Randomized trial of ultrasound‐indicated cerclage in singleton women without lower genital tract inflammation

Abstract

Aim: This is the first report of a randomized trial of cerclage on pure cervical shortening without vaginosis or cervicitis. The objective of our multicenter randomized controlled trial was to assess the benefits of ultrasoundindicated cervical cerclage in the mid-trimester to prevent preterm birth in women who have no signs of infection or inflammation of the lower genital tract. Material and Methods: Women with a short cervical length < 25 mm between 16 and 26 weeks of gestation were randomly assigned to receive a Shirodkar cerclage, McDonald cerclage, or bedrest (no cerclage). Before being randomly assigned to one of the three groups, all women were screened for infection/inflammation of the lower genital tract; those with positive results were excluded from the study. The ratio of preterm delivery as a primary end-point was evaluated in the groups. Results: A total of 106 singleton patients with a short cervical length were assessed for study eligibility; 106 patients were randomized to the three treatment options. Ultimately, 98 patients (in the Shirodkar [n = 34], McDonald [n = 34] and bedrest [n = 30] groups) were analyzed. No differences in preterm delivery or perinatal outcomes were found between the three groups. Significantly fewer patients in the Shirodkar group required hospitalization for treatment of threatened preterm labor when compared to patients in the bedrest group. Conclusion: For women with a short cervical length < 25 mm between 16 and 26 weeks of gestation, Shirodkar cerclage might be considered to reduce the occurrence of threatened preterm labor.

Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis

“…119 A trial that assessed cerclage vs no cerclage in singleton gestations with a short cervix (cervical length <25 mm) was excluded because data on 14 women with a previous preterm birth that were included in this study could not be obtained. 120 Thus, only one new trial (the OPPTI-MUM study 91 ) was included in this updated indirect comparison meta-analysis. In total, 10 trials met the inclusion criteria that provided data for 769 women with a singleton gestation, previous spontaneous preterm birth, and a cervical length <25 mm at midtrimester.…”

“…Second, data for 14 patients with a singleton gestation, previous preterm birth, and cervical length <25 mm who participated in a trial 120 that compared Shirodkar cerclage, McDonald cerclage, and bed rest (no cerclage) could not be obtained from the investigators. It was not possible to determine how many of these patients had a previous spontaneous preterm birth.…”

“…It was not possible to determine how many of these patients had a previous spontaneous preterm birth. In this trial, 120 a total of 104 women with no signs of infection or inflammation of the lower genital tract and a cervical length <25 mm between 16 and 26 weeks of gestation were randomly allocated to 1 of the 3 groups. Overall, there were no significant differences between the cerclage and no cerclage groups in the risk of preterm birth and adverse perinatal outcomes.…”

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

“…A control group of usual care or placebo was compared with progesterone (either type) in 17 studies, [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] with cerclage in 12 studies [44][45][46][47][48][49][50][51][52][53][54][55] and with pessary in three studies. [56][57][58] In addition, one study compared 17-OHPC with cerclage 59 and three studies compared natural progesterone with 17-OHPC [60][61][62] (Table 1, and see Supporting information, Figure S2).…”

“…Our findings for pessary, based on three studies, differed from the previous individual systematic review of one study. Overall, nine studies were included in this review that were not present in previous reviews [41][42][43]55,57,58,[60][61][62] , including the largest studies to date on progesterone and pessary. 43,58 Studies included in previous reviews that we excluded are listed in the Supporting information (Table S5).…”