Early Total Cervix Occlusion (ETCO)

Introduction

Recurrent late abortions and very preterm births 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.

Pathophysiology

One of the main reasons for late abortions and very preterm births (≤ 32+0 weeks) are ascending infections from the vagina (see also “Late abortions and prematurity/causes”). Therefore we advise all pregnant women to have screenings performed by a physician/midwife for disturbances of the vaginal milieu or infections on a regular basis and, furthermore, to participate in our Self-Care-Program. However for some women this is not sufficient, particularly in cases with higher risk of (recurrent) late miscarriage and very preterm birth.

Cervical Insufficiency vs. Dysfunction of Cervical Closure

Unfortunately, for these cases the term “cervical insufficiency” is still often used. It would be better to talk of “dysfunction of cervical closure”. According to Ramsauer (Ramsauer 2012) there are various causes such as:

• ascending infections
• insufficient production of functional vaginal mucus
• insufficient functional length of the cervix for pressure load through the volume of the uterus (e. g. following to conisation or multiple pregnancies or polyhydramnios)
• tissue alterations of the cervix (connective tissue diseases, condition after trauma, Emmet rupture or multiple curettages).

In addition, Romero et al. (2006) discuss also congenital disorders and the inhibition of progesterone action. Of course, the causes might be mutually dependent, e. g. several of the causes listed above could favor the ascension of infections. However, and taken altogether, infections play the most important role. According to Romero, among pregnant women presenting with “cervical insufficiency” the prevalence of microbial invasion of the amniotic cavity (MIAC) is 51.5 %. In this field of study further research is definitely necessary.

Early Total Cervix Occlusion as preventive measure

In cases with repeated late abortions and preterm births, the Early Total Cervix Occlusion (ETCO) is the most effective measure of prevention and differs definitely from cerclage (see below). 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 threatening 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 prolapse of membranes.

Our approach 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 history (see below)
• the pregnancy is not advanced (best at about 13+0 weeks)
• 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 and thereby prevents the ascension of microorganisms, the cerclage (or pessary) in contrast, only tightens the canal (fig. 1) and leads to much poorer results (see below).

	Fig. 1: Comparison of Early Total Cervix Occlusion and cerclage or pessary Please click on the miniature picture.

Definitions

With regard to the Total Cervix Occlusion (TCO) we differentiate between “early” and “late” and between “small” and “extensive” (table 1). Because the results to prevent prematurity are much better (see below) we recommend to perform the TCO “early” (ETCO) rather than “late” (LTCO). For most cases we recommend to perform the Total Cervix Occlusion as early as possible (ETCO.

Table 1: Definitions with regard to Total Cervix Occlusion (TCO)

Indications and contraindications

Indications for Early Total Cervix Occlusion (ETCO)

1. The “classical indication” for ETCO are two or more
   • late abortions (≥ 12+0 gw)
   • or very preterm births (< 32+0 gw)
   in the patient’s history which could be
   • either infections as cause for these events
   • or when no other specific cause could be identified. Please note, that the main reason for premature rupture of the membranes (PROM) are ascending vaginal infections!
2. Up to now no study is available whether in cases with only one previous late abortion or preterm birth a consequent screening for vaginal infections (see Prematurity-Prevention-Program) in connection with the Self-Care-Program for Pregnant Women would lead to similar good results as the ETCO. Therefore one might consider an ETCO even after only one abortion or preterm birth, particularly when additional risks exist, for instance, when the patient is older or when there had been problems with fertility. Therefore, in numerous clinics in Germany, the indication for ETCO is nowadays significantly more often given than before. (In cases with only one late abortion or preterm birth a “small” occlusion of the cervix (see table 1) may be sufficient. Though, we do not know in how many clinics in Germany this possibility is implemented at all.)
3. For multiple pregnancies Schulze (2008) was able to achieve a clear reduction in the number of preterm 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 fertilization, 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.
4. Nowadays, some obstetricians even recommend the ETCO after extensive conisation because of the higher risk of preterm delivery (compare e. g. Ramsauer 2012). Unfortunately, up to date no relevant studies exist but the possibility of ETCO should at least be discussed with the pregnant women concerned. Ramsauer also discusses repeated Hegar-dilatation in the patient’s history as a possible indication.
5. Further and more rare indications would be, e. g. the state post Asherman-syndrome (Dr. Gallinat, Hamburg, Germany, pers. comm.) or several connective tissue diseases.

Contraindications for ETCO

Contraindications for ETCO are an already dilatated cervix with apparent signs of infection or labor activity which cannot be inhibited therapeutically.

Indications for Late Total Cervix Occlusion

Originally, the Total Cervix Occlusion (TCO) was applied by Szendi in 1961 as a late emergency measure and can of course still be applied nowadays as secondary measure:

• e. g. in the case of noticeable and increasing shortening of the portio
• e. g. as emergency measure in combination with the reposition of a prolapsed but still intact amniotic sac. In this case, some surgeons combine TCO with cerclage. Whereas they were successful with the late TCO in 40 % of the cases in the 1980s (which was a huge success already in those years!) (Giffei 1990, Saling 1990), the results for these highly endangered pregnancies (when performed by experienced surgeons) are with an almost 90 % success rate very promising (see e. g. Ramsauer 2012).

However, if possible the preventive (early) occlusion has absolutely to be given preference (see also further down under results).

Scheduling the operation

The ETCO should be performed preferably between 13+0 and 24+0 weeks, and when the cervix is not yet altered.

The reason for this timing is based on the intention to perform surgery not too early but to wait whether the pregnancy stays intact during its first trimester (or perhaps miscarriage occurs for some other reasons). On the other hand, ascension of infections prior to the occlusion has to be prevented as far as possible. For most cases occlusion is indicated at around 12 gw. Though, if necessary (especially in case of abortions in the patient’s history that had occurred rather early during pregnancy) the total cervix occlusion can be applied already before 12 gw.

Preoperative measures

Examinations for infections are compulsory, for example vaginal, cervical and urethral smears with microscopic and/or bacteriologic examinations. In case of pathological findings the patient should receive an appropriate local or a systemic therapy.

Operation technique

Instruments

For the performance of the operative Total Cercix Occlusion (TCO) the usual instruments for operations at the cervix are recommended, and in addition a special loop-instrument and a device for smoothing down, which are both explained below. Figures A and B both show the instruments that are used in the Vivantes Clinic Berlin Neukölln (Berlin, Germany). Special instruments are marked.

Fig. A: Instruments for the TCO (as used in the Vivantes Clinic Berlin Neukölln (Berlin, Germany)) 1) Portio loop for tighten up the portio (Faromed art. no 11-400) 2) Device for removing the epithelium (by Aesculap B. Braun, see below) 3) Special pliers for external fixation of the cervix walls when the cervix has already opened a bit (If the cervix is still closed hook pliers which are applied from the side are used.)

Fig. B: Device for removing the epithelium 2a) angled handpiece (by Aesculap-B. Braun, art. no GD455M) 2b) cutter taper (by Aesculap-B. Braun, art. no GD075R) 2c) body abrasive diamond (by Aesculap-B. Braun, art. no GC975R)

Ligature with the loop instrument

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 and Lescinski 1989, see figs. 3 and 4).

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

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

There is a ratchet at the loop instrument 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

As mentioned above: the cervix can only grow completely together properly, when prior to the sutures the upper surface of the portio has been dissected, that is to say, the epithelium has been almost completely removed. (Otherwise, it is not a Total Cervix Occlusion after Saling, but just a form of cerclage.)

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. 5: Rotating tips Please click on the miniature picture.

Fig. 6: Removal of the portio epithelium Please click on the miniature picture.

After removing the epithelium of the portio, 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. 7).

Fig. 7: Removal of the glandular epithelium in the cervical canal Please click on the miniature picture.

Stitching technique

Then 2–3 inner circular stitches are made to close the cervical canal (fig. 8). Consequently two rows of knotted stitches are made, which close the outer os uteri completely (fig. 9). For all the stitching we use synthetic monofile thread like PDS. These threads, when compared to catgut, are much better for the healing process and are reabsorbed much more slowly.

Fig. 8: Inner circular stitches Please click on the miniature picture.

Fig. 9: Condition after the operation, and stitching Please click on the miniature picture.

Postoperative period

Recommendations for the time after surgery

After complete healing (see fig. 10) which takes approx. 2 weeks, the expectant mother may behave as any other pregnant woman (of course, as far as no other reasons speak against it).

Fig. 10: State after healing Please click on the miniature picture.

Shortening of the cervix after ETCO

In some cases after the Early Total Cervix Occlusion (ETCO) a shortening or even funnelling of the cervix is observed. Without ETCO this would be taken as risk predictor for a threatening preterm delivery. However, experience has shown that after ETCO the shortening is not of relevance. **

Measures at the end of pregnancy

In the late phase of the pregnancy the outer os uteri can spontaneously have opened already slightly.

Some colleagues have already had good experiences with waiting until the scar opened by itself during labor.

Then – in order to dilatate – we penetrate the loose cervical tissue in the assumed direction of the cervical canal with the finger to a depth of about 1–2 cm (fig. 11).

Fig. 11: Introduction of the finger in the direction of the internal os uteri Please click on the miniature picture.

Mode of delivery

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 cervix not opened before the operation or of a 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. 12 to 14)

Fig. 12: Condition after one ETCO: slightly scarred portio Please click on the miniature picture.

Fig. 13: Condition after one ETCO: portio like a nullipara Please click on the miniature picture.

Fig. 14: Condition after three ETCOs: slightly indented portio Please click on 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 preterm 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. Furthermore – at least not in Germany where ETCO has already become very popular – very likely no women would agree to being integrated into a control group of a randomized study anyway after the obligatory pre-operation discussion. Therefore an acceptable solution is to compare the outcome of pregnancies after performing an ETCO with the outcome of former pregnancies of the same patients (Saling 1984, 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 preterm births the woman has previously had (McManemy et al. 2007).

Results from the 1980s and 1990s

In 1990 (Giffei 1990, Saling 1990) 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 %).

If one considers the 38 cases where the pregnancy was unsuccessful, there were 10 newborns with an extremely low birth weight, 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 1990). 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 it can be concluded that no remarkable negative effects have been proven in connection with the operative total cervical occlusion.

Latest Results

In later publications, e. g. from Ramsauer (2012), even better outcome numbers are reported: Ramsauer in her publication refers to the ETCO as prophylactic or “primary” cervix occlusion. Thereby for 315 pregnancies in the period 2008–2011 a success rate of 95 % could be achieved, and with the so-called secondary cervical occlusion (late TCO) still a success rate of around 90 %.

ETCO versus Cerclage

The cerclage – despite controversial discussions – is still a widespread measure about which numerous publications exist. Various 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). The cerclage – and in principle this holds also true for pessaries – is hardly capable of preventing the ascension of infections because this method only tightens the cervical canal and does not close it (fig. 1). In our sample of women who were treated with ETCO (Saling 1990) 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 and of 40 % with “late” TCO). 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 operative 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.

Multiple pregnancy 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 medical history:

Since 1990 Schulze (2008) has performed 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 with it: From a total of 219 multiple pregnancies he performed an ETCO on 96 of the women, whereas the other 123 women did not have the operation. The rate of very preterm births – 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 without ETCO was 4 % and with ETCO it was 1 %. Consequently the perinatal mortality in cases after ETCO was almost half as much. Without ETCO it was 4.1 % and with ETCO it was 2.5 %.

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 no 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 fertilization, 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 very preterm births, 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 TCO

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.

Download (file size approx. 7 or 9 MB, respectively – only recommended with a DSL connection). If you download the video directly, we would appreciate a donation.

  Video in German (9:20 Min.)    (Real Media | Windows Media)
  Video in English (9:30 Min.)    (Real Media | Windows Media)

You can order the video by post. Please donate 30 € (Entry: TCO video) and let us know, whether you would like to have the video in English or in German.

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
• Brix, N.; Secher, N. J.; McCormack, C. D.; Helmig, R. B.; Hein, M.; Weber, T. et al. (2013): Randomised trial of cervical cerclage, with and without occlusion, for the prevention of preterm birth in women suspected for cervical insufficiency. BJOG 120 (5), 613–620.
• Giffei JM (1990): Der totale operative Muttermundverschluß. Ein neues Verfahren zur Vermeidung der wiederholten Spätaborte und Frühgeburten. Inauguraldissertation, Medizinische Fachbereiche der Freien Universität Berlin
• Hormel K, Künzel W (1995): Der totale Muttermundverschluß. Prävention von Spätaborten und Frühgeburten, Gynäkologe 28 (3), 181–186
• McManemy, Julie; Cooke, Erinn; Amon, Erol; Leet, Terry (2007): Recurrence risk for preterm delivery. Am J Obstet Gynecol 196 (6), 576.e1–576.e7.
• Ramsauer, Babett (2012): Spätabort und extreme Frühgeburt. Mechanische Eingriffe zur Prävention. Der Gynäkologe 45 (7), 527–532.
• Romero, Roberto; Espinoza, Jimmy; Erez, Offer; Hassan, Sonia (2006): The role of cervical cerclage in obstetric practice: can the patient who could benefit from this procedure be identified? Am J Obstet Gynecol 194 (1), 1–9.
• Romero, Roberto; Gonzalez, R.; Sepulveda, W.; Brandt, F.; Ramirez, M.; Sorokin, Y. et al. (1992): Infection and labor. VIII. Microbial invasion of the amniotic cavity in patients with suspected cervical incompetence: prevalence and clinical significance. Am J Obstet Gynecol 167 (4 Pt 1), 1086–1091.
• Saling E (1981): Der frühe totale Muttermundverschluß zur Vermeidung habitueller Aborte und Frühgeburten. Z Geburtshilfe 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 Geburtshilfe Perinatol 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 (eds.): Perinatale Medizin, Bd. XIII. (14. Deutscher Kongreß für Perinatale Medizin, Berlin, 1989). Thieme: Stuttgart, New York, 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. Geburtsh. Neonat. 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 Mehrlingsschwangerschaften – 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 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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