Induction & Cervical Ripening Methods

Background / Context for Labor Induction

  • Labor induction is becoming all the more common!

    • CDC data shows that as of 2018, over 27% of labor in the USA is induced, representing an over 2-fold increase since 1990.

    • While the effects of the ARRIVE trial and similar studies are still playing out, it’s reasonable to think that rates of induction may only continue to rise.

  • Reasons for labor induction are varied and significant. ACOG CO 818 is a great resource to review many common reasons for induction prior to 39 weeks.

Bishop Scoring

  • The Bishop score was developed by Dr. Edward Bishop, published in the Green Journal in August 1964. The score used a combination of five physical examination criteria to predict the success of induction of labor:

    • Cervical dilation

    • Cervical effacement

    • Fetal station with respect to the ischial spines

    • The position of the cervix (posterior/mid/anterior)

    • The consistency of the cervix (firm/medium/soft)

      • The first three components, dilation, effacement, and station, are known as the “modified Bishop score.” 

    • In multiparous patients, a score of 6 or greater portends favorability with labor induction with oxytocin.

    • In nulliparous patients, a score of 8 or greater portends favorability.

      • If the score is less than these, the recommendation is to pursue cervical ripening prior to augmenting labor with oxytocin. 

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Cervical Ripening: How the Cervix Works!

  • Obviously, cervical remodeling is a HUGE part of labor. It has to completely reshape to get the baby out! This takes the form of:

    • Collagen breakdown and rearrangement

    • Changes in the glycosaminoglycan and cytokine environment

    • Infiltration of leukocytes. 

  • These changes occur with numerous local signaling pathways which cause local release of prostaglandins at the level of the cervix, as well as ultimately the central hormonal signaling pathway to begin oxytocin release from the posterior pituitary gland.

Cervical Ripening

  • When the cervix isn’t ready to dilate, as is the case with labor induction or even with procedures for pregnancy termination or demise management such as D&E, these methods improve success and reduce complications.

  • Mechanical methods use a combination of local action to physically cause cervical dilation, as well as release local endogenous prostaglandins to promote cervical dilation. 

  • Pharmacologic methods use synthetic prostaglandins or oxytocin to cause a direct pharmacologic effect on the uterus/cervix. 

Mechanical Methods of Cervical Ripening

  • Foley Balloons

    • This is probably the most common and well-tolerated form of mechanical cervical ripening. 

    • In essence, a Foley balloon can be placed into the cervix behind the internal cervical os, and filled with 20-80cc of saline.

      • This “tricks” the cervix into believing there’s a well-engaged fetal head, which promotes pure mechanical dilation just from pressure of the balloon on the cervix, as well as localized prostaglandin release.

      • Some “double balloon” devices exist, which have a second balloon acting at the external os that may help promote cervical dilation/prostaglandin release further.

    • There are relatively few contraindications to the Foley ballon.

      • Unlike pharmacologic methods, it is not associated with tachysystole or fetal heart rate abnormalities. It can also be removed easily if there is an adverse reaction.

      • An absolute contraindication might be latex allergy, if you use a balloon that contains latex.

      • Relative contraindications include: 

        • Low-lying placenta, where the balloon contacting the placenta may cause vaginal bleeding.

        • Ruptured membranes: while data is mixed on this, there is thought that placing a balloon after membrane rupture may increase risk of chorioamnionitis.

        • Variable/unstable fetal lie: putting a balloon in the cervix may displace the fetal head, so have a low threshold to re-scan for presentation if you suspect the baby may have floated away!

  • Mechanical dilators: Laminaria and Dilapan

    • These mechanical dilators could also be considered, and in philosophy are very similar to Foley balloons in how they promote cervical ripening. 

      • Laminaria, a sterilized seaweed hygroscopic dilator, has fallen out of favor for term labor induction in most centers due to studies demonstrating increased risk of infection.

        • However, laminaria is still routinely used safely for cervical ripening prior to D&E procedures.

      • Dilapan (a synthetic hygroscopic dilator) has been examined in an RCT for labor induction and has been found to be safe and acceptable for patients

        • In most places, its expense is a barrier to use versus the Foley.

  • Amniotomy & Membrane Stripping

    • Membrane stripping is a technique in which an examiner uses the gloved finger to “stir” the membranes at the internal cervical os. This promotes localized prostaglandin release and can be used to help ripen the cervix in a “natural” and low risk way.

      • Complications of this can include bleeding, contractions, and inadvertent amniotomy, but overall it’s a low risk procedure that can be considered in most low-risk women at term.

    • Amniotomy, or as it’s better known on the labor floor -- AROM / artificial rupture of membranes -- is when an examiner breaks the amniotic sac using a tool such as a plastic hook. 

      • This allows for descent of the fetal head to the cervix (engagement) to promote physical cervical dilation, as well as likely some localized prostaglandin release.

        • Amniotomy alone is likely not appropriate for ripening/labor induction.

        • Most commonly, it is used in combination with pharmacologic methods, and it seems to be very effective in this context -- most studies demonstrate a shorter intervention-to-delivery time of combination medicine/amniotomy method versus only one of these alone.

      • The most feared complication of amniotomy is cord prolapse, in which the umbilical cord prolapses in front of the fetal head into the vagina. This requires emergent cesarean delivery, as further descent of the fetal head may compress the cord and cause asphyxia.

        • Rates of cord prolapse with amniotomy are low though, with rates in the literature ranging from 0.1 - 0.7%. 

      • Other complications/contraindications relate to infection, like chorioamnionitis, or fetal heart rate abnormalities related to fluid decrease/umbilical cord compression -- these are generally variable decelerations which can be corrected with amnioinfusion.

      • Given the break in the barrier between the fetus and the vaginal environment, early amniotomy is generally not recommended in patients with HIV or hepatitis B or C. 

Pharmacologic Methods

  • Misoprostol & Other Prostaglandins

    • Misoprostol, aka PGE1, is a synthetic prostaglandin and can be administered in a variety of doses and routes - for labor induction/ripening, typically bucally, orally, or vaginally. 

      • The majority of adverse outcomes noted in studies looking at term labor has been with doses over 25 mcg.

      • It is well tolerated, effective, and generally safe! However, some complications/risks:

        • Unlike oxytocin, which has a short half-life and is given IV, when misoprostol is given, it cannot be stopped or taken away (need to use a tocolytic)!

          • Institutions providing birth services should have protocols to monitor fetal heart rate patterns and for uterine tachysystole, and have strict time intervals for dosing for this reason. Misoprostol is potent and can definitely cause tachysystole and resulting fetal heart rate abnormalities.

        • Given the potency, misoprostol is absolutely contraindicated for patients who are induced and have a prior uterine scar (i.e., TOLAC), as there is an association with its use and uterine rupture (6% rupture rate in some studies!).

        • Misoprostol should also not be administered in the context of suspicious CTG/EFM, given its potency and inability to stop the medication quickly. 

        • Additional side effects of misoprostol can include high fevers and GI upset, particularly when administered via the oral or buccal routes. This is likely due to higher absorption/systemic concentration by these routes.

    • PGE2, available as a vaginal insert containing 10mg of dinoprostone, commercially known as Cervidil. A vaginal dinoprostone gel (Prostin) was formerly in common use in the USA, but now is more commonly used internationally. 

      • There is not a significant difference in how PGE2 works versus misoprostol for cervical ripening; however, one advantage is that the vaginal insert can be removed, and the half-life is shorter -- so unlike miso, the action can be stopped relatively easily. 

      • PGE2 is likewise contraindicated in the context of TOLAC due to presumed increased uterine rupture risk. 

  • Oxytocin

    • The OG! Oxytocin is the natural hormone from the posterior pituitary that promotes uterine contractions and labor. It can be used for cervical ripening as well in patients with unfavorable cervix, particularly for patients where prostaglandins may be contraindicated. 

      • For instance with TOLACs, there is a slightly higher risk of uterine rupture with oxytocin (~2%).

        • However this is dose-dependent and lower risk compared to prostaglandins; thus some institutions will allow for oxytocin induction of TOLACs. 

      • Institutions have different protocols for “low-dose” and “high-dose” oxytocin drips; studies vary in their description of the efficacy of one over another.

    • Oxytocin has specific uterine receptors, which promote intracellular calcium release in uterine muscle and also localized prostaglandin production. It has a positive feedback mechanism with the posterior pituitary during parturition, thus more oxytocin is produced/released over the course of childbirth. 

    • Complications are fairly few with synthetic oxytocin, since it is so similar to our biologic form; however:

      • As a posterior pituitary hormone, oxytocin has similar chemical structure to anti-diuretic hormone (ADH). Thus, in large doses (particularly if infused fast and not on an IV pump), oxytocin can lead to fatal water intoxication / hyponatremia. It should always be run on a pump by specifically-trained nursing personnel! 

  • Nipple stimulation is a way to cause endogenous oxytocin release, and may be favored by some patients for home “induction start” or cervical ripening.

    • It has only been studied in low-risk pregnancies, and generally seems to work better in patients with a favorable Bishop score already.

    • Nipple stimulation has also been associated with an increased trend in perinatal death, so ACOG does not recommend its use in an unmonitored setting until there is further study. 

Which method is best?

  • That’s the million dollar question!

  • You can likely find literature to support your position.

    •  Trials comparing labor induction methods are highly variable in their populations and outcome measures. 

      • Even in outcome measures, what’s most valuable? C-section rate? Time from induction to delivery? Length of oxytocin use? Rates of infection or other complications? The literature is full of examples that have used each and every one of these, so comparisons are hard to make! 

  • There are some likely general conclusions to take away:

    • Combination of mechanical and pharmacologic methods are likely faster to achieve delivery than mechanical methods alone. 

    • If you’re concerned about fetal status or uterine tachysystole, misoprostol is probably not the best choice.

    • The patient in front of you is going to dictate what is best -- the indication for induction, the varying factors of the patient’s medical and pregnancy history, and your institution’s experience and personnel are all paramount to making induction successful!

Informed Consent

What is informed consent and shared decision making? 

Informed consent is a part of both medical ethics and law (though exact wording and definition may vary based on locality). It entails that a medical provider must tell a patient about all potential benefits, risks, alternatives, etc to a medical procedure or course of treatment.

In order to be able to obtain informed consent, we need a few things:

  • Patient who is able to give consent 

  • Presentation of accurate information that includes: 

    • Diagnosis (if it is known) 

    • Nature and purpose of the recommended interventions 

    • The risks, benefits, and alternatives of all options 

  • Documentation of the conversion and the ultimate decision 

Shared decision making is similar, and is also a key component of patient-centered healthcare. It is a process in which clinicians and patients work together to make decisions, selection treatments, that is based both on evidence and balances risks/benefits and patient values 

  • It is not a menu of everything that is available!

Some special situations:

  • Patient that lacks decision-making capacity

    1. Any physician can determine if a patient has capacity!

    2. A brief aside on capacity/competency:

      1. Capacity: a person’s ability to use information they are given and make a choice that is congruent with their own choices and preferences. Law and ethics have settled on four decision-making abilities that constitute it, which are:

        1. Understanding

        2. Expressing a choice

        3. Appreciation

        4. Reasoning.

      2. Competency: a legal judgement that is informed by an assessment of capacity. Basically, whether an individual has the legal right to make their own decisions.

    3.  Times to assess capacity:

      1. Presence of cognitive impairment from any cause.

      2. Circumstance where patient’s decision is inconsistent with prior decision.

    4. How to assess capacity:

      1. Should be done with open-ended questions to basically understand if patient has understanding, expressing a choice, appreciation (recognizing facts and how they are relevant to themselves), and reasoning for their decision 

      2.  There are a few validated instruments out there:

        1. MacArthur Competency Assessment Tool for Treatment 

        2. Assessment of Capacity for Everyday Decisions

        3. Capacity to Consent to Treatment Interview 

    5. Even if the patient is not deemed to have adequate capacity, they should still be engaged in their care as much as possible!

      1. Identify an appropriate surrogate on the patient’s behalf - either through durable power of attorney or through family members.

      2. Sometimes, if there is question to capacity or to a surrogate, or any other questions, may be a reason to consult an ethics board. 

  • Minors

    1. Not considered to have capacity to make healthcare decisions on their own except for a few cases. This varies by situation and by state.

      1. Minors who become pregnant in some states can be considered capable of making their own decisions regarding their care (ie. abortion, epidurals, etc).

    2. Emancipated minors may make their own healthcare decisions in most jursidictions.

  •  Situation that does not require informed consent

    1. Usually: 

      1. Emergency - person is unconscious or in danger of death or serious outcomes (loss of limb) if medical care is not given, then informed consent may not be required 

      2. If there is an advanced directive stating that patient refuses certain types of care 

      3. If there is decision by a court that overrides the patient’s decision 

Placenta Accreta Part II: Management

After last week’s initial episode, we talk through some pearls for management. Keeping it simple today:

  • Antenatal care considerations:

    • Pelvic rest, avoid travel - don’t get into a bad situation!

    • Prenatal care is fairly routine.

    • Hospitalization practices will vary by region and level of resources — i.e., admission for proximity. Bleeding should prompt admission, likely until delivery.

    • Sweet spot for delivery typically between 34-35’6 weeks, though some centers pushing towards 36+ weeks.

      • However, as Dr. Einerson mentions, the worst thing you can do is end up in an emergent delivery scenario with these patients!

    • Don’t forget about using late preterm steroids!

  • Cesarean hysterectomy tips:

    • Collins 2019 paper on evidence-based management. Don’t deliver too late!

    • Multidisciplinary / interdisciplinary care leads to less morbidity.

    • Ureteral stents: if you need them to identify ureters to safely perform surgery.

    • Some tips from our guests:

      • Approach through VML skin incision, though Maylard / Cherney incisions are also reasonable. Fundal hysterotomy (typically) to avoid messing with the placenta.

      • Decrease blood flow before addressing the bladder - they often take the uterine vessels before developing the bladder.

      • Arterial catheters such as the REBOA are to be used in experimental settings only, and are associated with serious complications.

      • If bleeding - the most experienced operators need to be there.

      • Bipolar vessel sealing devices (such as LigaSure) are helpful!

  • Conservative management?

    • To be done only on an experimental basis at this time! Reasonable to examine in a trial for a number of reasons.

    • Methotrexate does NOT work for retained placenta — MTX kills rapidly dividing cells, not stagnant cells left behind.

  • Patient resources / advocacy:

Placenta Accreta Part I - Pathophysiology, Diagnosis, and Imaging

Today we welcome two special guests to the podcast — Dr. Scott Shainker, who is an assistant professor at Beth Israel Deaconess in Boston, MA, and Dr. Brett Einerson, who is an assistant professor at the University of Utah in Salt Lake City, UT. Both Dr. Shainker and Dr. Einerson are experts in the world of placenta accreta spectrum, with numerous publications, guideline papers, and advocacy efforts to their names. We did a two part series with them on PAS. This first episode, we focus on pathology, diagnosis, and imaging. Next week, we’ll get into management and future directions.

For further reading, check out ACOG’s Obstetric Care Consensus on PAS.

PAS has traditionally been thought of as an “invasive” disease, but that thinking is evolving to think of PAS as a disease of uterine dehiscence. The loss of the uterine decidua due to prior uterine scarring (i.e., due to surgery) brings about abnormal attachment and a “superhighway of vascularity,” thus that when delivery comes, the placenta fails to separate normally. Uterine muscle dehiscence likely accounts for the degree of invasiveness. It’s likely that cesarean scar pregnancies are a precursor to PAS.

https://resident360.nejm.org/clinical-pearls/placenta-accreta-spectrum

https://resident360.nejm.org/clinical-pearls/placenta-accreta-spectrum

The PAS diagnosis and terminology is also changing, from the traditional accreta / increta / percreta divide seen above, to a FIGO staging system with both surgical and pathologic criteria. You can review those here.

We review some of the risk factors, but far and away the biggest is a combination of a prior cesarean and placenta previa. Dr. Shainker mentions Dr. Robert Silver’s landmark paper on this - the percentages are worth committing to memory. Other risk factors include other types of uterine surgery like abdominal myomectomy; IVF and ART; and potentially dilation and curettage, though that is controversial.

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Imaging is great in research capacities with high sensitivity (approaching 90+%), but only 50% of patients with accreta know about it before delivery. So the real world sensitivity is very poor. Risk factors should raise suspicion primarily, and the use of imaging help guide your preoperative suspicion. SMFM has now published a consensus on ultrasound diagnosis, which is the gold standard. More data should hopefully improve the real-world detection rates for PAS.