Randomized comparison of subcutaneous tissue reapproximation alone and in combination with...

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227 CHORIONIC VILLUS SAMPLING INCREASES THE ALPHA-FETOPROTEIN LEVEL BUT NOT THE NUMBER OF FETAL ERYTHROCYTES IN MATERNAL BLOOD DENISE PELIKAN 1 , SICCO SCHERJON 1 , WILMA MESKER 2 , GODELIEVE GROOT - SWINGS 1 , HANS TANKE 2 , HUMPHREY KANHAI 1 , 1 Leiden University, Obstetrics, Leiden, Netherlands, Netherlands, 2 Leiden University, Molecular Cell Biology, Leiden, Netherlands, Netherlands OBJECTIVE: To investigate the relation between alpha-fetoprotein (AFP) levels and the number of fetal erythrocytes in maternal blood before and after chorionic villus sampling (CVS). STUDY DESIGN: Blood samples of 53 women between 11 and 13 gestational weeks undergoing CVS, were collected 15 minutes before and after CVS. All pregnancies were cytogenetically normal. A biopsy forceps (n = 47) and a canula (n = 3) were used for transcervical CVS. An aspiration needle (n = 3) was used for transabdominal sampling. The AFP measurements were performed in a single run using the Chemiluminescent Microparticle Immunoassay. Super- vised automated microscopy of Kleihauer-Betke stained slides was applied to quantify fetal erythrocytes. Per sample G 2.0x106 cells were evaluated. RESULTS: AFP measurements before and after CVS were obtained in 48 patients, whereas paired slides were complete in 50 patients. The mean AFP level before CVS was 13.9 mg/L (range 6.4-36.4, median 11.7, SD 7.3, SEM 1.1, 95% CI 11.8-16.0) and after CVS 37.2 mg/L (range 8.2-241.7, median 18.4, SD 46.4, SEM 6.7, 95% CI 23.7-50.7), indicating a significant increase of the AFP level in maternal plasma after CVS (Wilcoxon signed ranks test, P ! .0001). The mean number of fetal erythrocytes before CVS was 1.5 (range 0–24, median 0, SD 3.8, SEM 0.5, 95% CI 0.4–2.6) and after CVS 2.0 (range 0 – 23, median 1.0, SD 4.4, SEM 0.6, 95% CI 0.7–3.2). There was no significant increase in the fetal erythrocyte count before versus after CVS (Wilcoxon signed ranks test, P = .327). Consequently, the correlation between the fetal erythrocyte difference before and after CVS and the AFP level difference was not significant (r = ÿ0.13, P = .39). CONCLUSION: Although an increase was found in AFP levels after CVS, no increase in fetal erythrocytes could be detected. This suggests that the CVS procedure results in a leakage of proteins due to placental tissue damage, rather than increased trafficking of fetal cells through the placental barrier. 228 OBSTETRIC HEMORRHAGE AND MATERNAL MORTALITY: IMPROVEMENT IN OUTCOME THROUGH SYSTEMATIC CHANGE DANIEL SKUPSKI 1 , ISAAC LOWENWIRT 2 , GARY EGLINTON 3 , 1 Cornell University Medical College, Obstetrics and Gynecology, Flushing, New York, 2 New York Hospital Queens, Anesthesiology, Flushing, New York, 3 New York Hospital Queens, Obstetrics and Gynecology, Flushing, New York OBJECTIVE: Obstetric hemorrhage (major bleed) and cesarean hysterectomy (C-hyst) rates have increased because of increasing rates of cesarean delivery (CD) and subsequent complications. Two maternal deaths due to obstetric hemorrhage in 2000-1 at our hospital prompted systematic change. Our objective was to provide a clinical pathway for obstetrical patients at risk for hemorrhage. STUDY DESIGN: In early 2001, systematic change was instituted through an interdisciplinary task force including personnel from anesthesiology, neonatol- ogy, nursing, the blood bank, maternal-fetal medicine, administration, physician members of the trauma team and the OR staff. A rapid response team was formulated using the cardiac arrest team as a model. Mock drills of the rapid response team on all shifts occur quarterly. Protocols for assessment and management of patients at high risk for obstetric hemorrhage were developed and popularized. Major hemorrhage was defined as EBL >1500 mL, need for uterine packing, uterine artery ligation, blood transfusion and/or hysterectomy. Chi-square analysis was used. RESULTS: There was a substantial increase in the number of deliveries overall and in cases of obstetric hemorrhage from 2000-4. There was an improvement in maternal mortality between 2000-1 and 2002-4 (P = .08). 11/17 C-hyst cases were associated with prior CD and accreta. CONCLUSION: There is a 92% probability that our observed improvement in maternal mortality due to obstetric hemorrhage between the time periods studied is a true improvement attributable to our systematic change process. Attempts to limit CD need to be studied in an effort to prevent maternal mortality from obstetric hemorrhage. OB hemorrhage at NYHQ 2000-2004 Year Births CD Major bleed C-hyst Mat. mort. 2000 2718 516 3 1 1 2001 3111 801 8 5 1 2002 3337 903 8 5 0 2003 3393 932 14 4 0 2004 589 135 3 1 0 229 RANDOMIZED COMPARISON OF SUBCUTANEOUS TISSUE REAPPROXIMATION ALONE AND IN COMBINATION WITH SUBCUTANEOUS DRAIN IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY PATRICK RAMSEY 1 , ANNA WHITE 1 , DEBRA GUINN 2 , GEORGE LU 3 , LINDA FONSECA 4 , ASHLEY CASE 1 , DWIGHT ROUSE 1 , 1 University of Alabama at Birmingham, Obstetrics/Gynecology, Birmingham, Alabama, 2 Northwest Perinatal Center and Women’s Healthcare Associates, Obstetrics/Gynecology, Portland, Oregon, 3 Obstetrix Medical Group of Kansas & Missouri, Kansas City, Missouri, 4 University of Texas Health Science Center at Houston, Obstetrics, Gynecology and Reproductive Sciences, Houston, Texas OBJECTIVE: To compare the efficacy of subcutaneous (SQ) suture reapprox- imation alone to suture plus SQ drain for the prevention of wound complications in obese women undergoing cesarean delivery. STUDY DESIGN: We conducted a prospective multicenter randomized trial of obese women undergoing cesarean delivery. Women preoperatively consented and only those with R4 cm of SQ thickness documented at fascial closure were randomized to either SQ suture closure alone (N = 148) or suture plus SQ drain (N = 132). Women receiving the drain had it placed to bulb suction and was removed at 72 hrs or earlier if output !30 mL/24 hour. The primary study outcome was a composite wound complication rate (defined by any of the following noted at the wound assessment: wound dehiscence, seroma, hema- toma, or abscess). RESULTS: From 04/01-07/04 a total of 280 women were enrolled. Ninety-four percent of women (264/280) had a follow-up wound assessment. Both groups were similar with respect to age, parity, weight, cesarean indication, diabetes, steroid/antibiotic use, chorioamnionitis, and SQ thickness. The overall compos- ite wound complication rate was 16.9% (24/142) in the suture group and 23.0% (28/122) in the suture + drain group (RR 1.4: 95% CI 0.8-2.2, P = .22). Individual wound complication rates are shown in the Table. CONCLUSION: The additional use of a SQ drain to a standard SQ suture reapproximation technique is not effective for the prevention of wound com- plications in obese women undergoing cesarean delivery. Individual wound complication rates Outcome Suture alone (n = 142) Suture + drain (n = 122) RR (95% CI) P value Wound dehiscence (%) 15.8 22.1 1.4 (0.9-2.4) .17 Seroma (%) 8.5 10.7 1.3 (0.6-2.7) .53 Hematoma (%) 2.1 2.5 1.2 (0.2-5.7) 1.0 Abscess (%) 0.7 3.3 4.7 (0.5-41) .2 Fascial dehiscence (%) 1.4 1.7 1.2 (0.2-8.5) 1.0 Readmission for wound complication (%) 2.8 6.7 2.4 (0.7-7.7) .15 230 RISK FACTORS FOR WOUND COMPLICATIONS IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY ANNA WHITE 1 , PATRICK RAMSEY 1 , DEBRA GUINN 2 , GEORGE LU 3 , SUSAN RAMIN 4 , ASHLEY CASE 1 , DWIGHT ROUSE 1 , 1 University of Alabama at Birmingham, Obstetrics/Gynecology, Birmingham, Alabama, 2 Northwest Perinatal Center and Women’s Healthcare Associates, Obstetrics/Gynecology, Portland, Oregon, 3 Obstetrix Medical Group of Kansas & Missouri, Obstetrics/ Gynecology, Kansas City, Missouri, 4 University of Texas Health Science Center at Houston, Obstetrics/Gynecology, Houston, Texas OBJECTIVE: To characterize demographic, antepartum, and intrapartum risk factors for wound complications among obese women undergoing cesarean delivery. STUDY DESIGN: This study was a secondary analysis of data from a pro- spective multicenter randomized clinical trial of wound closure techniques for obese women undergoing cesarean delviery. Women enrolled in the trial had R4 cm of SQ thickness documented at fascial closure and received similar perioperative management aside from the SQ closure technique (suture vs suture plus drain). The primary study outcome was a composite wound complication rate (defined by any of the following noted at the formal wound assessment: wound dehiscence, seroma, hematoma, or abscess). RESULTS: Of the 280 women enrolled in the trial, wound assessment data was available on 94%. The overall composite wound complication rate was 19.7% (52/264). Women with and without wound complications were similar with respect to age, gestational age at cesarean, labor type, peripartum antibiotic use, surgery length, and antepartum steroid use. Significant differences were noted between the two groups with respect to recruitment center (P = .03), race (P = .03), indication for cesarean (P = .003), type of skin incision (P ! .0001), nulliparity (P = .01), insulin dependent diabetes (P = .004) and SQ thickness (P = .005). In a multivariable model, including factors included which were significant in the univariate analysis, only arrested labor (OR 3.3; 95% CI 1.2- 8.8), fetal distress (OR 3.1; 95% CI 1.2-8.6), vertical/paramedian skin incision (OR 3.1; 95% CI 1.2-7.9) and SQ thickness R6 cm (OR 2.3; 95% CI 1.1-4.9), were significantly associated with composite wound complication. CONCLUSION: Risk factors for wound complications in obese women undergoing cesearean delivery include the arrested labor and fetal distress indications for cesarean, vertical/paramedian skin incision and SQ thickness R6 cm. S72 SMFM Abstracts

Transcript of Randomized comparison of subcutaneous tissue reapproximation alone and in combination with...

227 CHORIONIC VILLUS SAMPLING INCREASES THE ALPHA-FETOPROTEIN LEVEL BUTNOT THE NUMBER OF FETAL ERYTHROCYTES IN MATERNAL BLOOD DENISE PELIKAN1,SICCO SCHERJON1, WILMA MESKER2, GODELIEVE GROOT - SWINGS1, HANS TANKE2,HUMPHREY KANHAI1, 1Leiden University, Obstetrics, Leiden, Netherlands,Netherlands, 2Leiden University, Molecular Cell Biology, Leiden, Netherlands,Netherlands

OBJECTIVE: To investigate the relation between alpha-fetoprotein (AFP)levels and the number of fetal erythrocytes in maternal blood before and afterchorionic villus sampling (CVS).

STUDY DESIGN: Blood samples of 53 women between 11 and 13 gestationalweeks undergoing CVS, were collected 15 minutes before and after CVS. Allpregnancies were cytogenetically normal. A biopsy forceps (n = 47) and a canula(n = 3) were used for transcervical CVS. An aspiration needle (n = 3) was usedfor transabdominal sampling. The AFP measurements were performed ina single run using the Chemiluminescent Microparticle Immunoassay. Super-vised automated microscopy of Kleihauer-Betke stained slides was applied toquantify fetal erythrocytes. Per sample G 2.0x106 cells were evaluated.

RESULTS: AFP measurements before and after CVS were obtained in 48patients, whereas paired slides were complete in 50 patients. The mean AFP levelbefore CVS was 13.9 mg/L (range 6.4-36.4, median 11.7, SD 7.3, SEM 1.1, 95%CI 11.8-16.0) and after CVS 37.2 mg/L (range 8.2-241.7, median 18.4, SD 46.4,SEM 6.7, 95% CI 23.7-50.7), indicating a significant increase of the AFP level inmaternal plasma after CVS (Wilcoxon signed ranks test, P ! .0001).

The mean number of fetal erythrocytes before CVS was 1.5 (range 0–24,median 0, SD 3.8, SEM 0.5, 95% CI 0.4–2.6) and after CVS 2.0 (range 0 – 23,median 1.0, SD 4.4, SEM 0.6, 95% CI 0.7–3.2). There was no significant increasein the fetal erythrocyte count before versus after CVS (Wilcoxon signed rankstest, P = .327). Consequently, the correlation between the fetal erythrocytedifference before and after CVS and the AFP level difference was not significant(r = �0.13, P = .39).

CONCLUSION: Although an increase was found in AFP levels after CVS, noincrease in fetal erythrocytes could be detected. This suggests that the CVSprocedure results in a leakage of proteins due to placental tissue damage, ratherthan increased trafficking of fetal cells through the placental barrier.

228 OBSTETRIC HEMORRHAGE AND MATERNAL MORTALITY: IMPROVEMENT IN OUTCOMETHROUGH SYSTEMATIC CHANGE DANIEL SKUPSKI1, ISAAC LOWENWIRT2,GARY EGLINTON3, 1Cornell University Medical College, Obstetrics andGynecology, Flushing, New York, 2New York Hospital Queens,Anesthesiology, Flushing, New York, 3New York Hospital Queens, Obstetricsand Gynecology, Flushing, New York

OBJECTIVE: Obstetric hemorrhage (major bleed) and cesarean hysterectomy(C-hyst) rates have increased because of increasing rates of cesarean delivery(CD) and subsequent complications. Two maternal deaths due to obstetrichemorrhage in 2000-1 at our hospital prompted systematic change. Our objectivewas to provide a clinical pathway for obstetrical patients at risk for hemorrhage.

STUDY DESIGN: In early 2001, systematic change was instituted through aninterdisciplinary task force including personnel from anesthesiology, neonatol-ogy, nursing, the blood bank, maternal-fetal medicine, administration, physicianmembers of the trauma team and the OR staff. A rapid response team wasformulated using the cardiac arrest team as a model. Mock drills of the rapidresponse team on all shifts occur quarterly. Protocols for assessment andmanagement of patients at high risk for obstetric hemorrhage were developedand popularized. Major hemorrhage was defined as EBL >1500 mL, need foruterine packing, uterine artery ligation, blood transfusion and/or hysterectomy.Chi-square analysis was used.

RESULTS: There was a substantial increase in the number of deliveries overalland in cases of obstetric hemorrhage from 2000-4. There was an improvement inmaternal mortality between 2000-1 and 2002-4 (P= .08). 11/17 C-hyst caseswere associated with prior CD and accreta.

CONCLUSION: There is a 92% probability that our observed improvement inmaternal mortality due to obstetric hemorrhage between the time periods studiedis a true improvement attributable to our systematic change process. Attempts tolimit CD need to be studied in an effort to prevent maternal mortality fromobstetric hemorrhage.

OB hemorrhage at NYHQ 2000-2004

Year Births CD Major bleed C-hyst Mat. mort.

2000 2718 516 3 1 12001 3111 801 8 5 12002 3337 903 8 5 02003 3393 932 14 4 02004 589 135 3 1 0

S72 SMFM Abstracts

229 RANDOMIZED COMPARISON OF SUBCUTANEOUS TISSUE REAPPROXIMATION ALONEAND IN COMBINATION WITH SUBCUTANEOUS DRAIN IN OBESE WOMENUNDERGOING CESAREAN DELIVERY PATRICK RAMSEY1, ANNA WHITE1,DEBRA GUINN2, GEORGE LU3, LINDA FONSECA4, ASHLEY CASE1, DWIGHT ROUSE1,1University of Alabama at Birmingham, Obstetrics/Gynecology, Birmingham,Alabama, 2Northwest Perinatal Center and Women’s Healthcare Associates,Obstetrics/Gynecology, Portland, Oregon, 3Obstetrix Medical Group of Kansas& Missouri, Kansas City, Missouri, 4University of Texas Health Science Centerat Houston, Obstetrics, Gynecology and Reproductive Sciences, Houston, Texas

OBJECTIVE: To compare the efficacy of subcutaneous (SQ) suture reapprox-imation alone to suture plus SQ drain for the prevention of wound complicationsin obese women undergoing cesarean delivery.

STUDY DESIGN: We conducted a prospective multicenter randomized trial ofobese women undergoing cesarean delivery. Women preoperatively consentedand only those with R4 cm of SQ thickness documented at fascial closure wererandomized to either SQ suture closure alone (N = 148) or suture plus SQ drain(N = 132). Women receiving the drain had it placed to bulb suction and wasremoved at 72 hrs or earlier if output !30 mL/24 hour. The primary studyoutcome was a composite wound complication rate (defined by any of thefollowing noted at the wound assessment: wound dehiscence, seroma, hema-toma, or abscess).

RESULTS: From 04/01-07/04 a total of 280 women were enrolled. Ninety-fourpercent of women (264/280) had a follow-up wound assessment. Both groupswere similar with respect to age, parity, weight, cesarean indication, diabetes,steroid/antibiotic use, chorioamnionitis, and SQ thickness. The overall compos-ite wound complication rate was 16.9% (24/142) in the suture group and 23.0%(28/122) in the suture + drain group (RR 1.4: 95% CI 0.8-2.2, P = .22).Individual wound complication rates are shown in the Table.

CONCLUSION: The additional use of a SQ drain to a standard SQ suturereapproximation technique is not effective for the prevention of wound com-plications in obese women undergoing cesarean delivery.

Individual wound complication rates

OutcomeSuturealone (n = 142)

Suture + drain(n = 122) RR (95% CI) P value

Wound dehiscence (%) 15.8 22.1 1.4 (0.9-2.4) .17Seroma (%) 8.5 10.7 1.3 (0.6-2.7) .53Hematoma (%) 2.1 2.5 1.2 (0.2-5.7) 1.0Abscess (%) 0.7 3.3 4.7 (0.5-41) .2Fascial dehiscence (%) 1.4 1.7 1.2 (0.2-8.5) 1.0Readmission for wound

complication (%)2.8 6.7 2.4 (0.7-7.7) .15

230 RISK FACTORS FOR WOUND COMPLICATIONS IN OBESE WOMEN UNDERGOINGCESAREAN DELIVERY ANNA WHITE1, PATRICK RAMSEY1, DEBRA GUINN2, GEORGE LU3,SUSAN RAMIN4, ASHLEY CASE1, DWIGHT ROUSE1, 1University of Alabama atBirmingham, Obstetrics/Gynecology, Birmingham, Alabama, 2NorthwestPerinatal Center and Women’s Healthcare Associates, Obstetrics/Gynecology,Portland, Oregon, 3Obstetrix Medical Group of Kansas & Missouri, Obstetrics/Gynecology, Kansas City, Missouri, 4University of Texas Health Science Centerat Houston, Obstetrics/Gynecology, Houston, Texas

OBJECTIVE: To characterize demographic, antepartum, and intrapartum riskfactors for wound complications among obese women undergoing cesareandelivery.

STUDY DESIGN: This study was a secondary analysis of data from a pro-spective multicenter randomized clinical trial of wound closure techniques forobese women undergoing cesarean delviery. Women enrolled in the trial had R4cm of SQ thickness documented at fascial closure and received similarperioperative management aside from the SQ closure technique (suture vssuture plus drain). The primary study outcome was a composite woundcomplication rate (defined by any of the following noted at the formal woundassessment: wound dehiscence, seroma, hematoma, or abscess).

RESULTS: Of the 280 women enrolled in the trial, wound assessment data wasavailable on 94%. The overall composite wound complication rate was 19.7%(52/264). Women with and without wound complications were similar withrespect to age, gestational age at cesarean, labor type, peripartum antibiotic use,surgery length, and antepartum steroid use. Significant differences were notedbetween the two groups with respect to recruitment center (P= .03), race(P = .03), indication for cesarean (P = .003), type of skin incision (P ! .0001),nulliparity (P = .01), insulin dependent diabetes (P = .004) and SQ thickness(P = .005). In a multivariable model, including factors included which weresignificant in the univariate analysis, only arrested labor (OR 3.3; 95% CI 1.2-8.8), fetal distress (OR 3.1; 95% CI 1.2-8.6), vertical/paramedian skin incision(OR 3.1; 95% CI 1.2-7.9) and SQ thickness R6 cm (OR 2.3; 95% CI 1.1-4.9),were significantly associated with composite wound complication.

CONCLUSION: Risk factors for wound complications in obese womenundergoing cesearean delivery include the arrested labor and fetal distressindications for cesarean, vertical/paramedian skin incision and SQ thicknessR6 cm.