Cesarean Section Technique: What’s New in the Evidence Base? No Disclosures

Marya G. Zlatnik, MD, MMS Maternal Fetal Medicine UCSF

Hamano, Teisuke. 1880. Kainin no kokoroe (Information on ). Japanese Woodblock Print Collection, Archives & Special Collections, UCSF Library & Center for Knowledge Management.

Cesarean Rates Continue to Rise Learning Objectives

• Review new techniques & literature re: C/S – “Gentle” cesarean – Infection prevention – (Pain control) – Hemorrhage – Sutures • Evidence-base (according to me)

1 Family-Centered or “Gentle” Cesarean Is “family-centered” or “gentle” cesarean a good idea?

A. Yes, we do this at my hospital 42% B. Yes, we’re working on it

27% C. We do it only because patients ask 23% D. No, I’m worried about infection &

disruption in the OR 5% 3% E. What is it? . it t? ...... i s n a . is o o p in t h g t a y in e u h k s o m r au b W t o c a a w e d is e b ie h ’r ly r t e n r o o o d w t w e s, i w e o ’m , Y d , I s e o Ye W N

UCSF Family-Centered Cesarean UCSF Family-Centered Cesarean

• Mother may choose music to be played in OR +Ev • Double drape (with clear window) used • Buy in from OB, Peds, Nursing, Anesthesia • Anesthesia places ECG leads away from mother’s chest • Clear double drapes • Mother’s chest warmed prior to skin-to-skin with instant hot pack • Elevate head of bed, to facilitate viewing the birth & skin-to-skin • Staffing (extra RN) • After delivery of head, OB delivers body slowly • After delivery of head, drape dropped if mother desires to see birth • UCSF Protocol created by Dr. Robyn Lamar • Consider delayed cord clamping for 30-60 seconds +Ev • Pediatricians receive the baby as usual; 1 min APGAR on warmer; goal to be back to mom by 5 minutes for skin-to-skin +Ev • After close, while drapes are removed & mother is cleaned, partner may help with weighing baby & observe other routine care • Once mother is on recovery bed, baby placed skin-to-skin again & the dyad transported together to recovery

2 Family-Centered or “Gentle” Cesarean What are your routine prophylactic antibiotics? (no PCN-allergy) Contraindications: • Prematurity A. Any agent given after cord clamp 77% • Emergency cesarean • Anticipated resuscitation (ex: anomalies, nonreassuring B. Ampicillin pre-incision FHR) Protocol inappropriate in some situations & clinical C. Cephalosporin (cefazolin) pre- judgment always takes precedent incision •Ex: with vasa previa, slow delivery of body inadvisable 11% 9% •Ex: increased BMI, elevating the head of the bed may D. Cefazolin + azithromycin 2% 1% impact surgical visualization . n .. in n E. Other pre-incision . io . c io o s n y s c ci li i r n o m c e -i z ro in ft e fa h e- •Ex: insufficient nursing staff to remain with baby in OR a r e it r n p c z p e n ( a r v li in + e gi il r h t ic o lin t n p sp o O e m lo z g A a fa a h e ny p C A Ce

Pre-incision Atbx: Decreased SSI vs After Cord Clamp Prophylactic Atbx—Extended Spectrum Regimens 8 p= 0.002 2005-2006 n= 800 • RCT adding metronidazole vag gel p= 0.014 After 2006 6 n= 516 – 224 pts; vaginal gel vs placebo gel – Less endometritis (7 vs 17%), trend towards less 4 fever; no difference in wound infxn, LOS

SSI (%) SSI p= 0.020 Pitt 2001 2 • Ureasplasma increases risk for C/S SSI – Cephalosporin doesn’t cover 0 Overall Endometritis Cellulitis – Post-cord-clamp cefotetan plus placebo or doxy+azithro 12 Kaimal SMFM 2008 Andrews 2003

3 Extended spectrum Prophylaxis Extended spectrum Prophylaxis

• UAB studies over 14 years • Multicenter RCT: C/SOAP Trial – In 2000, IV cefotetan or cefazolin & IV azithro at cord clamp – 2013 pts, C/S in labor or ROM (chorio excluded) – Decreased endometritis – Ave BMI 35 (>60% had BMI >30) – Decreased wound infections – Std atbx + Azithro prior to incision Tita ObGyn 2009 – Fewer SSIs, fevers, PP readmits 14 Tita AJOG 2008 15 Tita NEJM 2016

Extended spectrum Prophylaxis? Do you prep the prior to C/S?

• UCSF baseline rate much lower (<1%) A. Yes, every case 66% • Hesitant to extend atbx spectrum for all C/S pts B. Yes, if ruptured membranes – Concerns re: atbx resistance, messing up microbiome C. Yes, if chorio • Selectively extend atbx spectrum D. No, never 13% 11% 8% – eg, pt w/ DM/obesity E. Not sure 1% – Cefazolin 2-3g IV preop + azithro 500mg IV after e r s es io e re a n r v u c a o e s cord clamp (mix in 250mL/give over 1 hr ) y r ch n t r b f , o e m i o N v e , N , e s s m Ye e d Y re tu p ru f , i 17 18 s Ye

4 ZMG2 ZMG2 Vaginal Prep prior to C/S Vaginal Cleansing prior to C/S

• Povidone-iodine prep -> decreased • New meta-analysis Sept 2017 endometritis, esp w/ ROM • Povidone-iodine prep -> decreased • No difference in fever or wound complications endometritis, fever, esp w/ labor/ROM • ? benefit if already chorio • No difference in wound complications • Possible effect on neonatal thyroid studies • Only 6 of 16 specified pre-incision atbx • Risk of vaginal lac • ? benefit if already chorio • Dahlke gives a “B”

– Caissutti ObGYN 2017 – Cochrane 2010, Reid 2001, Rouse 1997, Starr 2005

CORONIS Trial Lancet 2016 • International, pragmatic trial 2x2x2x2x2 • 19 sites in S. America, Africa, India, Pakistan • 1st or 2nd C/S, follow up at 3 yrs • 15,633 women studied: – Blunt vs. sharp abdominal entry – Repair of in or out – 1 vs. 2 layer closure of uterus – Closure vs. non-closure of peritoneum – Chromic vs. polyglactin-910 for uterus • Outcomes of subsequent , pain

5 Incision Type, Uterine Repair, Etc.

Placental Delivery

– CORONIS Trial 2016

Uterine Exteriorization Incision Type, Uterine Repair, Etc. • No differences

CORONIS Trial 2016

6 Management of Hemorrhage Uterine repair • CMQCC hemorrhage toolkit V2.0 (revised March 2015) https://www.cmqcc.org/resources-tool- kits/toolkits/ob-hemorrhage-toolkit

Photo courtesy of CMQCC and David Lagrew, MD

NPR.org

CMQCC OB Hemorrhage Obstetric Hemorrhage Emergency Management Plan: Table Chart Format version 2.0 Assessments Meds/Procedures Blood Bank Stage 0 Every woman in labor/giving birth Emergency Management · Assess every woman Active Management · If Medium Risk: T & Scr Management of Hemorrhage Stage 0 focuses for risk factors for 3rd Stage: · If High Risk: T&C 2 U on risk hemorrhage · Oxytocin IV infusion or · If Positive Antibody assessment and · Measure cumulative 10u IM Screen (prenatal or active quantitative blood · Fundal Massage- current, exclude low level management of loss on every birth vigorous, 15 seconds min. anti-D from Plan the third stage. RhoGam):T&C 2 U Blood loss: > 500ml vaginal or >1000 ml Cesarean, or Stage 1 VS changes (by >15% or HR ³110, BP £85/45, O2 sat <95%) Obstetric Emergency Management Plan: Flow Chart Format Release 2.0 7/9/2014 · Activate OB · IV Access: at least 18gauge · T&C 2 Units PRBCs Follow appropriate workups, planning, preparing Hemorrhage Protocol (if not already done) Identify patients with special consideration: · Increase IV fluid (LR) and Pre- Placenta previa/accreta, Bleeding disorder, or of resources, counseling and notification Stage 1 is short: and Checklist Oxytocin rate, and repeat Admission those who decline blood products Verify Type & Screen on prenatal activate · Notify Charge nurse, fundal massage record; Low Risk: Draw blood and hold specimen if positive antibody screen on prenatal hemorrhage OB/CNM, Anesthesia · Methergine 0.2mg IM (if Time of Screen All Admissions for hemorrhage risk: Medium Risk: Type & Screen, Review Hemorrhage Protocol or current labs (except low level anti-D protocol, initiate · VS, O2 Sat q5’ not hypertensive) Low Risk, Medium Risk and High Risk High Risk: Type & Crossmatch 2 Units PRBCs; Review Hemorrhage from Rhogam), Type & Crossmatch 2 preparations and · Record cumulative May repeat if good admission Protocol Units PBRCs give Methergine blood loss q5-15’ response to first dose, BUT nd IM. · Weigh bloody materials otherwise move on to 2 Ongoing Cumulative Blood Loss rd · Careful inspection with level drug (see Stage 0 All women receive active management of 3 stage Evaluation: >500 ml Vag; >1000 ml CS NO Standard Postpartum below) Oxytocin IV infusion or 10 Units IM, 10-40 U infusion Quantification of >15% Vital Sign change -or- Management good exposure of All Births blood loss and HR ≥ 110, BP ≤ 85/45 Fundal Massage vaginal walls, cervix, · Empty bladder: straight cath vital signs O2 Sat <95%, Clinical Sx uterine cavity, placenta or place foley with urimeter INCREASED BLEEDING Blood Loss: YES >500 ml Vaginal Increase IV Oxytocin Rate Stage 2 Continued bleeding with total blood loss under 1500ml Methergine 0.2 mg IM (if not hypertensive) Activate Hemorrhage Protocol nd >1000 ml CS OB back to bedside (if 2 Level Uterotonic Drugs: · Notify Blood Bank of Vigorous Fundal massage; Empty Bladder; Keep Warm CALL FOR EXTRA HELP Stage 1 not already there) · Hemabate 250 mcg IM or OB Hemorrhage Administer O2 to maintain Sat >95% Increased nd Activate Rule out retained POC, laceration or hematoma NO Postpartum · Extra help: 2 OB, · Misoprostol 800 mcg SL · Bring 2 Units PRBCs Continued heavy Stage 2 is nd Hemorrhage Order Type & Crossmatch 2 Units PRBCs if not already done Rapid Response Team 2 IV Access (at least to bedside, transfuse bleeding Surveillance focused on Protocol (per hospital), assign 18gauge) per clinical signs – do YES sequentially Blood Loss: Vaginal Birth: roles Bimanual massage not wait for lab values CALL FOR EXTRA HELP advancing Bimanual Fundal Massage · VS & cumulative Vaginal Birth: (typical order) · Use blood warmer for 1000-1500 ml Give Meds: Hemabate 250 mcg IM -or- through Retained POC: Dilation and Curettage blood loss q 5-10 min · Move to OR transfusion Misoprostol 600-800 SL or PO medications and Stage 2 Lower segment/Implantation site/Atony: Intrauterine Balloon · Weigh bloody materials · Repair any tears Consider thawing 2 FFP Laceration/Hematoma: Packing, Repair as Required Transfuse 2 Units PRBCs per clinical procedures, · Complete evaluation · D&C: r/o retained placenta (takes 35+min), use if Sequentially Consider IR (if available & adequate experience) signs Increased mobilizing help · of vaginal wall, cervix, · Place intrauterine balloon transfusing > 2u PRBCs Advance through Cesarean Birth: Do not wait for lab values Postpartum Continued Atony: B-Lynch Suture/Intrauterine Balloon and Blood Bank Medications & Consider thawing 2 Units FFP Surveillance

placenta, uterine cavity BloodLoss Cumulative Evaluation Ongoing support, and · Selective Embolization · Determine availability of Procedures Continued Hemorrhage: Uterine Artery Ligation keeping ahead · Send additional labs, (Interventional Radiology) additional RBCs and including DIC panel Cesarean Birth: (still intra-op) with volume and other Coag products Unresponsive Coagulopathy: To OR (if not there); (typical order) Cumulative Blood Loss NO blood products. · If in Postpartum: Move Blood Loss: After 10 Units PBRCs and full Activate Massive Hemorrhage Protocol >1500 ml, 2 Units Given, to L&D/OR · Inspect broad lig, posterior >1500 ml coagulation factor replacement, Mobilize Massive Hemorrhage Team Vital Signs Unstable · Evaluate for special uterus and retained may consider rFactor VIIa TRANSFUSE AGGRESSIVELY RBC:FFP:Plts  6:4:1 or 4:4:1 Consider ICU cases: placenta Stage 3 Care; Increased -Uterine Inversion · B-Lynch Suture Conservative Surgery Postpartum -Amn. Fluid Embolism · Place intrauterine balloon Activate B-Lynch Suture/Intrauterine Balloon YES Fertility NO Surveillance Massive Uterine Artery Ligation Strongly Definitive Surgery Total blood loss over 1500ml, or >2 units PRBCs given Hemorrhage Hypogastric Ligation (experienced surgeon only) Desired Consider IR (if available & adequate experience) Stage 3 or VS unstable or suspicion of DIC Protocol HEMORRHAGE CONTINUES CONTROLLED

· Mobilize team · Activate Massive Transfuse Aggressively California Maternal Quality Care Collaborative (CMQCC), Hemorrhage Taskforce (2009) visit: www.CMQCC.org for details Stage 3 is -Advanced GYN Hemorrhage Protocol Massive Hemorrhage Pack This project was supported by funds received from the State of California Department of Public Health, Center for Family Health; Maternal, Child and Adolescent Health Division focused on the surgeon · Laparotomy: · Near 1:1 PRBC:FFP Massive -2nd Anesthesia Provider -B-Lynch Suture · 1 PLT apheresis pack Transfusion -OR staff -Uterine Artery Ligation per 4-6 units PRBCs protocol and -Adult Intensivist -Hysterectomy Unresponsive Every hospital will need to customize the invasive surgical · Repeat labs including · Patient support Coagulopathy: approaches for coags and ABG’s -Fluid warmer After 8-10 units PRBCs control of · Central line -Upper body warming device and full coagulation factor bleeding. · Social Worker/ family -Sequential compression replacement: may consult protocol—but the point is every hospital support stockings re rFactor VIIa risk/benefit Copyright California Department of Public Health, 2014; supported by Title V funds. Developed in partnership with California Maternal Quality Care Collaborative Hemorrhage Taskforce Visit: www.CMQCC.org for details needs one

7 Do you use Tranexamic Acid? Management of Hemorrhage: TXA 44% 39% A. Yes, all the time TPA B. Yes, if it’s a bad PPH • Tranexemic Acid C. No, waiting for more data 11% 6% D. Huh? What’s TXA? Fibrin degradation

e H a ? m P t A ti P a X e d d T h a re ’s t b o t ll a ha a s m s, t’ r W e i fo ? Y if g h s, n u e ti H Y ai w o, N Pacheco ObGyn 2017

Management of PPH: TXA Management of PPH: TXA Maternal Death • WOMAN trial: 20,060 women with PPH after VD or CS • RCT: 1g IV TXA or placebo • Outcomes: death from hemorrhage, death from all causes, or hysterectomy • Funding: London School of Hygiene & Tropical Medicine, Pfizer, UK Dept Health, Wellcome Trust, Bill & Melinda Gates Foundation

WOMAN Trial Lancet 2017 WOMAN Trial Lancet 2017

8 Management of PPH: TXA Management of Hemorrhage Laparotomy for bleeding by subgroup Tranexamic Acid (TXA) Protocol

WOMAN Trial Lancet 2017

Skin Closure Management of Hemorrhage

• Topical recombinant activated Factor VII – Case series, 5 pts with previa, 5 controls, Denmark – “swab” soaked in saline containing recombinant activated Factor VII (1 mg in 246 ml) applied to placental bed, repeated x1 prn – Median EBL 490 ml (300-800 ml) – No changes in thrombin, fibrinogen, PTT, INR, plts

Schjoldager AJOG 2017

9 Skin Closure: Re-approximation of subQ Skin Staples, Suture, or Glue? • A few meta-analyses – Some included all pt, others included those with > 2cm subQ fat – 3-0 plain gut, 2-0 polyglactin, 3–0 polyglycolic mostly running stitches – Decreased wound complications, NNT = 16

Pergialiotis BJOG 2017, Chelmow 2004, Cochrane 2006

Staples vs. SubQ Suture Suture vs. Suture

• A few RCTs, 2 meta-analyses • Staples quicker (by ~5-9 min) • Pts often prefer suture • Sutures fewer wound infections/ breakdowns – NNT 16 • Comparison of Subcuticular Suture Type for Skin Closure After • Sew if there is time Cesarean Delivery: A Randomized Controlled Trial • RCT: Monocryl vs Vicryl • Composite wound measure: 8.8% vs 14.4% • No difference when analyzed by actual suture used Frishman 1997, Tuuli 2011, Clay 2011 Buresch, AM et al. Obstetrics & Mackeen 2014 Gynecology130(3):521-526, September 2017. doi: 10.1097/AOG.0000000000002200

10 Conclusions SubQ Suture vs Skin Glue • Maybe: • Yes: • A few small studies, – Add azithro – Prophylactic Atbx (pre- – Prep vagina 1 RCT (107 pts) incision, add azithro if – Family-friendly • No difference: risk mod-high) – Blunt or sharp abdominal – ERAS – OR time entry • No: – wound disruption (?) – Repair of uterus in or out – Not ready for aF7 – scar scores – 1 or 2 layer closure of – Gluing, stapling skin – NOT POWERED uterus – TXA for PPH – Monocryl for skin Daykan AJOG 2017

Thank You!

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