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Outpatient Cervical Ripening

Katie Sampene, MD

Division of Academic Specialists in OB/GYN

UW Department of OB/GYN

UW School of Medicine and Public Health

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Disclosures

None

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Learning Objectives

Identify appropriate candidates for outpatient cervical ripening
Articulate the advantages and disadvantages to various outpatient cervical ripening options
Evaluate your practice regarding usefulness, satisfaction, and feasibility for outpatient cervical ripening

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Outline

Part 1: Very basics
Part 2: Data
Short Break + check out the Dilapan
Part 3: The details of how

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Getting to know you

Are you a physician? APP? Resident? Fellow? Other role?
Do you practice outside of Madison?
Is your practice in a rural setting?
Do you balance labor management with other responsibilities such as clinic?
Are you currently offering outpatient cervical ripening?

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Case Scenario

A 41 year-old G1P0 presents to your office at 8 weeks for her NOB, and she has many questions about your practice norms.

Can I await natural labor?

What are your tips to avoid a cesarean?

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What is Outpatient Ripening?

Using prostaglandins or mechanical methods to initiate ripening in the outpatient setting, prior to a planned admission for induction

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Why Outpatient Ripening?

Less time inpatient

Patient may view as a satisfier
Provider may view as a satisfier

Potential cost savings
Potential to re-allocate personnel and rooms

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Candidates – Term, Unfavorable cervix

Choose your cut-off: usually <4-6

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Contraindications for Outpatient Ripening

Anything that precludes labor (malpresentation, etc)
Patient unwilling/unable to follow care instructions
Anything that requires maternal/fetal monitoring (no strict criteria, it’s per your judgement):

fetal growth restriction

oligohydramnios

multiple gestation

hypertensive disorders

prior cesarean

vaginal bleeding

rupture of membranes

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Monitoring

Determine pre/post-ripening evaluation (FHT/NST, provider discretion)

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RCT, 61 outpatient, 50 inpatient
Outpatients had AFI and NST before leaving
Outpatients came back next morning at 06:00 for IOL
Instructed to stay home if foley extruded prior to 06:00
Inpatients did not get Pitocin until foley extruded
Average time foley in place:

Inpatient 9.3h

Outpatient 12.9h

For outpatient ripening, 9.6 hours less time inpatient
Lower cesarean rate for outpatient, but not statistically significant

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Retrospective review
1,905 patients, no adverse events
Conclusion: outpatient foley ripening safe

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Outpatient cervical ripening in parous women does not shorten the time from labor ward admission until delivery if oxytocin is initiated simultaneously with inpatient transcervical catheter placement.

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Pitocin started on admission
Outpatient: 4.3h shorter admission to delivery
Admitted before scheduled IOL:

Outpatient 22%

Inpatient 5%

Mean Bishop score:

Outpatient 3

Inpatient 1

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Study group: Dilapan x 12 hours, then oxytocin
Control group: nothing x 12 hours, then oxytocin
Duration of labor from start oxytocin to delivery: no difference
Amniotomy was done when painful contractions and exam allowed
Conclusion: Dilapan does not reduce time in labor, does not reduce cesarean rate

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Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term.
Advantages of Dilapan-S over Foley:

FDA approval

no protrusion from the introitus

no need to keep under tension

better patient satisfaction (sleep, relaxation time, perform desired activities)

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Adverse events seem rare, insufficient evidence to detect differences
No apparent impact on maternal/neonatal health
Some evidence outpatient ripening reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth.
Patient preferred method unknown
Cost effectiveness unknown

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2020
7 RCTs: 3 PGE, 4 foley
“Data on the effectiveness, safety and women's experiences of home versus inpatient induction of labour are limited and of very low-certainty. Given that serious adverse events are likely to be extremely rare, the safety data are more likely to come from very large observational cohort studies rather than relatively small RCTs.”

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12 publications, 9 RCTs
“Outpatient labour induction in resource-rich settings is at least as effective and safe, in carefully selected patient populations, when compared with inpatient labour induction. Whether outpatient labour induction results in lower rates of caesarean deliveries needs to be explored further.”

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30 RCTs, 10 cohort studies
“In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.”

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Retrospective cohort, 273 early amniotomy and 273 not
No difference in cesarean rate
Delivered in 24h from Foley placement:

Ruptured within 1 hour of foley removal: 42%

Not ruptured within 1 hour of foley removal: 33%

Time to delivery from Foley removal:

Ruptured within 1 hour of foley removal: 10h

Not ruptured within 1 hour of foley removal : 13h

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Early amniotomy had higher rate of cesarean for labor dystocia (15 vs 3%)
Early amniotomy: if no regular contractions or cervix changing <1cm/hr primip/1.2cm/hr multip, oxytocin started
Late amniotomy: Pitocin started right away. Amniotomy when 3 contractions in 10 min, or cervix changing
No difference in duration of labor

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Delivered in 24h:

Ruptured at 3cm: 89%

Await SROM: 45%

Time to delivery:

Ruptured at 3cm: 13h

Await SROM: 22h

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Location

Clinic

Triage

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Options

Prostaglandins
Mechanical:

lower rates of tachysystole and fetal heart rate abnormalities
Not contraindicated with GBS
No increased rates of maternal/neonatal clinical infection (ROM excluded)

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Prostaglandins

ACOG educational case: Outpatient protocol for misoprostol

-Pre-miso NST x 20min, then dose miso in triage vaginally, then post-miso 60min NST. Home x 3 hours. Repeat as needed x3 additional doses.

-Cost savings $293

-Trade-off may be patient satisfaction

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Mechanical

Double Balloon

Single Balloon

Hygroscopic dilators

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Double Balloon

Higher cost than single balloon
No tension
Up to 80cc (60-80cc vs 30cc reduce time to birth by 2 hours)
Usually up to 12 hours

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Single Balloon

Lower cost than double
Tension desirable (decrease time to expulsion but not to birth
Tape to leg most common
Typically up to 30cc (can pop if overdistended)
Usually up to 12 hours

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Balloons in General

Increase bishop score 3-5 points within 12 hours
94% favorable within 12 hours

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Hygroscopic dilators�

Two types

Natural Seaweed (laminaria tents)

Synthretic (Dilapan-S)

Gradually absorb moisture and expand
Equally safe and effective to other methods
Can stay up to 24 hours

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Synthetic (Dilapan-S)

Expensive
Price – about $70 per rod (25 in box)
Nothing hanging out of vagina
Removal at 12-24 hours

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Procedure - equipment

2 sponge forceps
Bivalve vaginal speculum
Sterile water or saline
Sterile gauze pads
Betadine or chlorhexidine
Dilapan-S rods (typically 3-5)

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Insertion�Steps

Remove from pouch, use sterile technique
Moisten with sterile saline to lubricate
Clean Cervix
Insert with ring forcep, collar/handle visible
Place the number cervix accommodates without undue pressure
Moisten/fold gauze and leave in vagina as back-stop
Record # of Dilapan-S and Gauze in place

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Removal steps

Remove gauze
Remove rods with ring forcep (grasp handle or string, not collar)
Don’t twist, often come out in clump
If stuck to surrounding tissue, moisten it with sterile saline
Account for all gauze and rods
Can do a second round x 24 hours per manufacturer

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Patient Instructions

At home you can eat light meals and drink liquids. You can shower, but do not put anything in to your vagina (no sex, no douching). You may have some mild cramping and light spotting or blood-tinged mucous. Once the cervix opens, the dilator may fall out.
Manufacturer recommends avoiding bathing

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