66 An aggressive, interventional protocol for previable premature rupture of the membranes (PROM)

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Volume 185, Number 6 AmJ Obstet Gynecol 65 FIRST TRIMESTER CYSTIC HYGROMA--A POPULATION BASED SCREENING STUDY (THE FASTER TRIAL) FERGAL D. MALONE 1, ROBERT H. BALL2, DAVID A. NYBERG3, SUSAN J. GROSS4, CHRISTINE H. COMSTOCK5, GEORGE R. SAADE6, KEITH A. EDDLEMAN 7, SABRINA D. CRAIGO 8, ILAN E. TIMOR 9, STEPHEN R. CARR 1°, JOHN C. HOBBINS n, KIMBERLY A. DUKES 12, FELIX DE LA CRUZ 15, MARY E. D'ALTON1; 1Columbia University, Maternal Fetal Medicine, New York, NY; 2University of Utah Medical Center, Salt Lake City, UT; 3Swedish Medical Center, Seattle, WA; 4Montefiore Medical Center, Bronx, NY; 5William Beaumont Hospital, Royal Oak, MI; 6University of Texas Medical Branch, Galveston, TX; 7Mount Sinai Medical Center, New York, NY: 8New England Medical Center, Boston, MA; 9NYU Medical Center, New York, NY; 10Women and Infants Hospital, Providence, RI; UUniversity of Colorado Health Sciences Center, Denver, CO; 12DM-STAT, Boston, MA; 13National Institute of Child Health and Human Development, Bethesda, MD OBJECTIVE: Current data on outcome of cystic hygromas are limited to retrospective case series. To our knowledge no population based screening data are available. Our objective was to define the outcome of fetuses diag- nosed with cystic hygroma in the first trimester in an unselected population. STUDY DESIGN: The FASTER Trial is a muhicenter study evaluating first and second trimester screening programs for aneuploidy. All patients have a nnchal translucency (NT) ultrasound at 10-14 weeks, performed only by specially trained staff: All patients are followed to pregnancy completion using a computerized tracking system. Cystic hygroma (increased NT with septations) is an exclusion criterion for further FASTER Trial participation. Such patients are offered immediate counseling and diagnosis. We prospec- tively collated outcome data on all cases of cystic hygroma seen in the FASTER Trial. RESULTS: To date 20,645 patients have been enrolled into the FASTER Trial. 61 fetuses had cystic hygroma (incidence 1/338). Karyotype evaluation was performed in 46 cases, yielding 22 euploid fetuses (36%) and 24 aneuploid fetuses (39%) {9 Downs, 7 Turners, 3 trisomy-18, 3 triploidy, 2 trisomy-13}. For euploid fetuses there were 9 cases of major structural malformation {4 skeletal dysplasia, 3 hypoplastic left heart, 1 multiple pterygium, and 1 pleural effi~sion needing in utero shunt}. Pregnancy was terminated in 32 cases (52%). In 29 continuing pregnancies, there were 6 intrauterine demises (10%), and 9 cases of hygroma resolution with normal outcome (15%). Overall, 43 cases (71%) were classified as bad outcome and 16 (26%) as good outcome. A further 2 cases (3%) did not have pediatric outcome. CONCLUSION: First trimester cystic hygroma is considerably more common than previously thought in the general unselected population. The majority of cases are associated with adverse pregnancy outcome. If first trimester sonograpbic screening is implemented these data will be vital to provide adequate patient counseling. 67 SMFM Abstracts S99 CLINICAL AND IMMUNOLOGICAL FOLLOW UP OF INFANTS BORN AFTER PLATELET TRANSFUSIONS AND TRANSPLACENTAL IMMUNO- GLOBULIN TREATMENT CELINE RADDER t, MONIQUE HAAN DE 2, ELLEN MEER V.D. 3, DAVE ROELEN 3, FRANS CLAAS 3, ANNEKE BRAND 3, HUMPHREY KANHAI4; 1Leiden University Medical Center, Obstetrics, H4-P, Leiden; '-'Leiden University Medical Center, Perinatal Center, J6-S, Leiden; 3Leiden University Medical Center, hnmunohematology, E3-Q, Leiden; 4Leiden University Medical Center, Obstetrics, Kr-P, Leiden OBJECTIVE: Patients with fetal or neonatal alloimmune thrombocyto- penia (FNAIT) are successfully treated with intrauterine platelet transfusions (IUPT) and/or maternally administered intravenoUS imnmnoglobulins (WIG). To the best of our knowledge, the effect of IUPT and MG on the development and long-term follow up of treated children has never been examined. MG is known for its immune suppressive characteristics, thus influencing fetal immunity. STUDY DESIGN: The aim of this study was to examine the effect of IUPT and/or WIG on the maturing fetal immune system by means of lymphocyte subsets of FNAIT-newborns (n = 19) and by means of general and neuro- developmental follow up of FNAIT-children (n = 37, age 2-12 years). RESULTS: Natural Killer cell (CD 56, CD57), mature and inmmture T-cell (CD45RA, CD45R0), mature and immature B<ell (CD5, CD19, CD20, CD38) and activated cell (CD25, CD62L) parameters were analyzed on mononuclear cells in heparinized umbilical cord blood by flow cytometry. Considerable dispersal of values per parameter was observed, but lymphocyte subsets showed no differences compared to randomly chosen healthy newborns. Clinical follow up of 37 children revealed no signs of disturbance of the immune response. Four children had mild neurological or developmental problems and one child had a serious developmental delay. CONCLUSION: The general and neurodevelopmental outcome of chil- dren prenatally treated with IUPT and/or 1VIG is satisfactory. Immunological analysis of cord blood reveals no suppression of a particular subset and no premature development of neonatal immunity, which is in accordance with the clinical outcome. 66 AN AGGRESSIVE, INTERVENTIONAL PROTOCOL FOR PREVIABLE PREMATURE R ~ OF THE MEMBRANES (PROM)JOHN O'BRIEN 1, JOHN BARTON 1, DOUGLAS MILLIGAN 1, 1Central Baptist Hospital, Lexing- ton, KY OBJECTIVE: To evaluate a novel protocol for treatment of previable PROM. STUDY DESIGN: Women with PROM at <-21 weeks gestation with a structurally normal singleton; having no evidence of infection, active bleeding, or labor; and a maximum vertical fluid pocket of <I.5 cm were candidates. Prophylactic antibiotics were administered. Interventions included amnio- infusion, cervical cerclage, and administration of gelatin sponge (Gelfoam®) into the anmiotic cavity. Weekly assessment of fluid status was performed and if oligohydramnios returned, patients were offered repeat amnioinfusion. RESULTS: Twenty women were counseled. Two suffered a fetal demise prior to the procedure and three elected termination. Fifteen women with PROM at 17.9 _+ 2.2 weeks (range 13-21) underwent initial cervical cerclage, infusion, and gelatin sponge adnfinistration at 20.1 +_ 1.4 weeks. Spontaneous PROM was the diagnosis in 14 patients and one experienced iatrogenic PROM after fetoscopy. The amniotic fluid index increased in all patients but supplemental amnioinfusion was required in six women. Chorioamnionitis was diagnosed in 6 of 7 previable deliveries. Eight fetuses reached viability, (>24 weeks, 53%) with six newborns surviving to hospital discharge (30%) and two suffering intra-uterine demise. The average gestational age of delivery for survivors was 31.8 _+4.3 weeks, range 25-36. Talipes equivarus was observed in three survivors (50%). Bilateral hip dysplasia and torticollis were also diag- nosed in two infants. Respiratory distress syndrome was diagnosed in all cases delivering <32 weeks but was not observed tbereafleI: No adverse sequelae have been attributed to gelatin sponge exposure mad two patients subsequently delivered at term after the index pregnancy. CONCLUSION: The observed survival rate in this pilot study justifies further investigation with this population at highest risk for pregnancy loss after PROM. This protocol may not reduce the rate of musculoskeletal abnormalities. 68 CERVICAL DYNAMICISM: DEFINITION AND INCIDENCE IN PRETERM PATIENTS WITH AND WITHOUT PRETERM LABOR SYMPTOMS SHERI JENKINS 1, JAMES KURTZMAN 2, WENDY BREWSTER3; 1University of Califoruia, Irvine, Ob/Gyn, Irvine, CA; 2University of California, Irvine, Ob/ Gyn, Lagama Hills, CA; 3University of California, Irvine, Ob/Gyn, Orange, CA OBJECTIVE: To define cervical dynamicism (real-time cervical change) during Wansvaginal ultrasound (US) and to compare its incidence in preterm patients with and without preterm labor (PTL) symptoms. STUDY DESIGN: Transvaginal US was performed on 147 patients from 24 to 34 weeks' estimated gestational age (EGA), including 84 patients with PTL symptoms and 63 asymptomatic patients. Cervical lengths were measured in each patient at 1-minute intervals over a 10-minute observation period. Initial, mean and nadir cervical lengths as well as maximum change in length were compared between tile 2 groups. Maximum change in cervical length over 10 minutes was defined as normal if it was within 2 standard deviations (SD) of the mean maximum change for asymptomatic patients; a cervix was defined as "dynamic" if it demonstrated > 2 SD of maximum change. The frequency of cervical dynmnicism was then compared between the symptomatic and asymptomatic groups. RESULTS: The mean EGA of the symptomatic group at examination was slightly greater than the asymptomatic group (28.9 vs. 27.7 weeks' gestation, P .02). Mean measurements over 10 minutes were significantly shorter in the symptomatic group, and these patients exhibited greater maximum change in cervical length (Table). Based on the ->2 SD definition, a celwix was dynamic if> 6mm of maximum change occurred during real-drne observation. Forty-two symptomatic patients (50%) and 5 asymptolnatic patients (8%) had cervical dyaaamicism (P < .001). Initial cervical length was equal to the nadir length in only 12% of symptomatic patients. Nadir length was not reached for the majority of symptomatic padents until -> 5 minutes into their observation period. CONCLUSION: Cervical dynamicism is commonly seen in patients who are symptomatic for PTL. The common clinical practice of measuring only a single cervical length in these patients would not detect ~90% of shortest cervical lengths that occur with continued observation. Table Mean cervical meamt~ments during 10-minute observation period MEAN CERVICAL SYMPTOMATIC ASYMPTOMATIC P LENGTH (CM +/- 1 SD) PATIENTS PATIENTS VALUE Initial 3.02 +/- 1.1 3.81 +/- 0.7 <.001 Average 2.86 +/- 1.0 3.81 +/- 0.7 <.001 Nadir 2.51 +/- 1.1 3.60 +/- 0.7 <.001 Maximum change 0.71 +/- 0.5 0.35 +/- 0.3 <.001

Transcript of 66 An aggressive, interventional protocol for previable premature rupture of the membranes (PROM)

Page 1: 66 An aggressive, interventional protocol for previable premature rupture of the membranes (PROM)

Volume 185, Number 6 A m J Obstet Gynecol

65 FIRST TRIMESTER CYSTIC HYGROMA--A POPULATION BASED SCREENING STUDY (THE FASTER TRIAL) FERGAL D. MALONE 1, ROBERT H. BALL 2, DAVID A. NYBERG 3, SUSAN J. GROSS 4, CHRISTINE H. COMSTOCK 5, GEORGE R. SAADE 6, KEITH A. EDDLEMAN 7, SABRINA D. CRAIGO 8, ILAN E. TIMOR 9, STEPHEN R. CARR 1°, J O H N C. HOBBINS n , KIMBERLY A. DUKES 12, FELIX DE LA CRUZ 15, MARY E. D'ALTON1; 1Columbia University, Maternal Fetal Medicine, New York, NY; 2University of Utah Medical Center, Salt Lake City, UT; 3Swedish Medical Center, Seattle, WA; 4Montefiore Medical Center, Bronx, NY; 5William Beaumont Hospital, Royal Oak, MI; 6University of Texas Medical Branch, Galveston, TX; 7Mount Sinai Medical Center, New York, NY: 8New England Medical Center, Boston, MA; 9NYU Medical Center, New York, NY; 10Women a n d Infants Hospital , Providence, RI; UUniversity of Colorado Health Sciences Center, Denver, CO; 12DM-STAT, Boston, MA; 13National Institute of Child Heal th and H u m a n Development, Bethesda, MD

OBJECTIVE: Current data on outcome of cystic hygromas are limited to retrospective case series. To our knowledge no popula t ion based screening data are available. O u r objective was to define the outcome of fetuses diag- nosed with cystic hygroma in the first trimester in an unselected population.

STUDY DESIGN: The FASTER Trial is a muhicenter study evaluating first and second trimester screening programs for aneuploidy. All patients have a nncha l t rans lucency (NT) u l t rasound at 10-14 weeks, p e r f o r m e d only by specially trained staff: All patients are followed to pregnancy completion using a computer ized t racking system. Cystic hygroma ( increased NT with septations) is an exclusion criterion for fur ther FASTER Trial participation. Such patients are offered immediate counseling and diagnosis. We prospec- tively collated outcome data on all cases of cystic hygroma seen in the FASTER Trial.

RESULTS: To date 20,645 patients have been enrolled into the FASTER Trial. 61 fetuses had cystic hygroma (incidence 1/338). Karyotype evaluation was per formed in 46 cases, yielding 22 euploid fetuses (36%) and 24 aneuploid fetuses (39%) {9 Downs, 7 Turners, 3 trisomy-18, 3 triploidy, 2 trisomy-13}. For euploid fetuses there were 9 cases of major structural malformation {4 skeletal dysplasia, 3 hypoplastic left heart, 1 multiple pterygium, and 1 pleural effi~sion needing in utero shunt}. Pregnancy was terminated in 32 cases (52%). In 29 cont inuing pregnancies, there were 6 intrauterine demises (10%), and 9 cases of hygroma resolution with normal outcome (15%). Overall, 43 cases (71%) were classified as bad outcome and 16 (26%) as good outcome. A fur ther 2 cases (3%) did not have pediatric outcome.

CONCLUSION: First t r imester cystic hygroma is considerably more common than previously thought in the general unselected population. The majori ty of cases are associated with adverse p r egnancy outcome. If first t r imester sonograpbic screening is implemented these data will be vital to provide adequate patient counseling.

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SMFM Abstracts S99

CLINICAL AND IMMUNOLOGICAL FOLLOW UP OF INFANTS BORN AFTER PLATELET TRANSFUSIONS AND TRANSPLACENTAL IMMUNO- GLOBULIN TREATMENT CELINE RADDER t, MONIQUE HAAN DE 2, ELLEN MEER V.D. 3, DAVE ROELEN 3, FRANS CLAAS 3, ANNEKE BRAND 3, HUMPHREY KANHAI4; 1Leiden University Medical Center, Obstetrics, H4-P, Leiden; '-'Leiden University Medical Center, Perinatal Center, J6-S, Leiden; 3Leiden University Medical Center, hnmunohema to logy , E3-Q, Leiden; 4Leiden University Medical Center, Obstetrics, Kr-P, Leiden

OBJECTIVE: Patients with fetal or neonatal a l lo immune thrombocyto- penia (FNAIT) are successfully treated with intrauterine platelet transfusions (IUPT) a n d / o r maternally administered intravenoUS imnmnoglobulins (WIG). To the best of our knowledge, the effect of IUPT and M G on the development and long-term follow up of treated chi ldren has never been examined. M G is known for its i m m u n e suppressive characteristics, thus inf luencing fetal immunity.

STUDY DESIGN: The aim of this study was to examine the effect of IUPT a n d / o r WIG on the matur ing fetal immune system by means of lymphocyte subsets of FNAIT-newborns (n = 19) and by means of genera l and neuro- developmental follow up of FNAIT-children (n = 37, age 2-12 years).

RESULTS: Natural Killer cell (CD 56, CD57), mature and inmmture T-cell (CD45RA, CD45R0), mature and immature B<ell (CD5, CD19, CD20, CD38) and activated cell (CD25, CD62L) parameters were analyzed on mononuclear cells in hepar in ized umbilical cord b lood by flow cytometry. Considerable dispersal of values per parameter was observed, but lymphocyte subsets showed no differences c o m p a r e d to r andomly chosen heal thy newborns. Clinical follow up of 37 chi ldren revealed no signs of d is turbance of the i m m u n e response. Four chi ldren had mild neurological or developmental problems and one child had a serious developmental delay.

CONCLUSION: The general and neurodevelopmental outcome of chil- dren prenatally treated with IUPT a n d / o r 1VIG is satisfactory. Immunological analysis of cord b lood reveals no suppression of a part icular subset and no premature development of neonatal immunity, which is in accordance with the clinical outcome.

66 AN AGGRESSIVE, INTERVENTIONAL PROTOCOL FOR PREVIABLE PREMATURE R ~ OF THE MEMBRANES (PROM)JOHN O'BRIEN 1, J O H N BARTON 1, DOUGLAS MILLIGAN 1, 1Central Baptist Hospital, Lexing- ton, KY

OBJECTIVE: To evaluate a novel pro tocol for t rea tment of previable PROM.

STUDY DESIGN: Women with PROM at <-21 weeks gestat ion with a structurally normal singleton; having no evidence of infection, active bleeding, or labor; and a maximum vertical fluid pocket of <I.5 cm were candidates. Prophylactic antibiotics were adminis tered. Interventions inc luded amnio- infusion, cervical cerclage, and administration of gelatin sponge (Gelfoam®) into the anmiotic cavity. Weekly assessment of fluid status was per formed and if ol igohydramnios re turned, patients were offered repeat amnioinfusion.

RESULTS: Twenty women were counseled. Two suffered a fetal demise pr ior to the procedure and three elected termination. Fifteen women with PROM at 17.9 _+ 2.2 weeks (range 13-21) underwent initial cervical cerclage, infusion, and gelatin sponge adnfinistration at 20.1 +_ 1.4 weeks. Spontaneous PROM was the diagnosis in 14 patients and one experienced iatrogenic PROM after fetoscopy. The amniot ic fluid index increased in all pat ients bu t supplemental amnioinfusion was required in six women. Chorioamnionitis was diagnosed in 6 of 7 previable deliveries. Eight fetuses reached viability, (>24 weeks, 53%) with six newborns surviving to hospital discharge (30%) and two suffering intra-uterine demise. The average gestational age of delivery for survivors was 31.8 _+ 4.3 weeks, range 25-36. Talipes equivarus was observed in three survivors (50%). Bilateral hip dysplasia and torticollis were also diag- nosed in two infants. Respiratory distress syndrome was diagnosed in all cases delivering <32 weeks but was not observed tbereafleI: No adverse sequelae have been attr ibuted to gelatin sponge exposure mad two patients subsequently delivered at term after the index pregnancy.

CONCLUSION: The observed survival rate in this pilot study justifies fur ther investigation with this populat ion at highest risk for pregnancy loss after PROM. This pro tocol may no t reduce the rate of musculoskeletal abnormalities.

68 CERVICAL DYNAMICISM: DEFINITION AND INCIDENCE IN PRETERM PATIENTS WITH AND WITHOUT PRETERM LABOR SYMPTOMS SHERI JENKINS 1, JAMES KURTZMAN 2, WENDY BREWSTER3; 1University of Califoruia, Irvine, Ob /Gyn , Irvine, CA; 2University of California, Irvine, O b / Gyn, Lagama Hills, CA; 3University of California, Irvine, Ob /Gyn , Orange, CA

OBJECTIVE: To define cervical dynamicism (real-time cervical change) dur ing Wansvaginal ul t rasound (US) and to compare its incidence in pre term patients with and without preterm labor (PTL) symptoms.

STUDY DESIGN: Transvaginal US was per formed on 147 patients from 24 to 34 weeks' estimated gestational age (EGA), including 84 patients with PTL symptoms and 63 asymptomatic patients. Cervical lengths were measured in each patient at 1-minute intervals over a 10-minute observation period. Initial, mean and nadir cervical lengths as well as maximum change in length were compared between tile 2 groups. Maximum change in cervical length over 10 minutes was defined as normal if it was within 2 s tandard deviations (SD) of the mean maximum change for asymptomatic patients; a cervix was defined as "dynamic" if it demonstra ted > 2 SD of maximum change. The frequency of cervical dynmnicism was then c o m p a r e d between the symptomatic and asymptomatic groups.

RESULTS: The mean EGA of the symptomatic group at examination was slightly greater than the asymptomatic group (28.9 vs. 27.7 weeks' gestation, P .02). Mean measurements over 10 minutes were significantly shorter in the symptomatic group, and these patients exhibited greater maximum change in cervical length (Table). Based on the -> 2 SD definition, a celwix was dynamic if> 6mm of maximum change occurred dur ing real-drne observation. Forty-two symptomatic patients (50%) and 5 asymptolnatic patients (8%) had cervical dyaaamicism (P < .001). Initial cervical length was equal to the nadir length in only 12% of symptomatic patients. Nadir length was not reached for the majority of symptomatic padents until -> 5 minutes into their observation period.

CONCLUSION: Cervical dynamicism is commonly seen in patients who are symptomatic for PTL. The common clinical practice of measuring only a single cervical length in these pat ients would not detect ~90% of shortest cervical lengths that occur with cont inued observation.

Table Mean cervical meamt~ments during 10-minute observation per iod

MEAN CERVICAL SYMPTOMATIC ASYMPTOMATIC P L E N G T H (CM +/- 1 SD) PATIENTS PATIENTS VALUE

Initial 3.02 +/- 1.1 3.81 +/- 0.7 <.001 Average 2.86 +/- 1.0 3.81 +/- 0.7 <.001 Nadir 2.51 +/- 1.1 3.60 +/- 0.7 <.001 Maximum change 0.71 +/- 0.5 0.35 +/- 0.3 <.001