17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographically short cervix: A randomized controlled trial.

The aim of this study was to compare 17-alpha-hydroxyprogesterone caproate (17OHP-C) with vaginal progesterone suppository for the prevention of preterm birth in women with a sonographically short cervix and to evaluate the changes of the cervical length (CL) over time. In this prospective randomized controlled trial, eligible patients were asymptomatic pregnant women with a sonographically short cervix. The participants in group 1 (n = 147) received vaginal progesterone suppositories at a dose of 400 mg daily and the women in group 2 (n = 150) received an i.m. dose of 250 mg 17OHP-C once a week. Transvaginal sonography was repeated every 3 weeks until 36 gestational weeks or the occurrence of preterm labor. A total of 304 singleton pregnant women between 16 and 24 gestational weeks with CL < 25 mm were enrolled in our study. The rates of preterm birth were 10.4% in the progesterone group and 14% in the 17OHP-C group: a difference that was not statistically significant (P = 0.416). Moreover, 264 participants underwent ultrasound examination five times and CL changes were studied for 15 weeks. The results showed that the CL changes over 15 weeks were statistically significant (P < 0.001), but the method of intervention (progesterone/17OHP-C) had no significant effect on CL change (P = 0.64). Our findings showed that vaginal progesterone and 17OHP-C had the same effect on the risk of preterm labor in asymptomatic women with a sonographically short cervix. We detected no significant difference between the effect of 17OHP-C and vaginal progesterone on CL changes over time.

Pirjani R ，Heidari R ，Rahimi-Foroushani A ，Bayesh S ，Esmailzadeh A ... -  《-》

Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial.

Facchinetti F ，Vergani P ，Di Tommaso M ，Marozio L ，Acaia B ，Vicini R ，Pignatti L ，Locatelli A ，Spitaleri M ，Benedetto C ，Zaina B ，DʼAmico R ... -  《-》

17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial.

The objective of the study was to evaluate the efficacy of 17 alpha-hydroxyprogesterone caproate (17OHP-C) in prolonging gestation in patients with a short cervix and other risk factors for preterm delivery, such as previous preterm birth, cervical surgery, uterine anomalies, or prenatal diethylstilbestrol (DES) exposure. This open-label, multicenter, randomized controlled trial included asymptomatic singleton pregnancies from 20(+0) through 31(+6) weeks of gestation with a cervical length less than 25 mm and a history of preterm delivery or cervical surgery or uterine malformation or prenatal DES exposure. Randomization assigned them to receive (or not) 500 mg of intramuscular 17OHP-C weekly until 36 weeks. The primary outcome was time from randomization to delivery. After enrolling 105 patients, an interim analysis demonstrated the lack of efficacy of 17OHP-C in prolonging pregnancy. The study was discontinued because of futility. The groups were similar for maternal age, body mass index, parity, gestational age at inclusion, history of uterine anomalies, DES syndrome, previous preterm delivery or midtrimester abortion, and cervical length at randomization. The enrollment-to-delivery interval did not differ between patients allocated to 17OHP-C (n = 51) and those allocated to the control group (n = 54) (median [interquartile range] time to delivery: 77 [54-103] and 74 [52-99] days, respectively). The rate of preterm delivery less than 37 (45% vs 44%, P > .99), less than 34 (24% vs 30%, P = .51), or less than 32 (14% vs 20%, P = .44) weeks was similar in patients allocated to 17OHP-C and those in the control group. 17OHP-C did not prolong pregnancy in women with singleton gestations, a sonographic short cervix, and other risk factors of preterm delivery (prior history, uterine malformations, cervical surgery, or prenatal DES exposure).

Winer N ，Bretelle F ，Senat MV ，Bohec C ，Deruelle P ，Perrotin F ，Connan L ，Vayssière C ，Langer B ，Capelle M ，Azimi S ，Porcher R ，Rozenberg P ，Groupe de Recherche en Obstétrique et Gynécologie ... -  《-》

Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety.

El-Refaie W ，Abdelhafez MS ，Badawy A 《-》

[Is universal screening for cervical length among singleton pregnancies with no history of preterm birth justified?].

The ultrasonographic measurement of cervical length with a cutoff of 15mm is currently the best method to identify a group of asymptomatic women in the general population at risk of spontaneous preterm birth, especially among asymptomatic patients with a singleton pregnancy with no history of preterm birth. Cerclage and 17 alpha-hydroxyprogesterone caproate (17OHP-C) are ineffective to reduce the risk of preterm birth among asymptomatic patients with a short cervix in midtrimester. However, vaginal progesterone (200-mg capsules of micronized progesterone or gel containing 90mg progesterone) has been demonstrated effective in 2 large randomized trials to reduce the risk of preterm birth and possibly the composite morbidity and perinatal mortality associated among asymptomatic women with a short cervix in the general population screened by ultrasound of the cervix in midtrimester. Three cost-effectiveness analyses are converging to show that universal screening for cervical length with vaginal progesterone treatment seems to be cost-effective compared with no screening. However, it is too early to definitively conclude that universal screening is justified for several reasons: many women must be screened to prevent a relatively small number of preterm births. Moreover, the epidemiology of preterm delivery is such that the use of progesterone in asymptomatic women with a short cervix screened by ultrasound in midtrimester in the general population will not significantly reduce the prevalence of preterm births; there are no data comparing the effectiveness of universal ultrasound screening followed by vaginal progesterone treatment in case of short cervix versus no universal screening associated to a progesterone treatment in case of incidentally observed short cervix; the universal ultrasound screening may not produce the same results in practice than those observed in published randomized trials, due to population differences, "indication creep", or "stretching of the cutoff" defining the short cervix. Moreover, the implementation of unevaluated or not recommended treatments, such as bed rest, tocolytics, 17OHP-C or cerclage, can potentially cause unintended deleterious consequences and reduce the cost-effectiveness; the cost-effectiveness analyses evaluating universal screening for cervical length present uncertainties on critical variables, notably the short cervix prevalence and the progesterone efficacy. In conclusion, although the implementation of such a screening strategy can be considered by individual practitioners, this screening cannot be universally mandated.

Rozenberg P 《-》