Does knowledge of cervical length and fetal fibronectin affect management of women with threatened preterm labor? A randomized trial. A randomized trial of cerclage vs. 17 alpha-hydroxyprogesterone caproate for treatment of short cervix. Routine ultrasound fetal examination in pregnancy: the 'Alesund' randomized controlled trial.
The purpose of this study was to estimate the effect of sonographic cervical length (CL) and fetal fibronectin (FFN) on length of evaluation and outcomes in women with preterm labor (PTL).
                Women with threatened PTL were randomized to either a knowledge group (results of CL and FFN available and used according to study protocol), or a standard group (blinded to CL and FFN). Primary outcome was length of evaluation in triage.
                One hundred women were randomized. There was no significant difference between groups in length of evaluation, but in women with CL > or = 30 mm, the mean time for evaluation was significantly shorter in the knowledge group (1:58 h +/- 0:50 vs 2:53 h +/- 0:50, P = .004). Incidence of spontaneous preterm birth (SPTB) in the knowledge group was significantly reduced (13.0 vs 36.2%, P = .01).
                The knowledge of CL and FFN was associated with reduction in length of evaluation in women with CL > or = 30 mm and in incidence of SPTB in all women with PTL. To determine pregnancy outcome in patients with short cervix on transvaginal ultrasound between 16 and 24 weeks' gestation treated with McDonald cerclage compared to weekly intramuscular injections of 17 alpha-hydroxyprogesterone caproate (17OHP-C).
                From November 2003 through December 2006, asymptomatic, singleton pregnancies were screened with transvaginal ultrasound between 16-24 weeks' gestation. Patients with a cervical length (CL) < or =25 mm were offered enrollment. Patients were randomly assigned to treatment with McDonald cerclage or weekly intramuscular injections of 17OHP-C. The primary outcome was spontaneous preterm birth (PTB) prior to 35 weeks' gestation.
                Seventy-nine patients met inclusion criteria; 42 were randomly assigned to the cerclage and 37 to 17OHP-C. Spontaneous PTB prior to 35 weeks' gestation occurred in 16/42 (38.1%) of the cerclage group and in 16/37 (43.2%) of the 17OHP-C group (relative risk, 1.14 95% CI, 0.67, 1.93). A post hoc analysis of patients with a prior PTB showed no difference in spontaneous PTB <35 weeks between groups. A similar analysis of patients with a CL< or =15 mm showed a reduction in spontaneous PTB <35 weeks in the cerclage group (relative risk 0.48, 0.24-0.97).
                Women with CL < or =25 mm in the second-trimester appear to have similar risks of delivering prior to 35 weeks' gestation when treated with 17OHP-C or McDonald cerclage. However, cerclage may be more effective in preventing spontaneous PTB in women with CL< or =15 mm. To evaluate the possible benefits of the routine use of ultrasound screening in pregnancy.
                A randomized controlled trial was designed to detect a 50% difference in the incidence of induction for apparent post-term pregnancies between women who were screened with ultrasound and unscreened women. A total of 1628 pregnant women from the general population were included. Eight hundred and twenty-five were allocated to an ultrasound examination at the 18th and 32nd week of pregnancy in addition to receiving routine antenatal care. The remaining 803 women received standard antenatal care, but could only be referred for ultrasound examination on clinical indication.
                The incidence of induced labor due to apparent post-term pregnancies was approximately 70% lower in the ultrasound-screened group. Inductions from all causes were also less frequent among ultrasound-screened women. There were six perinatal deaths among the screened and seven among the controls after excluding three lethal malformations among the controls. There was no difference in Apgar score after 1 min, but the proportion with Apgar score less than 8 after 5 min was lower among the screened group (P = 0.04). The need for positive pressure ventilation for more than 1 min was lower among the screened group (P = 0.02). Birth weight was slightly higher in the screened group (39 g), but the difference was not statistically significant. Among the controls three pairs of twins remained undiagnosed until the mothers were admitted to the hospital in labor at between 36 and 38 weeks gestation.
                These results suggest that for women who were screened with ultrasound, obstetricians were less likely to induce labor due to apparent post-term pregnancy, than for women who were not screened. All 10 pairs of twins in the screened group were diagnosed at the routine examination. These data also suggest that perinatal morbidity might be slightly lower in the screened group.
Currently, there is insufficient evidence to recommend routine screening of asymptomatic or symptomatic pregnant women with TVU CL. Since there is a non-significant association between knowledge of TVU CL results and a lower incidence of PTB at less than 37 weeks in symptomatic women, we encourage further research. Future studies should look at specific populations separately (e.g., singleton versus twins; symptoms of PTL or no such symptoms), report on all pertinent maternal and perinatal outcomes, and include cost-effectiveness analyses. Most importantly, future studies should include a clear protocol for management of women based on TVU CL results, so that it can be easily evaluated and replicated.