Dilapan-S®:

Frequently Asked

Questions

If used for labor induction, won’t the DILAPAN-S® rods break the waters when being inserted?

Theoretically this option could happen, but based on clinical experience the issue is irrelevant. Clinical evidence did not show, that this issue would be connected with DILAPAN-S® use. Several studies have found no incidence of this at all. On the other hand, membranes rupture can occur spontaneously during the cervical ripening process as a part of the onset of active labor.

Can DILAPAN-S® be used also in cases with membranes already being ruptured?

It is not contraindicated and from clinical data collections it can be seen, that women with membranes, that were already ruptured, were also included into the evaluation without any complications related to the insertion of dilators. But strong clinical evidence, supporting this kind of cases is missing, so it is up to every doctor´s responsibility.

Won’t the DILAPAN-S® rod fall out if the patient stands?

The issue is reported very rarely and is usually connected with spontaneous onset of the labor or with incorrect insertion of the device, when the end of active part of the rod did not pass the internal os. When the rod goes through the external part of the cervix, but the internal os remains closed, this could cause the expulsion of the rod. Some doctors use vaginal tamponade to ensure the right position of the dilators, but it is not mandatory. In general, patients can walk, go to toilet, take a shower, on the other hand patients should be instructed to avoid bathing, douching and should refrain from intercourse while DILAPAN-S® is in place.

How long will the patient have to stay in bed following DILAPAN-S® insertion?

There is no recommendation for that and as the insertion procedure is completed patient can leave her bed.

Can DILAPAN-S® be used in outpatient regimen?

Yes, the patient may be allowed to go home, if she is considered to be in a low risk group.

Is it necessary to monitor CTG during the cervical ripening process?

CTG monitoring is not mandatory during the use of Dilapan-S. Clinical evidence has confirmed that the use of the product is not connected with a danger of excessive uterine contractions or with uterine hyperactivity, resulting in fetal distress, so the product offers significant safety benefit.

Can DILAPAN-S® be used for labor induction in women with a history of previous Cesarean section?

YES, DILAPAN-S® can be used in this indication. Because it has no pharmacological content, the process of cervical ripening is gentle and gradual and it does not cause uterine hyperactivity or fetal distress. Therefore DILAPAN-S® represents an optimal candidate for induction of labor for women with previous Cesarean section in medical history. Dr Maier's study from 2017, evaluating labor induction with unfavorable cervix after a Cesarean section with DILAPAN-S®, contained 96 women after Cesarean section. The cervical ripening successful rate (defined as increasing of Bishop score enabling induction of labor) in subgroup of patients with previous Caesarean section in medical history was 83% and vaginal delivery rate went up to 65%. Therefore, DILAPAN-S® was evaluated as effective and safe in this subgroup of patients.

If DILAPAN-S® is used for cervical ripening, what is then used for induction of labor?

Studies have shown that up to 20% of women go on to spontaneous labour after cervical ripening with DILAPAN-S® without any further pharmacological intervention. When induction of labor is required, oxytocin or dinoprostone may be used.

For how long should DILAPAN-S® be inserted?

It depends on initial status of the cervix and on further factors influencing the cervical ripening process. Usually dilators are placed for period around 10-12 hours. DILAPAN-S® should not be left in situ for more than 24 hours. DILAPAN-S® does not only dilate the cervix; reversible partial dehydration of the cells supports tissue softening and mechanical pressure initiates releasing of endogenous prostaglandins. These additional factors promote further natural cervical ripening.

How many pieces of DILAPAN-S® should be used?

Instruction for use recommends to use as many pieces as can be inserted without strong resistance. From clinical practice we know that 3 pieces have the power of increasing the Bishop score to the level enabling labor induction, but generally 4-5 pieces are recommended.

Is insertion of DILAPAN-S® painful?

94% of patients evaluated DILAPAN-S® insertion as fully acceptable. Thanks to the gentle and gradual cervical ripening process without excessive uterine contractions, most of the patients can relax and sleep (79%). Health care professionals often benefit from that and place the product overnight to enable patients to go smoothly through the cervical ripening phase.

While using DILAPAN-S® for induction of labor, the product dilates the cervical canal, but doesn't improve the effacement. How does this work?

In general, the Bishop Score evaluates 5 parameters - dilation, consistency (softening) and effacement of the cervix, its position and fetal station. The aim is to increase the Bishop score over a value of 6 to be able to induce a labor. In clinical trials, it is not exactly evaluated, which parameter has been changed for how much, but the total score is used and matters. That means, it is not so important, which parameter exactly grew for how much, but if the cervical preparation (the total Bishop Score) allows to induce a labor. If we look at dilation and effacement, both are scored by points from 0 to 3 and nowhere is written, that the effacement is more important than the dilation. In terms of DILAPAN-S® mode of action; it is true that the main effect of DILAPAN-S® is usually a dilation. Second significant effect is softening due to partial reversible dehydration of the cervical tissue.Shortening of the cervix, even if not that significant, also occurs while DILAPAN-S® is in situ. Sufficient dilation will allow to proceed ARM (artificial rupture of membranes), which promotes further natural mechanisms of labor, including also the entry of newborn´s head into the cervical canal, which also promotes the final effacement.

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