Efficacy and Safety

In peer-reviewed studies, Dilapan-S® has been proven to
predictably
ripen the cervix and result in high rates of vaginal delivery.1-5

Clinical efficacy Flexible cervical ripening Safety profile Patient satisfaction

Consistent clinical efficacy

Dilapan-S® achieves reliable cervical ripening success

In 2 clinical studies, the majority of women who used Dilapan-S® did not require additional cervical ripening.1,2

93 % (N=444) Gupta 2018 2
87 % (N=208) Saad 2019 1
Selected Important Safety Information

Potential Complications/Risks: 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.

Twisting of device during removal may cause the device to break.

(See Instructions for Use)

Broad worldwide use

Dilapan-S® is available in 40+ countries.6

Dilapan-S® prepares women for successful vaginal delivery

In 3 clinical studies, Dilapan-S® achieved a vaginal delivery rate ranging from 70% to 81%.1-3*

70% (310/444)
Gupta 20182†
81% (169/208)
Saad 20191
75% (44/61)
Vlk 20143

In 4 clinical studies, Dilapan-S® achieved a vaginal delivery rate ranging from 52% to 75% among vaginal birth after cesarean (VBAC) populations.2-5*

52% (21/41)
Gupta 20182
65% (22/34)
Vlk 20143
75% (9/12)
Maier 20154
55% (18/33)
Maier 20185

*Includes ventouse/vacuum and/or forceps assisted delivery.
†Includes women with a history of previous cesarean delivery.

Count on predictable cervical ripening from Dilapan-S®

Flexible cervical ripening window2,7,8

12-24 hours consistent ripening

AVERAGE TIME

to successful cervical ripening 12-15 hours

MAXIMUM

insertion time 24 hours

80% of rod expansion occurs within 4-6 hours

Selected Important Safety Information

Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus.

(See Instructions for Use)

Favorable safety profile

No pharmacologically active substances

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.

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Patient Satisfaction

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

ALMOST 80% 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.

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