228 Impact of Prepidil Pre-Induction Cervical Treatment

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226 227 Volume 168 Number 1, Part 2 GESTATIOlfAL DIABETES AL'l'ERS HUHAH PIACEIl'l'AL VASCULlUt RESPOHSES TO CHANGES IN O 2 , R. Figueroa, H. Omar, N. Tejani, M. Wolin T Depts.Physiol.&Ob/Gyn., New York Me, Valhalla OBJEC'1'IVE:To determine tone responses to 02 changes in placental vessels from gestational diabetic (GDM) term pregnancies (T-Prg). STUDY DESIGN: Precontracted isolated placental arteries (PA) (n-S) & veins (PV) (n-10) from well controlled GD and normal(N) (n-S) T-Prg, with & without endothelium, were exposed to hypoxia(P0 2 8-10torr) for 5-7 minutes followed by rapid reoxygenation and cumulative doses of H 2 0 2 Prostaglandin(PG) role was determined by treat- ment with indomethacin. ANOVA & t-tests were used. RESULTS:Hypoxia caused a larger PG-independent relaxation in & of GDM com- pared to (p<0.05). With reoxygenation or H 2 0 2 , GDM vessels underwent a larger contraction in & PV compared to (p<0.05). Both responses were elimi- nated in study and control vessels by pretreat- ment with indomethacin, indicating PG mediation. Responses were unaltered by removal of the endo- thelium. CONCLUSION,PA & PV in GDM T-Prg showed consid- erable alterations in tone responses to hypoxia and reoxygenation. MEC:XaItDI: IT·S PREVAI.DCE, SIGa'D'ICAR'CE, ARD EFFECT 011 0U"rCmm. K. Amyot X , R. KeltxX, .J. Dept. of OB/CYN and Pathology, Albany Medical Ctr., Albany, NY. OB.lBC!'IVE: The literature states that the prevalence of meconium 1s 17%. To evaluate thiS, a two phase study was undertaken to examine the prevalence and slgnificance of meconium in an obstetrical population. STUDY DESIGJI: A retrospective study of 100 consecutive placentas submitted to pathology found evidence of meconium in 43%, utll1z1na meconium containing macrophages as the indicator. A subsequent prospective study examined placentas frOlll 98 consecutive deliveries _ comparina those with meconium (n:.59) to those without (n:39) in a number of categories. ltESULTS: Meconium's effect on the fetal-placental unit can be defined utilizina both clinical and pathological parameters. CliniCians have described meconium density (clear_ tinged/thin_ moderate, thick/pea-soup), while pathologists have evaluated histologic markers (membrane edema, amnion denudation, vacuolization, and hyperplasia, pigmented macrophages). Both have attempted to correlate the presence of meconium with fetal outcome. There was no statistically significant difference with regard to patient age, race, gravidity, or gestational age. Of the .59 pl.ceneas found. to have meconium stained macrophaaes, 47 (71%) were reported to have clear fluid grossly suegesting previous release and eventual clearing. Three cases (13%) with reported gross stainina showed no meconium within macrophages suggesting that the release was due to an acute event. There was no significant difference with regard to the type of l.bor or the use of oxytocin. The presence of meconium was related to vaginal delivery as compared to Cesarean section (p 0.1). There was no correlation with the coamonly utilized indicators of poor outcome, namely Apgar scores at 1 and 5 minutes and cord pH. The presence of meconium was inversely correlated with lflCU admissions. a.cLUSla.S: Usina meconium stained macrophaaes as a marker, its prevalence i. more frequent than previously stated, demolraphics had little effece, clinical correlation was inconsistent, and there was no major on outcome. 228 229 SPO Abstracts 361 III'ACT Of PREPIDIL PRE-III)tJCTlOII CERViCAl TREATllENT. S. Haas,X N.J. Lucas, The Upjohn Co., Kalamazoo, NI and Dept. Ob/Gyn, Univ. TX Southwestern Ned. Ctr., Dallas, TX. OBJECTIVE: To evaluate the efficacy of a conmercially prepared PGE 2 gel in .... lti-site trials of preinduction cervical treatment a STlIIY DESIGII: From 1983 to 1986, Upjohn sponsored randomized trials to evaluate the effects of intracervical preinduction treatment with a 0.5 mg suspension of PGE 2 in 2.5 cc aqueous gel. El igible patients had an unripe cervIX and an indication for induction of labor. Both treated and untreated women had a latent interval of 12 hours after enrollment before labor induction, at which time the Bishop score was reassessed. Najor end points for coq>arison consisted of onset of labor during the latent interval (prior to induction), change in Bishop score, successful attairvnent of active labor within 12 hours of induction, duration of labor, and rate of cesarean del ivery. RESULTS: 1731 women were enrolled and randomized at 42 sites within 3 broad geographic areas. Neta-analysis suggested that conbining the results of the 3 trial areas would be val id. Prepidil treatment was associated with significant endpoint effects: an increased rate of active labor attainment within the study interval (80% vs 61%); a 37% net increase in labor onset before induction (43% vs 6%); a 7% increase in success of induction (66% vs 59%) likely related to a significant increase in Bishop score; a cesarean section rate of 24.5% in the treated group coq>ared to 29% in the controls. COIICLUSIOll: Prepidil Gel" pre-induction treatment of the cervix has s i gni fi cant effects on the onset of spontaneous labor, success of induction, labor interval and cesarean section rate. It could be anticipated that introduction of this treatment would qual itatively irrprove the experience of labor and del ivery for patients, conserve attendant resources, and reduce costs and morbidity associated with operative del ivery. THE USE OF PROSTAGLANDIN E2 (PGE2) GEL IN PATIENTS WITH PREVIOUS CESAREAN SECTION. C. Lockwood, G. Berkowitz, L. Lynch, M. Alvarez, R. Lapinski, R. Berkowitz. Dept. of Ob/Gyn. The Mount Sinai School of Medicine, NY, NY. OBJECTIVE: The aim of this study is to determine whether preinduction cervical ripening with PGE2 gel in patients with one previous cesarean section (CIS) may be used with the same safety and efficacy as in patients without a uterine scar. STUDY DESIGN: Primiparous patients (n = 94) with one previous CIS were retrospectively compared to nulliparous patients (n = 866). Both groups underwent preinduction cervical ripening with 2 mg intracervical PGE2 gel. Logistic regression was performed to control for confounding factors. Our statistical power was 90% for detecting a doubling of the complication rate from 10% to 20%. RESULTS: There were no significant differences in the duration of ruptured membranes or length of labor between the two groups. No significant differences were detected in the CIS rate, indications for CIS, presence of thick meconium, epidural use, amnionitis or maternal and neonatal morbidity. There were no cases of uterine rupture in either group. Fetal tachycardia was more common whereas the presence of thin meconium and fetal bradycardia was less common among patients with a prior CIS. Logistic regression controlling for race, socioeconomic factors, gestational age> 41 weeks, chronic hypertenSion and diabetes confirmed that thin meconium and fetal tachycardia were significantly different between the two groups. CONCLUSION: PGE2 gel may be used with the same safety and efficacy in patients with previous CIS as in nulliparas.

Transcript of 228 Impact of Prepidil Pre-Induction Cervical Treatment

Page 1: 228 Impact of Prepidil Pre-Induction Cervical Treatment

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Volume 168 Number 1, Part 2

GESTATIOlfAL DIABETES AL'l'ERS HUHAH PIACEIl'l'AL VASCULlUt RESPOHSES TO CHANGES IN O2, R. Figueroa, H. Omar, N. Tejani, M. WolinT

Depts.Physiol.&Ob/Gyn., New York Me, Valhalla OBJEC'1'IVE:To determine tone responses to 02 changes in placental vessels from gestational diabetic (GDM) term pregnancies (T-Prg). STUDY DESIGN: Precontracted isolated placental arteries (PA) (n-S) & veins (PV) (n-10) from well controlled GD and normal(N) (n-S) T-Prg, with & without endothelium, were exposed to hypoxia(P02 8-10torr) for 5-7 minutes followed by rapid reoxygenation and cumulative doses of H202• Prostaglandin(PG) role was determined by treat­ment with 10~M indomethacin. ANOVA & t-tests were used. RESULTS:Hypoxia caused a larger PG-independent relaxation in PA(40%~8) & PV(45%~8) of GDM com­pared to N(PA-13%~2;PV~21%~5) (p<0.05). With reoxygenation or H202, GDM vessels underwent a larger contraction in PA(1019mg~253) & PV (1400mg~485) compared to N(PA~156mg~69;PV-

463mg~71) (p<0.05). Both responses were elimi­nated in study and control vessels by pretreat­ment with indomethacin, indicating PG mediation. Responses were unaltered by removal of the endo­thelium. CONCLUSION,PA & PV in GDM T-Prg showed consid­erable alterations in tone responses to hypoxia and reoxygenation.

MEC:XaItDI: IT·S PREVAI.DCE, SIGa'D'ICAR'CE, ARD EFFECT 011 0U"rCmm. K. AmyotX, R. KeltxX, .J. Bloc~, Dept. of OB/CYN and Pathology, Albany Medical Ctr., Albany, NY. OB.lBC!'IVE: The literature states that the prevalence of meconium 1s 17%. To evaluate thiS, a two phase study was undertaken to examine the prevalence and slgnificance of meconium in an obstetrical population. STUDY DESIGJI: A retrospective study of 100 consecutive placentas submitted to pathology found evidence of meconium in 43%, utll1z1na meconium containing macrophages as the indicator. A subsequent prospective study examined placentas frOlll 98 consecutive deliveries _ comparina those with meconium (n:.59) to those without (n:39) in a number of categories. ltESULTS: Meconium's effect on the fetal-placental unit can be defined utilizina both clinical and pathological parameters. CliniCians have described meconium density (clear_ tinged/thin_ moderate, thick/pea-soup), while pathologists have evaluated histologic markers (membrane edema, amnion denudation, vacuolization, and hyperplasia, pigmented macrophages). Both have attempted to correlate the presence of meconium with fetal outcome. There was no statistically significant difference with regard to patient age, race, gravidity, or gestational age. Of the .59 pl.ceneas found. to have meconium stained macrophaaes, 47 (71%) were reported to have clear fluid grossly suegesting previous release and eventual clearing. Three cases (13%) with reported gross stainina showed no meconium within macrophages suggesting that the release was due to an acute event. There was no significant difference with regard to the type of l.bor or the use of oxytocin. The presence of meconium was related to vaginal delivery as compared to Cesarean section (p 0.1). There was no correlation with the coamonly utilized indicators of poor outcome, namely Apgar scores at 1 and 5 minutes and cord pH. The presence of meconium was inversely correlated with lflCU admissions. a.cLUSla.S: Usina meconium stained macrophaaes as a marker, its prevalence i. more frequent than previously stated, demolraphics had little effece, clinical correlation was inconsistent, and there was no major si&nif~canee on f~tal outcome.

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SPO Abstracts 361

III'ACT Of PREPIDIL PRE-III)tJCTlOII CERViCAl TREATllENT. S. Haas,X N.J. Lucas, The Upjohn Co., Kalamazoo, NI and Dept. Ob/Gyn, Univ. TX Southwestern Ned. Ctr., Dallas, TX. OBJECTIVE: To evaluate the efficacy of a conmercially prepared PGE2 gel in .... lti-site trials of preinduction cervical treatment a

STlIIY DESIGII: From 1983 to 1986, Upjohn sponsored randomized trials to evaluate the effects of intracervical preinduction treatment with a 0.5 mg suspension of PGE2 in 2.5 cc aqueous gel. El igible patients had an unripe cervIX and an indication for induction of labor. Both treated and untreated women had a latent interval of 12 hours after enrollment before labor induction, at which time the Bishop score was reassessed. Najor end points for coq>arison consisted of onset of labor during the latent interval (prior to induction), change in Bishop score, successful attairvnent of active labor within 12 hours of induction, duration of labor, and rate of cesarean del ivery. RESULTS: 1731 women were enrolled and randomized at 42 sites within 3 broad geographic areas. Neta-analysis suggested that conbining the results of the 3 trial areas would be val id. Prepidil treatment was associated with significant endpoint effects: an increased rate of active labor attainment within the study interval (80% vs 61%); a 37% net increase in labor onset before induction (43% vs 6%); a 7% increase in success of induction (66% vs 59%) likely related to a significant increase in Bishop score; a cesarean section rate of 24.5% in the treated group coq>ared to 29% in the controls. COIICLUSIOll: Prepidil Gel" pre-induction treatment of the cervix has s i gni fi cant effects on the onset of spontaneous labor, success of induction, labor interval and cesarean section rate. It could be anticipated that introduction of this treatment would qual itatively irrprove the experience of labor and del ivery for patients, conserve attendant resources, and reduce costs and morbidity associated with operative del ivery.

THE USE OF PROSTAGLANDIN E2 (PGE2) GEL IN PATIENTS WITH PREVIOUS CESAREAN SECTION. ~X C. Lockwood, G. Berkowitz, L. Lynch, M. Alvarez, R. Lapinski, R. Berkowitz. Dept. of Ob/Gyn. The Mount Sinai School of Medicine, NY, NY. OBJECTIVE: The aim of this study is to determine whether preinduction cervical ripening with PGE2 gel in patients with one previous cesarean section (CIS) may be used with the same safety and efficacy as in patients without a uterine scar. STUDY DESIGN: Primiparous patients (n = 94) with one previous CIS were retrospectively compared to nulliparous patients (n = 866). Both groups underwent preinduction cervical ripening with 2 mg intracervical PGE2 gel. Logistic regression was performed to control for confounding factors. Our statistical power was 90% for detecting a doubling of the complication rate from 10% to 20%. RESULTS: There were no significant differences in the duration of ruptured membranes or length of labor between the two groups. No significant differences were detected in the CIS rate, indications for CIS, presence of thick meconium, epidural use, amnionitis or maternal and neonatal morbidity. There were no cases of uterine rupture in either group. Fetal tachycardia was more common whereas the presence of thin meconium and fetal bradycardia was less common among patients with a prior CIS. Logistic regression controlling for race, socioeconomic factors, gestational age> 41 weeks, chronic hypertenSion and diabetes confirmed that thin meconium and fetal tachycardia were significantly different between the two groups. CONCLUSION: PGE2 gel may be used with the same safety and efficacy in patients with previous CIS as in nulliparas.