Intrapartum chlorhexidine vaginal irrigation and chorioamnion and placental microbial colonization.

OBJECTIVES: To determine whether intrapartum chlorhexidine vaginal irrigation reduces microbial colonization of the chorioamnion or placenta. METHODS: Secondary analysis was made of a randomized trial. Cultures for aerobic and anaerobic bacteria, Mycoplasma species and Ureaplasma urealyticum were performed using standard isolation techniques. RESULTS: The placentas of 83 trial participants allocated to chlorhexidine and 93 allocated to placebo underwent evaluation. These two groups were statistically balanced for risk factors for infection. Aerobic bacteria were isolated from 47% of the chlorhexidine placentas vs. 51% of the placebo placentas (relative risk 0.9, 95% confidence interval 0.7-1.3), anaerobic bacteria from 30% and 35%, respectively (0.8, 0.5-1.3), group B streptococcus from 12% and 15% (0.8, 0.4-1.7), U. urealyticum from 18% and 29% (0.6, 0.4-1.1), Mycoplasma species from 6% and 11% (0.6, 0.2-1.6), and any organism from 57% and 67%, respectively (0.8, 0.7-1.1). CONCLUSIONS: Intrapartum chlorhexidine vaginal irrigation was associated with non-significant reductions in the rates of placental microbial isolation.

The effect of the increasing prevalence of maternal obesity on perinatal morbidity.

OBJECTIVE: In this study, we assessed the temporal trends and relative and attributable perinatal risks of maternal obesity over a 20-year period. STUDY DESIGN: We conducted a retrospective cohort study between 1980 and 1999 by using a computerized perinatal database of all women who received prenatal care and delivered their infants within a regional health care system. The main outcome measures were as follows: (1) annual mean body weight and the percentage of women classified as obese at the first prenatal visit (primary definition > or = 200 lb; secondary definitions > or = 250 lb, > or = 300 lb, body mass index > 29 kg/m(2)); and (2) relative and attributable risks of obesity for selected maternal and perinatal morbidities in successive 5-year periods. RESULTS: From 1980 to 1999, the mean maternal weight of women at the first prenatal visit increased 20% (144-172 lb), as did the percentage of women > or = 200 lb (7.3-24.4), the percentage > or = 250 lb (1.9-10.7), the percentage > or = 300 lb (0.5-4.9), and the percentage with a body mass index > 29 kg/m(2) (16.3-36.4), P < .01 for all. Controlling for maternal age, race, and smoking status, obese women were at increased risk at each period for cesarean delivery (range of adjusted relative risk, 1.5-1.8), gestational diabetes (range, 1.8-2.9), and large (> 90th percentile) for gestational age infants (range, 1.8-2.2). From the earliest 5-year period (1980-1984) to the most recent (1995-1999), the percentage of obesity-attributable cesarean deliveries more than tripled from 3.9 to 11.6. Similar percentage increases were observed for the obesity-attributable risks for gestational diabetes (12.8-29.6) and large for gestational age infants (6.5-19.1). Trends for secondary obesity definitions were similar, although the magnitude of the increased attributable risks was smaller. CONCLUSIONS: Efforts to reduce the frequency of certain perinatal morbidities will be constrained unless effective measures to prevent, or limit the risks of, maternal obesity are developed and implemented.

Active phase labor arrest: revisiting the 2-hour minimum.

OBJECTIVE: To generate contemporary uterine activity and labor progress data for oxytocin-augmented labor, and assess whether 2 hours of active phase labor arrest with at least 200 Montevideo units justifies cesarean delivery. METHODS: Five hundred and one consecutive spontaneously laboring term women with abnormally progressive labor were managed by a standardized protocol: oxytocin and intrauterine pressure catheter with an intent to sustain at least 200 Montevideo units for 4 hours or more before cesarean for labor arrest. Uterine activity was measured, and maternal and neonatal outcomes were evaluated. With a sample of this size, the upper 95% confidence interval limit for an event with an observed rate of 1% is below 3%. RESULTS: During oxytocin augmentation, nulliparas who were delivered vaginally dilated at a median rate of 1.4 cm/hour versus 1.8 cm/hour for parous women. In both groups, the 5th percentile of cervical dilation rate was 0.5 cm/hour. Thirty-eight women experienced labor arrest for over 2 hours despite at least 200 sustained Montevideo units; 23 (61%) achieved a vaginal delivery. Rates of chorioamnionitis and endometritis for the 38 women were 26%. None of their infants sustained a serious complication, including brachial plexus injury, even though three of the 23 vaginal deliveries (13%) were complicated by shoulder dystocia. CONCLUSION: These data demonstrate that oxytocin-augmented labor proceeds at substantially slower rates than spontaneous labor, and support our previous contention that the criteria of labor arrest for 2 hours, despite at least 200 sustained Montevideo units, are insufficiently rigorous for the performance of cesarean.

Comparison of two oxytocin regimens to prevent uterine atony at cesarean delivery: a randomized controlled trial.

OBJECTIVE: To determine if high-dose oxytocin reduces the need for additional uterotonic agents at cesarean. METHODS: A randomized, double-masked trial of two oxytocin regimens was performed to prevent postpartum uterine atony in laboring women. The pharmacy prepared sequentially numbered oxytocin solutions containing either 10 U/500 mL or 80 U/500 mL of lactated Ringer's solution infused over 30 minutes after cord clamping. The need for additional uterotonic agents was determined by the surgical team. Hypotension was diagnosed and treated with crystalloid or a pressor agent. To detect a 50% decrease in the need for additional uterotonic agents and considering a beta error of 0.2, 220 patients would be required in each group (alpha = 0.05, two-tailed chi(2) test). RESULTS: The low-dose group (n = 163) received 333 mU/min, and the high-dose group (n = 158) received 2667 mU/min of oxytocin. The groups were similar with respect to risk factors for atony. Women in the low-dose group received additional uterotonic medication significantly more often than those in the high-dose group (39% compared with 19%, P <.001, relative risk 2.1, 95% confidence interval 1.4, 3.0). Moreover, more women in the low-dose group received methylergonovine, 15-methyl prostaglandin F(2alpha) or both (9% compared with 2%, relative risk 4.8, 95% confidence interval 1.4, 16) after additional oxytocin (median 20 U) had been added to the study solution. The incidence of hypotension was similar in both groups. CONCLUSION: Compared with an infusion rate of 333 mU/min, oxytocin infused at 2667 mU/min for the first 30 minutes postpartum reduces the need for additional uterotonic agents at cesarean delivery.

Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection.

BACKGROUND: Infection with Trichomonas vaginalis during pregnancy has been associated with preterm delivery. It is uncertain whether treatment of asymptomatic trichomoniasis in pregnant women reduces the occurrence of preterm delivery. METHODS: We screened pregnant women for trichomoniasis by culture of vaginal secretions. We randomly assigned 617 women with asymptomatic trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g doses of metronidazole (320 women) or placebo (297 women) 48 hours apart. We treated women again with the same two-dose regimen at 24 to 29 weeks of gestation. The primary outcome was delivery before 37 weeks of gestation. RESULTS: Between randomization and follow-up, trichomoniasis resolved in 249 of 269 women for whom follow-up cultures were available in the metronidazole group (92.6 percent) and 92 of 260 women with follow-up cultures in the placebo group (35.4 percent). Data on the time and characteristics of delivery were available for 315 women in the metronidazole group and 289 women in the placebo group. Delivery occurred before 37 weeks of gestation in 60 women in the metronidazole group (19.0 percent) and 31 women in the placebo group (10.7 percent) (relative risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004). The difference was attributable primarily to an increase in preterm delivery resulting from spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative risk, 3.0; 95 percent confidence interval, 1.5 to 5.9). CONCLUSIONS: Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended.

Midtrimester vaginal Mycoplasma genitalium in women with subsequent spontaneous preterm birth.

OBJECTIVE: We sought to determine the midtrimester prevalence of Mycoplasma genitalium in women who had subsequent spontaneous preterm birth. STUDY DESIGN: In a prospective study of lower genital tract infections, we identified 127 women who subsequently had spontaneous preterm birth. Vaginal samples were obtained between 21 and 25 weeks' gestation for pH, for bacterial vaginosis Gram stain, and cultures that yielded Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. M genitalium was identified by using validated polymerase chain reaction (PCR) primers, and the results were compared to pregnancy outcomes. RESULTS: Of 124 women with spontaneous preterm births, only five (3.9%) had PCR assays positive forM genitalium. The mean +/- SD delivery gestational age was similar for women with a positive PCR (34.6 +/- 2.2 weeks) and a negative PCR (34.0 +/- 2.7 weeks) (P =.62). None of the women with positive PCR results tested positive for any other sexually transmitted disease, whereas 36 (30%) women with negative PCR results tested positive. CONCLUSIONS: The occurrence of M genitalium in the vagina at midtrimester is infrequent in women with subsequent spontaneous preterm birth.

Periodontal infection and preterm birth: results of a prospective study.

BACKGROUND: Previous studies have suggested that chronic periodontal infection may be associated with preterm births. The authors conducted a prospective study to test for this association. METHODS: A total of 1,313 pregnant women were recruited from the Perinatal Emphasis Research Center at the University of Alabama at Birmingham. Complete periodontal, medical and behavioral assessments were made between 21 and 24 weeks gestation. After delivery, medical records were consulted to determine each infant's gestational age at birth. From these data, the authors calculated relationships between periodontal disease and preterm birth, while adjusting for smoking, parity (the state or fact of having born offspring), race and maternal age. Results were expressed as odds ratios and 95 percent confidence intervals, or CIs. RESULTS: Patients with severe or generalized periodontal disease had adjusted odds ratios (95 percent CI) of 4.45 (2.16-9.18) for preterm delivery (that is, before 37 weeks gestational age). The adjusted odds ratio increased with increasing prematurity to 5.28 (2.05-13.60) before 35 weeks' gestational age and to 7.07 (1.70-27.4) before 32 weeks' gestational age. CONCLUSIONS: The authors' data show an association between the presence of periodontitis at 21 to 24 weeks' gestation and subsequent preterm birth. Further studies are needed to determine whether periodontitis is the cause. CLINICAL IMPLICATIONS: While this large prospective study has shown a significant association between preterm birth and periodontitis at 21 to 24 weeks' gestation, neither it nor other studies to date were designed to determine whether treatment of periodontitis will reduce the risk of preterm birth. Pending an answer to this important question, it remains appropriate to advise expectant mothers about the importance of good oral health.

Accuracy of self-reported cigarette smoking among pregnant women in the 1990s.

In large, prospective studies of pregnancy conducted in the 1960s, women reported very accurately whether or not they smoked. However, in the 1990s, pregnant women who smoke are often pressured to reduce or quit smoking, and the incentive to misreport may be greater than in the past. To assess the accuracy of reported smoking, the authors compared self-reported smoking with cotinine in the serum and/or urine of 105 women who participated in the Calcium for Pre-eclampsia Prevention pilot study in 1992. Cotinine confirmed the report of 84.6% of women who reported smoking and 94.5% of women who denied smoking. These fractions are virtually identical to those obtained in a pregnancy cohort from the 1960s. The authors conclude that in the setting of two obstetrical research studies not specifically focused on smoking, the accuracy of self-reported cigarette smoking did not change substantially from the 1960s to the 1990s.

Nutrient intake and hypertensive disorders of pregnancy: Evidence from a large prospective cohort.

OBJECTIVE: The objective of this analysis was to prospectively determine the effects of nutrient intakes on the incidences of preeclampsia and pregnancy-associated hypertension among women enrolled in the Calcium for Preeclampsia Prevention study. STUDY DESIGN: This was a prospective observational cohort study of women in a randomized clinical trial that included women seeking prenatal care at university medical centers and affiliated clinics and hospitals in 5 US communities. A total of 4589 nulliparous women were recruited between 13 and 21 weeks' gestation. Preeclampsia and pregnancy-associated hypertension were the main outcome measures. RESULTS: Preeclampsia was noted in 326 (7.6%) of the 4314 women with known pregnancy outcomes followed up until > or =20 weeks' gestation, and pregnancy-associated hypertension was noted in 747 (17.3%). As previously reported, there was no significant difference in these outcomes between cohorts randomly assigned to supplementation with calcium or placebo. By means of logistic regression a baseline risk model was constructed for preeclampsia and pregnancy-associated hypertension. After adjustment for treatment and clinical site, body mass index >26 kg/m(2) and race were significantly associated with an increased risk of preeclampsia. Body mass index > or =35 kg/m(2), race, and never smoking were significantly associated with an increased risk of pregnancy-associated hypertension. After adjustment for baseline risks, none of the 28 nutritional factors analyzed were significantly related to either preeclampsia or pregnancy-associated hypertension. CONCLUSION: We found no evidence in this study for a significant association of hypertensive disorders of pregnancy with any of the 23 nutrients measured.

The Preterm Prediction Study: association between cervical interleukin 6 concentration and spontaneous preterm birth. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

OBJECTIVE: The aim of this study was to determine the interrelationship between cervical concentration of interleukin 6 and detection of fetal fibronectin and other risk factors for spontaneous preterm birth. STUDY DESIGN: All patients with spontaneous preterm birth at <35 weeks' gestation (case patients; n = 125) and subjects matched for race, parity, and center delivered at > or = 37 weeks' gestation (n = 125; control subjects) were selected from women enrolled in the National Institute of Child Health and Human Development's Preterm Prediction Study. Interleukin 6 concentrations were determined by enzyme-linked immunosorbent assay in cervical swabs obtained at 22 weeks' to 24 weeks 6 days' gestation. Cutoffs to define an elevated interleukin 6 concentration included the 90th and 95th percentiles for control subjects (>305 and >538 pg/mL, respectively). RESULTS: The mean (+/-SD) interleukin 6 concentration was significantly higher in case patients than in control subjects (212 +/- 339 vs 111 +/- 186 pg/mL; P = .008). With either cutoff value elevated interleukin 6 concentration was significantly associated with spontaneous preterm birth (90th percentile, 20% vs 9.6%; P = .02; 95th percentile, 12% vs 4.8%; P = .04). Cervical interleukin 6 levels were highest within 4 weeks of delivery, and the trend continued until term. Elevated interleukin 6 concentration was not significantly associated with bacterial vaginosis, maternal body mass index <19.8 kg/m2, or a short cervix (< or = 25 mm), but it was significantly associated with a positive cervicovaginal fetal fibronectin test result (90th percentile, odds ratio, 5.5; 95% confidence interval, 2.6-11.9; 95th percentile, odds ratio, 5.3, 95% confidence interval, 2.1-12.9). The mean interleukin 6 concentration among women with a positive fibronectin test result was 373 +/- 406 pg/mL; that among women with a negative fetal fibronectin test result was 130 +/- 239 pg/mL (P = .001). In a regression analysis that adjusted for risk factors significantly associated with spontaneous preterm birth in this population (positive fetal fibronectin test result, body mass index <19.8 kg/m2, vaginal bleeding in the first or second trimester, previous spontaneous preterm birth, and short cervix) elevated cervical interleukin 6 concentration was not independently associated with spontaneous preterm birth (odds ratio, 1.8; 95% confidence interval, 0.8-4.3). CONCLUSIONS: At 24 weeks' gestation cervical interleukin 6 concentration in women who subsequently had a spontaneous preterm birth at <35 weeks' gestation was significantly elevated relative to those who were delivered at term. The association was particularly strong within 4 weeks of testing. A positive fetal fibronectin test result was strongly associated with elevated cervical interleukin 6 concentration, but bacterial vaginosis was not.

Current evidence regarding periodontal disease as a risk factor in preterm birth.

Preterm birth, resulting in babies born too little and too soon, is a major cause of morbidity. Evidence indicates that infections can be major risk factors in preterm birth. Case-control studies point to an association between periodontal infection and increased rates of preterm birth. This paper summarizes evidence to date and the strategies that ongoing intervention studies are using to answer the fundamental clinical question: can periodontal therapy reduce the risk of preterm birth?

Preterm delivery in women with pregestational diabetes mellitus or chronic hypertension relative to women with uncomplicated pregnancies. The National institute of Child health and Human Development Maternal- Fetal Medicine Units Network.

OBJECTIVE: The purpose of this study was to compare the rates of indicated and spontaneous preterm delivery among women with chronic hypertension or pregestational diabetes mellitus with the rates among healthy women. STUDY DESIGN: This was a secondary analysis of data from healthy women with singleton gestations enrolled in a prospective observational study for prediction of preterm delivery (control group, n = 2738), women with pregestational diabetes mellitus requiring insulin therapy (n = 461), and women with chronic hypertension (n = 761). The two latter groups were enrolled in a randomized multicenter trial for prevention of preeclampsia. The main outcome measures were rates of preterm delivery, either spontaneous (preterm labor or rupture of membranes) or indicated (for maternal or fetal reasons), and neonatal outcomes. RESULTS: The overall rates of preterm delivery were significantly higher among women with diabetes mellitus (38%) and hypertension (33.1%) than among control women (13.9%). Rates were also significantly higher for delivery at <35 weeks' gestation. Women with diabetes mellitus had significantly higher rates of both indicated preterm delivery (21.9% vs 3.4%; odds ratio, 8.1; 95% confidence interval, 6.0-10.9) and spontaneous preterm delivery (16.1% vs 10.5%; odds ratio, 1.6; 95% confidence interval, 1.2-2.2) than did women in the control group. In addition, they had significantly higher rates of both indicated preterm delivery (odds ratio, 4.8; 95% confidence interval, 3.0-7.5) and spontaneous preterm delivery (odds ratio, 2.1; 95% confidence interval, 1.4-3.0) at <35 weeks' gestation than did control women. Compared with control women those with chronic hypertension had higher rates of indicated preterm delivery at both <37 weeks' gestation (21.9% vs 3.4%; odds ratio, 8.1; 95% confidence interval, 6.2-10.6) and at <35 weeks' gestation (12.1% vs 1.6%; odds ratio, 8.2; 95% confidence interval, 5.7-11.9), but there were no differences in rates of spontaneous preterm delivery. CONCLUSION: The increased rate of preterm delivery among women with chronic hypertension relative to control women was primarily an increase in indicated preterm delivery, whereas the rates of both spontaneous and indicated preterm delivery were increased among women with pregestational diabetes mellitus.

Criteria for failed labor induction: prospective evaluation of a standardized protocol.

OBJECTIVE: To assess the safety and efficacy of a protocol that mandated at least 12 hours of oxytocin administration after membrane rupture before cesarean delivery for failed labor induction in the latent phase. METHODS: Gravidas at or beyond 36 weeks' gestation undergoing indicated induction with cervical dilatation up to 2 cm were studied prospectively. Prior cesarean was an exclusion criterion. If the fetal heart rate pattern was reassuring, cesarean was not permitted before the active phase of labor (4-cm dilatation and at least 90% effacement or 5-cm dilatation regardless of effacement) unless the membranes had been ruptured and oxytocin administered for at least 12 hours. RESULTS: Five hundred nine women were treated according to protocol; 360 (71%) were nulliparas and 149 (29%) were parous. Twenty-five percent of nulliparas and 9% of parous women were delivered by cesarean. After 6 hours of ruptured membranes and oxytocin, 14% of nulliparas were still in the latent phase; 39% of whom delivered vaginally, compared with 7% still in the latent phase after 9 hours (vaginal delivery rate 28%), and 4% after 12 hours (vaginal delivery rate 13%). In contrast, after 6 hours of ruptured membranes and oxytocin, only five (3%) parous women were still in the latent phase. Among those, none remained in the latent phase for 12 hours and all were delivered vaginally. No women had serious complications. Severe neonatal morbidities were infrequent and not related to duration of the latent phase. CONCLUSION: By requiring a minimum of 12 hours of oxytocin after membrane rupture before failed labor induction could be diagnosed, many nulliparas who remained in the latent phase at 6 and 9 hours had safe vaginal deliveries, and failed labor induction was eliminated as an indication for cesarean in parous women.

Umbilical cord serum levels of thromboxane B2 in term infants of women who participated in a placebo-controlled trial of low-dose aspirin.

OBJECTIVE: Our aim was to quantify thromboxane B2 (TXB2) in umbilical cord serum of term infants of nulliparous, low-risk women who were randomly assigned to either placebo or low-dose (60 mg) aspirin (ASA) on a daily basis from 24 weeks' gestation through delivery as part of a randomized clinical trial for prevention of preeclampsia. METHODS: Umbilical cord sera from 230 singleton, term infants whose mothers were involved in our low-dose ASA trial were assayed for TXB2, the stable metabolite of thromboxane A2, without knowledge of treatment or outcome data. The data were related to assigned treatment group, longitudinal pattern of maternal serum TXB2 levels, and other maternal and newborn characteristics. The data also were analyzed according to whether or not maternal serum levels of TXB2 at 29-31, 34-36, and delivery were reduced > or =50% compared to values prior to initiation of the trial. RESULTS: Umbilical cord TXB2 levels (ng/ml, mean +/- SE) were significantly lower at term in the ASA group (36.1 +/- 3.3, n = 111) than in the placebo group (56.6 +/- 5.7, n = 119; P = 0.002). Umbilical cord TXB2 levels were correlated to those in maternal serum at delivery in the ASA group (r = 0.3441; P = 0.0005) but not in the placebo group (r = 0.0626; P = 0.53). Regardless of assigned treatment group, infants whose mothers had a > or =50% longitudinal reduction in serum TXB2 had lower umbilical cord TXB2 levels (39.2 +/- 3.6, n = 114) than infants whose mothers had <50% reductions in TXB2 (54.6 +/- 5.9, n = 116; P = 0.027). Birthweights of these infants correlated inversely (r = 0.1678, P = 0.017) with maternal serum TXB2 at delivery but not to umbilical cord TXB2 levels; the best correlation between birthweight and maternal serum TXB2 was noted in pregnancies assigned to receive placebo (r = -0.2558, P = 0.009). CONCLUSIONS: Umbilical cord serum levels of TXB2 1) are reduced in instances of long-term maternal ingestion of ASA, 2) correlate well with maternal serum levels of TXB2 at delivery when there is evidence for consistent maternal use of ASA, but 3) do not correlate with maternal serum TXB2 levels when there is no evidence for frequent maternal ingestion of cyclooxygenase inhibitors. These data suggest that the capacity for platelet production of TXA2 in fetal and maternal compartments are regulated independently. Finally, there is an inverse relationship between maternal serum TXB2 levels at delivery and birthweight of newborn infants that is most evident among the pregnancies assigned to placebo and also among pregnancies in which there was little evidence to suggest a pattern of cyclooxygenase inhibitor use during pregnancy.

Should the definition of preeclampsia include a rise in diastolic blood pressure of >/=15 mm Hg to a level <90 mm Hg in association with proteinuria?

OBJECTIVE: This study was undertaken to compare baseline characteristics and pregnancy outcomes between normotensive women who did and those who did not have a rise in diastolic blood pressure of >/=15 mm Hg in association with proteinuria. STUDY DESIGN: We studied 4302 healthy nulliparous women from the Calcium for Preeclampsia Prevention trial who were delivered at >/=20 weeks' gestation. We selected as the study group normotensive women who developed proteinuria within 7 days of a rise in diastolic blood pressure of >/=15 mm Hg with respect to baseline on 2 occasions 4 to 168 hours apart. Baseline blood pressure was the mean of measurements at 2 clinic visits before 22 weeks' gestation. Other normotensive women used for comparison were those who did not develop gestational hypertension or a rise in diastolic blood pressure of >/=15 mm Hg in association with proteinuria. RESULTS: Except for greater weight (P <.001), body mass index (P <.001), and systolic blood pressure (P =.05) the baseline characteristics of the 82 women with a rise in diastolic blood pressure of >/=15 mm Hg in association with proteinuria did not differ significantly from those of the other normotensive women. Although they had a greater rate of weight gain (P <.005), larger babies (P =.06), and a 2-fold increase in abdominal delivery (P <.001), there was little other evidence of adverse pregnancy outcomes among these women. CONCLUSION: During normotensive pregnancy a rise in diastolic blood pressure of >/=15 mm Hg in association with proteinuria appears to be benign and is not a useful clinical construct.

Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial.

OBJECTIVE: To determine which of three methods of cervical ripening resulted in the lowest cesarean rate in women with unfavorable cervices and indications for labor induction. METHODS: Consenting women with singleton gestations, vertex presentations, and unfavorable cervices (dilatation under 2 cm and effacement under 75%) were randomly assigned to laminaria and standard intravenous oxytocin, serial doses of intracervical prostaglandin (PG) E(2) gel (Prepidil, Pharmacia & Upjohn, Inc., Kalamazoo, MI) 0.5 microg every 6 hours for two doses followed by oxytocin if indicated, or extra-amniotic saline infusion and oxytocin. RESULTS: An interim analysis after recruitment of 321 subjects, 67% of the planned sample, found similar cesarean rates for the three groups (laminaria 36%; PGE(2) gel 33%; saline infusion 29%; P =.59); however, the mean randomization-to-delivery interval was significantly longer in the PGE(2) group. Stochastic curtailment, as part of the interim analysis, indicated a low likelihood of achieving a statistically significant difference in cesarean rates between PGE(2) gel and the other two groups. Therefore, we completed the study with saline infusion and laminaria. The saline infusion and laminaria groups had similar preinduction characteristics. The cesarean rates were similar (saline infusion 25.4% versus laminaria 30.3%; P =.32), but the mean interval from randomization to delivery was shorter in the saline infusion group (18.0 versus 21.5 hours, P =.002). There were no significant differences in selected maternal and neonatal morbidities. CONCLUSION: Cervical ripening with extra-amniotic saline infusion, PGE(2), or laminaria resulted in comparable cesarean rates in women with an unfavorable cervix and indications for labor induction. Extra-amniotic saline infusion had the shortest randomization-to-delivery interval without increasing maternal or neonatal morbidity.

Puerperal infection after cesarean delivery: evaluation of a standardized protocol.

OBJECTIVE: Our goal was to evaluate an antibiotic protocol for treatment of postcesarean endometritis. STUDY DESIGN: Endometritis was diagnosed as a persistent fever > or =100.4 degrees F beyond 24 hours after cesarean delivery and one or more of the following: uterine tenderness, tachycardia, foul lochia, or leukocytosis. Antibiotic therapy included gentamicin plus clindamycin and ampicillin (or vancomycin) as a triple antimicrobial in 148 women. Antibiotic failure was defined as persistent fever after 5 days of antibiotics and 72 hours of triple antibiotics. RESULTS: Between 1993 and 1996, 322 of 1643 (20%) women were diagnosed with postcesarean endometritis. One hundred seventy-four patients (54%) were cured with clindamycin-gentamicin, and 129 who additionally received ampicillin or vancomycin (40%) were cured. Nineteen of the 322 (6%) women had persistent fever despite triple antibiotics. Of these, 6 had a wound complication, 12 were suspected to have antimicrobial resistance, and 1 had an infected hematoma. CONCLUSION: A prospective protocol consisting of clindamycin-gentamicin plus the selective addition of ampicillin or vancomycin cured 303 of 322 (94%) women with postcesarean endometritis.

Second-trimester cervical ultrasound: associations with increased risk for recurrent early spontaneous delivery.

OBJECTIVE: To determine whether short cervical length or internal os funneling before 20 weeks' gestation predicts early preterm birth or pregnancy loss in women with at least one prior spontaneous early preterm birth. METHODS: Transvaginal cervical ultrasound examinations were done every 2 weeks on 69 women with singleton gestations and histories of at least one prior spontaneous birth between 16 and 30 weeks' gestation. The results of those examinations were correlated with gestational age at delivery. RESULTS: Among 53 women who had ultrasound examinations before 20 weeks' gestation, those with cervical lengths at or below the tenth percentile for the study population (22 mm, n = 4) or funneling of the internal os (n = 5) were more likely than women without those factors to have spontaneous preterm births within 2 weeks (33% versus 0%, P = .01) or 4 weeks from the ultrasound examination (67% versus 0%, P < .001) or before 35 weeks' gestation (100% versus 19%, P < .001). Short cervical length or funneling between 20-24 and 25-29 weeks was also associated with increased risk of spontaneous preterm birth before 35 weeks' gestation (P < or = .05 and P = .002, respectively) but not with increased risk of spontaneous preterm birth within 2 or 4 weeks of ultrasound examination. CONCLUSION: Women with prior early spontaneous preterm births who have short cervical lengths or funneling of the internal cervical os before 20 weeks' gestation are at increased risk of subsequent spontaneous preterm birth.

Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units.

BACKGROUND: Bacterial vaginosis has been associated with preterm birth. In clinical trials, the treatment of bacterial vaginosis in pregnant women who previously had a preterm delivery reduced the risk of recurrence. METHODS: To determine whether treating women in a general obstetrical population who have asymptomatic bacterial vaginosis (as diagnosed on the basis of vaginal Gram's staining and pH) prevents preterm delivery, we randomly assigned 1953 women who were 16 to less than 24 weeks pregnant to receive two 2-g doses of metronidazole or placebo. The diagnostic studies were repeated and a second treatment was administered to all the women at 24 to less than 30 weeks' gestation. The primary outcome was the rate of delivery before 37 weeks' gestation. RESULTS: Bacterial vaginosis resolved in 657 of 845 women who had follow-up Gram's staining in the metronidazole group (77.8 percent) and 321 of 859 women in the placebo group (37.4 percent). Data on the time and characteristics of delivery were available for 953 women in the metronidazole group and 966 in the placebo group. Preterm delivery occurred in 116 women in the metronidazole group (12.2 percent) and 121 women in the placebo group (12.5 percent) (relative risk, 1.0; 95 percent confidence interval, 0.8 to 1.2). Treatment did not prevent preterm deliveries that resulted from spontaneous labor (5.1 percent in the metronidazole group vs. 5.7 percent in the placebo group) or spontaneous rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it prevent delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with metronidazole did not reduce the occurrence of preterm labor, intraamniotic or postpartum infections, neonatal sepsis, or admission of the infant to the neonatal intensive care unit. CONCLUSIONS: The treatment of asymptomatic bacterial vaginosis in pregnant women does not reduce the occurrence of preterm delivery or other adverse perinatal outcomes.