The CREST Study

Here’s the RoshReview Question of the Week!

Which of the following methods of sterilization has the highest relative risk for ectopic pregnancy?

• Bipolar coagulation

• Postpartum partial salpingectomy

• Silicone band methods

• Spring clips

Check your answer and get a special deal on RoshReview at the link above!

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Background: 

• Who did the study? 

  • Study was done by the US Collaborative Review of Sterilization Working Group 

  • CREST was part of the CDC and conducted with the NICHD 

  • Conducted with 10 year follow up and was done at multiple medical centers (Baltimore, MD, Buffalo, NY, Chapel Hill, NC, Honolulu, HI, Houston, TX, Memphis, TN, Sacramento CA, St. Louis, MO, San Francisco, CA) 

• Where was the study published? 

  • AJOG in 1996 

  • Presented at the Annual Meeting of the American Gynecological and Obstetrical Society in Napa, CA in 1995 

• Why was the study done?

  • Tubal sterilization is the most prevalent form of contraception among married women and formerly married women in the US 

  • While sterilization was common, there was not widespread data about their efficacy, especially over time 

• Objective: To assess the effectiveness of various methods of tubal occlusion 

Methods: 

• Who was included? 

  • Prospective study of women undergoing tubal sterilization at the above mentioned medical centers from 1978 -1986 

  • Ages 15-44 years 

  • Patients were approached before their sterilization procedure 

• How was it done? 

  • If the patient agreed, information about her history was obtained 

    • Characteristics of the surgical procedure, including complications during the surgery and afterward, were recorded 

    • Contacted at 1 month for brief follow-up 

    • Annual follow-up planned for 5 years for all patients 

    • If they were enrolled early enough, patients also had annual followup for 8-14 years after sterilization 

    • If the patient could not be contacted for the follow up then the last completed interview was used in the analysis 

  • At the follow up, all patients were asked: “Since your tubal sterilization, have you had a positive pregnancy test or been told by a physician that you were pregnant?” 

    • If yes, the interviewer then had a separate form with additional info about the pregnancy 

    • Excluded from further follow up if they became pregnant, had a repeat sterilization, a tubal anastomosis, or hysterectomy 

  • Type of tubal occlusion included: (don’t need to say all of these) 

    • Laparoscopic unipolar coagulation - don’t do these anymore! 

    • Laparoscopic bipolar coagulation - I have never seen this 

    • Laparoscopic silicone rubber band application - I think I did a few of these 

    • Laparoscopic spring clip application - Filshie clips? 

    • Partial salpingectomy (including Pomeroy, other types of partial, and total salpingectomy) 

  • If a pregnancy was identified, they were classified into: 

    • True failure (pregnancy conceived after sterilization) 

    • Luteal phase pregnancy (pregnancies conceived before sterilization but ID’ed after) 

    • Pregnancy resulting from tubal anastomosis or IVF 

    • Or pregnancy of unknown status (didn’t get the information) 

Results 

• Who: 

  • 10,863 women enrolled → 178 were excluded from analysis

    • Some were due to loss to follow up, refusal to be interviewed at 1 month follow up, or refusal for prolonged follow up 

    • Others excluded because of hysterectomy, repeat tubal ligation, or death  

  • Demographics 

    • Median age: 30 (so pretty young!) 

    • Most women were non-Hispanic White (52.7%) and had had at least 2 pregnancies 

    • Most common procedure: silicone band (31.2%), followed by bipolar coagulation (21.2%), postpartum partial salpingectomy (15.3%)

      • For us, that is super different! Since I think what i have done the most is postpartum or interval total salpingectomies 

      • Though for a bit, we also did Pomeroys and Parklands  

• Follow-up 

  • 89.2% were interviewed at 1 year after sterilization, 81% at 3 years, 73% at 5 years, and 57.7% 8-14 years (so some drop off, but that’s expected) 

  • At each follow up interval, younger women (age 18-27) had lower percentage of follow-up than older women 

  • Black, non Hispanic women also had lower rates of follow up compared to white non-Hispanic women 

• Sterilization failures

  • Out of 10,685 women in the analysis, only 143 were true sterilization failures = 1.3% failure rate  

    • 21 (14.7%) ended in SAB 

    • 26 (18.2%) were TABs 

    • 41 (28.7%) ended in delivery 

    • 47 (32.9%!!!) ended in ectopic pregnancies 

  • Another 34 women not included in analysis had luteal phase pregnancies  

  • 16 were from tubal anastomosis and IVF, and 5 were “unknown” classification

View fullsize

• Above table: lifetime accumulation of sterilization failure by method from 1-10 years per 1000 procedures and 95% CI (only showing years 1-4 because all the years made the table huge) 

  • We can see that for clip and interval partial salpingectomy, there seems to be a higher rate of lifetime pregnancies 

  • Lowest risk was postpartum partial salpingectomy 

• Also looked at 10-year cumulative probability of failure is affected by age at tubal sterilization 

  • Probability for failure in women <28 is greater than for women sterilized at ages >34 (makes sense … if you’re younger, you likely have more “fertile” years ahead of you) 

View fullsize

• After adjustment for age, race, and study site, interval partial salpingectomy, spring-clip application, and bipolar coagulation were more likely than postpartum partial salpingectomy to result in sterilization failure 

• After adjustment, black women were at higher risk than white women for sterilization failure 

• There were also interestingly differences between sites! 

So what did this all mean? 

• Sterilization failure rates 

  • Higher than previously thought! For all comers it was a little over 1% 

  • HIgher failure rates occurred after longer times (ie. more than 1-2 years, which was what other studies had looked at)

    • Failure rates between 5-10 years after procedure ranged from 1.2-8.3/1000 procedures depending on method 

  • Method failure rate also is affected by age, race, and also institution! (meaning how well or properly you do the procedure could affect effectiveness) 

  • Also, risk of ectopic increases with tubal ligation 

• What was the follow-up or impact of the CREST study? 

  • There was way more data collected than just this, and way more than just this study that was published from the CREST dataset 

  • Some other studies that were interesting: 

    • Risk of regret after tubal sterilization (1985) - 2% regretted after 1 year, 2.7% did so after 2 years 

      • Characteristics of those that had more regret: age <30 (regardless of parity), concurrent C/S

        • After 5 year follow up, risk of regret in those 20-24 was 4.3%, rate for those 30-34 was 2.4% 

        • Where do we get this 20% risk of regret from??? - different study from 1999 - in women <30 years of age 

          • In that same study for women >30, risk of regret was 5.9% 

          • Also, for women <30 the cumulative probability of regret decreased as time since birth of the youngest child increased

          • Risk of regret was actually lowest for women with no previous births!!

    • Unintended laparotomy associated with laparoscopic tubal sterilization: rate was: 51/5021, so about 1%

      • Increased risk: prior abdominal or pelvic surgeries  

    • Characteristics of those that sought tubal reanastomosis

      • 6.2% sought information for reanastomosis 

      • Women who were <30 were more likely to seek out this information 

      • Of those that actually had anastomosis, they were more likely to be white, have lower gravidity, and be younger, and to have experienced changes in marital status

• How does this change our practice? 

  • We are performing different procedures from the ones that were studied in the CREST procedure

    • Nevertheless, I still quote the findings from this study for patients when they want them: 

      • Risk of failure depends on method

      • Risk overall of failure is low, but can be as high as 1% overall, and even higher depending on age and type of procedure 

      • Risk of conversion to laparotomy from laparoscopy is overall low but increases with more surgeries in the belly 

      • Risk of regret is as high as 20% – I think I may now qualify this only for certain populations! 

    • We shouldn’t NOT perform sterilization procedures, however, just because of risk of regret 

      • Even if someone is nulliparous, young, and not married, if they are well counseled and still desire sterilization, we can perform it 

#MedEd: Applying into Pediatric and Adolescent Gynecology (PAG)

Today we welcome back Dr. Aimee Morrison, a current resident in OB/GYN at UPenn heading into specialization in Pediatric and Adolescent Gynecology (PAG). She shares with us some tips on the application experience and getting set up optimally to pursue this specialty — which is wonderful given it’s a smaller specialization with fewer mentors available.

Some highlights from the episode:

• PAG is a two-year fellowship typically; some one-year programs do exist.

• There’s a wide variety in care, which is often multidisciplinary in nature. There’s a good amount of endocrine issues (PCOS, CAH), as well as disorders or delays in sexual development; surgical care in Mullein anomalies and congenital malformations; and trans care, menstrual problem management, and contraception.

• Aimee suggests getting involved with some exposure in years I and II, and often times this might be through an REI with a specific PAG interest, given the limited number of PAG specialists currently in existence.

  • Starting a research project or two is also helpful for applications - and in PAG, because of small numbers, case reports/series, literature reviews, and retrospective chart reviews are very normal and typical.

• If you can, get involved with and go to NASPAG!

  • Can even open you up to mentoring opportunities from far away!

The Term Breech Trial

Actual title: Planned cesarean section versus planned vaginal birth for breech presentation at term: a randomized multicenter trial

Background:

• Who did the study, and who published it?

  • Another large collaborative group study – the Term Breech Trial Collaborative Group

    • Primary authors of the group based in Canada

    • Participating sites spanned Europe, Canada, Australia, Central/South America, Africa, Middle-East, India & Pakistan

    • Funded by Canadian Institutes of Health Research (like Canada’s NIH)

• Why was the study done?

  • As we covered in our ECV and breech birth podcasts, breech presentation affects about 3-4% of term pregnancies.

  • At the time this was conducted (published in 2000), it was a controversial question for delivery approach:

    • Cohort studies prior to this trial suggested that cesarean section was potentially better.

      • However, these cohort studies were potentially confounded by inclusion of pregnancies that would not be considered for breech birth (i.e., footling presentation) or by lack of experience with breech deliveries by the participating physicians. 

    • Two smaller RCTs prior to this trial and a meta-analysis did not find any substantial benefit to planned cesarean.

  • Thus this ambitious trial was carried out to determine which was truly better.

• What was the research question?

  • “To determine whether planned cesarean section was better than planned vaginal birth for selected fetuses in the breech presentation at term.” 

Methods:

• Who participated and when?

  • Enrollment between Jan 1997 and April 2000 at 121 centers in 26 countries.

  • Eligibility:

    • Breech presentation at or after 37 weeks → assigned to planned cesarean or planned vaginal delivery after consent by telephone system.

    • If assigned to CD group: planned CD was scheduled for 38+ weeks.

      • If patient presented in labor, CD was performed as soon as possible.

      • Presentation was confirmed again prior to cesarean and if cephalic, vaginal birth was then planned.

    • If assigned to VD group: management was expectant until spontaneous labor began, unless an indication to induce labor or a different reason for cesarean developed.

      • Labor management protocol was standardized (a LOT of standards):

        • Induction and amniotomy were allowed for standard OB indications

        • FHR monitoring by intermittent auscultation or cEFM

        • Augmentation with oxytocin was permitted, “so long as the clinician was confident that there was no evidence of cephalopelvic disproportion.”

        • Adequate labor progress in 1st stage was 0.5cm/h after onset of active labor, and in 2nd stage was descent of breech to pelvic floor within 2hr of full dilation, and delivery being imminent within 1hr of active pushing.

          • If fetal heart rate abnormalities were encountered or lack of progress in labor occurred, CD was performed.

        • Anesthesia choice was left to patient and providers.

        • Delivery means was recommended to have no intervention until spontaneous exit of the infant to the umbilicus, and minimum intervention thereafter with no traction on the body; and controlled delivery of the head using forceps or Mariceau-Smellie-Veit maneuver. 

          • Total breech extraction was not permitted.

      • Deliveries were to be attended by an “experienced clinician” – defined as someone who considered themselves to be skilled and experienced at vaginal breech delivery and confirmed by their department head at their institution. 

        • Each clinician was assigned a code number prior to study enrollment and there was info recorded on their qualifications and years of experience with breech delivery. 

• What were they looking for?

  • Primary outcome: perinatal or neonatal mortality at less than 28 days of age, or one or more serious neonatal morbidities such as:

    • Birth trauma, such as subdural hematoma, IVH, spinal cord injury, basal skull fracture, peripheral nerve injury, or clinically significant genital injury; 

    • Seizures at less than 24h of age or requiring 2+ drugs to control; 

    • Apgar of less than 4 at 5 mins

    • Cord base deficit of 15 or greater

    • Hypotonia for at least 2 hours

    • Stupor, decreased response to pain, or coma

    • Intubation and ventilation for at least 24h

    • Tube feeding for four days or more

    • NICU admission longer than 4 days

  • Secondary outcome: maternal mortality or serious maternal morbidity for up to six weeks postpartum, such as:

    • PPH > 1500 cc or need for transfusion

    • D&C for bleeding or retained tissue

    • Hysterectomy

    • Cervical laceration involving lower uterine segment (if SVD)

    • Vertical incision or serious hysterotomy extension (if CD)

    • Vulvar or perineal hematoma requiring evacuation

    • DVT / PE

    • Pneumonia, ARDS

    • Wound infection requiring prolonged hospital stay, wound breakdown

    • Bladder / ureter / bowel injury requiring repair, or development of fistula

    • Bowel obstruction

    • Other serious morbidities

  • They also used multiple logistic-regression analyses to test for interactions between demographic / baseline characteristics and outcomes:

    • I.e., looking at the perinatal outcomes for babies, looked at interaction with maternal age, parity, type of breech presentation, gestational age, labor vs induction, EFW by US vs Leopold’s, etc. 

  • They also looked at center’s standard of care in “usual care” vs “high standard of care” environments (as determined by a pre-study survey) and maternal/perinatal mortality rate in the center’s country

    • High standard of care was defined as:

      • Having ability to perform a cesarean within 10 mins (vs 60 mins)

      • Personnel to bag-mask a baby available immediately (vs 10 mins)

      • Personnel to intubate / provide PPV to baby within 10 mins (vs 30 mins)

      • Ability to ventilate a baby for >24h (vs need for transfer for this)

Results:

• Who was recruited?

  • 2088 pregnant patients were randomized, with 1043 assigned to CD and 1045 assigned to VD

    • Maternal outcomes were available for 1041 (CD) and 1042 (VD) groups

    • Neonatal outcomes were available for 1039 (CD) and 1039 (VD) groups

      • Overall very low loss to follow up!

  • Groups were overall very similar:

    • 52% in each group were nulliparous

    • EFW > 3kg in ~66% in each group (with 60% in each group estimated by ultrasound)

      • 21.9% in each group underwent attempted ECV

    • 35% of deliveries in each arm took place in “high standard of care” centers.

    • ~42% in each group presented in labor, and ~23% in each group had membranes ruptured on presentation.

    • Median GA at delivery was similar in each group (39w3d CD vs 39w6d VD)

  • In the planned CD group:

    • 90% had a CD, and 10% had a VD

  • In the planned VD group:

    • 43.3% had a CD, and 56.7% had a VD

      • CDs most commonly performed for:

        • Fetopelvic disproportion or abnormal progress in labor (50.1%)

        • Fetal heart rate abnormality (28.6%)

        • Footling breech presentation (15.3%)

        • Patient request (13.5%)

        • Medical or OB complication (10%)

        • Cord prolapse (2.7%)

    • ~15% of labor was induced, and ~50% of labor was augmented.

      • Only 9% had a protocol violation of labor management:

        • 3.6% for prolonged labor

        • 1.4% for footling or uncertain presentation of breech at delivery

        • 2.7% had no experienced clinician at delivery 

• Outcomes:

  • Primary

    • There was a significantly lower risk of perinatal/neonatal morbidity in the planned cesarean group:

      • 17/1039 (1.6%) CD vs 52/1039 (5.0%) VD (RR 0.33)

        • This held true in both countries with low perinatal mortality rates and high perinatal mortality rates.

        • This difference lessened (but remained statistically significant) with increasing experience of the attending provider – that is, there was less risk of morbidity when more experienced personnel were present.

        • This difference also lessened (but remained statistically significant) when excluding induced/augmented labor, deliveries without a skilled clinician, and those with footling/uncertain breech presentation 

          • Bottom line: there is higher perinatal morbidity with planned VD, despite increasingly optimal environments in subanalyses

    • There were 3 neonatal deaths in the cesarean group, and 13 in the vaginal delivery group.

      • One of the CD group deaths was actually a vaginal birth with difficult delivery.

      • Two of the vaginal birth deaths were likely prior to enrollment; two were of neonates discharged from the hospital in good condition otherwise; and two were suspected intrapartum demises before a cesarean section could be started.

    • The reduction in perinatal morbidity was much greater in countries with lower perinatal mortality rates, despite a higher likelihood of cesarean birth in the VD groups in those countries

      • I.e., in an area with low perinatal mortality and a higher likelihood to get cut intrapartum, the benefit of planned CD was even greater

    • There was more birth trauma, seizures, hypotonia, low Apgars, cord blood acidemia, need for mechanical ventilation, and longer NICU stays in the planned vaignal delivery group. 

    • Birth weight over 4000g was more likely in the VD group (5.8% vs 3.1%). 

  • Secondary

    • No major group differences in maternal morbidity/mortality. 

Impact

What was the impact of all of this, and what are we doing now?

• Well you kind of know already – how many planned breech births have you done?

  • For most of us, that answer is probably 0 “planned” and maybe 1 or 2 “unplanned.”

• This was absolutely a practice-changing paper – and has guided how we approach the patient with breech presentation at term ever since.

• What criticisms exist of this trial?

  • High number of patients were randomized in labor, and questionable counseling:

    • ~42% in each arm – this begs the question about how “planned” each method actually was, and how much counseling or selectivity may have been realistically applied to each patient.

    • Can also see this in the higher rate of >4kg babies in the VD arm, as well as only 20% in each arm had an attempt at ECV. 

  • Standard of care was not consistent

    • Continuous EFM (for better or worse) was not standard

    • Fetal weight and attitude of the head, while recorded for trial data, did not have to be assessed by US

    • Generalizability is hard to interpret with the pooled results:

      • I.e., would you take your chances on a breech in Australia with a well-counseled patient with CTG in a place where you can do a C-section in under 10 minutes and have highly qualified neonatal staff immediately available? Or in another location where you can’t do a c-section even by 60 minutes? 

        • The subgroup analyses by perinatal mortality rate of countries tried to answer that, but it is curious they didn’t choose to divide it up by their “high standard” versus “usual standard” centers.

      • Subsequent analysis has shown that 30% of the morbidity/mortality in the VD group can be attributed to the 6.7% of vaginal deliveries attended by no experienced provider – also calling into question the impact of experience. 

  • Enrollment scheme:

    • Units would call to centralized location to get allocation and this was not stratified by center – theoretically, a highly experienced obstetrician could call and end up with randomization to cesarean each time, and likewise an inexperienced one could call and randomize to vaginal delivery each time.

  • Numerous protocol violations and enrollment questions

    • Included initially in the trial were: 2 demised infants, 2 sets of twins, an anencephalic baby, a baby with spina bidfida, and another baby with suspected anomalies. 

    • 2 of the vaginal delivery group deaths were suspected to have been prior to randomization, yet counted in the perinatal mortality. 

      • And a number of other deaths in the VD arm may not have been related to the delivery itself – i.e., SIDS, GI issues, anomalies, inadequate respiratory resuscitation or resources.

What about doing breech births? Can we? / should we?

• We don’t recommend breech birth – that would be irresponsible to do outright!

• Well counseled, well-selected patients in centers with experience in breech delivery, ability to perform cesarean, and provide immediate neonatal resuscitation – it may be reasonable, though this trial doesn’t totally answer that question based on problems with generalizability.

  • In the wake of this trial, the PREMODA study was performed in France and Belgium – a prospective observational study allowing providers to select mode of delivery where breech delivery was still an option/standard.

    • ⅔ of women were allocated to cesarean delivery, but 71% of those undergoing planned vaginal breech birth were successful. 

    • There was no difference in perinatal mortality/morbidity was noted between groups in this study – suggesting that rigorous protocols and assessment by those with experience may make breech birth safer.

Interesting critique of trial: https://www.ogmagazine.org.au/14/2-14/term-breech-trial/ 

Planned Home Birth

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What is the history of home birth? 

• Until recent history, the home was the place for birth! In fact, the term was not coined until the 19th century because until then, birth usually occurred at home and not in a birthing center or hospital.

  • In the United States, in 1900, close to 100% of births were at home 

  • In 1938, rates had fallen to 50%, and then fewer than 1% in 1955 

  • In other countries like the UK, the trend to non-home births was slower, but still occurred; IN the UK, 80% of births occurred at home in the 1920s, and only 1% in 1991 

  • In Japan, this happened much later: In 1950, 95% of births occurred at home, but only 1.2% in 1975 

  • However, recently between 2004-2009, the number of home births in the US increased by 41% 

•  Where in the world are there still home births? 

  • Many countries! 

• So why did home births decrease over the years?

  • Hard to know exactly why 

  • There is some increased medicalization of birth 

  • In the hospital, there was the promise of anesthesia – ie. you could get an epidural 

  • At the same time, there was a trend of decrease maternal mortality and morbidity as well as decreased infant morbidity 

Why is there an increased movement to home birth? 

• One note 

  • We want to discuss planned home births, not unplanned ones! 

• Lots of reasons 

  • Some birthing people like the familiar environment of their home, and do not like the medically centered birth experience 

  • Some people feel it is more relaxing at home 

  • In one study published in the Journal of Midwifery and Women’s Health the top five reasons were: 

    • Safety 

    • Avoidance of unnecessary medical interventions 

    • Previous negative hospital experiences 

    • More control 

    • Comfortable and familiar environments 

  • One other study found that women experienced pain differentially and less negatively in the home setting 

• This speaks to some of the things that we in hospitals or even birth centers can do to make patients feel safer and more comfortable! 

  • Clearly, some patients do not feel safe in the hospital setting, even though as doctors, we would argue that the hospital is the “safest” place to deliver a baby because of quick access to resources (ie. blood banks, ORs, NICUs) 

  • So I think this study gives us a good way to figure out what we can do in the hospital to make patients feel more comfortable

  • See our episode on limiting interventions in birth! 

• What about now? Where in the US is there increases in home birth?

  • Top five in 2020:

    • Idaho (3.2%) 

    • Vermont (3%) 

    • Wisconsin (2.8%) 

    • Montana (2.6%) 

    • Utah (2.6%) 

So, now that we know there is increased desire for home birth, what is the evidence for or against home birth? 

• A word on the evidence

  • Our gold standard is of course to have a randomized controlled trial, but you really can’t do that ethically for home birth! 

  • So most data is from observational studies, but they are often limited by methodological problems, including small sample size, lack of appropriate control group, reliance on birth certificate data, reliance on voluntary submission of data or self-reporting, limited ability to distinguish accurately between planned and unplanned home births, and variations in skill, training, and certification of birth attendants etc.  

The data for home birth for moms 

• Patients don’t want unnecessary interventions — and look at all the interventions we do!

• Even in TOLACers it seems that we do a lot – maybe it’s safe to TOLAC at home  

  • In England, women planning a home trial of labor after cesarean exhibited fewer obstetric risk factors, more likely to deliver vaginally, and had similar maternal and perinatal outcomes compared with those planning hospital TOLAC 

The data against home birth for moms 

• Most research about home birth cohorts recently have strict selection criteria for appropriate candidates

  • So remember: these studies usually select so that there is absence of preexisting maternal disease, absence of significant disease arising in pregnancy (so think of all your GDMs! Your hypertensives!), singleton fetus, cephalic presentation, gestational age >36 or 37 weeks and less than 41-42, labor is spontaneous 

• Finally, while in many other countries they may have safe methods of identifying risk and reasons to get moms to the hospital, most places in the US do not have this 

  • The relatively low rates of morbidity and mortality reported for planned home births from Ontario, British Columbia, and the NEtherlands were from highly integrated health care systems with established criteria and provisions for emergency intrapartum transport 

  • In the US, however, the home birth attendant (midwife, etc) do not always have hospital privileges or are not connected to a doctor that has hospital privileges 

  • There is not a safe and timely way to transfer the patient intrapartum to the hospital if needed 

  • There is also a reported risk of needing intrapartum transport to hospital of 23-37% for nulliparous women and 4-10% for multiparous women 

  • Reasons for transport: lack of labor progress, nonreassuring fetal status, need for pain relief, hypertension, bleeding, and fetal malposition 

Conclusion: It does appear that home births can be safe for mom, but only in a selected populations. We would recommend that if someone desires to have a home birth, that they have a birth attendant that is a certified nurse midwife (CNM) or a physician who practices obstetrics within an integrated and regulated health system. They should also have a plan about when and how to come into the hospital if there are complications. 

They should also be a specifically selected population:

• Absence of preexisting maternal disease 

• Absence of significant disease during pregnancy 

• Singleton fetus 

• Cephalic presentation 

• Term gestation, and not post dates 

• Spontaneous labor 

• No uterine scars (ie. no TOLAC) 

That data for home births for babies 

• While we can see that in previous data, there was some increased risk of neonatal morbidity and mortality, there was a recent big paper that looked at 10,609 births that came out in the Green Journal in November 2021, published by midwives in Washington state 

• https://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=2021&issue=11000&article=00002&type=Fulltext

• Basically, they compared planned home births (40.9% of the population they studied) vs. planned birth center births (59.1%) 

  • Their results were really great! Not only did they have a C/S rate of 11.4% for the nulliparous women and 0.87% for the multiparous women, the perinatal mortality rate after onset of labor was 0.57/1000 (super low, compared even to older data)

  • Compared to planned birth center births, planned home births had similar risks in crude and adjusted analyses 

  • Overall, numbers were low anyway for 

• The data against home births for babies 

  • That’s all well and good for Washington

  • But let’s not forget that these women were carefully selected for a planned home birth 

    • They followed ACOG’s guidelines 

    • If we look at the demographics, most of these women were <35 (only 21% were 35 or older) 

    • These women were thin (63% had normal BMIs, and only 14% had BMIs >30) 

    • Most of them were white (83.8%) 

    • They likely were of higher social class (62% had commercial insurance) 

    • Most of them were multiparous (63.9%, and 8.4% had >4 prior births) 

    • Only 3.2% had gestational diabetes

    • Basically, very healthy population that not all people fit the mold for 

  • There is a lot more increased perinatal morbidity for babies in other data! And mortality!

    • Basically: there is about a 2.43x risk of perinatal mortality if we look at all data and a 3x increase risk of neonatal seizures or serious neurological dysfunction 

    • Overall, yes these numbers are small (death is 1-2/1000 and seizures/neurological dysfunction is 0.4-0.6/1000)  

    • Even in this study from Washington state, nulliparous women had a 1.04/1000 birth perinatal mortality rate

Conclusions: Again everyone has the right to choose what type of birth they have. However, if we look at data as a whole, neonatal outcomes are overall worse with planned home births overall compared to in hospital births. While these outcomes are overall low, patients should still be counseled the risk of perinatal death is approximately 2x higher in planned home birth and neonatal seizures/neurological dysfunction is about 3x higher. It’s likely that these outcomes can be mitigated in the right population with a good plan to transfer patients/babies to a hospital and with the right birth attendant. 

However, the fact remains that there is not always infrastructure in place to make sure that all of these things can happen. 

Therefore, it’s important to discuss these studies with your patients and especially review with them if they are a good candidate or not. Remember they should also be a specifically selected population:

• Absence of preexisting maternal disease 

• Absence of significant disease during pregnancy 

• Singleton fetus 

• Cephalic presentation 

• Term gestation, and not post dates 

• Spontaneous labor 

• No uterine scars (ie. no TOLAC) 

Mastitis

Here’s the RoshReview Question of the Week:

A 30-year-old woman presents to the office with right-sided breast swelling and pain. She is 8 weeks postpartum from a spontaneous vaginal delivery of a term infant and is currently breastfeeding. She states her right breast is very painful, swollen, and red, and she has had a fever for the last 2 days. Which one of the following is the most appropriate next step for this patient?

• Breast ultrasound

• Dicloxacillin

• Discontinue breastfeeding

• Vancomycin

Check your answer and get a special discount at the link above!

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For more on breastfeeding, see our prior breastfeeding episodes (Part I and Part II) with Dr. Erin Cleary 

Before we get into mastitis… Breastfeeding is challenging!

• There are many benefits to breastfeeding

  • Decrease in breast cancer, ovarian cancer, diabetes, HTN, heart disease 

  • Recommendation for breastfeeding for first 6 months of life or longer 

  • Benefits to the infant as well 

• However in the US, as high as 45% of women report early, undesired weaning

  • Can be because of many things; nipple pain, perception of low milk supply, difficulty with latch

  • Other social factors, ie. limited access to maternity leave, barriers to breastfeeding in the workplace  

  • Depression, previous negative breastfeeding experiences 

• Also, many things can occur in breastfeeding that can be a challenge 

What can look like mastitis? 

• Engorgement

• Physiologic breast fullness that often occurs between day 3-5 postpartum 

• Typically reassuring sign that mature milk is being secreted 

• However, can cause symptoms of distention, pain, tenderness, firmness and even fever (usually lower fever) - which can make it easy to confuse with mastitis 

• Slightly swollen and tender lymph nodes 

• Can sometimes be very pronounced and there should be anticipatory guidance 

• Treatment:

  • Overall, data on prevention is limited

  • Can try acupuncture, hot and cold packs, cabbage leaves - but all from systematic reviews have found insufficient evidence to recommend a particular treatment regimen 

  • Can use milk expression to relieve some symptoms 

• Persistent breast pain with feeding

  • Can be caused by many things  

    • Nipple damage from baby or with overuse/misuse of pump

      • Infant with tight lingual frenulum “tongue tie” - can get frenotomy or frenectomy 

      • Can help observe pumping session and adjust level of suction or fit of flange with lactation consultants  

    • Psoriasis, eczematous conditions - need to apply emollient and reduce identifiable triggers 

    • Candida infections - topical azole and antifungal ointment or cream are ok, or even oral fluconazole 

    • Herpes simplex or zoster - can be seen a small, clustered tender vesicles

      • Treatment with oral antiviral therapy 

      • Stop breastfeeding on that side temporarily 

• Galactocele - milk retention cyst 

  • Usually just a collection of fluid that is caused by obstructed milk duct - usually soft cystic masses 

https://creogsovercoffee.com/notes/2019/6/16/breastfeeding-part-ii-facts-and-myth-busting

• Infant’s chest rests against maternal body

• Infant’s chin touches the breast, tongue is down 

• Lips flanged outward

• Little or no areola is visualized 

• Rhythmic sucking present 

• Audible swallowing present

• Latch is not uncomfortable or painful and nipple is not injured or misshapen after breastfeeding  

What is mastitis? 

• Defined as inflammation of the breast 

  • Can occur spontaneously, but today we’re talking just about mastitis in the context of breastfeeding 

• Can occur in about 10% of patients who are breastfeeding 

  • Is especially problematic because it can lead to discontinuation of breastfeeding 

• Risk factors:

  • Infant attachment issues - ie. short frenulum, cleft lip/palate

  • Cracked nipples, local milk stasis 

  • Missed feedings 

  • Poor maternal nutrition 

  • Previous mastitis 

  • Primiparity

  • Use of breast pump 

  • Yeast infection 

• Diagnosis

  • Usually is made clinically 

  • Presentation usually is:

    • Localized, unilateral breast tenderness + erythema 

    • Fever - usually high! >101.0F (38.5C)

    • Can also have malaise, fatigue, body aches, headache 

    • Rarely will need to have culture to identify organism 

  •  On exam: will find redness, tenderness on one aspect of a breast (can be in different quadrants)

    • Be sure to examine for fluctuance - is there an abscess?  

  • When to get imaging:

    • If you suspect abscess on physical exam 

    • If symptoms are not improving despite medical management 

    • Usually can diagnose via ultrasonography  

• Treatment

  • Breastfeeding technique

    • Lactation consultation to improve technique 

    • Counsel that patient should not stop breastfeeding or pumping on that side, as stopping can lead to milk stasis and more likely to develop abscess 

    • Can continue breastfeeding!  

    • Usually, the baby is already colonized by the same organism 

  •  Medical management

    • Antibiotics are usually needed for 10-14 days

    • Possible treatments include:

      • Augmentin 875 mg BID 

      • Keflex 500 mg 4x/day (hard to do 4x/day meds) 

      • Clindamycin 300 mg 4x/day - can be used against MRSA 

      • Dicloxacillin 500 mg 4x/day 

      • Bactrim DS (160mg/800 mg) BID - can be used against MRSA, but usually may want to avoid in patients with preterm infants 

• When to refer

  • Abscess

    • Usually needs to be drained 

    • Can often be done at the bedside, and usually will not need to refer to breast surgery if you feel comfortable 

    • However, can depend on individual provider’s level of comfort  

  •  Abnormal presentation/lack of response to treatment

    • Most mastitis should resolve after initial treatment, and recurrence is not common, but can result from inappropriate or incomplete antibiotic therapy 

    • Most abscesses do not recur 

    • Inflammatory breast cancer can resemble mastitis at times, but may be differentiated by skin thickening as well as axillary lymphadenopathy