Original Research
Management of Cervical Insufficiency and
Bulging Fetal Membranes
George Daskalakis, MD, PhD, Nikolaos Papantoniou,
and Aris Antsaklis, MD, PhD
OBJECTIVE: To evaluate the efficacy of emergency cer-
clage in cases with dilated cervix and protruding fetal
membranes in a group of women considered at low risk
for preterm delivery by their obstetric histories.
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.
Twenty-nine women underwent an emergency cervical
cerclage and composed the cerclage group, whereas 17
others refused and formed the bed rest group. All
patients were given antibiotics and prophylactic toco-
lysis.
RESULTS: The mean prolongation of pregnancy (8.8
weeks) and the mean birth weight (2,101 g) after cerclage
placement differed significantly from those of the bed
rest group (3.1weeks and 739 g, respectively). Twenty-
five of the 29 pregnancies in the cerclage group ended in
live birth, compared with 7 of the 17 pregnancies in the
bed rest group (P ⴝ .001) (relative risk [RR] 0.33, 95%
confidence interval [CI] 0.11– 0.98). Neonatal survival was
96% in the cerclage group and 57.1% in the bed rest
group (P ⴝ .025) (RR 0.09, 95% CI 0.01– 0.76). The preterm
delivery rate less than 32 weeks was 31% and 94.1% in
the cerclage and the bed rest groups, respectively (P <
.001) (RR 0.33, 95% CI 0.19 – 0.57), whereas the admission
to neonatal intensive care unit was 28% and 85.7% in the
2 groups, respectively, (P ⴝ .01) (RR 0.33, 95% CI 0.16 –
0.66).
CONCLUSION: Emergency cervical cerclage can be ac-
complished safely in women with dilated cervix and
bulging membranes. It can reduce preterm delivery be-
See related editorial on page 219.
From the First Department of Obstetrics and Gynecology, University of Athens,
“Alexandra” Hospital, Athens,Greece.
Corresponding author: George Daskalakis, 5 Katsarou Street, 12351-Athens,
Greece; e-mail: gdaskalakis@yahoo.com.
© 2006 by The American College of Obstetricians and Gynecologists. Published
by Lippincott Williams & Wilkins.
ISSN: 0029-7844/05
VOL. 107, NO. 2, PART 1, FEBRUARY 2006
MD, PhD, Spiros Mesogitis, MD, PhD,
fore 32 weeks and improve neonatal survival compared
with bed rest.
(Obstet Gynecol 2006;107:221–6)
LEVEL OF EVIDENCE: II-1
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
after discharge from the hospital, and often during
childhood, is associated with an increased cost to the
health care system.3 Women with a short cervix due
to low cervical resistance are considered to be at a
much greater risk of preterm delivery.4 Although the
incidence of cervical insufficiency cannot be deter-
mined readily due to the lack of clear criteria for the
diagnosis, it seems that it is responsible for approxi-
mately 10 –25% of second-trimester pregnancy loss-
es.5,6 Management of these women usually involves
the placement of a cervical suture to support the
cervix, which is considered insufficient. Shirodkar7
first described cervical cerclage, and McDonald later
simplified the technique.8 Although several observa-
tional studies claimed high rates of successful preg-
nancy outcome,9,10 there is still considerable contro-
versy regarding its effectiveness. There have been
only 6 randomized trials of cervical cerclage. Two of
them relied on past obstetric history or cervical
assessment score, but failed to demonstrate any im-
provement for those treated with cerclage.11,12 The
third relied mainly on the obstetrician uncertainty for
the diagnosis and showed a possible reduction of
preterm delivery only in patients with a history of 3 or
more second-trimester miscarriages or preterm deliv-
eries.13 However, it claimed that the operation was
associated with increased medical intervention and
puerperal pyrexia. Three recent studies were per-
formed to assess the benefits of cerclage in patients
with cervical changes identified with transvaginal
ultrasonographic assessment of the cervix. Although 1
OBSTETRICS & GYNECOLOGY 221
of these showed a reduction in the preterm delivery
rate in the cerclage group,14 the other 2 failed to
demonstrate a significant improvement regarding pre-
term delivery or any other perinatal outcome.15,16
One of the major biases of the studies reporting
on cervical cerclage is patient selection. There are
many differences among studies concerning the
method of patients selection (obstetric history, vaginal
ultrasound), the type of cervical changes detected for
inclusion in the study (short cervical length, internal
os dilatation), the cutoff of cervical length for cerclage
placement, gestational age at enrollment, preopera-
tive management, and suture material. Women at
high risk for preterm delivery are those presenting at
mid trimester with cervical dilation and membrane
prolapse. In these women an attempt can be made to
perform an emergency cervical cerclage aiming at
prolonging the pregnancy and improving the perina-
tal outcome. This report describes our treatment
protocol for the management of such cases and
presents our experience with emergency cerclage.
MATERIALS AND METHODS
During the period 1999 –2005 all pregnant women
who had a second trimester scan anomaly between 18
and 23 weeks of gestation at the Fetal Medicine Unit
of Alexandra University Hospital, Athens, Greece,
were offered the option of having preterm delivery
screening. The study received the approval of the
Ethics Committee of the hospital. In all cases written
consent was given before the screening, which in-
volved transvaginal ultrasonographic cervical assess-
ment. Patient characteristics, including demographic
data and previous obstetric and medical history, were
obtained from the women and entered into a com-
puter database. The women were asked to empty
their bladders and were placed in the dorsal lithotomy
position. Cervical length was measured with a trans-
vaginal transducer of 7.0 MHz. The probe was in-
serted in the anterior vaginal fornix, and a sagittal
view of the cervix was obtained by putting the
calipers at the internal and the external cervical os.
Three measurements were taken and the shortest 1
was recorded. The gestational age was determined by
the last menstrual period or, when there was a dis-
crepancy of more than a week, by a first-trimester
scan. Women with a previous spontaneous preterm
delivery, previous mid trimester spontaneous abor-
tion or termination of pregnancy, multiple gestation,
oligohydramnios or hydramnios, placenta previa, fe-
tuses with congenital or chromosomal abnormalities,
known congenital uterine malformation, cervical in-
sufficiency, or a cervical cerclage were excluded from
222 Daskalakis et al Emergency Cerclage in Cervical Insufficiency
the study. A detailed ultrasound scan was always
performed to confirm gestational age and exclude
fetal malformations.
Women with a short cervix (⬍ 15 mm) were
offered the option to have either a cervical cerclage,
or weekly transvaginal ultrasonographic scanning
with the intention of treatment when further cervical
changes were observed. Moreover, speculum exami-
nation was performed to assess possible dilation of the
cervix and membranes prolapse. When a woman was
found to have cervical dilation with membranes at or
beyond a dilated external cervical os at any time of
screening before 26 weeks of gestation, she was
offered the option of having an emergency cervical
cerclage and entered the study protocol. All the
women with cervical dilation were asymptomatic at
the time of diagnosis. Women who underwent an
emergency cerclage composed the cerclage group
and those who declined operation the bed rest group.
Entry criteria for the study were 1) live intrauterine
singleton pregnancy with no obvious fetal malforma-
tions, 2) gestational age between 18 and 26 weeks, 3)
cervical dilation more than 2 cm and membrane
prolapse, 4) intact membranes, 5) absence of uterine
contractions, 6) absence of clinical evidence of cho-
rioamnionitis, and 7) absence of significant vaginal
bleeding. Patients with premature rupture of mem-
branes, vaginal bleeding, or persisting contractions
were excluded from the study. Before treatment, the
potential risks and benefits were explained to the
patients and an informed consent was obtained. All
patients were observed for 8 –24 hours to exclude
preterm labor as the cause of the cervical dilation.
Uterine activity was assessed with patient perception
of contractions as well as abdominal palpation. Infec-
tion was excluded clinically by absence of pyrexia,
uterine tenderness, and maternal or fetal tachycardia.
Moreover, a white blood count of less than
14,000/mL and a negative C-reactive protein test
were necessary. All women had a high vaginal and
cervical swab as well as blood culture taken. Cervical
dilation was established by transvaginal sonographic
assessment and confirmed by speculum or digital
examination. The patients who entered the study
underwent emergency McDonald cerclage placement
under general anesthesia. The women were placed in
lithotomy position with steep Trendelenburg tilt, the
vulva was prepared with the usual manner, and the
situation was assessed by direct visualization using a
Sim’s speculum. The vaginal walls and fornices were
carefully prepared with antiseptic solution. Then 4
sponge-holding forceps grasped the edges of the
cervix gently. A moist swab on sponge-holding for-
OBSTETRICS & GYNECOLOGY
ceps was used to push the membranes back into the
uterine cavity, which was also facilitated by traction of
the forceps attached to the edges of the cervix. Then
a 5-mm polyester cerclage tape (Cervix-Set, Aesculap
AG, Tuttlingen, Germany) with a large needle was
placed, while the membranes were protected from
accidental perforation by being held away with a
smaller moist swab. The knot was tied anteriorly and
a long tail of the tape was left to ease removal before
vaginal delivery.
All patients were given cefuroxime and metroni-
dazole intravenously in the operating room and con-
tinued for 48 hours. In addition, they received eryth-
romycin 1.5 g orally daily for 10 days after the
operation. After the procedure they were given pro-
phylactic tocolysis using 100 mg indomethacin rec-
tally twice a day for 2 days and 5 mg ritodrine orally
every 6 hours for 2 weeks. All women were restricted
to bed in the hospital for 7 days. They were then
discharged home with instruction for strict bed rest
until 32 weeks. During the bed rest period all women
received daily low-molecular-weight heparin for
thrombosis prophylaxis. Follow-up included antena-
tal clinic assessment at 2-week intervals. Ultrasound
examination of the cervix was performed 48 hours
postoperatively to confirm correct placement of the
stitch.
After 32 weeks, women were allowed mobiliza-
tion with plenty of rest. The suture was removed at 37
weeks of gestation or whenever labor was established.
The primary efficacy variable was pregnancy prolon-
gation. A power analysis revealed that, with this
sample size, the study had 99% power to detect a
significant increase of pregnancy prolongation from
the bed rest to the cerclage group.
For the statistical analysis the variables were first
tested for normality. When the normality assumption
was satisfied, Student t tests were used for the com-
parison of means of continuous variables between the
2 groups of women, and the Mann–Whitney test was
used when the distribution was not normal. For the
comparison of proportions of categorical variables
Table 1. Characteristics of the Study and Control Groups
Study Group
(n ⴝ 29)
Age (y) 27.1 (⫾ 3.6)
Gestational age at diagnosis (wk) 22.4 (⫾ 1.7)
Smoking 4 2
Cervical conization 1 0
Primigravidas 12
Cervical dilation (cm) 4.1 (⫾ 1.4)
Values are n or mean (⫾ standard deviation).
VOL. 107, NO. 2, PART 1, FEBRUARY 2006 Daskalakis et al
Fisher exact or ␹2 tests were used. Risk ratios and their
95% confidence intervals were calculated to present
the association of preterm delivery, neonatal survival,
and other factors with cervical cerclage.
RESULTS
During the study period 1.1% of all the women who
fulfilled the entry criteria for the study had a cervical
length less than 15 mm. During the follow-up scans 46
of them were found to have cervical dilation with
membranes at or beyond a dilated external cervical
os, and they were offered the option of having an
emergency cervical cerclage. Twenty-nine of them
accepted cerclage, whereas 17 others refused and
served as the bed rest group. The details of both
groups are shown in Table 1. Cerclage was techni-
cally successful in all cases. Membrane rupture did
not occur at the time of cerclage placement in any
patient, and there were no operative or anesthetic
complications. None of the procedures had more than
50 mL of blood loss, nor in any case was it necessary
to repeat the cerclage during the pregnancy. In all
cases the cervix remained closed 48 hours postopera-
tively, and the cervical length ranged from 4 –23 mm.
The perinatal outcome of both groups is summa-
rized in Table 2. The mean prolongation of preg-
nancy after cerclage placement was 8.8 weeks (range
0 –17 weeks) and differed significantly (P ⬍ .001) from
the mean prolongation of pregnancy in the bed rest
group, which was 3.1 weeks (range 0 –11weeks). Of
the 29 women, 4 aborted, whereas 25 pregnancies
ended in live births. Only 7 of the 17 pregnancies of
the bed rest group ended in live births (risk ratio [RR]
0.33, 95% confidence interval [CI] 0.11– 0.98). Twen-
ty-four of the 25 liveborn infants survived in the
cerclage group, compared with 4 of the 7 liveborn
infants in the bed rest group (RR ⫽ 0.09, 95% CI
0.01– 0.76). Seven of the 25 liveborn infants were
admitted to the neonatal intensive care unit in the
cerclage group and 6 of the 7 in the bed rest group
(RR 0.33, 95% CI 0.16 – 0.66). The mean birth weight
was 2,101 g (range 410 –3,340 g), whereas the median
Control Group
(n ⴝ 17) Statistical Test P
26.4 (⫾ 3.4) Mann Whitney U .647
22.6 (⫾ 1.6) Student t .747
Fisher exact 1.0
Fisher exact 1.0
8 ␹2 .708
4.0 (⫾ 1.3) Mann Whitney U .820
Emergency Cerclage in Cervical Insufficiency 223
Table 2. Pregnancy Outcome in the Study and Control Groups
Study Group
(n ⴝ 29)
Prolongation of pregnancy (wk) 8.8 (3.9)
Birth weight (g) 2,101.0 (698.9)
Live birth 25/29 (86.2)
Neonatal survival 24/25 (96.0)
Admission at NICU 7/25 (28.0)
PTD ⬍ 32 weeks 9/29 (31.0)
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
these were significantly greater (P ⬍ .001) than the
mean and median birth weight in the bed rest group,
which was 739 g (range 345–2,130 g) and 530 g,
respectively. Nine of the 29 women in the cerclage
group and 16 of the 17 women in the bed rest group
had a preterm delivery less than 32 weeks (RR 0.33,
95% CI 0.19 – 0.57
The suture was removed in 3 patients. In 2 of
them this was due to preterm rupture of membranes,
3 and 12 days after the procedure, respectively, and in
the third due to strong persistent contractions 2 weeks
after the cerclage placement. All 3 had histologic
evidence of placental and chorioamnionic infection.
None of the 3 extremely preterm neonates survived.
Caesarean delivery rate was 24.1% in the cerclage
group, compared with 11.8% in the bed rest group. In
3 cases a cervical laceration was found at delivery in
the cerclage group. Moreover, cervical dystocia due
to scar tissue which prevented cervical dilation was
observed in another.
DISCUSSION
The main difference between our study and others is
the initial selection of potential candidates. All trials
included patients with risk factors of preterm delivery.
However, a short cervix in these women does not
necessarily mean cervical insufficiency. It may also be
the endpoint of different pathophysiologic process,
most commonly infection or abruptio placentae. This
study has focused exclusively on women with no
clinical risk factors who were found to have cervical
dilation and membrane prolapse at the time of a
scheduled mid trimester ultrasonographic assessment.
This progressive asymptomatic cervical dilation indi-
cates that these women were at increased risk of
preterm delivery due to cervical insufficiency. All
cases of cervical dilation were detected through a
transvaginal ultrasonographic cervical screening for
preterm delivery and confirmed by speculum exam-
ination. Our findings suggest that emergency cervical
224 Daskalakis et al Emergency Cerclage in Cervical Insufficiency
Control Group
(n ⴝ 17) Statistical Test P
3.1 (2.6) Student t ⬍ .001
739.0 (486.7) Mann Whitney U ⬍ .001
7/17 (41.2) ␹2 .001
4/7 (57.1) Fisher exact .025
6/7 (85.7) Fisher exact .01
16/17 (94.1) ␹2 ⬍ .001
cerclage in this group of women, between 18 and 26
weeks of gestation, can prolong pregnancy and can
lead to the delivery of a viable infant. It can promote
a 3-fold reduction in preterm delivery rate before 32
weeks, which in its turn results in a 3.5-fold increase in
neonatal survival rate. Moreover, the vast majority of
infants of the study group did not require admission to
a special care unit, in comparison with almost all
infants of the control group. These results are in
accordance with that of previous studies that reported
fetal survival rates up to 89%.17–24 Direct comparisons
among studies cannot be made, mainly due to the
small number of patients included and the observa-
tional nature of most of them. Moreover, there are
major disparities among studies concerning inclusion
criteria, cerclage technique, gestational age at enroll-
ment and preoperative and postoperative manage-
ment. There was only 1 prospective randomized trial
reporting on emergency cervical cerclage.25 This trial,
which included women at high risk of cervical insuf-
ficiency, showed that preterm delivery rate before 34
weeks, as well as the neonatal morbidity rate, were
significantly lower in the emergency cerclage group,
compared with the bed rest group.
The indications for cervical cerclage vary widely.
In a meta-analysis of randomized trials, it was found
that a prophylactic cervical stitch in women at risk of
preterm delivery or second-trimester pregnancy loss,
has no clear benefit on perinatal outcome.26 To
eliminate the use of unnecessary cervical cerclages,
many investigators supported transvaginal ultrasono-
graphic cervical assessment, for an optimal patient
selection. However, the results of 3 randomized trials
are contradictory.14 –16 The main problem of studies
reporting on cervical cerclage is that cervical insuffi-
ciency is extremely difficult to establish objectively.
The policy to delay an elective cerclage until the
appearance of cervical changes at ultrasound scan
may increase the percentage of women with a dilated
cervix and threatened abortion in the mid trimester.
When we undertook this study, we chose this group of
OBSTETRICS & GYNECOLOGY
women as candidates for cervical cerclage. Although
cervical dilation does not indicate impending la-
bor,27,28 the finding of a dilated cervix with bulging
membranes indicates that imminent delivery is likely.
To strengthen this even more, the preterm delivery
rate before 32 weeks in the group of women who
remained untreated in our study was 94.1%. We
considered 26 weeks the upper limit for study inclu-
sion, because before 26 weeks of gestation fetal sur-
vival is invariably low, making any intervention to
prolong the pregnancy justifiable.
We chose to use the McDonald technique be-
cause it is technically easier, has less intraoperative
blood loss, and requires less operating time compared
with the Shirodkar procedure. Various authors have
proposed both techniques, but there is no evidence
that there is an advantage of one over the other. 17–19,29
Harger17 and Hordnes et al22 reported rupture of the
membranes at the time of the procedure in 30% and
6.3% of cases, respectively. However, in our study as
in many others, membrane rupture did not occur in
any of our patients. It is of paramount importance for
a successful outcome after emergency cerclage place-
ment to exclude both women with placental abrup-
tion and women in labor as candidates for the proce-
dure. Therefore, an observation period before the
cerclage is mandatory. The main difficulty is to ex-
clude infection before insertion of the suture, because
this is the most likely cause of complications after
cerclage. Most patients with histologic evidence of
infection show no clinical signs that make the detec-
tion of intrauterine infection difficult. In 3 cases in
which we removed the stitch due to preterm prema-
ture rupture of membranes or preterm contractions
there was histologic evidence of infection. It is not
known whether infection is the cause of cervical
dilation or its result.
Unfortunately, there is no effective noninvasive
method to detect subclinical infection. Microbiologi-
cal assessment with high vaginal swab, as well as
C-reactive protein and white blood cell count estima-
tion are suboptimal, and because of this, of limited
value in deciding whether to apply a cerclage. Even
amniocentesis could not detect infection in cases
where it was undoubtedly present.20 Although there is
no proof that antibiotics may prevent infection after
emergency cerclage,30 we advocate the use of broad
spectrum antibiotics perioperatively to diminish the
number of microorganisms already present and re-
duce the risk of subsequent infection.
Whether the prophylactic use of uterine relaxants
is of value remains a subject of controversy.19,31,32 We
used the prostaglandin synthetase inhibitor indometh-
VOL. 107, NO. 2, PART 1, FEBRUARY 2006 Daskalakis et al
acin because any inflammatory disruption of mem-
branes from the decidua stimulates prostaglandin
production. Moreover, prostaglandin production is
augmented in patients undergoing cervical cerclage,
especially those with advanced cervical changes.32,33
In addition, prostaglandins may be released by the
local use of various genital tract microorganisms on
the bulging membranes in patients with a dilated
cervix.34 We also continued prophylactic tocolysis
with ␤-mimetics for 2 weeks, because in most patients
the uterus will remain irritable after cerclage.
The results of the present study as those of others
suggest that emergency cervical cerclage in women
with a dilated cervix and bulging membranes can be
safely accomplished, converting in most cases an
almost inevitable abortion into the delivery of a viable
infant. We believe that in cases in which cervical
dilatation is mainly related to mechanical failure,
emergency cerclage should be considered the first
option procedure. The stitch holds the cervix closed
so that the fetal membranes are protected from direct
exposure to vaginal bacteria. In contrast, when cervi-
cal changes are related to various aspects of infection,
emergency cerclage placement is contraindicated. We
acknowledge that safe conclusions regarding effec-
tiveness of such techniques can only be drawn after
prospective randomized trials. However, this is not
practical without using multicenter collected data.
Finally, we believe that due to the rarity of this
condition, single-center experience is of value and
should be appropriately reported.
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