IJG-07943; No of Pages 3 International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Elective removal of cervical cerclage and onset of spontaneous labor Ana O.F. Gomes da Costa a,⁎, Nuno Clode a,b, Luís M. Graça a,b a b
Department of Obstetrics and Gynecology, Central Hospital of Lisbon North, Hospital of Santa Maria, Lisbon, Portugal Faculty of Medicine, University of Lisbon, Lisbon, Portugal
a r t i c l e
i n f o
Article history: Received 11 September 2013 Received in revised form 27 January 2014 Accepted 27 March 2014 Keywords: Cerclage removal Cervical cerclage Onset of spontaneous labor
a b s t r a c t Objective: To determine the time interval between elective removal of cervical cerclage and onset of spontaneous labor. Methods: A retrospective cohort study was conducted between January 2005 and December 2012 at a tertiary care hospital in Lisbon, Portugal. All singleton pregnancies with a McDonald or Shirodkar cerclage electively removed at 36–37 weeks were evaluated for the time interval between cerclage removal and spontaneous labor. Delivery within 72 hours after cerclage removal was compared between patients with elective cerclage and those with non-elective cerclage. In the non-elective group, a sub-analysis of the results for ultrasound- and physical examination-indicated cerclage was performed. Results: Thirty-eight women were included. The time interval between cerclage removal and spontaneous labor did not differ significantly between the elective and the non-elective group (15.6 ± 7.6 vs 10.9 ± 7.4 days; P =0.063). A higher incidence of delivery 72 hours after cerclage removal was seen in the non-elective group but this was not significant (P = 0.061). There were no differences regarding the time interval from elective removal of cervical cerclage to onset of spontaneous labor between ultrasound-indicated and physical examination-indicated cerclage. Conclusion: Regardless of the indication for cervical cerclage, the probability of delivery soon after elective cerclage removal is low. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Preterm birth is the main cause of perinatal morbidity and mortality. It is a condition that may be influenced by many factors, including cervical insufficiency, short cervix, and amniotic inflammation [1,2]. Cervical insufficiency is classically defined as a recurrent and painless cervical dilation after the first trimester leading to expulsion of the pregnancy in the absence of signs and symptoms of clinical contractions, or labor [1–3]. There are many reasons for cervical insufficiency, such as congenital disorders (collagen or uterine abnormalities), prior cervical dilation and curettage, cervical lacerations that may occur during labor, and extensive conization [4,5]. Women with a history indicative of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. Cerclage is also indicated for women with singleton pregnancy who have experienced prior spontaneous preterm birth (SPTB) before 34 weeks and who have a cervical length less than 25 mm before 24 weeks, and those for whom physical examination shows effacement and dilation of the cervix [1,2,6–8]. The McDonald
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Central Hospital of Lisbon North, Hospital of Santa Maria, Av. Prof. Egas Moniz, 1649-035 Lisbon, Portugal. Tel.: +351 217805578; fax: +351 217805621. E-mail address: [email protected] (A.O.F. Gomes da Costa).
technique is the most commonly used to provide physical support to the cervix. When the cervix is too short, the Shirodkar technique should be used. Usually, the cerclage suture is removed before labor onset, at 36–37 weeks [9]. There is limited information about the time interval between the elective removal of a cervical cerclage and the onset of spontaneous labor; this information may be useful for counseling women regarding this issue and for clinical management. Therefore, our goal was to assess the time interval between elective cerclage removal and spontaneous delivery and to compare delivery within 72 hours after cerclage removal between women with elective (history-indicated) cerclage and those with nonelective (ultrasound- and physical examination-indicated) cerclage. 2. Materials and methods We conducted a retrospective study at the Department of Obstetrics and Gynecology of Santa Maria Hospital, which is a tertiary university/ public hospital in Lisbon, Portugal. The study was approved by the institutional ethics committee. Because it was a retrospective study, informed consent was not obtained. Data were collected from medical records of pregnant women with McDonald or Shirodkar cerclage performed between January 1, 2005, and December 31, 2012. Women underwent elective cerclage (history-indicated) at approximately 14–16 weeks if they had a poor obstetric history (e.g. previous second-trimester delivery in the absence of labor) and a suspected diagnosis of cervical insufficiency. Ultrasound-
http://dx.doi.org/10.1016/j.ijgo.2014.01.021 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
2
A.O.F. Gomes da Costa et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
Table 1 Demographic characteristics.a Variable
Elective cerclage (n = 16)
Non-elective cerclage (n = 22)
P value
Age, ya White Previous spontaneous pregnancy loss at 14–24 weeks Previous preterm delivery History of cervical treatment
35.5 (18–39) 10 (63) 15 (94) 2 (13) 0 (0)
32.5 (20–38) 16 (73) 4 (18) 5 (23) 1 (5)
0.022 0.752 b0.001 0.675 N0.99
a
Values are given as median (range) or number (percentage) unless otherwise indicated.
indicated cerclage was placed at 16–24 weeks if women had a prior SPTB at less than 34 weeks and a cervical length of less than 20 mm. If women presented with effacement and dilation of the cervix, physical examination-indicated cerclage was performed, in the absence of infection, uterine contractions, and vaginal bleeding. Exclusion criteria included multiple gestation, preterm delivery, premature rupture of membranes, suspected amnionitis, fetal death, cerclage removal at time of elective cesarean delivery, and induction of labor at any gestational age. Cervical cerclage was performed via McDonald or Shirodkar– Strömme technique using Mersilene tape (Ethicon, Somerville, NJ, USA). The Shirodkar–Strömme technique required careful dissection of the vaginal mucosa off the bladder and rectum (a 2-cm transverse incision, anteriorly and posteriorly) to enable the placement of the suture closer to the internal os. Before the procedure, fetal viability was confirmed, as well as the absence of fetal malformations; cervical and/or vaginal infections were treated with antibiotics before the intervention. Diagnostic amniocentesis was not routinely performed in the study department. All procedures were carried out under general anesthesia and tocolysis with indomethacin (100-mg rectal suppository 2 hours prior to the procedure, and every 12 hours for 24 hours). Antibiotics were always administered 2 hours before the intervention (900 mg of intravenous clindamycin every 8 hours for 24 hours and 500 mg/day of intravenous azithromycin). For asymptomatic women, the sutures were electively removed in an outpatient setting between 36 and 37 weeks. Women were counseled about labor signs and sent home, with follow-up visits scheduled weekly. Labor was induced at 41 weeks if it did not occur spontaneously, unless there was any medical indication to induce it sooner. Pregnancies with elective and non-elective cerclage were compared in terms of time interval between elective removal of cerclage and onset of spontaneous labor. We also compared the outcomes for ultrasoundand physical examination-indicated cerclage. Comparison of continuous variables was performed via Student t test or Mann–Whitney U test. Fisher exact test and Pearson χ2 test were used to compare categorical variables. P b 0.05 was considered to be statistically significant. Statistical analysis was performed with SigmaStat version 3.5 (Systat Software, Chicago, IL, USA). 3. Results During the study period, 88 cerclage procedures were performed in the study department (86 McDonald cerclage and 2 Shirodkar– Strömme cerclage). Of these, 38 were eligible for inclusion in the study. Thirty-two women were excluded for preterm birth, 7 for
multiple gestation, and 11 for elective cesarean delivery or induction of labor after elective removal of cerclage at 36–37 weeks. Sixteen (42%) women underwent elective cerclage and 22 (58%) underwent non-elective cerclage (16 ultrasound-indicated and 6 physical examination-indicated cerclage). Demographic characteristics are shown in Table 1. Women in the non-elective group were significantly younger than women in the elective group (P = 0.022). There were no significant differences regarding race (P = 0.752), history of preterm birth (P = 0.675), or cervical interventions (P N 0.99). Second-trimester pregnancy loss was more frequent in the elective group than in the non-elective group (P b 0.001). Because of the retrospective nature of the study and missing data, smoking status could not be evaluated. Pregnancy outcomes are shown in Table 2. In both groups, the median time of cerclage removal was 37 weeks (range, 36.0–37.9 weeks). Spontaneous labor occurred at 39.1 ± 1.2 weeks in the elective group and at 38.4 ± 1.1 weeks in the non-elective group (P = 0.074). The time interval between cerclage removal and spontaneous labor did not differ significantly between the elective group and the non-elective group (15.6 ± 7.6 vs 10.9 ± 7.4 days; P = 0.063). The overall mean time interval was 12.9 ± 7.8 days (range, 0–28 days). In the elective cerclage group, there were no cases of onset of spontaneous labor within 72 hours after cerclage removal, compared with 5 (23%) cases in the non-elective group (P = 0.061): 2 within 24 hours; 1 between 24 and 48 hours; and 2 between 48 and 72 hours (Table 2). Table 3 shows the demographic characteristics and pregnancy outcomes of women with ultrasound- and physical examination-indicated cerclage. Women with physical examination-indicated cerclage were significantly younger than women with ultrasound-indicated cerclage (P = 0.015). There was no significant difference in time interval between elective removal of cerclage and onset of spontaneous labor (P = 0.327). At the time of cerclage removal, there were no cases of cervical laceration or other complications such as infection or hemorrhage. 4. Discussion In the present study, there was no significant difference in mean time interval from elective removal of cervical cerclage to spontaneous delivery between women with elective cerclage and women with nonelective cerclage. A higher incidence of delivery within 72 hours after cerclage removal was seen in the non-elective group, although this was not significant. This may have been due to the relatively small number of cases in the sample because a shorter cervix caused by cervical insufficiency, with upper cervical changes visible in the ultrasound,
Table 2 Pregnancy outcomes.a Variable
Elective cerclage (n = 16)
Non-elective cerclage (n = 22)
P value
Gestational age at cerclage removal, wk Gestational age at spontaneous onset of labor, wk Interval from cerclage removal to spontaneous onset of labor, d Spontaneous labor within 72 hours
37.0 (36.7–37.3) 39.1 ± 1.2 15.6 ± 7.6 0 (0)
37.0 (36.0–37.9) 38.4 ± 1.1 10.9 ± 7.4 5 (23)
0.375 0.074 0.063 0.061
a
Values are given as median (range) or mean ± SD unless otherwise indicated.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
A.O.F. Gomes da Costa et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
3
Table 3 Demographic characteristics and pregnancy outcomes of women with non-elective cerclage.a Variable
Ultrasound-indicated cerclage (n = 16)
Physical examination-indicated cerclage (n = 6)
P value
Age, y White Previous spontaneous pregnancy loss at 14–24 weeks Previous preterm delivery History of cervical treatment Gestational age at cerclage removal, wk Gestational age at onset of spontaneous labor, wk Interval from cerclage removal to onset of spontaneous labor, d Spontaneous labor within 72 hours
32 ± 3.3 12 (75) 2 (13) 5 (31) 1 (6) 37.0 (36.0–37.9) 38.2 ± 1.1 9.9 ± 7.3 4 (25)
27 ± 5.7 4 (67) 2 (33) 0 (0) 0 (0) 37.0 (36.9–37.3) 38.9 ± 1.2 13.5 ± 7.7 1 (17)
0.015 N0.99 0.292 0.266 N0.99 0.481 0.235 0.327 N0.99
a
Values are given as mean ± SD, number (percentage), or median (range) unless otherwise indicated.
may lead to early onset of labor once the suture is removed [8]. In the non-elective group, there was no significant difference in time interval between elective removal of cerclage and onset of spontaneous labor between women with ultrasound-indicated cerclage and those with physical examination-indicated cerclage. Similar results have been reported in other studies, the largest of which included 269 pregnancies and reported an overall median time interval from elective removal of cervical cerclage to delivery of 14 days, with no significant difference between history-indicated and ultrasound-indicated cerclage [10]. However, the authors verified that women with ultrasound-indicated cerclage were 4 times more likely to labor spontaneously within 72 hours after cerclage removal [10]. Another study reported a mean time interval of 14 days and a higher risk for delivery within 48 hours in women with ultrasound-indicated cerclage [11]. Many obstetricians recommend elective removal of cerclage at 36–37 weeks. However, others prefer to wait for the onset of labor before removing the suture, which may be associated with a risk of cervical laceration, infection, or hemorrhage [2,10,11]. In the present study, there were no complications related to cerclage removal but a previous study found a 6% incidence of minor cervical lacerations [12,13]. The present study had some limitations. For example, it was retrospective, the sample size was small, and we were unable to determine whether there were any differences regarding smoking status. Furthermore, diagnostic amniocentesis was not performed before the procedures. Abnormal amniotic fluid inflammatory markers in the absence of a positive amniotic fluid culture seem to be associated with adverse pregnancy outcomes in patients undergoing non-elective cerclage [14]. Data are lacking regarding the time interval between elective cerclage removal and onset of spontaneous labor, especially comparing the outcomes between ultrasound- and physical examination-indicated cerclage. The present results represent the outcomes of a series of cerclage procedures performed at a tertiary center and may be important when counseling women at the time of cerclage removal. These women should be managed in an outpatient setting because the probability of delivery soon after suture removal is low. In the present study, the overall mean time interval between elective cerclage removal and spontaneous labor was approximately 13 days. Because many studies report a higher risk of spontaneous delivery in the first 48–72 hours after cerclage removal in cases of ultrasoundindicated cerclage, we believe that the suture should be removed only at 37 weeks in such cases, in the absence of other adverse factors (e.g. abnormal amniotic fluid markers, suspected amnionitis, or preterm
labor). This could prevent potential complications for late preterm/early term infants [15,16].
Conflict of interest The authors have no conflicts of interest.
References [1] Iams JD. Cervical Insufficiency. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moore T, editors. Creasy and Resnik's Maternal-Fetal Medicine: Principles and Practice. 6th ed. Philadelphia, PA: Elsevier Health Sciences; 2008. p. 583–95. [2] ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol 2014;123(2 Pt 1):372–9. [3] Berghella V. Preterm birth prevention. In: Berghella V, editor. Obstetric Evidence Based Guidelines. 2nd ed. London: Informa Healthcare; 2012. p. 150–63. [4] Romero R, Espinoza J, Erez O, Hassan S. The role of cervical cerclage in obstetric practice: can the patient who could benefit from this procedure be identified? Am J Obstet Gynecol 2006;194(1):1–9. [5] Vaisbuch E, Romero R, Mazaki-Tovi S, Erez O, Kusanovic JP, Mittal P, et al. The risk of impending preterm delivery in asymptomatic patients with a nonmeasurable cervical length in the second trimester. Am J Obstet Gynecol 2010;203(5):446.e1–9. [6] Owen J, Szychowski JM, Hankins G, Iams JD, Sheffield JS, Perez-Delboy A, et al. Does midtrimester cervical length ≥25 mm predict preterm birth in high-risk women? Am J Obstet Gynecol 2010;203(4):393.e1–5. [7] Iams JD, Berghella V. Care for women with prior preterm birth. Am J Obstet Gynecol 2010;203(2):89–100. [8] Guzman ER, Forster JK, Vintzileos AM, Ananth CV, Walters C, Gipson K. Pregnancy outcomes in women treated with elective versus ultrasound-indicated cervical cerclage. Ultrasound Obstet Gynecol 1998;12(5):323–7. [9] Graça LM. Cervical Cerclage. In: Graça LM, editor. Maternal-Fetal Medicine. 4th ed. Portugal: Lidel; 2010. p. 671–5. [10] Alabi-Isama L, Sykes L, Chandiramani M, Patel S, Rai R, Bennett PR, et al. Time interval from elective removal of cervical cerclage to onset of spontaneous labour. Eur J Obstet Gynecol Reprod Biol 2012;165(2):235–8. [11] Bisulli M, Suhag A, Arvon R, Seibel-Seamon J, Visintine J, Berghella V. Interval to spontaneous delivery after elective removal of cerclage. Am J Obstet Gynecol 2009;201(2):163.e1–4. [12] McDonald IA. Suture of the cervix for inevitable miscarriage. J Obstet Gynaecol Br Emp 1957;64(3):346–50. [13] Abdelhak YE, Aronov R, Roque H, Young BK. Management of cervical cerclage at term: remove the suture in labor? J Perinat Med 2000;28(6):453–7. [14] Aguin E, Aguin T, Cordoba M, Aguin V, Roberts R, Albayrak S, et al. Amniotic fluid inflammation with negative culture and outcome after cervical cerclage. J Matern Fetal Neonatal Med 2012;25(10):1990–4. [15] Cheng YW, Nicholson JM, Nakagawa S, Bruckner TA, Washington AE, Caughey AB. Perinatal outcomes in low-risk term pregnancies: do they differ by week of gestation? Am J Obstet Gynecol 2008;199(4):370.e1–7. [16] Dietz PM, Rizzo JH, England LJ, Callaghan WM, Vesco KK, Bruce FC, et al. Early term delivery and health care utilization in the first year of life. J Pediatr 2012;161(2) 234–9.e1.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Elective removal of cervical cerclage and onset of spontaneous labor Ana O.F. Gomes da Costa a,⁎, Nuno Clode a,b, Luís M. Graça a,b a b
Department of Obstetrics and Gynecology, Central Hospital of Lisbon North, Hospital of Santa Maria, Lisbon, Portugal Faculty of Medicine, University of Lisbon, Lisbon, Portugal
a r t i c l e
i n f o
Article history: Received 11 September 2013 Received in revised form 27 January 2014 Accepted 27 March 2014 Keywords: Cerclage removal Cervical cerclage Onset of spontaneous labor
a b s t r a c t Objective: To determine the time interval between elective removal of cervical cerclage and onset of spontaneous labor. Methods: A retrospective cohort study was conducted between January 2005 and December 2012 at a tertiary care hospital in Lisbon, Portugal. All singleton pregnancies with a McDonald or Shirodkar cerclage electively removed at 36–37 weeks were evaluated for the time interval between cerclage removal and spontaneous labor. Delivery within 72 hours after cerclage removal was compared between patients with elective cerclage and those with non-elective cerclage. In the non-elective group, a sub-analysis of the results for ultrasound- and physical examination-indicated cerclage was performed. Results: Thirty-eight women were included. The time interval between cerclage removal and spontaneous labor did not differ significantly between the elective and the non-elective group (15.6 ± 7.6 vs 10.9 ± 7.4 days; P =0.063). A higher incidence of delivery 72 hours after cerclage removal was seen in the non-elective group but this was not significant (P = 0.061). There were no differences regarding the time interval from elective removal of cervical cerclage to onset of spontaneous labor between ultrasound-indicated and physical examination-indicated cerclage. Conclusion: Regardless of the indication for cervical cerclage, the probability of delivery soon after elective cerclage removal is low. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Preterm birth is the main cause of perinatal morbidity and mortality. It is a condition that may be influenced by many factors, including cervical insufficiency, short cervix, and amniotic inflammation [1,2]. Cervical insufficiency is classically defined as a recurrent and painless cervical dilation after the first trimester leading to expulsion of the pregnancy in the absence of signs and symptoms of clinical contractions, or labor [1–3]. There are many reasons for cervical insufficiency, such as congenital disorders (collagen or uterine abnormalities), prior cervical dilation and curettage, cervical lacerations that may occur during labor, and extensive conization [4,5]. Women with a history indicative of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. Cerclage is also indicated for women with singleton pregnancy who have experienced prior spontaneous preterm birth (SPTB) before 34 weeks and who have a cervical length less than 25 mm before 24 weeks, and those for whom physical examination shows effacement and dilation of the cervix [1,2,6–8]. The McDonald
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Central Hospital of Lisbon North, Hospital of Santa Maria, Av. Prof. Egas Moniz, 1649-035 Lisbon, Portugal. Tel.: +351 217805578; fax: +351 217805621. E-mail address: [email protected] (A.O.F. Gomes da Costa).
technique is the most commonly used to provide physical support to the cervix. When the cervix is too short, the Shirodkar technique should be used. Usually, the cerclage suture is removed before labor onset, at 36–37 weeks [9]. There is limited information about the time interval between the elective removal of a cervical cerclage and the onset of spontaneous labor; this information may be useful for counseling women regarding this issue and for clinical management. Therefore, our goal was to assess the time interval between elective cerclage removal and spontaneous delivery and to compare delivery within 72 hours after cerclage removal between women with elective (history-indicated) cerclage and those with nonelective (ultrasound- and physical examination-indicated) cerclage. 2. Materials and methods We conducted a retrospective study at the Department of Obstetrics and Gynecology of Santa Maria Hospital, which is a tertiary university/ public hospital in Lisbon, Portugal. The study was approved by the institutional ethics committee. Because it was a retrospective study, informed consent was not obtained. Data were collected from medical records of pregnant women with McDonald or Shirodkar cerclage performed between January 1, 2005, and December 31, 2012. Women underwent elective cerclage (history-indicated) at approximately 14–16 weeks if they had a poor obstetric history (e.g. previous second-trimester delivery in the absence of labor) and a suspected diagnosis of cervical insufficiency. Ultrasound-
http://dx.doi.org/10.1016/j.ijgo.2014.01.021 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
2
A.O.F. Gomes da Costa et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
Table 1 Demographic characteristics.a Variable
Elective cerclage (n = 16)
Non-elective cerclage (n = 22)
P value
Age, ya White Previous spontaneous pregnancy loss at 14–24 weeks Previous preterm delivery History of cervical treatment
35.5 (18–39) 10 (63) 15 (94) 2 (13) 0 (0)
32.5 (20–38) 16 (73) 4 (18) 5 (23) 1 (5)
0.022 0.752 b0.001 0.675 N0.99
a
Values are given as median (range) or number (percentage) unless otherwise indicated.
indicated cerclage was placed at 16–24 weeks if women had a prior SPTB at less than 34 weeks and a cervical length of less than 20 mm. If women presented with effacement and dilation of the cervix, physical examination-indicated cerclage was performed, in the absence of infection, uterine contractions, and vaginal bleeding. Exclusion criteria included multiple gestation, preterm delivery, premature rupture of membranes, suspected amnionitis, fetal death, cerclage removal at time of elective cesarean delivery, and induction of labor at any gestational age. Cervical cerclage was performed via McDonald or Shirodkar– Strömme technique using Mersilene tape (Ethicon, Somerville, NJ, USA). The Shirodkar–Strömme technique required careful dissection of the vaginal mucosa off the bladder and rectum (a 2-cm transverse incision, anteriorly and posteriorly) to enable the placement of the suture closer to the internal os. Before the procedure, fetal viability was confirmed, as well as the absence of fetal malformations; cervical and/or vaginal infections were treated with antibiotics before the intervention. Diagnostic amniocentesis was not routinely performed in the study department. All procedures were carried out under general anesthesia and tocolysis with indomethacin (100-mg rectal suppository 2 hours prior to the procedure, and every 12 hours for 24 hours). Antibiotics were always administered 2 hours before the intervention (900 mg of intravenous clindamycin every 8 hours for 24 hours and 500 mg/day of intravenous azithromycin). For asymptomatic women, the sutures were electively removed in an outpatient setting between 36 and 37 weeks. Women were counseled about labor signs and sent home, with follow-up visits scheduled weekly. Labor was induced at 41 weeks if it did not occur spontaneously, unless there was any medical indication to induce it sooner. Pregnancies with elective and non-elective cerclage were compared in terms of time interval between elective removal of cerclage and onset of spontaneous labor. We also compared the outcomes for ultrasoundand physical examination-indicated cerclage. Comparison of continuous variables was performed via Student t test or Mann–Whitney U test. Fisher exact test and Pearson χ2 test were used to compare categorical variables. P b 0.05 was considered to be statistically significant. Statistical analysis was performed with SigmaStat version 3.5 (Systat Software, Chicago, IL, USA). 3. Results During the study period, 88 cerclage procedures were performed in the study department (86 McDonald cerclage and 2 Shirodkar– Strömme cerclage). Of these, 38 were eligible for inclusion in the study. Thirty-two women were excluded for preterm birth, 7 for
multiple gestation, and 11 for elective cesarean delivery or induction of labor after elective removal of cerclage at 36–37 weeks. Sixteen (42%) women underwent elective cerclage and 22 (58%) underwent non-elective cerclage (16 ultrasound-indicated and 6 physical examination-indicated cerclage). Demographic characteristics are shown in Table 1. Women in the non-elective group were significantly younger than women in the elective group (P = 0.022). There were no significant differences regarding race (P = 0.752), history of preterm birth (P = 0.675), or cervical interventions (P N 0.99). Second-trimester pregnancy loss was more frequent in the elective group than in the non-elective group (P b 0.001). Because of the retrospective nature of the study and missing data, smoking status could not be evaluated. Pregnancy outcomes are shown in Table 2. In both groups, the median time of cerclage removal was 37 weeks (range, 36.0–37.9 weeks). Spontaneous labor occurred at 39.1 ± 1.2 weeks in the elective group and at 38.4 ± 1.1 weeks in the non-elective group (P = 0.074). The time interval between cerclage removal and spontaneous labor did not differ significantly between the elective group and the non-elective group (15.6 ± 7.6 vs 10.9 ± 7.4 days; P = 0.063). The overall mean time interval was 12.9 ± 7.8 days (range, 0–28 days). In the elective cerclage group, there were no cases of onset of spontaneous labor within 72 hours after cerclage removal, compared with 5 (23%) cases in the non-elective group (P = 0.061): 2 within 24 hours; 1 between 24 and 48 hours; and 2 between 48 and 72 hours (Table 2). Table 3 shows the demographic characteristics and pregnancy outcomes of women with ultrasound- and physical examination-indicated cerclage. Women with physical examination-indicated cerclage were significantly younger than women with ultrasound-indicated cerclage (P = 0.015). There was no significant difference in time interval between elective removal of cerclage and onset of spontaneous labor (P = 0.327). At the time of cerclage removal, there were no cases of cervical laceration or other complications such as infection or hemorrhage. 4. Discussion In the present study, there was no significant difference in mean time interval from elective removal of cervical cerclage to spontaneous delivery between women with elective cerclage and women with nonelective cerclage. A higher incidence of delivery within 72 hours after cerclage removal was seen in the non-elective group, although this was not significant. This may have been due to the relatively small number of cases in the sample because a shorter cervix caused by cervical insufficiency, with upper cervical changes visible in the ultrasound,
Table 2 Pregnancy outcomes.a Variable
Elective cerclage (n = 16)
Non-elective cerclage (n = 22)
P value
Gestational age at cerclage removal, wk Gestational age at spontaneous onset of labor, wk Interval from cerclage removal to spontaneous onset of labor, d Spontaneous labor within 72 hours
37.0 (36.7–37.3) 39.1 ± 1.2 15.6 ± 7.6 0 (0)
37.0 (36.0–37.9) 38.4 ± 1.1 10.9 ± 7.4 5 (23)
0.375 0.074 0.063 0.061
a
Values are given as median (range) or mean ± SD unless otherwise indicated.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
A.O.F. Gomes da Costa et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
3
Table 3 Demographic characteristics and pregnancy outcomes of women with non-elective cerclage.a Variable
Ultrasound-indicated cerclage (n = 16)
Physical examination-indicated cerclage (n = 6)
P value
Age, y White Previous spontaneous pregnancy loss at 14–24 weeks Previous preterm delivery History of cervical treatment Gestational age at cerclage removal, wk Gestational age at onset of spontaneous labor, wk Interval from cerclage removal to onset of spontaneous labor, d Spontaneous labor within 72 hours
32 ± 3.3 12 (75) 2 (13) 5 (31) 1 (6) 37.0 (36.0–37.9) 38.2 ± 1.1 9.9 ± 7.3 4 (25)
27 ± 5.7 4 (67) 2 (33) 0 (0) 0 (0) 37.0 (36.9–37.3) 38.9 ± 1.2 13.5 ± 7.7 1 (17)
0.015 N0.99 0.292 0.266 N0.99 0.481 0.235 0.327 N0.99
a
Values are given as mean ± SD, number (percentage), or median (range) unless otherwise indicated.
may lead to early onset of labor once the suture is removed [8]. In the non-elective group, there was no significant difference in time interval between elective removal of cerclage and onset of spontaneous labor between women with ultrasound-indicated cerclage and those with physical examination-indicated cerclage. Similar results have been reported in other studies, the largest of which included 269 pregnancies and reported an overall median time interval from elective removal of cervical cerclage to delivery of 14 days, with no significant difference between history-indicated and ultrasound-indicated cerclage [10]. However, the authors verified that women with ultrasound-indicated cerclage were 4 times more likely to labor spontaneously within 72 hours after cerclage removal [10]. Another study reported a mean time interval of 14 days and a higher risk for delivery within 48 hours in women with ultrasound-indicated cerclage [11]. Many obstetricians recommend elective removal of cerclage at 36–37 weeks. However, others prefer to wait for the onset of labor before removing the suture, which may be associated with a risk of cervical laceration, infection, or hemorrhage [2,10,11]. In the present study, there were no complications related to cerclage removal but a previous study found a 6% incidence of minor cervical lacerations [12,13]. The present study had some limitations. For example, it was retrospective, the sample size was small, and we were unable to determine whether there were any differences regarding smoking status. Furthermore, diagnostic amniocentesis was not performed before the procedures. Abnormal amniotic fluid inflammatory markers in the absence of a positive amniotic fluid culture seem to be associated with adverse pregnancy outcomes in patients undergoing non-elective cerclage [14]. Data are lacking regarding the time interval between elective cerclage removal and onset of spontaneous labor, especially comparing the outcomes between ultrasound- and physical examination-indicated cerclage. The present results represent the outcomes of a series of cerclage procedures performed at a tertiary center and may be important when counseling women at the time of cerclage removal. These women should be managed in an outpatient setting because the probability of delivery soon after suture removal is low. In the present study, the overall mean time interval between elective cerclage removal and spontaneous labor was approximately 13 days. Because many studies report a higher risk of spontaneous delivery in the first 48–72 hours after cerclage removal in cases of ultrasoundindicated cerclage, we believe that the suture should be removed only at 37 weeks in such cases, in the absence of other adverse factors (e.g. abnormal amniotic fluid markers, suspected amnionitis, or preterm
labor). This could prevent potential complications for late preterm/early term infants [15,16].
Conflict of interest The authors have no conflicts of interest.
References [1] Iams JD. Cervical Insufficiency. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moore T, editors. Creasy and Resnik's Maternal-Fetal Medicine: Principles and Practice. 6th ed. Philadelphia, PA: Elsevier Health Sciences; 2008. p. 583–95. [2] ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol 2014;123(2 Pt 1):372–9. [3] Berghella V. Preterm birth prevention. In: Berghella V, editor. Obstetric Evidence Based Guidelines. 2nd ed. London: Informa Healthcare; 2012. p. 150–63. [4] Romero R, Espinoza J, Erez O, Hassan S. The role of cervical cerclage in obstetric practice: can the patient who could benefit from this procedure be identified? Am J Obstet Gynecol 2006;194(1):1–9. [5] Vaisbuch E, Romero R, Mazaki-Tovi S, Erez O, Kusanovic JP, Mittal P, et al. The risk of impending preterm delivery in asymptomatic patients with a nonmeasurable cervical length in the second trimester. Am J Obstet Gynecol 2010;203(5):446.e1–9. [6] Owen J, Szychowski JM, Hankins G, Iams JD, Sheffield JS, Perez-Delboy A, et al. Does midtrimester cervical length ≥25 mm predict preterm birth in high-risk women? Am J Obstet Gynecol 2010;203(4):393.e1–5. [7] Iams JD, Berghella V. Care for women with prior preterm birth. Am J Obstet Gynecol 2010;203(2):89–100. [8] Guzman ER, Forster JK, Vintzileos AM, Ananth CV, Walters C, Gipson K. Pregnancy outcomes in women treated with elective versus ultrasound-indicated cervical cerclage. Ultrasound Obstet Gynecol 1998;12(5):323–7. [9] Graça LM. Cervical Cerclage. In: Graça LM, editor. Maternal-Fetal Medicine. 4th ed. Portugal: Lidel; 2010. p. 671–5. [10] Alabi-Isama L, Sykes L, Chandiramani M, Patel S, Rai R, Bennett PR, et al. Time interval from elective removal of cervical cerclage to onset of spontaneous labour. Eur J Obstet Gynecol Reprod Biol 2012;165(2):235–8. [11] Bisulli M, Suhag A, Arvon R, Seibel-Seamon J, Visintine J, Berghella V. Interval to spontaneous delivery after elective removal of cerclage. Am J Obstet Gynecol 2009;201(2):163.e1–4. [12] McDonald IA. Suture of the cervix for inevitable miscarriage. J Obstet Gynaecol Br Emp 1957;64(3):346–50. [13] Abdelhak YE, Aronov R, Roque H, Young BK. Management of cervical cerclage at term: remove the suture in labor? J Perinat Med 2000;28(6):453–7. [14] Aguin E, Aguin T, Cordoba M, Aguin V, Roberts R, Albayrak S, et al. Amniotic fluid inflammation with negative culture and outcome after cervical cerclage. J Matern Fetal Neonatal Med 2012;25(10):1990–4. [15] Cheng YW, Nicholson JM, Nakagawa S, Bruckner TA, Washington AE, Caughey AB. Perinatal outcomes in low-risk term pregnancies: do they differ by week of gestation? Am J Obstet Gynecol 2008;199(4):370.e1–7. [16] Dietz PM, Rizzo JH, England LJ, Callaghan WM, Vesco KK, Bruce FC, et al. Early term delivery and health care utilization in the first year of life. J Pediatr 2012;161(2) 234–9.e1.
Please cite this article as: Gomes da Costa AOF, et al, Elective removal of cervical cerclage and onset of spontaneous labor, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2014.01.021
