- Email: [email protected]
290 Is Oligohydramnios Predictive of Pregnancy Outcome in Preterm Premature Rupture of Membranes?
378
SPO Abstracts
January 1993 Am J Obstel Gynecol
288 DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF
290
289
291 PERIVIABLE PROM: THE EFFECT OF GESTATIONAL
PIPERACILLIN SODIUM IN PRETERM MEMBRANE RUPTURE. J:.J... Lockwood, K. Costigan X, A. Ghidini x, R. Wein x, C. Cetrulo, M. Alvarez, R.L. Berkowitz. Tufts Univ. School of Med, Boston, MA, and Mt Sinai School of Med, NY, NY. OBJECTIVE: Preterm rupture of membranes (PROM) and subsequent labor may be caused by a chorio-decidual infection. Thus, antibiotic therapy has the potential to prolong pregnancy. To test this hypothesis we undertook a prospective, double·blind, placebo-controlled clinical trial utilizing intravenous (IV) piperacillin sodium (Pipracil, Lederle Labs) in PROM. STUDY DESIGN: Eligibility criteria included membrane rupture and gestational age between 24 and 35 weeks gestation by menstrual dates confirmed by ultrasound < 20 weeks. Exclusion criteria included penicillin allergy, placental abruption or previa, cerclage, maternal conditions requiring antibiotic therapy, maternal medical disorders or fetal complications mandating delivery. Patients were randomized to receive either 3 grams of Pipracil or placebo IV q 6 hrs. for 72 hrs., and managed conservatively until spontaneous delivery, chorioamnionitis or fetal distress. RESULTS: A total of 72 patients were randomized to receive Pipracil (n_36) or placebo (n=36). There were no differences between the Pipracil and placebo groups in the mean gestational age at randomization [30.1 (±3.0) vs. 30.5 (±2.8) wks; p=0.2] and gestational age at delivery [31.5 (±3.4) vs. 31.4 (±3.1) wks; p= 0.5]. The interval from ROM to delivery was significantly prolonged in the Pipracil compared with the placebo group (9.8t 16.6 vs. 6.4 ± 14.1 days; p- .004). No differences were observed between the two groups in birthweight [1844 (±791) vs 1721 (±S59) grams; p~0.5], incidence of neonatal respiratory distress [65.6% vs. 60.6%; p=0.7], or of suspected neonatal sepsis [75% vs. 70%; p=0.6]. The therapy caused no adverse fetal or maternal effects. CONCLUSIONS: Use of IV piperacillin sodium for 72 hrs. in PROM significantly delayed interval to delivery.
MULTICENTER DOUBLE·BLlND PROSPECTIVE RANDOM TRIAL OF CEFTIZOXlME va. PLACEBO IN WOMEN WITH PRETERM PREMATURE RUPTURED MEMBRANES (PPROMI . J. Blanco, J. lams. R. Artal, D. Baker. J. Hibbard. J. McGregor. C. Cetrulo. PPROM Ceftizoxime Study Group. OBJECTIVE: Compare ceftizoxime to placebo in prolonging rupture to delivery interval in woman with PPROM. STUDY DESIGN: 306 consenting women recruited from 40 centers at 23·36 weeks gestation with documented PPROM were randomly assigned to receiVe ceftizoxime sodium (2g IV q8hr. n= 1541 or placebo (n - 1621 for 7 days. Enrollment wa. limited to women who were not in labor, had no infection, and had not recently received antibiotics . The primary endpoint was the percentage of subjects
undelivered at 7 days. RESULTS: 39% of ceftizoxime and 34% of placebo subject. were undelivered at 7 days (p=0.481. Analysi. of 186 subjects (101 ceftizoxime. 86 placebol who received", 3 doses of study drug. who delivered after spontaneous labor,and who had not received tocolytics, steroids, or other antibiotics after enrollment, showed no
difference in % undelivered (50 vs 42%) at 7 days (p = 0.30). Median interval from 1st dose to delivery was 12.6 days and 9.8 days for ceftizoxime and placebo subjects respectively (p = O. 15). Similar statistically non-significant trends in favor of the ceftizoxime group were seen for subjects < 28 weeks, black women, and subjects enrolled 2: 13 hrs after rupture . Side effects were more common in
the ceftizoxime group (16% vs. 8%. p =0.031. but none were serious. CONCLUSIONS: There was no difference between ceftiloxime and placebo in the percentage of subjects who remained undelivered 7 days ofter enrollment. Sample size was not sufficient to evaluate potential benefit of ceftizoxime in some subsets of patients.
Our
results may differ from other reports of antibiotic prophylaxis in women with PPROM because of our study design which eliminated subjects with any evidence at labor at enrollment.
IS OLIGOHYDRAMNIOS PREDICTIVE OF PREGNANCY OUTCOME IN PRETERM PREMATURE RUPTURE OF MEMBRANES? T.N. Balaskas, E. Ottman', J.A. Spinnato. Dept. ObjGyn, Univ. of Louisville, Louisville, Ky. OBJECTIVE: To investigate whether oligohydramnios, as quantitated by amniotic fluid index (AFI), is associated with an increased risk of infectious complications and a decreased time interval to delivery in patients with preterm premature rupture of membranes (PPROM). STUDY DESIGN: Fifty women admitted with PPROM from 25 to 34 weeks gestation underwent AFI assessment upon admission and daily until delivery. All patients were managed conservatively. Patients with admission AFI values of ~2 vs >2 and ~5 vs >5 were compared to outcome variables of chorioamnionitis, neonatal sepsis, endometritis and time interval to delivery. Data were analyzed by x 2 analysis and Fisher's exact test. RESULTS: There was no significant difference found in the frequency of chorioamnionitis, neonatal sepsis or endometritis in patients with admission AFI values <2 va >2 or in patients with values of ~5-vs >5. There was alao no significant difference in the time interval to delivery among these groups. CONCLUSIONS: These data suggest that oligohydramnios is not significantly associated with an increased incidence of infectious complications and a decreased time interval to delivery in patients with PPROM.
AGE AT RUPTURE ON PERINA TAL OUTCOME. T.F. Kelly, K.J. Lundx , K. KobaJterX, T.R. Moore, Division of Perinatal Medicine, University of California, San Diego. OBJECTIVE: Recent studies of previable rupture of membranes (pROM) S 25 weeks indicate an inverse relationship between gestational age (GA) at rupture and latency period. The aim of this study was to identifY antenatal variables predictive of perinatal outcome which could be used in counseling. STUDY DESIGN: The maternal and neonatal records of 54 patients admitted with PROM prior to 29 weeks GA from 1985-91 were reviewed. Patients were divided into previable <,:::25 wks GA at rupture, n=14, PV) and viable (26-28 wks, V) groups. Multiple variables were assessed for their relationship to outcome. RESULTS: The mean (±SD) GA at PROM was 25 .7±2.5 wks, with 23.6± 1.3 in PV, 27.0± l.0 in V cases (p<.002). The latency intervals were similar in both groups (2.8 versus 2.1 weeks), and there was no correlation between GA at PROM and latency (r=.25 , p=NS). There were no differences in operative delivery (47%) and infectious maternal morbidity (50%). Overall perinatal mortality (PNM) was 28%, with 33% in PV and 25% in V (p=NS). PV was associated with earlier GA at delivery (26.4 wks vs 29.1 wks, p=O.004). Birthweights (BW) were significantly lower in PV vs V neonates (879 g versus 1440 g, p= 0.002), with only 67% of PV attaining BW~IOOO g vs 89% of V. CONCLUSIONS: PV and V have similar latency periods, thus perinatal outcome is determined primarily by GA at PROM. Maternal outcome is unaffected by GA at PROM in the periviable period.
SPO Abstracts
January 1993 Am J Obstel Gynecol
288 DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF
290
289
291 PERIVIABLE PROM: THE EFFECT OF GESTATIONAL
PIPERACILLIN SODIUM IN PRETERM MEMBRANE RUPTURE. J:.J... Lockwood, K. Costigan X, A. Ghidini x, R. Wein x, C. Cetrulo, M. Alvarez, R.L. Berkowitz. Tufts Univ. School of Med, Boston, MA, and Mt Sinai School of Med, NY, NY. OBJECTIVE: Preterm rupture of membranes (PROM) and subsequent labor may be caused by a chorio-decidual infection. Thus, antibiotic therapy has the potential to prolong pregnancy. To test this hypothesis we undertook a prospective, double·blind, placebo-controlled clinical trial utilizing intravenous (IV) piperacillin sodium (Pipracil, Lederle Labs) in PROM. STUDY DESIGN: Eligibility criteria included membrane rupture and gestational age between 24 and 35 weeks gestation by menstrual dates confirmed by ultrasound < 20 weeks. Exclusion criteria included penicillin allergy, placental abruption or previa, cerclage, maternal conditions requiring antibiotic therapy, maternal medical disorders or fetal complications mandating delivery. Patients were randomized to receive either 3 grams of Pipracil or placebo IV q 6 hrs. for 72 hrs., and managed conservatively until spontaneous delivery, chorioamnionitis or fetal distress. RESULTS: A total of 72 patients were randomized to receive Pipracil (n_36) or placebo (n=36). There were no differences between the Pipracil and placebo groups in the mean gestational age at randomization [30.1 (±3.0) vs. 30.5 (±2.8) wks; p=0.2] and gestational age at delivery [31.5 (±3.4) vs. 31.4 (±3.1) wks; p= 0.5]. The interval from ROM to delivery was significantly prolonged in the Pipracil compared with the placebo group (9.8t 16.6 vs. 6.4 ± 14.1 days; p- .004). No differences were observed between the two groups in birthweight [1844 (±791) vs 1721 (±S59) grams; p~0.5], incidence of neonatal respiratory distress [65.6% vs. 60.6%; p=0.7], or of suspected neonatal sepsis [75% vs. 70%; p=0.6]. The therapy caused no adverse fetal or maternal effects. CONCLUSIONS: Use of IV piperacillin sodium for 72 hrs. in PROM significantly delayed interval to delivery.
MULTICENTER DOUBLE·BLlND PROSPECTIVE RANDOM TRIAL OF CEFTIZOXlME va. PLACEBO IN WOMEN WITH PRETERM PREMATURE RUPTURED MEMBRANES (PPROMI . J. Blanco, J. lams. R. Artal, D. Baker. J. Hibbard. J. McGregor. C. Cetrulo. PPROM Ceftizoxime Study Group. OBJECTIVE: Compare ceftizoxime to placebo in prolonging rupture to delivery interval in woman with PPROM. STUDY DESIGN: 306 consenting women recruited from 40 centers at 23·36 weeks gestation with documented PPROM were randomly assigned to receiVe ceftizoxime sodium (2g IV q8hr. n= 1541 or placebo (n - 1621 for 7 days. Enrollment wa. limited to women who were not in labor, had no infection, and had not recently received antibiotics . The primary endpoint was the percentage of subjects
undelivered at 7 days. RESULTS: 39% of ceftizoxime and 34% of placebo subject. were undelivered at 7 days (p=0.481. Analysi. of 186 subjects (101 ceftizoxime. 86 placebol who received", 3 doses of study drug. who delivered after spontaneous labor,and who had not received tocolytics, steroids, or other antibiotics after enrollment, showed no
difference in % undelivered (50 vs 42%) at 7 days (p = 0.30). Median interval from 1st dose to delivery was 12.6 days and 9.8 days for ceftizoxime and placebo subjects respectively (p = O. 15). Similar statistically non-significant trends in favor of the ceftizoxime group were seen for subjects < 28 weeks, black women, and subjects enrolled 2: 13 hrs after rupture . Side effects were more common in
the ceftizoxime group (16% vs. 8%. p =0.031. but none were serious. CONCLUSIONS: There was no difference between ceftiloxime and placebo in the percentage of subjects who remained undelivered 7 days ofter enrollment. Sample size was not sufficient to evaluate potential benefit of ceftizoxime in some subsets of patients.
Our
results may differ from other reports of antibiotic prophylaxis in women with PPROM because of our study design which eliminated subjects with any evidence at labor at enrollment.
IS OLIGOHYDRAMNIOS PREDICTIVE OF PREGNANCY OUTCOME IN PRETERM PREMATURE RUPTURE OF MEMBRANES? T.N. Balaskas, E. Ottman', J.A. Spinnato. Dept. ObjGyn, Univ. of Louisville, Louisville, Ky. OBJECTIVE: To investigate whether oligohydramnios, as quantitated by amniotic fluid index (AFI), is associated with an increased risk of infectious complications and a decreased time interval to delivery in patients with preterm premature rupture of membranes (PPROM). STUDY DESIGN: Fifty women admitted with PPROM from 25 to 34 weeks gestation underwent AFI assessment upon admission and daily until delivery. All patients were managed conservatively. Patients with admission AFI values of ~2 vs >2 and ~5 vs >5 were compared to outcome variables of chorioamnionitis, neonatal sepsis, endometritis and time interval to delivery. Data were analyzed by x 2 analysis and Fisher's exact test. RESULTS: There was no significant difference found in the frequency of chorioamnionitis, neonatal sepsis or endometritis in patients with admission AFI values <2 va >2 or in patients with values of ~5-vs >5. There was alao no significant difference in the time interval to delivery among these groups. CONCLUSIONS: These data suggest that oligohydramnios is not significantly associated with an increased incidence of infectious complications and a decreased time interval to delivery in patients with PPROM.
AGE AT RUPTURE ON PERINA TAL OUTCOME. T.F. Kelly, K.J. Lundx , K. KobaJterX, T.R. Moore, Division of Perinatal Medicine, University of California, San Diego. OBJECTIVE: Recent studies of previable rupture of membranes (pROM) S 25 weeks indicate an inverse relationship between gestational age (GA) at rupture and latency period. The aim of this study was to identifY antenatal variables predictive of perinatal outcome which could be used in counseling. STUDY DESIGN: The maternal and neonatal records of 54 patients admitted with PROM prior to 29 weeks GA from 1985-91 were reviewed. Patients were divided into previable <,:::25 wks GA at rupture, n=14, PV) and viable (26-28 wks, V) groups. Multiple variables were assessed for their relationship to outcome. RESULTS: The mean (±SD) GA at PROM was 25 .7±2.5 wks, with 23.6± 1.3 in PV, 27.0± l.0 in V cases (p<.002). The latency intervals were similar in both groups (2.8 versus 2.1 weeks), and there was no correlation between GA at PROM and latency (r=.25 , p=NS). There were no differences in operative delivery (47%) and infectious maternal morbidity (50%). Overall perinatal mortality (PNM) was 28%, with 33% in PV and 25% in V (p=NS). PV was associated with earlier GA at delivery (26.4 wks vs 29.1 wks, p=O.004). Birthweights (BW) were significantly lower in PV vs V neonates (879 g versus 1440 g, p= 0.002), with only 67% of PV attaining BW~IOOO g vs 89% of V. CONCLUSIONS: PV and V have similar latency periods, thus perinatal outcome is determined primarily by GA at PROM. Maternal outcome is unaffected by GA at PROM in the periviable period.