Objective To determine whether treatment of bacterial vaginosis (BV) with vaginal clindamycin affects pregnancy outcome. Materials and methodsMothers with singleton pregnancies and without previous preterm delivery in 17 health centres in Oulu from March 1996 Until March 1998, in whom BV was diagnosed by Gram stain of a vaginal swab at the first antenatal visit (at the 12th gestational week) were randomised at Oulu University Hospital to have a one-week course of vaginal clindamycin, or placebo. A follow up sample of Gram stain was taken two weeks after randomisation and at the 30th gestational weeks. Pregnancy outcome data was obtained from hospital records. Primary outcome was preterm birth, and puerperal infectious morbidity the other outcome measure.Results During the study period 1956 women were screened, of whom 143 (7.3%) were BV-positive. One hundred and one were randomised. The total preterm birth rate of BV+ women randomised was 9.9% (lO/lOl). Preterm birth occurred in 20.7% (6/29) vs 0% (0/26) according to whether BV persisted or not (P < 0-01). The preterm birth rate was 13.7% (7/51) in the clindamycin group vs 6.0% (3/50) in the placebo group (OR 2.5,95% CI 06-10). BV was cured just after treatment in 17 out of 51 (33%) of the clindamycin-treated patients vs 17 out of 50 (34%) of the placebo-treated patients (OR 1.0,95% CI 0.4-2.2). There was a difference in puerperal infectious morbidity in patients where BV persisted (31%, 9/29) compared with those in which BV did not persist (7.7%, 1/26) (OR 5.4, 95% CI 1-04-28). Infections were seen in 4/51 (8%) of the clindamycin treated vs 10/50 (20%) of the placebo treated cases, (OR 0.3,95% CI 0.1-1.2). ConclusionThe prevalence of BV was lower than expected in this low risk population, but nevertheless it increased the risk of preterm birth and puerperal infectious morbidity, the risk being highest in cases where BV persisted during pregnancy. Vaginal clindamycin treatment for BV in the fist trimester of pregnancy did not appear to reduce the risk of preterm birth or puerperal infections.
Objective To determine the value of combinations of cervical interleukin-6 (IL-6), cervical interleukin-8 (IL-8), the phosphorylated isoform of insulin-like growth-factor binding protein-1 (IGFBP-1), and cervical ultrasonography in the prediction of preterm birth. Design Prospective follow up.Setting Oulu University Hospital maternity clinic from February 1997 to July 1998. Population Women with singleton pregnancies (n 77), referred from outpatient clinics at 22±32 weeks of gestation with symptoms (uterine contractions) or signs (cervical change) of threatened preterm birth. Symptomless women (n 78) matched for gestational age, parity and maternal age at recruitment were studied as a reference group.Methods A urine sample for bacterial culture was collected, and cervical swab samples for assays of interleukin-6 and -8 and phoshorylated IGFBP-1 were taken before digital cervical examination. A Pap smear for analysis of bacterial vaginosis and samples for analysis of chlamydia and streptococci were also obtained. Cervical measurements were made by transvaginal ultrasonography. The same sampling and cervical measurement were repeated twice at two-week intervals. The cutoff values of the markers were determined by receiveroperating characteristic curve analysis.Main outcome measure Preterm birth (,37 weeks). ResultsThe preterm birth (,37 weeks) rate for women in the study group was 16% (12/77). The cervical interleukin-6 cutoff value (61 ng/L) at ®rst visit had a sensitivity of 73% and a speci®city of 61% in predicting preterm birth, with a positive likelihood ratio (LR 1 ) of 1.9 (95% CI 1.2±3.0). An ultrasonographically measured cervical index value of . 0.36 at recruitment predicted preterm birth in 25% (5/20) of the study group compared with 9% (5/54); LR 1 2.2 (95% CI 1.03±4.7). Cervical phosphorylated IGFBP-1 . 6.4mg/L [LR 1 1.8 (95% CI 0.7±2.9)], interleukin-8 . 3739 ng/L [LR 1 1.4 (95% CI 0.9±2.4)], and ultrasonograpic cervical length , 29.3 mm [LR 1 2.7 (95% CI 0.8±9.7)] increased the risk of preterm birth. According to the logistic regression model, a combination of IL-6, and IL-8 and cervical index increased the speci®city to 97%, but the sensitivity fell to 30% in detecting preterm birth. There was a signi®cantly increased incidence of puerperal infections if phosphorylated IGFBP-1 concentrations were elevated (. 21.0 mg/L), 36% (4/11) compared with 4.6% (3/65), LR 1 6.7 (95% CI 2.7±17), the sensitivity being 67% (4/6) and the speci®city 90% (63/70). Elevated phosphorylated IGFBP-1 concentrations (. 21.6mg/L) were also associated with an increased risk of neonatal infections; LR 1 8.0 (95% CI 3.5±18).Conclusions An increase in cervical IL-6 concentration and the ultrasonographically measured cervical index appear to be associated with preterm birth. A combination of these markers with measurement of cervical IL-8 appears to be the best predictor of preterm birth. Neither the sensitivity nor speci®city of the tests used in this study are good enough to predict preterm birth for clinical decision making. C...
Objective To determine the value of combinations of cervical interleukin-6 (IL-6), cervical interleukin-8 (IL-8), the phosphorylated isoform of insulin-like growth-factor binding protein-1 (IGFBP-1), and cervical ultrasonography in the prediction of preterm birth. Design Prospective follow up.Setting Oulu University Hospital maternity clinic from February 1997 to July 1998. Population Women with singleton pregnancies (n 77), referred from outpatient clinics at 22±32 weeks of gestation with symptoms (uterine contractions) or signs (cervical change) of threatened preterm birth. Symptomless women (n 78) matched for gestational age, parity and maternal age at recruitment were studied as a reference group.Methods A urine sample for bacterial culture was collected, and cervical swab samples for assays of interleukin-6 and -8 and phoshorylated IGFBP-1 were taken before digital cervical examination. A Pap smear for analysis of bacterial vaginosis and samples for analysis of chlamydia and streptococci were also obtained. Cervical measurements were made by transvaginal ultrasonography. The same sampling and cervical measurement were repeated twice at two-week intervals. The cutoff values of the markers were determined by receiveroperating characteristic curve analysis. Main outcome measure Preterm birth (,37 weeks).Results The preterm birth (,37 weeks) rate for women in the study group was 16% (12/77). The cervical interleukin-6 cutoff value (61 ng/L) at ®rst visit had a sensitivity of 73% and a speci®city of 61% in predicting preterm birth, with a positive likelihood ratio (LR 1 ) of 1.9 (95% CI 1.2±3.0). An ultrasonographically measured cervical index value of . 0.36 at recruitment predicted preterm birth in 25% (5/20) of the study group compared with 9% (5/54); LR 1 2.2 (95% CI 1.03±4.7). Cervical phosphorylated IGFBP-1 . 6.4mg/L [LR 1 1.8 (95% CI 0.7±2.9)], interleukin-8 . 3739 ng/L [LR 1 1.4 (95% CI 0.9±2.4)], and ultrasonograpic cervical length , 29.3 mm [LR 1 2.7 (95% CI 0.8±9.7)] increased the risk of preterm birth. According to the logistic regression model, a combination of IL-6, and IL-8 and cervical index increased the speci®city to 97%, but the sensitivity fell to 30% in detecting preterm birth. There was a signi®cantly increased incidence of puerperal infections if phosphorylated IGFBP-1 concentrations were elevated (. 21.0 mg/L), 36% (4/11) compared with 4.6% (3/65), LR 1 6.7 (95% CI 2.7±17), the sensitivity being 67% (4/6) and the speci®city 90% (63/70). Elevated phosphorylated IGFBP-1 concentrations (. 21.6mg/L) were also associated with an increased risk of neonatal infections; LR 1 8.0 (95% CI 3.5±18).Conclusions An increase in cervical IL-6 concentration and the ultrasonographically measured cervical index appear to be associated with preterm birth. A combination of these markers with measurement of cervical IL-8 appears to be the best predictor of preterm birth. Neither the sensitivity nor speci®city of the tests used in this study are good enough to predict preterm birth for clinical decision making....
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