New Labor Guidance, Part 1

Back in 2019 we did a two-part series on preventing the primary cesarean (part 1, part 2). That series was based on the joint ACOG/SMFM Obstetric Care Consensus #1. As of the January edition of the Green Journal, ACOG & SMFM have now issued revised guidance in Clinical Practice Guideline #8 that retires the old document and shakes some things up a bit! 

In that spirit, we’ll review some definitions following CPG 8 and remark on some of the new changes as we go along.

Part two of CPG 8 also reviews evidence behind some ways to limit intervention in labor and delivery – we’ve podcasted on that before, too – but we’ll save that for a future episode.

Some definitions to get started:

  • Labor: onset of regular, painful uterine contractions resulting in cervical dilation, effacement, or both.

    • First stage: the time period from labor onset until full dilation (10 cm) is achieved. This is broken down into:

      • Latent phase: gradual, slow, early cervical change.

      • Active phase: time period of more rapid, predictable cervical change.

    • Second stage: the time period from complete dilation until delivery of the fetus, characterized by maternal pushing efforts.

    • Third stage: the time period from delivery of the fetus until delivery of the placenta.

  • How did we come up with these stages?

    • 1950s: Emanuel Friedman publishes graphs of cervical dilation of 1,000 term patients admitted to the hospital in spontaneous labor, and describe the period of rapid cervical change that characterizes “latent” from “active” first stage, in addition to a “deceleration” phase near the end of first stage.

      • This transition from latent to active in his data was thought to occur at around 4cm cervical dilation.

      • The 95%ile for active phase dilation was 1.2 cm/h in nulliparas, and 1.5cm/h in multiparas.

    • 2010: Zhang et al publish updated data using the Consortium for Safe Labor

      • Almost 63,000 term patients at 19 US hospitals with normal perinatal outcomes. Key takeaways:

        • The transition point from latent to active seemed to occur at around 6cm in both nulliparas and multparas, later than Friedman observed.

        • The rate of active phase cervical dilation was also slower than Friedman’s observations:

          • Nulliparas: 0.5 - 0.7 cm/h

          • Multiparas: 0.5 - 1.3 cm/h

    • Since 2010, multiple other studies using large data sets have been published – they’re too numerous to review, but in short, there seem to be several clinical factors that might affect labor progress.

      • Obesity

      • Hypertension

      • Gestational age

      • Multiple gestations

      • Presence of fetal anomalies

      • Fetal size

      • Fetal sex

Latent Phase of First Stage

  • In the Friedman curve, they demonstrated a 95%ile of latent phase length ranging from 14h in multiparas to 20h in nulliparas. 

  • Subsequently, in the Zhang and other curves, the data was all over the place. A conservative 95th percentile, per ACOG, seems to be around 16 hours.

    • Likely, this has something to do more with when someone is admitted to the hospital, and characterizing the length of latent phase is difficult to do.

    • Prolonged latent phase is somewhat associated with adverse obstetrical outcomes, but

    • The vast majority of people who have prolonged latent phase will either:

      • 1) stop contracting, or

      • 2) achieve active phase, particularly with amniotomy or oxytocin augmentation.

  • Therefore, there is no recommendation for defining “arrest of latent phase” or “failed latent phase.” 

    • As long as maternal and fetal status are appropriate, latent phase may continue.

    • Not changed from prior guidance.

  • What about induced labor and latent phase?

    • Induced labor is different - there is a definition of “failed induction of labor.”

      • Induced labor has a much longer potential latent phase, so the guidance is very conservative in order to maximize opportunities to get the patient into the active phase.

      • Recommendation: Oxytocin should be administered for a minimum of 12-18 hours after membrane rupture before deeming induction unsuccessful.

        • This recommendation is provided otherwise reassuring maternal/fetal status.

        • Going beyond 18 hours can be discussed with patients on an individual basis.

          • This recommendation is based on studies demonstrating only about 5% of patients remain in latent phase after amniotomy with oxytocin administration after 18h. 

          • This is largely an unchanged recommendation, but the previous Obstetric Care Consensus mentioned waiting until 24 hours.

            • Acknowledged this was based on expert opinion

            • So in the context of the CPG, shared-decision making is recommended rather than overtly recommending a 24 hour period after amniotomy to diagnose failed induction. 

Active Phase of First Stage

  • ACOG definitively puts forth a recommendation: the active phase of labor is denoted at 6cm dilation

    • This is based on the more conservative Zhang data

    • They acknowledge there may be a range of individualized starting points between 4-6cm based on individual patients.

      • The 6cm standard for active phase management allows as many as possible to be ruled in for active phase before the more stringent arrest definitions are applied.

      • Not changed from prior guidance (Obstetric Care Consensus).

  • ACOG defines active phase arrest in one of two ways:

    • No progression in cervical dilation after 6cm with rupture of membranes despite adequate contractions for 4 hours, or

    • No progression in cervical dilation after 6cm with rupture of membranes despite inadequate contractions and oxytocin augmentation for 6 hours.

      • Versus the old document, this is largely unchanged.

      • A protracted active phase can be conservatively defined as less than 1cm of cervical change in 2 hours.

    • They note slow, but progressive, labor in the first stage should not be an indication for cesarean:

      • A prospective study of over 300 patients with dysfunctional labor, when provided 4 additional hours of oxytocin, 50.7% of nulliparas and 41.7% of multiparas ultimately delivered vaginally.

        • This would have equated to a cesarean rate of over 35% without the additional time, versus just 18% with the additional time. 

  • Since providing these recommendations in 2014 with the original Obstetric Care Consensus, real-life benefit to cesarean rates have been mixed / modest at best.

    • There is not much data at all regarding maternal/neonatal morbidity.

    • However, the CPG authors describe that this approach likely balances risks of prolonged labor with benefits of avoiding cesarean in a safe way, based on the best data available. 

Managing an Abnormal First Stage of Labor

  • New to this document is an endorsement of an active management approach to the first stage of labor, which includes:

    • Standard criteria for diagnosis of arrest of labor

    • Early amniotomy

    • Administration of oxytocin for protracted labor

    • One-to-one nursing care

      • Studies of active management have not shown reduction in cesarean rates, but do point towards lower rates of maternal fever and shorter duration of labor.

      • Thus, knowing risks of protracted labor, ACOG endorses active management - new to this CPG and stands out as an addition versus the prior Obstetric Care Consensus.

        • Let’s review the components - we just talked about arrest definitions, so next we’ll talk:

  • Amniotomy

    • ACOG recommends amniotomy for patients undergoing augmentation or induction of labor to reduce the duration of labor.

      • An AHRQ-based systematic review of amniotomy in spontaneous labor determined that it helped reduce length of labor in nullliparas, without increasing risk for cesarean delivery, maternal infection, trauma to the pelvic floor, or postpartum hemorrhage.

        • There was no difference in rate of cord prolapse, either, in any of the randomized trials analyzed.

    • When should I perform amniotomy?

      • This in the literature is broken down into early vs late, where “early” is often defined as amniotomy as soon as feasible.

        • In one RCT, this was within 1 hour of Foley removal when used for cervical ripening, versus late being beyond 1 hour - higher rates of vaginal delivery within 24h and shorter labor duration in early group.

        • Another RCT - amniotomy concurrent with oxytocin starting, vs 4 hours after starting oxytocin – demonstrated shorter labor length in nulliparas and no effect on cesarean delivery rates.

        • Systematic review of four other RCTs of induced labor - average labor reduction of 5 hours, with similar rates of cesarean and no increasing risks of complications.

          • ACOG concludes that “there is high-quality evidence to recommend early amniotomy as adjunctive to the labor process” – a really significant new recommendation! 

  • Oxytocin use

    • ACOG recommends either high-dose or low-dose oxytocin regimens as reasonable to use with active labor management to reduce operative deliveries.

      • Similar to amniotomy, ACOG first discusses early vs late oxytocin augmentation, where early is defined as starting oxytocin once prolonged active phase is identified:

        • A few meta-analyses demonstrate modest increases in likelihood of vaginal delivery and modest reduction in cesarean birth.

      • Probably of more controversy is the use of high-dose vs low-dose protocols.

        • Low dose protocols generally use a starting dose of 0.5 - 2.0 mU/min, and increase by 1-2 mU/min every 15-40 minutes.

        • High dose protocols use a starting dose of 4 mU/min or higher, and increase by 3-6 mU/min every 15-40 minutes.

        • The data does not demonstrate any improved or worsened outcomes with one approach versus another, so ACOG states either approach is reasonable.

          • The previously-mentioned AHRQ systematic review did demonstrate lower cesarean rates and no difference in hemorrhage for nulliparous patients undergoing high-dose protocols – worth a consideration.

        • ACOG also notes a maximum dose of oxytocin has not been established – that was news to me!

    • ACOG does add a recommendation to use IUPCs in patients with protracted active labor, or in those whose contractions cannot be monitored externally.

      • They note IUPCs are a useful tool to help titrate oxytocin while also not causing or increasing adverse events.

      • Recall, 200 Montevideo units (MVUs) define adequacy, when looking at contraction strength in a ten-minute period.

        • There is some limited evidence that cesarean delivery is more likely with lower MVUs; but these cut offs, patterns of contractions, and definition of adequacy all need more study!

Third Stage of Labor, feat. Dr. Alyssa Hersh

Today we are joined by Dr. Alyssa Hersh, a resident at Oregon Health and Sciences University (OHSU) who is the lead author on a new Gray Journal (AJOG) review on the third stage of labor.

Check out the paper for all the good stuff, but here are the highlights of the podcast:

  • The third stage of labor occurs between fetal and placental delivery. It typically lasts 4-10 minutes, with complications starting to increase after 30 minutes.

  • WThe ACOG definition of postpartum hemorrhage is blood loss ≥1,000 milliliters regardless of mode of delivery, or blood loss along with signs of excessive blood loss.

    • Remember the 4 T’s of etiologies of postpartum hemorrhage, including tone, tissue, trauma and thrombin.

  • The original components of active management of the third stage of labor include:

    • Uterotonic, namely oxytocin;

    • Early cord clamping;

    • Controlled cord traction;

    • External uterine massage.

      • However, not all of these components are still evidence-based.

  • There may be more effective uterotonic regimens than oxytocin alone for preventing postpartum hemorrhage.

  • While TXA may be an effective adjunct to a uterotonic for prevention of postpartum hemorrhage, current evidence is conflicting and there is insufficient evidence to support its broad use at this time after all births.

  • There is evidence supporting the use of controlled cord traction, particularly for reducing the need for manual extraction of the placenta.

    • External uterine massage is not effective for preventing postpartum hemorrhage.

  • Early cord clamping has largely been replaced with delayed cord clamping due to the known benefits for both preterm and term infants.

  • Cord milking may be harmful for very preterm neonates without sufficient data to support using it for neonates at higher gestational ages.

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!