical examination-indicated cerclage placement. History-indicated cerclage procedures were performed between 12 and 16 weeks’ gestational age. The indication for ultrasound-indicated cerclage was cervical shortening to less than 25 mm on transvaginal sonogram in a patient with a history of a preterm delivery, second-trimester loss, or other risk factors for cervical insufficiency (eg, cervical surgery or multiple curettage procedures). Transvaginal sonogram was performed according to the technique described by Iams et al. Ultrasound-indicated cerclage procedures were performed between 14 and 23 weeks’ gestational age. Exclusion criteria were as follows: physical examination-indicated cerclages, multiple pregnancies, uterine anomalies, fetal anomalies, and lack of follow-up information. In all cases, a McDonald cerclage was placed using 5-mm Mersilene suture (Ethicon, Inc, Johnson and Johnson, New Brunswick, NJ). Five different maternal-fetal medicine physicians placed the cerclage sutures at the 2 institutions. All data was collected by the authors (D.D. and N.G.).
The obstetric history and documented examination were reviewed to confirm the diagnosis of suspected cervical insufficiency. We evaluated the overall rate of perioperative complications and compared characteristics based on indication for the cerclage. Intraoperative complications included: rupture of membranes, bleeding >100 mL, cervical laceration(s), injury to bladder or pelvic organs, inability to complete the procedure, and anesthesia complications. The postoperative period was defined as up to 2 weeks after cerclage placement. Postoperative complications included: PPROM, preterm labor leading to preterm delivery, chorioamnionitis (defined clinically and leading to preterm delivery), vaginal bleeding, cervical lacerations, suture displacement, and need for cerclage revision. Rates of complications were compared between history- and ultrasound-indicated cerclages using χ 2 for categorical variables and Student t test for continuous variables. Logistic regression was performed to control for confounding variables.
Results
Of the 309 patients in the cohort, 214 underwent history-indicated cerclage procedures and 95 underwent ultrasound-indicated cerclage procedures. Excluded were 21 patients who delivered at outside hospitals or were lost to follow-up, and 1 patient who had a congenital uterine anomaly. There were no significant differences in demographic variables or risk factors for cervical insufficiency between patients with history- or ultrasound-indicated cerclages ( Table 1 ).
