Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Cervical cerclage for prevention of preterm delivery in women with short cervix: randomised controlled trial. Intravaginal prostaglandin E2 for cervical ripening and initiation of labor. Comparison of a multidose gel and single, controlled-release pessary. Premature rupture of membranes in nulliparas at term with unfavorable cervices: a double-blind randomized trial of prostaglandin and placebo. An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term. Pre-operative cervical dilatation in termination of first trimester pregnancies using 16, 16-dimethyl-trans-delta 2 PGE1 methyl ester vaginal pessaries. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Cervical incompetence prevention randomized cerclage trial (CIPRACT): study design and preliminary results. Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery.
Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20-23 weeks of gestation reduces the rate of early preterm delivery.
                The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18-43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264.
                385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08-0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported.
                Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan.
                Instituto Carlos III.
                Copyright © 2012 Elsevier Ltd. All rights reserved. Cervical cerclage has been widely used in the past 50 years to prevent early preterm birth and its associated neonatal mortality and morbidity. Results of randomised trials have not generally lent support to this practice, but this absence of benefit may be due to suboptimum patient selection, which was essentially based on obstetric history. A more effective way of identifying the high-risk group for early preterm delivery might be by transvaginal sonographic measurement of cervical length. We undertook a multicentre randomised controlled trial to investigate whether, in women with a short cervix identified by routine transvaginal scanning at 22-24 weeks' gestation, the insertion of a Shirodkar suture reduces early preterm delivery.
                Cervical length was measured in 47?123 women. The cervix was 15 mm or less in 470, and 253 (54%) of these women participated in the study and were randomised to cervical cerclage (127) or to expectant management (126). Primary outcome was the frequency of delivery before 33 completed weeks (231 days) of pregnancy.
                The proportion of preterm delivery before 33 weeks was similar in both groups, 22% (28 of 127) in the cerclage group versus 26% (33 of 126) in the control group (relative risk=0.84, 95% CI 0.54-1.31, p=0.44), with no significant differences in perinatal or maternal morbidity or mortality.
                The insertion of a Shirodkar suture in women with a short cervix does not substantially reduce the risk of early preterm delivery. Routine sonographic measurement of cervical length at 22-24 weeks identifies a group at high risk of early preterm birth. A study was conducted to compare the efficacy and safety of two methods of delivering prostaglandin E2 (PGE2) as a low-dose gel delivered in up to two sequential, 2.5-mg doses and as a single-dose, controlled-release, 10-mg pessary. A cervical change was present in both groups, but a Bishop score > or = 8 occurred in more nulliparous patients in the pessary than in the gel group by 12 hours after dosing. Labor was initiated without oxytocin more frequently in the pessary than gel group for nulliparas and multiparas. Reversal of uterine hyperstimulation was possible by removal of the pessary without tocolytic therapy. The controlled-release PGE2 pessary was more effective in changing the cervix in nulliparas and in initiating labor and offered the advantage of removal when desired. To determine whether the use of a prostaglandin (PG) E2 3-mg pessary followed by a delay of 12 hours before stimulation of labor with oxytocin improves obstetric outcome compared with the use of a placebo pessary.
                One hundred fifty-five nulliparas at term with poor cervical scores (modified Bishop score below 6 of 10) and premature rupture of membranes (PROM) were recruited for this double-blind, placebo-controlled randomized trial. On admission to the study, either a PGE2 pessary or an identical-appearing placebo pessary was inserted into the posterior fornix. If labor did not start in the next 12 hours or if symptoms and signs of infection were evident, labor was induced with oxytocin infusion. Assignment was unblinded at the end of the study, and details of the labor and maternal and neonatal outcome in women who received a PG pessary were compared with those who received a placebo pessary.
                Women receiving a PG pessary were significantly less likely to require stimulation of labor at the end of 12 hours than were those given a placebo pessary (37 versus 58%, P = .002). The mean time between admission to study and delivery was significantly shorter in the PG group compared with the placebo group (15 versus 19 hours, P = .01). The rate of cesarean delivery was not statistically different in the two groups (13.9% with PG versus 15.8% with placebo).
                In nulliparas with poor cervical scores who present with PROM at term and no evidence of infection or obstetric complications, use of a PGE2 pessary resulted in more women establishing labor earlier, with a resultant reduction in the admission-to-delivery interval, compared with the use of a placebo pessary. The cesarean delivery rates in the two groups were similar, and there were no significant differences in neonatal outcome. The purpose of this randomized, double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor. Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks. One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary, containing 10 mg of prostaglandin (PG) E2. Compared with the placebo group, those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more (60 or 59% versus 21 or 18%; P less than .0001), change to a Bishop score of 6 or higher (59 or 58% versus 18 or 16%; P less than .0001), and active labor (68 or 67% versus 15 or 13%; P less than .0001). Including the crossover study, uterine hyperstimulation (28 of 182, 15%) and fetal heart rate abnormalities (18 of 182, 10%) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus. These temporary adverse effects appeared while the pessary was in place and after the onset of active labor. Oxytocin was unnecessary in 89 of 182 (49%) of the PGE2-treated cases and was used more often to augment than to induce labor. We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin. The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities, but these would be expected to reverse on removal of the pessary. The effect of a prostaglandin E1 analogue on the cervix prior to termination of first trimester pregnancy was studied in a double-blind placebo-controlled trial with 70 primigravid and 125 multigravid patients in the Hong Kong University Gynaecological Unit. One mg of 16, 16-dimethyl-trans-delta 2-prostaglandin E1 methyl ester (ONO 802) in the form of vaginal pessary was inserted 3 hours before vacuum aspiration. The cervical dilatation in patients receiving ONO 802 pessaries was significantly greater than that in patients who received no treatment or placebo pessaries but the difference in dilatation between patients who received no treatment or placebo was not significant. The blood loss during operation in patients receiving ONO 802 pessaries was also significantly less than that in patients receiving placebo pessaries. The side effects due to ONO 802 pessaries were mild and infrequent. The objective of the study was to assess cerclage to prevent recurrent preterm birth in women with short cervix.
                Women with prior spontaneous preterm birth less than 34 weeks were screened for short cervix and randomly assigned to cerclage if cervical length was less than 25 mm.
                Of 1014 women screened, 302 were randomized; 42% of women not assigned and 32% of those assigned to cerclage delivered less than 35 weeks (P = .09). In planned analyses, birth less than 24 weeks (P = .03) and perinatal mortality (P = .046) were less frequent in the cerclage group. There was a significant interaction between cervical length and cerclage. Birth less than 35 weeks (P = .006) was reduced in the less than 15 mm stratum with a null effect in the 15-24 mm stratum.
                In women with a prior spontaneous preterm birth less than 34 weeks and cervical length less than 25 mm, cerclage reduced previable birth and perinatal mortality but did not prevent birth less than 35 weeks, unless cervical length was less than 15 mm. The objective of this study was to compare different management strategies for women at risk for cervical incompetence.
                In an ongoing randomized trial patients with a previous preterm delivery at <34 weeks' gestation who met clinical criteria for the diagnosis of cervical incompetence are allocated to receive a prophylactic cerclage (prophylactic cerclage group) or not (observational group) in a proportion of 1:2. Transvaginal ultrasonographic follow-up examination of the cervix is performed in both groups. When a patient of the latter group has a cervical length <25 mm at <27 weeks' gestation, a further random assignment of therapeutic cerclage or no cerclage is performed. The analysis is by intent to treat.
                Primary random assignment allocated 23 women to the prophylactic cerclage group and 44 to the observational group. Both groups were comparable with respect to obstetric history. No significant difference was found between the prophylactic cerclage group and the observational group in preterm delivery at <34 weeks' gestation (3/23 vs 6/44, respectively) and neonatal survival (21/23 vs 41/44, respectively). A cervical length <25 mm was found in 18 patients (41%) in the observational group at a mean gestational age of 19.1 +/- 2.9 weeks' gestation. Incidence of preterm delivery at <34 weeks' gestation was significantly higher in the group with short cervical length (6/18 vs 0/26; P =.003). Secondary random assignment of the 18 patients with short cervical length allocated 10 to undergo therapeutic cerclage. Preterm delivery at <34 weeks' gestation was significantly less frequent in the therapeutic cerclage group (1/10 vs 5/8).
                Transvaginal ultrasonographic serial follow-up examinations of the cervix in women at risk for cervical incompetence, with secondary intervention as indicated, appears to be a safe alternative to the traditional prophylactic cerclage. Transvaginal ultrasonographic follow-up examination of the cervix can save the majority of women from unnecessary intervention. Placement of a therapeutic cerclage may reduce the incidence of preterm delivery at <34 weeks' gestation among high-risk patients. To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.
                Multicentre, prospective, randomised controlled trial.
                Non-hospital based antenatal clinics.
                4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.
                The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.
                Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.
                Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women.
The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.