Early Total Cervix Occlusion (ETCO)

Erich Saling, Prof. MD and Monika Schreiber, MD

Introduction

Recurrent late abortions and early prematurity continue to be two of the up to now insufficiently solved problems of modern obstetrics and perinatal medicine. The patients concerned often feel heavily burdened: On the one hand they deeply long for an infant and on the other hand they experience recurrent losses, which are often accompanied by increasing psychological problems. To achieve a surviving infant in such cases is a particularly important medical and psychological task.

In cases with repeated late abortions and premature births, the early total cervix occlusion (ETCO) is the most effective measure of prevention. The total cervix occlusion creates a complete barrier against ascending infections within the cervical canal. We introduced this measure in 1981 (Saling, 1981). Before that time in the literature there had been very few publications about a late occlusion of the cervix. The occlusion was performed almost only in cases of threatened abortions, and always when an advanced stage in the abortion process had been reached. For example, in 1961 Szendi published two articles on the subject ”Prevention of advanced miscarriages and abortion through total cervix occlusion". At that time the cervix occlusion was an emergency measure, particularly in cases with protuding membranes.

Our goal was completely different. We introduced the cervix occlusion as a measure to prevent early labor at all. It should be performed when:

• women have a poor past history (see below)

• the pregnancy is not advanced (at about 12 g.w.)

• the cervix is still in an anatomically undisturbed condition.

It is important to note, that the ETCO is quite different from a Cerclage (and in principle also from the occasionally used pessary). Whereas the ETCO really closes the cervical canal thus preventing ascension of organisms, the Cerclage in contrast, only tightens the canal (Fig. 1) and leads to much poorer results (see below).

Fig.1: Early Total Cervix Occlusion (ETCO) versus Cerclage or pessary. Please click onto the miniature picture

Definitions

With regard to the Total Cervix Occlusion (TCO) we differentiate between “early” and “late” and between ”small” and ”extensive” (Table 2). Because the results to prevent prematurity are much better (see below) we recommend to perform the TCO ”early” (ETCO) rather than ”late” (LTCO).

Table 1: Definitions with regards to Total Cervix Occlusion (TCO)
*The sonographic measurement of the cervical length is more reliable than the assessment using the Bishop-score and should therefore be preferred.
**Saling and Schumacher (1996), see Table 2

Table 2: Modified Bishop Score according to Saling (Saling and Schumacher 1996)

Indications and contraindication

1) Indication for ETCO is two or more

• late abortions (  12+0 gw)

• or early premature births (<32+0 gw)

in the patient’s history with

• either infection as cause for these events

• or when no other cause has been found, but when for instance PROM occurred. Please note, that the main reason for premature rupture of the membranes is ascending vaginal infection.

2) Up to now no study is available whether in cases with only one previous late abortion or premature birth a consequent screening for vaginal infection will lead to similar good results as the ETCO. Therefore one might consider an ETCO even after only one abortion or premature birth, particularly when additional risks exist, for instance, when the patient is older or when there had been problems with fertility. In these cases a ”small” occlusion of the cervix (see table 1) may be sufficient.

3) In multiple pregnancies Schulze (publication in preparation) was able to achieve a clear reduction in the number of premature births (see below) by performing an ETCO, even if there were no anamnestic risks. When considering the existing data material, it is perhaps too early to recommend ETCO to be performed generally in all multiple pregnancies before equally good results have been confirmed by other studies. Nevertheless in multiple pregnancies and when additional risks factors are present (e.g. after In-vitro fertilisation, or in a pregnant woman nearing the end of her possible reproductive time), we are of the opinion that the possibility of performing an ETCO should certainly be taken into consideration."

A contraindication is dilatation of the cervix with apparent signs of infection and labor activity which cannot be inhibited.

Preoperative diagnostics and measures

Screening for Infections

Examinations for infections are compulsory, for example vaginal, cervical and urethral smears with microscopic and/or bacteriologic examinations. Further, should pathological findings be present - such as bacterial vaginosis, candida, Trichomonas or Chlamydia infection - the patient should be given an appropriate local or a systemic therapy. Furthermore it is recommended to perform an egg-pole lavage directly before the operation (right on the operating table)

Pre-operative disinfection

2 to 3 days before the operation a pre-operative disinfection or germ-reducing therapy of the vagina should be performed by: .

• Inlay of 2x1 Hexetidine vaginal tablets e.g. VagiHex® or

• a twice daily intravaginal application of Octenidine-2HCL solution for local antiseptic treatment.

It is adviseable to continue the disinfection measures for 2-3 days after the operation. After this has finished a Lactobacillus acidophilus preparation should be administered for several days to help rebuild the normal vaginal flora.

Egg-pole Lavage (EPL, isthmical lavage) as imediate preoperative diagnostic

After an ETCO has been performed there is no further chance to examine whether organisms occasionally have already ascended to the intrauterine space. Therefore we recommend to perform a so-called egg-pole lavage (isthmical lavage, this means a lavage of the lower uterine extra-amniotic space) directly before the operative occlusion of the cervix. We introduced the EPL in 1992 (Saling 1992) and reported on the first experiences in 1992 (Brandt-Niebelschütz and cow. 1992).

With this method, by which fluid is obtained from the lower egg-pole and is bacteriologically examined, important information can be obtained, without the necessity of having to make a more invasive amniocentesis. If necessary the appropriate antibiotics can be administered.

Performing the EPL

When performing the egg-pole lavage, we use a small tube specially constructed for this purpose which has a soft silicone top part, through which a thin (1,5 mm diameter), sterile, easily flexible PVC catheter (special tube for feeding premature babies) is introduced (Fig. 2). The flexibility of the catheter ensures that no injuriy can occur.

Fig. 2: Lavage at the lower egg-pole (resp. isthmical lavage) Please click onto the miniature picture

Before the examination, the portio is disinfected at the external os uteri with a suitable antiseptic solution. Under sterile conditions the tube with the relatively soft silicone tip is carefully introduced a few cm into the cervical canal. Then the catheter is placed into the tube and is pushed into the cervical canal in the direction of the lower egg-pole until it meets resistance. Since the canal is sometimes uneven and often has an irregular path, we recommend to twist the catheter once or twice between your fingers, without pressing too hard, in order to allow the catheter to reach the upper region of the cervical canal.

2 ml sterile 0.9% saline solution are instilled through the catheter and then as much as possible is aspirated back. This lavage fluid is bacteriologically examined later on. If it's not possible to regain at least 0,3 ml of the saline solution (this is slightly more than the dead space volume of the 40 cm long catheter), we recommend a second or even third attempt, using 2 ml saline solution. The more fluid regained, the larger is the amount that was in contact with the lower egg-pole.

The aspirated fluid undergoes bacteriological examination. If the laboratory is close enough, the syringe with the fluid at body temperature can be brought directly to the laboratory for all examinations. Otherwise the fluid should be instilled into two blood culture bottles (one for aerobe and one for anaerobe examination). Additionally special transport media provided by the laboratory should be used for other examinations, such as for Chlamydia and N. gonorrhoea.

Using the egg-pole lavage organisms can be detected that are not apparent on a cervical smear. A weakness of this lavage method is that it is not yet possible to be certain of preventing some organisms being carried up to the cervical canal. On the other hand, it must be assumed that organisms that have already reached the cervical canal will probably ascend further to the lower egg-pole and can certainly develop pathogenicity there. Organisms from the vagina very probably are not transported, as the outer os uteri is treated with disinfectant before catheterization and the device is inserted under visual control directly into the cervical canal.

Operation technique

Before starting the operative occlusion, we highly recommend that the portio should be tied off as high as possible to prevent bleeding, in such a way that there is a nearly complete stoppage of the circulation. This measure has two decisive advantages:

1. The blood loss, which in pregnant patients can be considerable, due to the intense vascularisation, can be reduced to a minimum and

2. the visibility during the operation and later when the wound is being stitched is much better then if continuous, diffuse bleeding had occurred.

We have developed a special loop instrument for this purpose (Saling 1989, see Figs. 3 and 4)

Fig. 3: Loop instrument to reduce bleeding: Loop demonstrated on two fingers Please click onto the miniature picture

Fig. 4: Loop instrument to reduce bleeding : blocking device Please click onto the miniature picture

Ligature with the loop instrument

There is a ratchet at the loop instrument (Saling & Lescinski 1989) on the traction stick with a blocking spring (Fig. 4). This allows the stainless steel braided wire loop (Fig. 3), to be attached in a circle around the portio and to be fixed up in a tightened state. We always try to clamp the loop so tight that only minimal bleeding remains. This is a sign that the tissue circulation is not com­pletely interrupted. When the hemostasis has to be suspended at the end of the opera­tion, the traction stick is turned about 90°. The blocking spring slides out of the traction and the loop is set free. The loop instrument can be obtained from Faromed GmbH, Berlin

Removal of the epithelium

In order to allow the os uteri to grow completely together, the upper sur­face of the portio has to be dissected, that is to say, the epithelium has to be almost completely removed. The better the portio tissue grows together in such critical cases, namely when the portio remains completely occluded right until near term, the better are the chances that a good result can be achieved.

Earlier, the epithelium was removed from the portio surface by sharp dissection with a scalpel, which took time. In the meantime a better method has been introduced: by smoothing down the surface of the portio with a high revving rotating simple sterile wire brush (see Fig. 5a) , as is used in dermatology to smooth out scars. With this method the tissue is given a considerably better and more certain chance of regeneration.

Fig 5a: Rotating brush Please click onto the miniature picture

Fig 5b: Rotating Tips Please click onto the miniature picture

So as to clearly mark the surface to be removed, but also to find the exact positioning of the wounded area later for the row of stitches adapting the upper surface of the portio, we make a circular incision one millimeter deep with a radius of 10 - 15 mm round the external os uteri with a scalpel (Fig. 6).

Then we remove the portio epithelium with a quick rotating wire brush or a special metal rasp in a similar way as is used in dermatology to smooth out scars (Fig. 7). This wire brush is powered by a small accu supplied electric engine over a flexible wavelength. You can also use a high-revving rotating instrument powered by compressed air (see Fig. 5b) (Aesculap Co.). This has the advantage that the patient is never connected to any electric source. However this equipment is more expensive to obtain.

Fig 6: Marking through the incision Please click onto the miniature picture

Fig 7: Removal of the portio epithelium Please click onto the miniature picture

Afterwards, the glandular epithelium of the cervical canal is also removed, as far as possible to a depth of about 1 to 2 cm using the same rotating device, whilst the os uteri is spread using mosquito clamps (Fig. 8).

Fig 8: Removal of the glandular epithelium in the cervical canal Please click onto the miniature picture

Stitching technique

Then 2-3 inner circular stitches are made to close the cervical canal (Fig. 9). Consequently two rows of knotted stitches are made, which close the outer os uteri completely (Fig. 10). For all the stitching we use synthetic monofile thread like PDS or braided thread, such as Vicryl. These threads, when compared to catgut, are much better for the healing process and are reabsorbed much more slowly. Fig. 11 illustrates a very well healed occlusion.

Fig 9: Inner circular stitches Please click onto the miniature picture

Fig 10: Condition after the operation and stitching Please click onto the miniature picture

Fig 11: Condition after wound has healed Please click onto the miniature picture

Measures at the end of pregnancy

When the pregnancy has reached a sufficient number of weeks (for example 36-37 g.w.) or when spontaneous labor is indicated, an attempt must be made to recanalize the cervix. This is particularly difficult when the portio is not significantly effaced (still 2-3 cm). The scar should be opened at latest when:

• labor starts spontaneously,
• an induction of labor is planned, or
• 37 weeks of gestation are completed.

We generally cut the portio scar with scissors (Fig. 12) under local anesthesia or under peridural anesthesia (if this has been wanted for the labor). A prior ultrasonic examination of the cervix is recommended to clarify the anatomical proportions. Then we penetrate with the finger to a depth of about 1-2 cm into the loose cervical tissue in the assumed direction of the cervical canal (Fig. 13).

Fig 12: Opening of the portio scar Please click onto the miniature picture

Fig 13: Introdoction of the finger in the direction of the internal os uteri Please click onto the miniature picture

If the patient wants to leave the hospital after the scar has been opened, to wait until labor starts spontaneously, we see no reason why she should not do so, provided there are no signs of any increased risk.

We do not think that a primary cesarean section is necessary at all. Quite the contrary: When a recanalization of the cervix takes place during a vagi­nal delivery, this is in fact a good prerequisite for the reestablishment of normal anatomic conditions. Furthermore we would like to make you aware of a situation emerging from our own experience – after a primary cesarean section a recanalization of the before the operation not opened or not dilated cervix can be extremely difficult, due to complex anatomical conditions.

In all those patients who achieved a vaginal delivery after ETCO, the epithelium tissue around the wounded area of the portio recovered during the puerperium within a short space of time (a few weeks) and it is surprising – particularly since the introduction of the gentle epithelium removal technique – how little of the operational scar is to be seen later on after regeneration during the puerperium (Figs. 14 to 16)

Fig 14: Condition after an ETCO – slightly scarred portio Please click onto the miniature picture

Fig 15: Condition after an ETCO – portio like a nullipara Please click onto the miniature picture

Fig 16: Condition after three ETCOs – slightly indented portio Please click onto the miniature picture

Results

To assess the results of ETCO, particularly in comparison to the Cerclage, one should only look at high-risk-groups such as matching the above men­tioned indications for an ETCO ( 2 late abortions or premature births). We have no knowledge of any random­ized study about the ETCO. On the basis of the results published so far we do not think that the operation can be withheld from any woman with such a critical history. A randomized study would not receive the approval of any ethic council - at least not in Germany - and no woman is likely to agree to being integrated into a control group anyway. Therefore an ac­ceptable solution is to compare the outcome of pregnancies after perform­ing an ETCO with the outcome of former pregnancies of these patients (Saling 1984b, Saling & Schumacher 1996, Hormel & Künzel 1995). We should also consider that the chances of giving birth to a surviving infant are reduced the more late abortions or premature births the woman has previously had (Künzel 1995).

In 1990 (Saling 1993) we evaluated retrospectively the data of a group of 113 patients with previous recurrent abortions. From a total of 389 wanted preg­nancies only 101 infants were born alive (26%). However, 35 of these infants died in the neonatal period. In total 66 survived, which means that only 17 % of all these pregnancies resulted in a surviving infant. Through the introduction of the total cervical occlusion (either early or late TCO) the same patients achieved 132 pregnancies with 94 live and surviving infants (71% !). We could also show, that the results in cases with an “early” TCO are twice as good as with a “late” TCO (80% vs. 40%) (Saling 1993).

If one considers the 38 cases where the pregnancy was unsuccessful, there were 10 prematures with an extremely low birthweight, who died shortly after birth. In the remaining cases there were abortions, 13 of which occurred after a late occlusion, and 15 after an early occlusion. So the rate of abortions after the ”late” occlusion amounted to 43% against only 15% after the ”early” occlusion. (Saling 1990).

Similarly good results have been obtained by other clinicians performing the TCO: In 1996 we reported the results of a multi-center-evaluation, in which 11 German hospitals took part (Saling & Schumacher 1996) and the outcome of a total of 819 pregnancies with TCO was assessed. It emerged that the rate of surviving infants in the pregnancies before TCO had been performed was 21% compared to 74% in the pregnancies with TCO. Hormel and Künzel (1995) reported similar good results.

As far as the mode of delivery is concerned, 71% of the patients with a cervical occlusion had a spontaneous delivery and 15 % had an operative vaginal delivery. The rate of cesarean sections was 14% in comparison to 9% for the whole department at that time (Saling 1993).

This relatively low cesarean rate shows that in most cases after ETCO labor (after the scar has been opened) can mostly happen vaginally without any problems. This is actually recommendable, since the cervix is stretched, which can be regarded as advantageous for the regeneration process after the operative occlusion.

In 1997 we reported the results of a follow-up examination carried out on 52 women who had previously had a total cervical occlusion (Saling & Schumacher 1997). On the basis of these results generally we can conclude that up to now no remark­able negative effects have been proven in connection with the operative total cervical occlusion.

ETCO versus Cerclage

The Cerclage is a widespread measure and nu­merous publications exist. Some authors report good results - but one should look at these reports very closely and verify whether or not the Cer­clage had been performed on women at similar high risk (see above). But the Cerclage is hardly capable of preventing ascending infections because this method only tightens the cervical canal and does not close it (Fig. 1). In our sample of women treated with ETCO we found that in 51 previous pregnancies in which Cerclage was performed, only 13 infants survived. This is a survival rate of only 26% (as compared to a survival rate of 80% with ETCO). These results underline how advisable it is to give the ETCO preference over Cerclage in cases with such critical history. (An extensive discussion of the various oparative possibilities is to be found in Vetter and Kilavuz (2001).

Some colleagues combine the total cervix occlusion with an additional cerclage. We, however, have not found any reasons why this should be done. As has been explained already, the creation of a total barrier by the total occlusion is much more effective than a cerclage in the prevention of an ascending infection – the main cause of early prematurity. Our results (see above) prove this. Another aspect, namely the making of a circular scar as tissue irritation on the cerclage loop may be irrelevant, as it can hardly be assumed that a scar could seriously hinder a dilatation of the cervix or permanently prevent it. Furthermore after ETCO scars exist as a result of the circular intracervical stitches and also the two transverse rows of sutures in the region of the external os uteri. However the most important aspect for prevention of early prematurity is not a mechanical barrier, but stopping the ascension of organisms.

Multiple preganancy and ETCO

All the results published up to now concern women who had already had at least one early, respectively one late abortion in the past. In the meantime very new results are available whereby ETCO was performed as a general preventive measure in multiple pregnancies (which are known to have a higher risk of prematurity), even if the women concerned had not had a poor history:

Since 1990 Schulze (2008) has been performing an ETCO as a prophylactic measure in the Women’s Hospital in Cottbus (Germany) on all multiple pregnancies – when the patient agreed with his suggestion – and has achieved remarkable success: from a total of 219 multiple pregnancies he performed an ETCO on 96 of the women, and 123 did not have the operation. The rate of very early prematures – that is to say < 32 gw – was 24% in the cases without ETCO and 13.5% in those with ETCO. In the group of infants at extremely high risk, who were born with less than 28 completed weeks of gestation, the rate with ETCO was 1% and without ETCO it was 4%. Consequently the perinatal mortality in cases after ETCO was almost half as much. After ETCO it was 2.5% and without ETCO 4.1%.

When considering the existing data material, it is perhaps too early to recommend that an ETCO should be performed in all multiple pregnancies, before the good results have not been confirmed at other places. Furthermore up to now there is yet study existing whether the ETCO or the Self-Care-Program for Pregnant Women is more successful in multiple pregnancies in cases without poor history.) Nevertheless such a possibility should be seriously considered – particularly in multiple pregnancies with additional risk factors (e.g. after In-vitro fertilisation, or in a pregnant woman near the end of her potential reproductive time).

Conclusion

On the basis of previous experiences and available results the Total Cervix Occlusion - in particular the early occlusion - is a convincingly efficient operative measure for the prevention of late abortions and early prematurity, particularly in cases where such events had previously happened recurrently.

Classification

Diagnose after official ICD-10 Classification

O26.2 (Pregnancy care of habitual aborter
and/or
O34.3 Maternal care for cervical incompetence

Addresses

We have a list of obstetrical departments and clinics mainly in German speaking countries where – as far as we know – Early Total Cervix Occlusions are performed. We are taking trouble to get hold of more addresses.

If a clinic performing this operation is not included in the list, or certain changes may have taken place, please let us know.

Video about TMV

The complete course of the operation of the Total Cervix Occlusion is available for a small fee in the form of a self-made video with a commentary in German or English. The amount that exceeds the production costs benefit the non-profit making Erich-Saling-Institute of Perinatal Medicine.

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References

• Brandt-Niebelschütz S, Saling E, Küchler R (1992): Weitere Erfahrungen mit der Eipol-Lavage (EPL) im Zusammenhang mit der Vermeidung von Frühgeburten. Z Geburtshilfe Perinat 196: 229-237
• Giffei JM (1990): Der totale operative Muttermundverschluß. Ein neues Verfahren zur Vermeidung der wiederholten Spätaborte und Frühgeburten. Inauguraldissertation, Medizinische Fachbereiche der Freie Universität Berlin
• Hormel K, Künzel W (1995): Der totale Muttermundverschluss. Prävention von Spätaborten und Frühgeburten, Gynäkologe 28, 181-186
• Saling E (1981): Der frühe totale Muttermundverschluß zur Vermeidung habitueller Aborte und Frühgeburten. Z Geburtsh u Perinat 185: 259-261
• Saling, E. (1984): Der frühe totale operative Muttermundverschluß bei anamnestischem Abort- und Frühgeburtrisiko. Gynäkologe 17: 225-227
• Saling E, Lescinski R (1989): Schlingeninstrument zur Blutstillung bei operativen Eingriffen an der Portio. Z Geburtsh u Perinat 193(5): 241-242.
• Saling E (1990): Der totale operative Muttermundverschluß zur Vermeidung habitueller Spätaborte und sich wiederholender Frühgeburten - Fortentwicklung der Technik, weitere Erfahrungen und Ergebnisse. In: Dudenhausen JW, Saling E (Hrsg): Perinatale Medizin, Bd. XIII. (14. Deutscher Kongreß für Perinatale Medizin, Berlin, 1989). Thieme: Stuttgart, New York, S. 65-67
• Saling E (1992): Current  Measures to Prevent Late Abortion or Prematurity. In: Saling, E.: Nestlé Nutrition Workshop Series, Vol. 26. Raven Press, New York
• Saling E, Schumacher E (1996): Der operative Totale Muttermund-Verschluß (TMV). Erhebung von Daten einiger Kliniken, die den TMV einsetzen.
  Z Geburtshilfe Neonatol 200: 82-87
• Saling E, Schumacher E (1997): Ergebnisse einer Nachuntersuchung von Müttern nach vorausgegangenen operativen "Totalen Muttermund-Verschlüssen" (TMV) unter Berücksichtigung  auch der Daten ihrer Kinder.
  Z Geburtshilfe Neonatol 201: 122-127
• Schulze G (2008): Ergebnisse des Frühen Totalen Muttermundverschlusses nach Saling (FTMV) bei Mehrlingsschawangerschaften -- eine retrospektive Studie der Jahre 1995-2005 [Results of Early Total Cervix Occlusion (ETCO) According to Saling in Multiple Pregnancies -- a retrospective study of the period 1995-2005.] Z Gebutrtsh Neonatol 2008 212: 13-17
• Szendi B (1961): Verhinderung von fortgeschrittenen Fehl- und Frühgeburten durch vollkommenen Muttermundverschluss auf blutigem Weg.
  Acta Chirurgica II: 413-418
• Szendi B (1961): Vollständiges Zusammennähen des äußeren Muttermundes auf blutigem Wege zur Verhinderung von vorgeschrittenen Abortus und Frühgeburten. Zentralbl Gynakol 83: 1083-1087
• Vetter K, Kilavuz Ö (2001): Zervixinsuffizienz: operative Möglichkeiten.
  Gynäkologe 34: 726-731

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