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Original Research

Management of Cervical Insufficiency and


Bulging Fetal Membranes
George Daskalakis, MD, PhD, Nikolaos Papantoniou, MD, PhD, Spiros Mesogitis, MD, PhD,
and Aris Antsaklis, MD, PhD

OBJECTIVE: To evaluate the efficacy of emergency cer- fore 32 weeks and improve neonatal survival compared
clage in cases with dilated cervix and protruding fetal with bed rest.
membranes in a group of women considered at low risk (Obstet Gynecol 2006;107:221–6)
for preterm delivery by their obstetric histories. LEVEL OF EVIDENCE: II-1
METHODS: All cases of cervical dilatation and bulging
membranes were detected through a transvaginal ul-
trasonographic screening for preterm delivery be-
tween 18 and 26 weeks during a 6-year study period. P reterm delivery is the leading cause of neonatal
mortality and morbidity.1,2 Moreover, the need
for intensive neonatal care and for continuing support
Twenty-nine women underwent an emergency cervical
cerclage and composed the cerclage group, whereas 17 after discharge from the hospital, and often during
others refused and formed the bed rest group. All childhood, is associated with an increased cost to the
patients were given antibiotics and prophylactic toco- health care system.3 Women with a short cervix due
lysis. to low cervical resistance are considered to be at a
RESULTS: The mean prolongation of pregnancy (8.8 much greater risk of preterm delivery.4 Although the
weeks) and the mean birth weight (2,101 g) after cerclage incidence of cervical insufficiency cannot be deter-
placement differed significantly from those of the bed mined readily due to the lack of clear criteria for the
rest group (3.1weeks and 739 g, respectively). Twenty- diagnosis, it seems that it is responsible for approxi-
five of the 29 pregnancies in the cerclage group ended in
mately 10 –25% of second-trimester pregnancy loss-
live birth, compared with 7 of the 17 pregnancies in the
bed rest group (P ⴝ .001) (relative risk [RR] 0.33, 95%
es.5,6 Management of these women usually involves
confidence interval [CI] 0.11– 0.98). Neonatal survival was the placement of a cervical suture to support the
96% in the cerclage group and 57.1% in the bed rest cervix, which is considered insufficient. Shirodkar7
group (P ⴝ .025) (RR 0.09, 95% CI 0.01– 0.76). The preterm first described cervical cerclage, and McDonald later
delivery rate less than 32 weeks was 31% and 94.1% in simplified the technique.8 Although several observa-
the cerclage and the bed rest groups, respectively (P < tional studies claimed high rates of successful preg-
.001) (RR 0.33, 95% CI 0.19 – 0.57), whereas the admission nancy outcome,9,10 there is still considerable contro-
to neonatal intensive care unit was 28% and 85.7% in the versy regarding its effectiveness. There have been
2 groups, respectively, (P ⴝ .01) (RR 0.33, 95% CI 0.16 –
only 6 randomized trials of cervical cerclage. Two of
0.66).
them relied on past obstetric history or cervical
CONCLUSION: Emergency cervical cerclage can be ac-
assessment score, but failed to demonstrate any im-
complished safely in women with dilated cervix and
provement for those treated with cerclage.11,12 The
bulging membranes. It can reduce preterm delivery be-
third relied mainly on the obstetrician uncertainty for
the diagnosis and showed a possible reduction of
See related editorial on page 219.
preterm delivery only in patients with a history of 3 or
more second-trimester miscarriages or preterm deliv-
From the First Department of Obstetrics and Gynecology, University of Athens, eries.13 However, it claimed that the operation was
“Alexandra” Hospital, Athens,Greece.
associated with increased medical intervention and
Corresponding author: George Daskalakis, 5 Katsarou Street, 12351-Athens,
Greece; e-mail: gdaskalakis@yahoo.com.
puerperal pyrexia. Three recent studies were per-
© 2006 by The American College of Obstetricians and Gynecologists. Published
formed to assess the benefits of cerclage in patients
by Lippincott Williams & Wilkins. with cervical changes identified with transvaginal
ISSN: 0029-7844/05 ultrasonographic assessment of the cervix. Although 1

VOL. 107, NO. 2, PART 1, FEBRUARY 2006 OBSTETRICS & GYNECOLOGY 221
of these showed a reduction in the preterm delivery the study. A detailed ultrasound scan was always
rate in the cerclage group,14 the other 2 failed to performed to confirm gestational age and exclude
demonstrate a significant improvement regarding pre- fetal malformations.
term delivery or any other perinatal outcome.15,16 Women with a short cervix (⬍ 15 mm) were
One of the major biases of the studies reporting offered the option to have either a cervical cerclage,
on cervical cerclage is patient selection. There are or weekly transvaginal ultrasonographic scanning
many differences among studies concerning the with the intention of treatment when further cervical
method of patients selection (obstetric history, vaginal changes were observed. Moreover, speculum exami-
ultrasound), the type of cervical changes detected for nation was performed to assess possible dilation of the
inclusion in the study (short cervical length, internal cervix and membranes prolapse. When a woman was
os dilatation), the cutoff of cervical length for cerclage found to have cervical dilation with membranes at or
placement, gestational age at enrollment, preopera- beyond a dilated external cervical os at any time of
tive management, and suture material. Women at screening before 26 weeks of gestation, she was
high risk for preterm delivery are those presenting at offered the option of having an emergency cervical
mid trimester with cervical dilation and membrane cerclage and entered the study protocol. All the
prolapse. In these women an attempt can be made to women with cervical dilation were asymptomatic at
perform an emergency cervical cerclage aiming at the time of diagnosis. Women who underwent an
prolonging the pregnancy and improving the perina- emergency cerclage composed the cerclage group
tal outcome. This report describes our treatment and those who declined operation the bed rest group.
protocol for the management of such cases and Entry criteria for the study were 1) live intrauterine
presents our experience with emergency cerclage. singleton pregnancy with no obvious fetal malforma-
tions, 2) gestational age between 18 and 26 weeks, 3)
MATERIALS AND METHODS cervical dilation more than 2 cm and membrane
During the period 1999 –2005 all pregnant women prolapse, 4) intact membranes, 5) absence of uterine
who had a second trimester scan anomaly between 18 contractions, 6) absence of clinical evidence of cho-
and 23 weeks of gestation at the Fetal Medicine Unit rioamnionitis, and 7) absence of significant vaginal
of Alexandra University Hospital, Athens, Greece, bleeding. Patients with premature rupture of mem-
were offered the option of having preterm delivery branes, vaginal bleeding, or persisting contractions
screening. The study received the approval of the were excluded from the study. Before treatment, the
Ethics Committee of the hospital. In all cases written potential risks and benefits were explained to the
consent was given before the screening, which in- patients and an informed consent was obtained. All
volved transvaginal ultrasonographic cervical assess- patients were observed for 8 –24 hours to exclude
ment. Patient characteristics, including demographic preterm labor as the cause of the cervical dilation.
data and previous obstetric and medical history, were Uterine activity was assessed with patient perception
obtained from the women and entered into a com- of contractions as well as abdominal palpation. Infec-
puter database. The women were asked to empty tion was excluded clinically by absence of pyrexia,
their bladders and were placed in the dorsal lithotomy uterine tenderness, and maternal or fetal tachycardia.
position. Cervical length was measured with a trans- Moreover, a white blood count of less than
vaginal transducer of 7.0 MHz. The probe was in- 14,000/mL and a negative C-reactive protein test
serted in the anterior vaginal fornix, and a sagittal were necessary. All women had a high vaginal and
view of the cervix was obtained by putting the cervical swab as well as blood culture taken. Cervical
calipers at the internal and the external cervical os. dilation was established by transvaginal sonographic
Three measurements were taken and the shortest 1 assessment and confirmed by speculum or digital
was recorded. The gestational age was determined by examination. The patients who entered the study
the last menstrual period or, when there was a dis- underwent emergency McDonald cerclage placement
crepancy of more than a week, by a first-trimester under general anesthesia. The women were placed in
scan. Women with a previous spontaneous preterm lithotomy position with steep Trendelenburg tilt, the
delivery, previous mid trimester spontaneous abor- vulva was prepared with the usual manner, and the
tion or termination of pregnancy, multiple gestation, situation was assessed by direct visualization using a
oligohydramnios or hydramnios, placenta previa, fe- Sim’s speculum. The vaginal walls and fornices were
tuses with congenital or chromosomal abnormalities, carefully prepared with antiseptic solution. Then 4
known congenital uterine malformation, cervical in- sponge-holding forceps grasped the edges of the
sufficiency, or a cervical cerclage were excluded from cervix gently. A moist swab on sponge-holding for-

222 Daskalakis et al Emergency Cerclage in Cervical Insufficiency OBSTETRICS & GYNECOLOGY


ceps was used to push the membranes back into the Fisher exact or ␹2 tests were used. Risk ratios and their
uterine cavity, which was also facilitated by traction of 95% confidence intervals were calculated to present
the forceps attached to the edges of the cervix. Then the association of preterm delivery, neonatal survival,
a 5-mm polyester cerclage tape (Cervix-Set, Aesculap and other factors with cervical cerclage.
AG, Tuttlingen, Germany) with a large needle was
placed, while the membranes were protected from RESULTS
accidental perforation by being held away with a During the study period 1.1% of all the women who
smaller moist swab. The knot was tied anteriorly and fulfilled the entry criteria for the study had a cervical
a long tail of the tape was left to ease removal before length less than 15 mm. During the follow-up scans 46
vaginal delivery. of them were found to have cervical dilation with
All patients were given cefuroxime and metroni- membranes at or beyond a dilated external cervical
dazole intravenously in the operating room and con- os, and they were offered the option of having an
tinued for 48 hours. In addition, they received eryth- emergency cervical cerclage. Twenty-nine of them
romycin 1.5 g orally daily for 10 days after the accepted cerclage, whereas 17 others refused and
operation. After the procedure they were given pro- served as the bed rest group. The details of both
phylactic tocolysis using 100 mg indomethacin rec- groups are shown in Table 1. Cerclage was techni-
tally twice a day for 2 days and 5 mg ritodrine orally cally successful in all cases. Membrane rupture did
every 6 hours for 2 weeks. All women were restricted not occur at the time of cerclage placement in any
to bed in the hospital for 7 days. They were then patient, and there were no operative or anesthetic
discharged home with instruction for strict bed rest complications. None of the procedures had more than
until 32 weeks. During the bed rest period all women 50 mL of blood loss, nor in any case was it necessary
received daily low-molecular-weight heparin for to repeat the cerclage during the pregnancy. In all
thrombosis prophylaxis. Follow-up included antena- cases the cervix remained closed 48 hours postopera-
tal clinic assessment at 2-week intervals. Ultrasound tively, and the cervical length ranged from 4 –23 mm.
examination of the cervix was performed 48 hours The perinatal outcome of both groups is summa-
postoperatively to confirm correct placement of the rized in Table 2. The mean prolongation of preg-
stitch. nancy after cerclage placement was 8.8 weeks (range
After 32 weeks, women were allowed mobiliza- 0 –17 weeks) and differed significantly (P ⬍ .001) from
tion with plenty of rest. The suture was removed at 37 the mean prolongation of pregnancy in the bed rest
weeks of gestation or whenever labor was established. group, which was 3.1 weeks (range 0 –11weeks). Of
The primary efficacy variable was pregnancy prolon- the 29 women, 4 aborted, whereas 25 pregnancies
gation. A power analysis revealed that, with this ended in live births. Only 7 of the 17 pregnancies of
sample size, the study had 99% power to detect a the bed rest group ended in live births (risk ratio [RR]
significant increase of pregnancy prolongation from 0.33, 95% confidence interval [CI] 0.11– 0.98). Twen-
the bed rest to the cerclage group. ty-four of the 25 liveborn infants survived in the
For the statistical analysis the variables were first cerclage group, compared with 4 of the 7 liveborn
tested for normality. When the normality assumption infants in the bed rest group (RR ⫽ 0.09, 95% CI
was satisfied, Student t tests were used for the com- 0.01– 0.76). Seven of the 25 liveborn infants were
parison of means of continuous variables between the admitted to the neonatal intensive care unit in the
2 groups of women, and the Mann–Whitney test was cerclage group and 6 of the 7 in the bed rest group
used when the distribution was not normal. For the (RR 0.33, 95% CI 0.16 – 0.66). The mean birth weight
comparison of proportions of categorical variables was 2,101 g (range 410 –3,340 g), whereas the median

Table 1. Characteristics of the Study and Control Groups


Study Group Control Group
(n ⴝ 29) (n ⴝ 17) Statistical Test P
Age (y) 27.1 (⫾ 3.6) 26.4 (⫾ 3.4) Mann Whitney U .647
Gestational age at diagnosis (wk) 22.4 (⫾ 1.7) 22.6 (⫾ 1.6) Student t .747
Smoking 4 2 Fisher exact 1.0
Cervical conization 1 0 Fisher exact 1.0
Primigravidas 12 8 ␹2 .708
Cervical dilation (cm) 4.1 (⫾ 1.4) 4.0 (⫾ 1.3) Mann Whitney U .820
Values are n or mean (⫾ standard deviation).

VOL. 107, NO. 2, PART 1, FEBRUARY 2006 Daskalakis et al Emergency Cerclage in Cervical Insufficiency 223
Table 2. Pregnancy Outcome in the Study and Control Groups
Study Group Control Group
(n ⴝ 29) (n ⴝ 17) Statistical Test P
Prolongation of pregnancy (wk) 8.8 (3.9) 3.1 (2.6) Student t ⬍ .001
Birth weight (g) 2,101.0 (698.9) 739.0 (486.7) Mann Whitney U ⬍ .001
Live birth 25/29 (86.2) 7/17 (41.2) ␹2 .001
Neonatal survival 24/25 (96.0) 4/7 (57.1) Fisher exact .025
Admission at NICU 7/25 (28.0) 6/7 (85.7) Fisher exact .01
PTD ⬍ 32 weeks 9/29 (31.0) 16/17 (94.1) ␹2 ⬍ .001
NICU, neonatal intensive care unit; PTD, preterm delivery.
Values are mean (⫾ standard deviation) or n/N (%).

birth weight was 2,280 g for the cerclage group, and cerclage in this group of women, between 18 and 26
these were significantly greater (P ⬍ .001) than the weeks of gestation, can prolong pregnancy and can
mean and median birth weight in the bed rest group, lead to the delivery of a viable infant. It can promote
which was 739 g (range 345–2,130 g) and 530 g, a 3-fold reduction in preterm delivery rate before 32
respectively. Nine of the 29 women in the cerclage weeks, which in its turn results in a 3.5-fold increase in
group and 16 of the 17 women in the bed rest group neonatal survival rate. Moreover, the vast majority of
had a preterm delivery less than 32 weeks (RR 0.33, infants of the study group did not require admission to
95% CI 0.19 – 0.57 a special care unit, in comparison with almost all
The suture was removed in 3 patients. In 2 of infants of the control group. These results are in
them this was due to preterm rupture of membranes, accordance with that of previous studies that reported
3 and 12 days after the procedure, respectively, and in fetal survival rates up to 89%.17–24 Direct comparisons
the third due to strong persistent contractions 2 weeks among studies cannot be made, mainly due to the
after the cerclage placement. All 3 had histologic small number of patients included and the observa-
evidence of placental and chorioamnionic infection. tional nature of most of them. Moreover, there are
None of the 3 extremely preterm neonates survived. major disparities among studies concerning inclusion
Caesarean delivery rate was 24.1% in the cerclage criteria, cerclage technique, gestational age at enroll-
group, compared with 11.8% in the bed rest group. In ment and preoperative and postoperative manage-
3 cases a cervical laceration was found at delivery in ment. There was only 1 prospective randomized trial
the cerclage group. Moreover, cervical dystocia due reporting on emergency cervical cerclage.25 This trial,
to scar tissue which prevented cervical dilation was which included women at high risk of cervical insuf-
observed in another. ficiency, showed that preterm delivery rate before 34
weeks, as well as the neonatal morbidity rate, were
DISCUSSION significantly lower in the emergency cerclage group,
The main difference between our study and others is compared with the bed rest group.
the initial selection of potential candidates. All trials The indications for cervical cerclage vary widely.
included patients with risk factors of preterm delivery. In a meta-analysis of randomized trials, it was found
However, a short cervix in these women does not that a prophylactic cervical stitch in women at risk of
necessarily mean cervical insufficiency. It may also be preterm delivery or second-trimester pregnancy loss,
the endpoint of different pathophysiologic process, has no clear benefit on perinatal outcome.26 To
most commonly infection or abruptio placentae. This eliminate the use of unnecessary cervical cerclages,
study has focused exclusively on women with no many investigators supported transvaginal ultrasono-
clinical risk factors who were found to have cervical graphic cervical assessment, for an optimal patient
dilation and membrane prolapse at the time of a selection. However, the results of 3 randomized trials
scheduled mid trimester ultrasonographic assessment. are contradictory.14 –16 The main problem of studies
This progressive asymptomatic cervical dilation indi- reporting on cervical cerclage is that cervical insuffi-
cates that these women were at increased risk of ciency is extremely difficult to establish objectively.
preterm delivery due to cervical insufficiency. All The policy to delay an elective cerclage until the
cases of cervical dilation were detected through a appearance of cervical changes at ultrasound scan
transvaginal ultrasonographic cervical screening for may increase the percentage of women with a dilated
preterm delivery and confirmed by speculum exam- cervix and threatened abortion in the mid trimester.
ination. Our findings suggest that emergency cervical When we undertook this study, we chose this group of

224 Daskalakis et al Emergency Cerclage in Cervical Insufficiency OBSTETRICS & GYNECOLOGY


women as candidates for cervical cerclage. Although acin because any inflammatory disruption of mem-
cervical dilation does not indicate impending la- branes from the decidua stimulates prostaglandin
bor,27,28 the finding of a dilated cervix with bulging production. Moreover, prostaglandin production is
membranes indicates that imminent delivery is likely. augmented in patients undergoing cervical cerclage,
To strengthen this even more, the preterm delivery especially those with advanced cervical changes.32,33
rate before 32 weeks in the group of women who In addition, prostaglandins may be released by the
remained untreated in our study was 94.1%. We local use of various genital tract microorganisms on
considered 26 weeks the upper limit for study inclu- the bulging membranes in patients with a dilated
sion, because before 26 weeks of gestation fetal sur- cervix.34 We also continued prophylactic tocolysis
vival is invariably low, making any intervention to with ␤-mimetics for 2 weeks, because in most patients
prolong the pregnancy justifiable. the uterus will remain irritable after cerclage.
We chose to use the McDonald technique be- The results of the present study as those of others
cause it is technically easier, has less intraoperative suggest that emergency cervical cerclage in women
blood loss, and requires less operating time compared with a dilated cervix and bulging membranes can be
with the Shirodkar procedure. Various authors have safely accomplished, converting in most cases an
proposed both techniques, but there is no evidence almost inevitable abortion into the delivery of a viable
that there is an advantage of one over the other. 17–19,29 infant. We believe that in cases in which cervical
Harger17 and Hordnes et al22 reported rupture of the dilatation is mainly related to mechanical failure,
membranes at the time of the procedure in 30% and emergency cerclage should be considered the first
6.3% of cases, respectively. However, in our study as option procedure. The stitch holds the cervix closed
in many others, membrane rupture did not occur in
so that the fetal membranes are protected from direct
any of our patients. It is of paramount importance for
exposure to vaginal bacteria. In contrast, when cervi-
a successful outcome after emergency cerclage place-
cal changes are related to various aspects of infection,
ment to exclude both women with placental abrup-
emergency cerclage placement is contraindicated. We
tion and women in labor as candidates for the proce-
acknowledge that safe conclusions regarding effec-
dure. Therefore, an observation period before the
tiveness of such techniques can only be drawn after
cerclage is mandatory. The main difficulty is to ex-
prospective randomized trials. However, this is not
clude infection before insertion of the suture, because
practical without using multicenter collected data.
this is the most likely cause of complications after
cerclage. Most patients with histologic evidence of Finally, we believe that due to the rarity of this
infection show no clinical signs that make the detec- condition, single-center experience is of value and
tion of intrauterine infection difficult. In 3 cases in should be appropriately reported.
which we removed the stitch due to preterm prema-
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