I would like to have more and detailed information in order to be of help. 

Cerclage in twins is not supported by literature to the best of my knowledge. 

 Conservative management for multiple pregnancy recommended. There is no place for surgical management in this scenario. Cochrane review's small study did not show evidence of preventing preterm births and reducing perinatal deaths or neonatal morbidity.

Conservative management is the most appropriate. Prophylactic antibiotic therapy, cultures of the vagina and endocervix, and serial blood tests are the most common form of follow-up in these cases. The incidence of bronchopulmonary dysplasia is low in these weeks of gestation. Therefore, as long as there is no suspicion of chorioamnionitis, try to prolong gestation as much as possible

1.observation

2.antibiotic

3.corticosteroid

4.Tocolytics, as indicated

5.If displayed chorioamnionitis, birth induced

I wish the subject were so simple as some of the answers above indicate. It is unfortunate that most if not all of the studies (RCTs) regarding cerclage in singleton as well as twin gestations were poorly designed, poorly executed, poorly analyzed and poorly interpreted. Our specialty has been unable to resolve the question, "does cerclage improve outcomes?" for more than 6 decades now. Is it not time then to realize and accept that the paradigm of incompetent cervix needs total overhaul?

The entire treatment scheme in patients with short cervix with or without dilation is based on the concept of cervical incompetence. Such intrinsic cervical failure is rare and we all know the possible causes for such a failure. Instead, the main cause of cervical shortening is intrauterine proinflammatory changes; and I do not mean to indicate here the highly overrated intrauterine infection, which is usually a secondary event. I mean non-infectious pro-inflammatory changes which lead to breakdown of the collagen structure of the cervix (proteolysis) and at the same time create a low level of uterine contractility, which might be felt or not by the patient. Careful and properly guided history in such patients reveals always symptomatology that is identifiable but for the most part discounted by obstetricians as well as their patients, as normal pregnancy nuisances.

1.     Low pelvic pressure

2.     Lower back pain in the coccygeal area

3.     “Gas pains”

4.     Pulling sensation in the lower pelvis

5.     Feeling of wetness in the vagina; not excess discharge, just feeling wet.

The above symptoms can be elicited in the vast majority of patients who present with a short cervix with or without dilation, if one only knew what questions to ask.

The inflammatory changes in the uterine environment that are responsible for such cervical injury are the result of subchorionic clots, placental thrombosis with necrotic changes in the chorionic villi (fetal thrombotic vasculopathy), decidual ischemia and thrombosis. Such pathology is almost always overlooked prenatally and it is only realized after the poor outcome has happened and only when the placenta is sent to pathology. This is not the way it should happen. We have the technology and the know how to assess such intrauterine changes, identify their cause and treat them accordingly. There is nothing that can stop preterm labor unless the primary cause of the inflammation is addressed and treated. Therefore, any role of the cerclage should be only secondary to address the potential cervical weakness that might have been caused by the inflammation and the primary treatment should be to address the cause of inflammation, eliminate it and at the same time treat the patient with anti-inflammatory agents. Synthetic and natural progesterone exert a mild anti-inflammatory effect and can be helpful but if one truly wishes to stop the inflammatory process in its tracks, Indomethacin is the best choice and well proven to prolong the pregnancy significantly as well as reduce prematurity. {Zuckerman H, et al. Obstet Gynecol 1974;44:787, Niebyl J. et al. Am J Obstet Gynecol 1980;136:1014, Zuckerman H. et al. J Perinat Med 1984;12:2}

We have presented evidence of superior outcomes when progressive cervical shortening is treated with Indomethacin; 70% of patients responded to Indomethacin only and 30% required cerclage placement due to partial response to Indomethacin. {J Matern Fetal Neonatal Med. 2011 Jan;24(1):79-85 } It is clear that Indomethacin can be used safely and achieves excellent results.

One need be aware however of the complications and the fact that fetal cardiac assessment is in order prior to the use of the drug as well as during the treatment. We have treated as of today more than a thousand patients and we have never experienced any fetal side effects beyond mild and temporary increase in the ductal peak systolic velocity, which however remained always well within the normal ranges. (data to be published soon) There were never a need to stop the medication due to side effects and we have treated patients on an intermittent fashion until 34 weeks.  The best that can be achieved with progesterone (natural or synthetic) is a 30% prematurity; well, this is almost 3 times the national USA average prematurity rate. Is it really wise to consider this a successful treatment modality?

In all the studies that progesterone was successful it was not because it reduced prematurity below the national average but below the control group, which for some unknown reasons presented unnaturally high levels of prematurity { N Engl J Med. 2003 Jun 12;348(24):2379-85}.

What works well for singleton pregnancies, usually works well also for multiple gestations, albeit, less successfully. The minimum goal of every obstetrician should be to get any such pregnancy to 32 weeks by all means. This is the time where quality of life can be acceptable without serious immediate and long-term consequences. To be comfortable with any baby been delivered before 28 weeks is insanity. Survival is not the important requirement here; high “quality of life” survival should be the demanded outcome. One should understand that no matter what we do, we will fail in a number of cases; failing after intense effort is part of life but failing because of lack of effort should be unacceptable. There is enough evidence for those willing to find it that doing nothing should be only a rare event and not the norm.  

Therefore, and with the above in mind, the answer to your question is as follows:

1.     Prepare the pregnancy for the worst possible outcome, early delivery

a.     Steroids

b.     Possible neuroprophylaxis with MgS04.

2.     Rule out infection

a.     Possible amniocentesis (controversial) of twin A to rule out intra-amniotic infection (10% of twin A have evidence of bacteria in the amniotic cavity when the cervix is dilated, most likely a secondary event). {Am J Obstet and Gynecol, 1990 Sep;163(3):757-61}.

b.     Cervical and vaginal cultures

3.     If you consider antibiotics (controversial), the use of Macrolides is a better choice due to inhibition of proteolysis that reduces the risk for amniotic sac damage.

4.     Indomethacin 50 mg p.o. stat and then q6h for a minimum of 7 days.

a.     Evaluate ductus arteriosus prior to indomethacin initiation and complete fetal echo (any MFM specialist should be able to do so).

b.     Baseline amniotic fluid for further evaluation during indomethacin treatment. Mild and clinically insignificant reduction of fluid is common in such cases but it reverses within 24 hours post discontinuation of treatment.

c.      After initial 7-day course, use Indomethacin for 2-3 days per week until 32-34 weeks and as long as the fetal ductus remains normal.

d.     Nifedipine XL 60 mg p.o. BID

5.     When infection has been ruled out, cerclage should be performed unless the cervical length responded well and improved after the start of Indomethacin.

a.     If the cervix remains dilated, use of 30 cc Foley balloon should be used to push the membranes back into the cavity so the cerclage can be placed at least 2-3 cm above the external cervical os. The mild reduction of the amniotic fluid from the use of Indomethacin will help also reduce the pressure of the amniotic sac and make it easier to push back again during the cerclage. In rare occasions, amniocentesis for amnioreduction might be the only way to place a cerclage. {Evans DJ, Kofinas AD, King K. Obstet Gynecol. 1992 May;79(5 ( Pt 2)):881-2.}

This might be the best treatment plan that could help you get this pregnancy to a safe gestational age assuming she has not been infected already.

Educate your patients about the mild symptoms mentioned above so you will identify such patients at an earlier stage at which time you will have a much better chance to succeed and prevent prematurity.

Dear all

There are few articles addressing the question of how to manage cases of twin pregnancy with asymptomatic dilated cervix and visible membranes at speculum exam prior to 24 weeks gestation. I have presented the only retrospective cohort of cerclage versus control cases (expectant management) with a table that summarized all available literature in this topic: Cerclage in twin pregnancy with dilated cervix between 16 to 24 weeks of gestation: retrospective cohort study. Roman A, Rochelson B, Martinelli P, Saccone G, Harris K, Zork N, Spiel M, O'Brien K, Calluzzo I, Palomares K, Rosen T, Berghella V, Fleischer A.Am J Obstet Gynecol. 2016 Jul;215(1):98.e1-98.e11. doi: 10.1016/j.ajog.2016.01.172. PMID:26827881

There is no dedicated RCT addressing this question and that is why we started this RCT. Here I am answering some of the most common questions I receive:

Topics that create discussion:

Amniocentesis: I didn't include amniocentesis as a mandatory step prior to randomization, it is strongly encouraged to select the sample with non-chorio. I had this step at the beginning but the IRB committee rejected the application as they feel this step to be coercive. So declining amniocentesis is not an exclusion, but then a waiting observation period is advised.

Cerclage surgical technique: Preferred single stitch, McDonald technique in these patients, any suture material. Balloon can be used to push membranes up and avoid puncture of the amniotic membranes

Use of prophylactic antibiotics and/or indomethacin prior or during the cerclage, The RCT on this area in singleton only showed prolongation > 28 days but not actual change in GA at delivery or interval from diagnosis to delivery. At Jefferson we only use indomethacin for 48 hours starting prior to randomization or several hours prior to cerclage (in singletons) but not antibiotics. There are no data on twins with dilated cervix. If Indocin used, is recommended to start prior to randomization.

Vaginal progesterone: The expectant management doesn't include any other therapy (like progesterone or pessary) as nothing have been proven effective and I don't want to cloud the result with multiple therapies. The use of vaginal progesterone is possible but it is not part of the study, if given or not this information should be included in the data collection (some patients may have been identified with short cervix before and started on progesterone), this is not an exclusion criteria. There is no information regarding the use of IM or vaginal progesterone in singleton or twins with dilated cervix

Admission of antepartum unit, some places admit patient with dilated cervix until 28 weeks, you are free to manage this point per your protocols. At Jefferson they go home, in fact if comfortable they go back to work. Bed rest increased the risk of preterm delivery, DVT and deconditioning.

Steroid for FLM, earliest GA at steroids according to each site. At Jefferson the earliest steroids will be given at 22 5/7 weeks

Bed rest. If you want to do is OK, at Jefferson they have at lib physical activity

Viability: Gestational age at when resuscitation efforts will be started varies according to institution/state/country. When >23 weeks, we discuss with our patients the desired management in the event of PPROM during the procedure, cerclage procedure will be suspended or cerclage removed, patient may elect expectant management under the PPROM protocol or termination of pregnancy

The study limits for enrollment is 16-23 6/7 weeks and 1-5cm dilation, if your group is not comfortable with those limits you can decreased them, but not increase them. Some places do cerclages up to 28 weeks and some other groups wanted  >5cm of cervical dilation.

I will be happy to answer any other questions at [email protected]

We are looking for more sites for enrollment