Dilapan-S® works with the body, without medications.7-9
No uterine tachysystole
In 2 large studies representing a total of 640 women (including VBAC
patients) using Dilapan-S®, there were no cases of uterine tachysystole
related to Dilapan-S® use during cervical ripening.3,8
Non-serious adverse events
Of 444 women treated with Dilapan-S® during induction of labor2:
<1% reported cramping or pain
2.7% experienced bleeding during Dilapan-S® insertion or removal
No maternal infections (including chorioamnionitis, urinary tract infections, endometritis, and wound infections) were attributed to use of Dilapan-S® by the investigating physicians
No serious adverse neonatal outcomes were attributed to use of Dilapan-S®
Selected Important Safety Information
Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse.
A proven, versatile cervical ripening agent for a broad variety of patients
In a clinical study of 444 women, the average increase in Bishop score with Dilapan-S® was +3.6.2
+3.6
All Women
+3.7
Nulliparous
+3.5
Multiparous
+3.8
TOLAC
Broad utility across patient types1,2,5
NULLIPAROUS
MULTIPAROUS
ELECTIVE (≥39 WEEKS)
POST-DATES (>41 WEEKS)
OBESITY
DIABETES
PREECLAMPSIA
TOLAC
OLIGOHYDRAMNIOS
Selected Important Safety Information
Dilapan-S® is contraindicated in the presence of clinically apparent genital tract infection.
Speak with a representative to learn more about Dilapan-S®
Significantly higher patient satisfaction with Dilapan-S®1
In a head-to-head trial with 419 pregnant women, patients were more satisfied with Dilapan-S® compared with Foley balloon in 3 domains (P<0.05).
Patients who received Dilapan-S® reported1:
Better sleep (P=0.01)
More relaxing time (P=0.001)
Ability to perform daily activities (P=0.001)
93%of patients described the comfort of insertion as fully acceptable3
ALMOST80%of patients were able to sleep during cervical ripening3
Selected Important Safety Information
Patients should return to the physician for removal of Dilapan-S® at the indicated time and should be instructed not to attempt self-removal under any circumstances.
Dilapan-S® is for use by healthcare professionals trained in OB/GYN whenever cervical softening and dilation are desired, such as for cervical ripening during term labor induction or gynecological procedures that require cervical preparation.
Contraindication:Dilapan-S® is contraindicated in the presence of clinically apparent genital tract infection.
Warnings & Precautions:
Dilapan-S® is intended for single use only. Do not reuse, resterilize, reprocess, or use if primary packaging has been opened or damaged. Discard after use.
Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus (see Instructions for Use—Insertion). The device should not be left in place more than 24 hours. Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse. Patients should return to the physician for removal of Dilapan-S® at the indicated time and should be instructed not to attempt self-removal under any circumstances.
Potential Complications/Risks: Twisting of device during removal may cause the device to break (see Instructions for Use—Removal). Complications may include: device entrapment and/or fragmentation, expulsion, or retraction; patient discomfort or bleeding; spontaneous rupture of membranes; spontaneous onset of labor; cervical laceration.
Storage & Handling:
Store between +15°C and +30°C and keep away from direct sunlight and high humidity.
Please click here to download the full Instructions for Use.
You may report a product complaint or adverse event related to the
use of Dilapan-S® by calling 1 (888) 257-9676 (United States Only).