Cervical Insufficiency (Cervical Incompetence) aka “too easy out” Brian McCulloch MD Maternal – Fetal Medicine March 5, 2011 FIRST RECOGNIZED IN 1658 BY COLE AND CULPEPPER THE MANAGEMENT HAS BEEN MORE SO SURGICAL THAN MEDICAL ABRAHAM LASH AND HIS BROTHER WORKING HERE IN CHICAGO REMOVED A PIECE OF TISSUE FROM THE Cx ISTHMUS AREA IN THE NON PREGNANT STATE (THIS LEFT ~ 45 % INFERTILITY ) V.N. SHIRODKAR FROM BOMBAY INDIA IN 1955 ADVOCATED ENCIRLING THE INCOMPETENT CERVIX WITH FASCIA LATA. HE PLACED THE SUTURE MEDIAL TO THE BLOOD VESSELS IAN MCDONALD FROM MELBOURNE AUSTRLIA IN 1957 COMPILED 70 CASES MOSTLY BETWEEN 20 – 24 WEEKS NO SUCCESS LESS THAN 20 WEEKS NO TOCOLYSIS EVEN TRIED TO TIE AMNION PERFORATIONS EMBRYLOGICALLY IT IS DERIVED FROM THE FUSION OF THE MULLERIAN DUCTS AND SUBSEQUENT CENTRAL ATROPHY THE CERVIX IS PRIMARILY FIBROUS TISSUE WITH SOME MUSCLE THE PROXIMAL CERVIX MAY HAVE UP TO 29 % MUSCLE AND THE DISTAL PORTION LESS THAN 10 % DURING PREGNANCY THE MUSCULAR UTERINE ISTHMUS DISTENDS AND ELONGATES BETWEEN 12 TO 20 WEEKS BEFORE 15 WEEKS CERVICAL MEASUREMENTS ARE DIFFICULT ON ULTRASOUND AND NOT RECOMMENDED NON PREGNANT CERVICAL TEST ARE INACCURATE OR UNPROVEN AND NOT RECOMMENDED TO Dx INSUFFICENCY HEGAR DILATOR SIZE 8 TRACTION TEST USING AN INFLATED FOLEY CATHETER INTERNAL OS MEASUREMENT >8mm ON HYSTEROSALPINGOGRAM If a Non – Pregnant HSG or a Sonohysterogram or a MRI does diagnose a septum or anatomic abnormality then it can help alert the clinician to the possibility of a cervical issue or a factor leading to preterm delivery . ONE PER 222 DELIVERIES TO ONE PER 182 DELIVERIES ACOG PRACTICE BULLETIN 2004 OTHER AUTHORS HAVE A WIDER RANGE OF 1 IN A THOUSAND TO 1 IN A HUNDRED LUTHERAN GENERAL HOSPITAL CERCLAGE STATISTICS 1989 78 1990 62 1991 48 Gradual painless dilatation and effacement of the cervix with bulging and later rupture of the membranes Typically short labor Progressively shorter labors with subsequent deliveries Progressively earlier deliveries Vaginal or lower abdominal pressure Frequent urination Increased vaginal discharge (watery) Bloody or mucus discharge Congenital Mullerian anomalies with the highest risk with bicornuate and unicornuate utrei Abnormal uterine shape Also abnormal cervical muscular content( Ehlers – Danlos syndrome ) Acquired incompetence Traumatic cervical procedures (cone bx) Cone bx’s with a height of > 2 cms is a risk factor Obstetrical cervical lacerations Iatrogenic Embryological Drug induced (DES) (about 25 % have structural defects) THE INCIDENCE OF PRETERM BIRTH IN THE USA HAS BEEN INCREASING FROM 9.4 % IN 1981 TO 12.7 % in 2007 Martin Nat. Vital Stat. Rep 2009;57:1 - 102 RELIANCE ON RISK FACTORS ALONE WILL FAIL TO IDENTIFY MORE THAN 50 % OF PREGNANCIES THAT DELIVER< 37 WEEKS CREASY AJOG 1980 MERCER AJOG 1996 DIGITAL EXAMINATION SPECULUM EXAM TRANSABDOMINAL ULTRASOUND TRANSPERINEAL OR TRANSLABIAL ULTRASOUND TRANSVAGINAL ULTRASOUND Ultrasound assessment of the cervix Vincenzo Berghella MD 2003 Trans abdominal scanning needs a full maternal bladder and can therefore elongate the cx length can be very difficult to see the external os Transperineal cervical measurements Gas of the rectum will hamper visualization of the cx especially the external os Transvaginal technique Enlarge the image so that it occupies about two thirds of the total image Obtain 3 images and record the shortest. Transfundal pressure should be for about 15 seconds Generally sonographers should be supervised for about 50 procedures. Check the Equipment – – Appropriately cleaned w/ soap & water + soaked Use 5 to 7 MHz endovaginal probe – Make sure the image is set to “EV” Don’t use 8 MHz – poor tissue penetration (endovaginal ) Not Obstetrical or Abdominal Empty Maternal Bladder – – Void just before the exam If bladder is seen to be large, stop exam & void again CONSISTENTLY UNDERESTIMATES THE CERVICAL LENGTH COMPARED TO VAGINAL PROBE ULTRASOUND HIGHLY SUBJECTIVE NON- STANDARDIZED SERIAL DIGITAL EXAMS IN THE MID TO LATE SECOND TRIMESTER IS USEFUL IF THE EXAM REMAINS NORMAL UNFORTUNATELY ABNORMAL CERVICAL FINDINGS ARE ASSOCIATED WITH ONLY 12 - 20 % OF HIGH RISK PRETERM DELIVERES AND EVEN LESS IN THE LOW RISK PATIENTS ~ 4 % THERE IS A STRONG REPRODUCIBLE INVERSE CORRELATION BETWEEN CX LENGTH AND PRETERM DELIVERY IF THE CX LENGTH IS LESS THAN 10 % (25 mm) THERE IS A 6 FOLD INCREASED RISK OF DELIVERY PRIOR TO 35 WEEKS IAMS NEJM 1996;334:567-57 PROGRESSIVE CX SHORTENING TO 20 mm OR LESS FUNNEL LENGTH >16 mm OR FUNNELING >40 % MEASUREMENTS MUST BE OBTAINED TRANSVAGINALLY WHY IS LENGTH RELATED TO PRETERM DELIVERY ? OCCULT CONTRATIONS BIOLOGIC VARIATION LOWER TRACT INFECTION UPPER TRACT INFECTION CX LENGTH OF LESS THAN 15 mm AT 23 WEEKS OCCURS IN LESS THAN 2 % OF LOW RISK WOMEN WHEN THIS DOES OCCUR IT IS PREDICTIVE OF PTD < 28 WEEKS IN 60 % OF CASES < 32 WEEKS IN 90 % OF CASES Where to Put the Calipers? Where the anterior and posterior walls of the canal touch Spend enough time to see whether a small echolucent area is stable or is going to open up YES NO BERGHELLA’S STUDY IN JAMA IN 2001 SHOWED A SENSITIVITY OF 69% BUT IF ONLY THE INITIAL MEASUREMENT WAS USED (16-18 wks) THEN THE SENSITIVITY WENT DOWN TO 19% VIABLE DELIVERY RATE OF 70 – 90 % A LOWER RATE OF DELIVEY PRIOR TO 33 WEEKS (13 % COMPARED TO CONTROL OF 17 %) General a higher rate of tocolysis usage 34% vs 27 % Higher puerperal infections 6% vs 3 % CERLAGE GROUP HAD LESS DELIVERIES BEFORE 37 WEEKS BUT NO DIFFERENCE LESS THAN 35 WEEKS CERCLAGE HELPED IF CX LENGTH WAS <25mm’s BUT IT DID NOT CHANGE THE OUTCOME IF VERY SHORT CX <15mm’s TWINS HAD A INCREASED DELIVERY LESS THAN 35 WEEKS AND A HIGHER PERINATAL MORTALITY NUMEROUS STUDIES HAVE CONFIRMED THE ASSOCIATION OF CERVICAL SHORTENING AND PTB REVIEW OF 35 STUDIES HAD SHOWN SENSITIVITY FROM 68 – 100 % SPECIFICITIES FROM 44 – 79 % PROSPECTIVE STUDY OF 2900 WOMEN AT 24 AND AGAIN 28 WEEKS (LEVEL II-B STUDY ) 40mm 35mm 30mm 26mm 22mm 13mm RR=2.8 PTD RR =3.52 RR =5.39 RR= 9.57 RR=13.88 RR=24.94 VAGINAL PROBE MEASUREMENTS CAN SUPPORT A DIAGNOSIS OF CERVICAL INCOMPETENCE BUT SHOULD NOT BE THE SOLE CRITERIA RESIDUAL CERVICAL LENGTH IS MORE IMPORTANT THAN THE OTHER MEASUREMENTS RR OF PTD AS CX LENGTH SHORTENED 25 20 15 RR 10 5 0 40 35 30 26 22 13 ROUTINE USE OF CX LENGTH IS NOT RECOMMENDED BECAUSE IT LACKS ENOUGH DISCRIMINATORY POWER INTRINSIC WEAK CERVICOISTHMIC JUNCTION SOME STUDIES HAVE FOUND THIS TO BE AN INDEPENDENT RISK FACTOR FOR PTB ( INDEPENDENT OF CX LENGTH ) CERVICAL STRESS TEST Transvaginal Cervical Sonography Illustration by James Cooper MD Found in Callen, 4th edition 20 years ago Zilianti described the continuum from a “T “ to a “ Y” to a “V “ and finally to a “U” shaped lower segment. Moderate funneling defined as 25- 50% cervical shortening had a increased preterm birth of 50 % Cervical Effacement = T Y V U T Y V U Zilanti M, et al: JUM 1995 If the cervical length is deviated (defined as greater than 5mm from straight) then 2 straight lines should be used. Usually a short Cx not deviated If the cx canal is closed then the only measurement that is necessary is the cervical length . Don’t Trace to Measure the Cervical Length If the is > 3 mm, use two measures SHOULD BE REPORTED TO THE PATIENT REPEAT IN 1 – 2 WEEKS OPTION OF CERCLAGE BED REST / RESTRICTED ACTIVITY DISCUSSED DIFFERENT FOR MULTIPLE GESTATION ? PTD IN CURRENT PREGNANCY HISTORY OF PTD INDEPENDENT OF OTHER RISK FACTORS: RACE , Ffn , BLEEDING , BACTERIAL VAGINOSIS ,BMI ,CONTRACTIONS RANDOMIZED 61 SINGLETON FUNNEL 1.5 cms WIDE 1.8 cms DEEP McDONALD vs OBSERVATION NO DIFFERENCE IN OUTCOME MORE PTD LESS THAN 34 WEEKS , LESS DELIVERIES BEFORE 28 WEEKS IF CERCLAGE Randomized study of prophylactic cerclage in twins showed no benefit GOI 1982 13:55 Cerclage in multiples with shortened cervix also showed no benefit ajog 2002 186 634 CX LENGTH IS NORMALLY DISTRIBUTED LENGTH INVESELY RELATED TO PTD RISK T –Y –V –U AT ALL GESTATIONAL AGES LENGTH MORE IMPORTANT THAN FUNNEL CX SONOGRAPHY NOT EQUAL TO PTD PREVENTION Between 22 and 30 weeks of gestation, the length of the cervix is described by a normal bell-shaped curve 5th percentile at 20 mm 10th percentile at 25 mm 50th percentile at 35 mm 90th percentile at 45 mm Cervical Effacement = T Y V U T Y V U Zilanti M, et al: JUM 1995 PRACTICE MAKES PERFECT PELIC EXAM INITIALLY COAT THE EXTERNAL OS WITH GEL MATERNAL BLADDER EMPTY ANTERIOR FORNIX THEN INTERNAL OS EXTERNAL OS NEXT FUNDAL PRESSURE 10 – 15 SEC MOST AUTHORS FEEL THEY ARE ADDITIVE IN HELPING PREDICT PRETERM BIRTH HIGH RISK WOMEN WITH A CX LENGTH OF < 25mm AND A POSITIVE fFN HAVE A 65 % CHANCE OF DELIVERY AT < 35 WEEKS IAMS AJOG 1998;178:1035-1040 ULTRASOUND AND fFN TESTING MAY BE HELPFUL IN DETERMINING WOMEN AT HIGH RISK FOR PTD HOWEVER THEIR CLINICAL USEFULNESS MAY REST WITH THEIR NEGATIVE PREDICTIVE VALUE Debris: Mobile Variable Echogenic Material Near the Cervix Intramniotic debris ( Sludge ) Sonographic finding of hyperechoic matter floating in the amniotic fluid Possible cellular material related to infection or inflammation A high correlation with poorer prognosis A Cx length <25 mm between 16 and 24 weeks has been shown to be the most reliable threshold for a increased risk of preterm delivery. Two Randomized trials (cerclage for short cervix) Rust study:(2001) 113 women all with either Cx length 2.5 or funneling 25% 47% had preterm birth and 20% had a prior 2nd trimester loss and there were 8 rescue cerclages, and 16 % had twins Used indocin for all patients Cerclage in this group did not change the preterm delivery rate Althuisius’ study: (2001) was smaller 35 women with a good history for Cx insufficiency Short Cx only were excluded 74 % had a prior preterm birth and 46 % had a 2nd trimester loss and only 2 rescue cerclages Indocin used in cerclage arm only Cerclage did show a decreased preterm delivery rate Cerclage for prior preterm delivery in women with a short cervix Owens 1014 2009 screened 302 randomized Decreased the previable rate <24 weeks Birth rate less than 35 weeks was unchanged unless the cervix was especially short <15 mm