Comparison of maternal and neonatal morbidity in transvaginal versus transabdominal cerclage patients: A retrospective study from two tertiary hospitals.

OBJECTIVE: To compare the maternal and neonatal morbidity in patients with transvaginal (TVC) versus transabdominal (TAC) cerclage. MATERIALS AND METHODS: Retrospective analysis of patients who received cervical cerclage and terminated the pregnancy in the second trimester or third trimester in two tertiary hospitals. Data on basic clinical characteristics, predelivery maternal morbidity, intrapartum morbidity, postpartum morbidity and neonatal morbidity of TVC patients and TAC patients were analysed and compared. RESULTS: Seventy-two TVC patients and 120 TAC patients were included. The rates of abnormal fetal presentation and placental disorders were significantly higher in TAC patients than that in TVC patients (21.67% vs 5.56% and 18.33% vs 4.17%, respectively). The rates of premature rupture of membranes and intrauterine infection were significantly higher in TVC patients than that in TAC patients (25.00% vs 2.50% and 11.23% vs 3.33%, respectively). Compared with TVC patients, the rates of estimated intrapartum hemorrhage ≥500 ml, uterine rupture and cesarean delivery in the third trimester were significantly higher in TAC patients than in TVC patients. Gestational age at delivery and neonatal morbidity were comparable between TVC patients and TAC patients. CONCLUSION: Compared with TVC patients, TAC patients were associated with a significantly higher incidence of maternal morbidity in placental disorders, abnormal fetal presentation, intrapartum hemorrhage ≥500 ml and uterine rupture.

Novel Vaginal Cerclage Assisted Laparoscopic Cervico-Sacropexy Technique for Uterovaginal Prolapse.

AIM: Laparoscopic hysteropexy is a complicated procedure that requires specialized surgical skills, including precise dissection and suturing. The aim is to describe the technical considerations for performing a new, feasible, and minimally invasive technique to correct apical and concurrent apical and anterior vaginal wall defects. METHOD: A retrospective analysis was conducted on 70 consecutive women who underwent surgery for stage ≥3 uterovaginal prolapse. As a part of the technique, an anterior 2-cm long transverse incision was made at the anterior cervicovaginal junction, and the bladder was dissected through blunt and sharp dissection to the level of the isthmus. A posterior colpotomy was performed. A polypropylene tape was inserted into the cervical connective tissue, and the free arms of the tape were inserted into the peritoneum via the posterior colpotomy. Two arms of the tape were passed from the tunnel parallel and medial to a right sacrouterine fold, then fixed to the anterior longitudinal ligament via the laparoscopic route. RESULTS: The tape can be inserted into the cervix in a median of 15 min, and the laparoscopy procedure can be completed in 24 min. No mesh erosion or long-term complications occurred. At a 1-year control, there were no cases of recurrence. CONCLUSIONS: This novel cervico-sacrocolpopexy technique is a feasible and safe, minimally invasive way to correct apical or multicompartment defects, with a short operation time and an anatomical result that mimics the normal sacrouterine ligament.

Obstetric outcomes of transabdominal cerclage: A retrospective observational study in Japan.

OBJECTIVE: This study aimed to investigate the obstetric outcomes of transabdominal cerclage (TAC) in Japan. METHODS: Questionnaires on TAC were sent to 183 institutions performing high-quality perinatal management in Japan. As a first-step questionnaire, we asked whether TAC was performed between January 1, 2011, and December 31, 2022. In the second step of the questionnaire, the characteristics of all cases were asked from all institutions in which TAC was performed. RESULTS: The response rate for the first survey was 59% (108/183). Of the 108 institutions, 27 performed TAC (25%) in 133 pregnancies. Of these 27 institutions, 19 responded to the second survey. One hundred twenty-five pregnancies were included in this study, five of which were aborted (gestational weeks <22 weeks), and 69 babies were born after 37 gestational weeks (55%). Eighty-two open abdominal cerclages were performed at 17 institutions and 43 laparoscopic TACs at three institutions. There were no differences in the age at TAC, gestational weeks at TAC, operative time of TAC, gestational weeks at delivery, incidence rate of second-trimester loss, or preterm delivery (before 37 gestational weeks) rate between the two groups. However, blood loss during open TAC was greater than that during laparoscopic TAC. CONCLUSION: TAC is a rare surgery for cervical insufficiency in Japan. TAC may be a safe and useful method for preventing second-trimester loss and preterm delivery in high-risk patients. TAC may also be a key option in Japan to improve perinatal outcomes in patients with cervical insufficiency.

Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial.

BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT "Stitch, Pessary, or Progesterone Randomised Trial" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy. METHODS AND FINDINGS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks' gestation. Secondary outcomes included PTB <34 weeks', <30 weeks', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic. CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix. TRIAL REGISTRATION: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.

Effectiveness and pregnancy outcomes of ultrasound-indicated and physical examination-indicated cervical cerclage: a retrospective study from a single centre.

OBJECTIVE: Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality worldwide, and cervical incompetence (CIC) is a significant contribution. Cervical cerclage (CC) is an effective obstetric intervention. However, many clinical factors affect the success rate of surgery. The objective was to investigate and compare the pregnancy and neonatal outcomes of patients who underwent ultrasound- and physical examination-indicated cervical cerclage and to explore the influencing factors of preterm delivery before 34 weeks. METHODS: The sociodemographic characteristics and clinical data of patients with a diagnosis of cervical incompetence who underwent ultrasound- and physical examination-indicated transvaginal cervical cerclage at Nanjing Maternal and Child Health Hospital from January 2020 to December 2022 were retrospectively analyzed. The pregnancy and neonatal outcomes of the patients were evaluated. Continuous variables were compared using Student's t test (for normally distributed data) or the Mann-Whitney U test (for nonnormally distributed data). Categorical variables were analysed using the chi-square test or Fisher's exact test. Additionally, logistic regression analyses and receiver operating characteristic curves were used to evaluate the associations of inflammatory markers with maternal and neonatal outcomes. RESULTS: This study included 141 participants who underwent cervical cerclage, including 71 with ultrasound-indicated cerclage and 70 with physical examination-indicated cerclage. Compared to those in the ultrasound-indicated cerclage group, the duration from cerclage to delivery, birth weight, and APGAR score in the physical examination-indicated cerclage group were significantly lower, and the rates of delivery at < 28 weeks, < 32 weeks, < 34 weeks, and < 37 weeks of gestation and neonatal mortality were significantly higher (all P < 0.05). Compared to those in the physical ultrasound-indicated cerclage group, in the physical examination-indicated cerclage group, maternal blood inflammatory markers, such as C-reactive protein (CRP), the systemic immune-inflammation index (SII) and the systemic inflammation response index (SIRI) were significantly higher (P < 0.05). Additionally, maternal blood inflammatory markers, such as the CRP, white blood cell count, platelet to lymphocyte ratio (PLR), SII, and SIRI were significantly higher in the group with delivery before 34 weeks of gestation. Furthermore, the results demonstrated that twin pregnancy had the highest OR for preterm delivery before 34 weeks of gestation (OR = 3.829; 95% CI 1.413-10.373; P = 0.008), as well as the following: the SII level (OR = 1.001; 95% CI 1.000-1.002; P = 0.003) and CRP level (OR = 1.083; 95% CI 1.038-1.131; P = 0.022). The risk factors for preterm delivery before 34 weeks of gestation were twin gestation, an increased SII level and an increased CRP level, which had good combined predictive value. CONCLUSION: In patients with cervical insufficiency, ultrasound-indicated cervical cerclage appears to lead to better pregnancy outcomes than physical examination-indicated cerclage. Twin pregnancy and maternal blood inflammatory markers, such as the CRP level and the SII, are associated with preterm delivery before 34 weeks of gestation.

Concurrent progestogen and cerclage to reduce preterm birth: a multicenter international retrospective cohort.

BACKGROUND: Both progestogens and cerclage are individually effective in preterm birth prevention in high risk pregnancies. However, national and international guidelines cite a lack of data available to comment on the potential benefit of concurrent progestogen therapy after cerclage has been placed. Studies to date have been small with mixed results regarding benefit of concurrent progestogen with cerclage leaving uncertainty regarding best clinical practice. OBJECTIVE: This study aimed to evaluate whether cerclage with progestogen therapy was superior to cerclage alone in the prevention of spontaneous preterm birth in singleton pregnancies. METHODS: This is an international retrospective cohort study of singleton pregnancies, without major anomaly or aneuploidy, and with cerclage placed at 10 different institutions in the United States and Colombia from June 2016 to June 2020. Exclusion criteria were lack of documentation regarding whether progestogen was prescribed, unavailable delivery outcome, and pregnancy termination (spontaneous or induced) before 16 weeks' gestation. The exposure of interest was progestogen use with cerclage placement, which included those who continued to use progestogen or who started progestogen after cerclage. The comparison group consisted of those without progestogen use after cerclage placement, which included those who had no progestogen use during the entire pregnancy or who initiated progestogen and then stopped it after cerclage placement. Progestogen type, cerclage indication, maternal baseline characteristics, and maternal/neonatal outcomes were collected. The primary outcome was spontaneous preterm birth at <37 weeks. The secondary outcomes were spontaneous preterm birth at <34 weeks, gestational age at delivery, and a composite neonatal outcome including ≥1 of the following: perinatal mortality, confirmed sepsis, grade III or IV intraventricular hemorrhage, retinopathy of prematurity, respiratory distress syndrome, and bronchopulmonary dysplasia. There were planned subgroup analyses by cerclage indication, progestogen type (vaginal progesterone vs 17-hydroxyprogesterone caproate), preterm birth history, and site. Continuous variables were compared in adjusted analyses with analysis of covariance, and categorical variables were compared with multivariable logistic regression, adjusting for potential confounders with adjusted odds ratio. A Cox regression survival curve was generated to compare latency to spontaneous delivery, censored after 37 weeks. RESULTS: During the study period, a total of 699 singletons met the inclusion criteria: 561 in the progestogen with cerclage group and 138 with cerclage alone. Baseline characteristics were similar, except the higher likelihood of previous spontaneous preterm birth in the progestogen group (61% vs 41%; P<.001). Within the progestogen group, 52% were on 17-hydroxyprogesterone caproate weekly, 44% on vaginal progesterone daily, and 3% on oral progesterone daily. Progestogen with cerclage was associated with a significantly lower frequency of spontaneous preterm birth <37 weeks (31% vs 39%; adjusted odds ratio, 0.59 [0.39-0.89]; P=.01) and <34 weeks (19% vs 27%; adjusted odds ratio, 0.55 [0.35-0.87]; P=.01), increased latency to spontaneous delivery (hazard ratio for spontaneous preterm birth <37 weeks, 0.66 [0.49-0.90]; P=.009), and lower frequency of perinatal death (7% vs 16%; adjusted odds ratio, 0.37 [0.20-0.67]; P=.001). In planned subgroup analyses, association with reduced odds of preterm birth <37 weeks persisted in those on vaginal progesterone, those without a previous preterm birth, those with ultrasound- or examination-indicated cerclage, those who started progestogen therapy before cerclage, and in sites restricted to the United States. CONCLUSION: Use of progestogen with cerclage was associated with reduced rates of spontaneous preterm birth and early spontaneous preterm birth compared with cerclage alone. Although this study was not sufficiently powered for subgroup analysis, the strength of evidence for benefit appeared greatest for those with ultrasound- or examination-indicated cerclage, and with vaginal progesterone. El resumen está disponible en Español al final del artículo.

Robotic-assisted single-site abdominal cerclage in the bicornuate uterus patient with cervical insufficiency.

OBJECTIVE: To demonstrate the surgical techniques for improving safety in robotic-assisted abdominal cerclage in patients with bicornuate uteri complicated by recurrent pregnancy loss and cervical insufficiency. DESIGN: Stepwise demonstration with narrated video footage. SETTING: An academic tertiary care hospital. PATIENTS: Our patient is a 22-year-old G2P0020 with a history of recurrent pregnancy loss. During her first pregnancy, she was asymptomatic until 19 weeks and delivered because of a preterm premature rupture of membranes. A transvaginal cerclage was performed for her second pregnancy at 14 weeks, which ended at 16 weeks because of preterm premature rupture of membranes. The final magnetic resonance imaging report noted a "bicorporeal uterus with duplication of the uterine body, resulting in two markedly divergent uterine horns that are fused at the isthmus... unlike a typical didelphic uterus, a single, non septated cervix is noted, which shows normal appearances, measuring 3.8 cm in length." Given her history of a uterine anomaly and recurrent pregnancy loss in the absence of other biochemical factors, her maternal-fetal medicine specialist referred her to us as the patient strongly desired future viable pregnancies. The patient was counseled on multiple alternatives, including different methods of performing the cerclage, and ultimately decided on the robotic-assisted (Da Vinci Xi) prophylactic abdominal cerclage. INTERVENTIONS: The bicornuate uterus is a rare class IV mullerian duct anomaly caused by the impaired fusion of the mullerian ducts in the uterus, classically appearing in imaging studies as a heart-shaped uterus. This patient demographic reports a high incidence of obstetric complications. Pregnancy in such a uterus causes complications like first- and second-trimester pregnancy loss, preterm labor, low-birthweight infants, and malpresentation at delivery.1 Researchers have postulated that there is an abnormal ratio of muscle fibers to connective tissue in a congenitally abnormal cervix. During pregnancy, an inadequate uterine volume may lead to increased intrauterine pressure and stress on the lower uterine segment, which can lead to cervical incompetence.2 To address cervical incompetence, cervical cerclages are a commonly utilized procedure, as recent studies demonstrate that the incidence of term pregnancies in the group with documented cervical incompetence treated with cerclage placement increased from 26% to 63%.3 One observational study noted improved obstetrical outcomes occurred with interval placement, a cerclage placed in between pregnancies in the nongravid uterus, compared with cerclage placement between 9 and 10 weeks gestation, with the mean gestational age for delivery at 32.9 weeks and 34.5 weeks when a cerclage was placed in gravid and nongravid women, respectively.4 In addition, another retrospective study was done, which demonstrated a lower incidence of neonatal death with prophylactic cerclages.5 Operating on a nonpregnant uterus offers several benefits, including its reduced size, fewer and smaller blood vessels, and simplified handling. Moreover, there are clearly no concerns regarding the fetus. In the decision to use a robotic-assisted platform vs. laparoscopic, a systematic review showed the rates of third-trimester delivery and live birth (LB) using laparoscopy during pregnancy were found to be 70% and 70%-100%, respectively. The same review demonstrated slightly improved outcomes via the robotic route regarding gestational age at delivery (median, 37 weeks), rates of LB (90%), and third-trimester delivery (90%).6 Additional factors contributing to the preference for robotics in surgical procedures include incorporating advanced tools, which can enhance the robotic system's advantages compared with traditional laparoscopy. An invaluable tool in this context is the simultaneous utilization of Firefly mode, which employs a near-infrared camera system, achieved through injecting indocyanine green dye or integrating other light sources concurrently. The intravenous administration of indocyanine green is acknowledged widely for its safety and efficacy as a contrast agent in the evaluation of microvascular circulation and organ vascularization. This property equips surgeons with heightened precision when guiding the needle, proving especially advantageous when faced with challenges in visualizing vascular anatomy. In our specific case, we harnessed the capabilities of Firefly mode in conjunction with hysteroscopic light, enabling us to vividly illustrate the contours of a bicornuate uterus from both external and internal perspectives. We demonstrate a simplified technique of the abdominal cerclage, one cerclage around the internal cervical os of the uterus, using a robotic-assisted platform in a nongravid patient. The surgery began with the eversion of the umbilicus, and a 15-mm skin incision was made in the umbilicus. A Gelpoint mini advanced access site laparoscopy device was inserted into the incision, and CO2 was allowed to insufflate the abdominal cavity with careful attention given to intraabdominal pressure. Once the DaVinci was docked, the surgeon began the creation of a bladder flap. The bladder was carefully dissected from the lower uterine segment and both uteri using monopolar scissors. The anatomical differences of a bicornuate uterus prompted the surgeon to dissect a wider circumference for safety reasons, where a wider dissection offers a better view of the uterine vessels and ease of introducing the Mersilene tape later on. Bilateral uterine vessels were further skeletonized and exposed anteriorly using blunt dissection and monopolar scissors. After further dissection and lateralization, the final result creates a landmark medial to the right uterine vessels at the level of the internal cervical os with which the needle of the Mersilene tape will be able to pass through. The Mersilene tape was guided from anterior to posterior via a previously straightened needle. Similarly, a landmark was created on the left, and the Mersilene tape was directed from anterior to posterior. The Mersilene tape was placed circumferentially around the internal cervical os of the bicornuate uterus, medial to the uterine vessels. Both ends of the Mersilene tape were then gently pulled, ensuring that the tape was lying flat on the anterior of the internal cervical os with no bowels or uterine vessels within it. The tape was then tied posteriorly at the 6 o'clock position with appropriate tension. A 2-0 silk was then sutured to the tails of the tape using the purse-string technique to ensure that it would remain securely tied and in the correct position. Hemostasis was assured. Both a hysteroscopy and a cystoscopy were done after the completion of the cerclage to ensure that no tape or sutures were seen within the cervical canal or the uterine cavity. None were observed. MAIN OUTCOMES MEASURES: The success criteria for the surgery were identified as the patient's ability to attain a viable pregnancy after the cerclage placement, along with achieving LB. RESULTS: Subsequently, a spontaneous pregnancy was achieved. An infant weighing 3 pounds and 16 ounces was delivered by cesarean section at 36 weeks because of an oligohydramnios. The infant is currently healthy at 13 pounds. CONCLUSION: Robotic-assisted abdominal cerclage around the internal cervical os in a bicornuate uterus offers a possibly feasible and straightforward technique for surgeons seeking to reduce risks, although further research is needed.

A Retrospective Study Comparing Laparoscopic Transabdominal Cerclage: Pre-Pregnancy Versus in Pregnancy With Their Reproductive Outcomes and Safety.

OBJECTIVES: To compare the efficacy of laparoscopic transabdominal cerclage (TAC) pre-pregnancy and laparoscopic TAC in pregnancy in treating cervical insufficiency. METHOD: A retrospective analytical study comparing outcomes of laparoscopic TAC pre-pregnancy with laparoscopic TAC in pregnancy. A total of 178 patients who underwent laparoscopic TAC at our hospital were enrolled in the study. In total, 122 patients underwent interval cerclage, and 56 patients underwent cerclage during pregnancy. RESULTS: A total of 178 patients who met the inclusion criteria were included in the analysis. Second-trimester abortions decreased by 50%, with an overall increase in full-term live births (32.53%) in patients undergoing laparoscopic TAC pre-pregnancy. The fetal survival rate was around 90% and 85% with laparoscopic TAC pre-pregnancy and laparoscopic TAC in pregnancy, respectively. Although the obstetric outcomes of laparoscopic TAC pre-pregnancy and in pregnancy were comparable, laparoscopic TAC pre-pregnancy was safer than laparoscopic TAC in pregnancy due to the complications associated with the procedure during pregnancy. CONCLUSIONS: Laparoscopic TAC pre-pregnancy yielded better reproductive outcomes than laparoscopic TAC in pregnancy and was associated with fewer perioperative complications.

Favorable surgical and obstetrical outcomes in pre- and postconceptional laparoscopic abdominal cerclage: a large multicenter cohort study.

BACKGROUND: Cervical incompetence is an important cause of extremely preterm delivery. Without specialized treatment, cervical incompetence has a 30% chance of recurrence in a subsequent pregnancy. Recently, the first randomized controlled trial showed significant superiority of abdominal cerclage compared with both high and low vaginal cerclage in preventing preterm delivery at <32 weeks of gestation and fetal loss in patients with a previous failed vaginal cerclage. OBJECTIVE: This study aimed to assess surgical and obstetrical outcomes in patients with pre- and postconceptional laparoscopic abdominal cerclage placement. Furthermore, it also aimed to perform subgroup analysis based on the indication for cerclage placement in order to identify patients who benefit the most from an abdominal cerclage. STUDY DESIGN: A retrospective multicenter cohort study with consecutive inclusion of all eligible patients from 1997 onward in the Dutch cohort (104 patients) and from 2007 onward in the Boston cohort (169 patients) was conducted. Eligible patients had at least 1 second- or third-trimester fetal loss due to cervical incompetence and/or a short or absent cervix after cervical surgery. This includes loop electrosurgical excision procedure, conization, or trachelectomy. Patients were divided into the following subgroups based on the indication for cerclage placement: (1) previous failed vaginal cerclage, (2) previous cervical surgery, and (3) other indications. The third group consisted of patients with a history of multiple second- or early third-trimester fetal losses due to cervical incompetence (without a failed vaginal cerclage) and/or multiple dilation and curettage procedures. The primary outcome measure was delivery at ≥34 weeks of gestation with neonatal survival at hospital discharge. Secondary outcome measures included surgical and obstetrical outcomes, such as pregnancy rates after preconceptional surgery, obstetrical complications, and fetal survival rates. RESULTS: A total of 273 patients were included (250 in the preconceptional and 23 in the postconceptional cohort). Surgical outcomes of 273 patients were favorable, with 6 minor complications (2.2%). In the postconceptional cohort, 1 patient (0.4%) had hemorrhage of 650 mL, resulting in conversion to laparotomy. After preconceptional laparoscopic abdominal cerclage (n=250), the pregnancy rate was 74.1% (n=137) with a minimal follow-up of 12 months. Delivery at ³34 weeks of gestation occurred in 90.5% of all ongoing pregnancies. Four patients (3.3%) had a second-trimester fetal loss. The indication for cerclage in all 4 patients was a previous failed vaginal cerclage. The other subgroups showed fetal survival rates of 100% in ongoing pregnancies, with a total fetal survival rate of 96%. After postconceptional placement, 94.1% of all patients with an ongoing pregnancy delivered at ³34 weeks of gestation, with a total fetal survival rate of 100%. Thus, second-trimester fetal losses did not occur in this group. CONCLUSION: Pre- and postconceptional laparoscopic abdominal cerclage is a safe procedure with favorable obstetrical outcomes in patients with increased risk of cervical incompetence. All subgroups showed high fetal survival rates. Second-trimester fetal loss only occurred in the group of patients with a cerclage placed for the indication of previous failed vaginal cerclage, but was nevertheless rare even in this group.

"I had given up on being a mother": a survey of 183 women's experience of transabdominal cerclage (TAC).

BACKGROUND: Transabdominal cerclage (TAC) is a relatively uncommon intervention for preventing preterm birth. This study aimed to investigate the experience of women who had undergone this procedure. METHODS: The survey was designed in collaboration with a preterm birth studies public and patient involvement (PPI) group and ethical approval was granted by KCL BDM Research Ethics Panel (LRS-19/20-13205). Members of closed Facebook group, UK TAC Support, were invited to complete an online questionnaire about their experience of TAC, and pregnancies before and after having it placed. The survey was open between December 2019 and May 2020. Open and closed questions provided both qualitative and quantitative data for analysis, which was carried out using NVivo Pro 2020 v.1.4.1 qualitative data management software and SPSS Statistics 27 (IBM). RESULTS: One hundred eighty-three participants completed the survey, having had TAC procedures carried out in 36 hospitals. Altogether, participants had experienced 287 preterm births (PTB) and late miscarriages (LM), equating to an average of 1.6 each (range 0-5), including 18 stillbirths. TAC was indicated in 123 (67%) for previous PTB and/or LM, 29 (16%) for cervical surgery and 31 (17%) for both. 151 (83%) TAC procedures were open, 32 (17%) laparoscopic. 86% (n = 157) were placed outside pregnancy. Of those placed in pregnancy, gestation at TAC ranged from 7 to 16 weeks. When comparing earliest pre- and post-TAC pregnancy gestation (excluding first trimester losses), median gestational weeks gained following TAC was 15.5 weeks (SD 6.89). Qualitative themes included: the struggle to get treatment; lack of TAC knowledge amongst clinicians; gratitude, hope and feeling protected; possible detrimental effects of TAC. CONCLUSIONS: This very high-risk group found having a TAC gave great reassurance and hope, and were very grateful to have found the care they needed. However, they often struggled to get this support, frequently due to lack of clinician awareness. This may improve following roll-out of NHS England's Saving Babies Live Care Bundle and NHS commissioning guidelines for care of women at risk of PTB.

Characteristic impairment of progesterone response in cultured cervical fibroblasts obtained from patients with refractory cervical insufficiency.

Preterm birth (PTB) is the leading cause of neonatal mortality, and reducing the PTB rate is one of the most critical issues in perinatal medicine. Cervical insufficiency (CI), a major cause of PTB, is characterised by premature cervical ripening in the second trimester, followed by recurrent pregnancy loss. Although multiple clinical trials have suggested that progesterone inhibits cervical ripening, no studies have focused on progesterone-induced molecular signalling in CI. Here, we established a primary culture system for human uterine cervical fibroblasts using a sample of patients with refractory innate CI who underwent transabdominal cervical cerclage and patients with low Bishop scores who underwent elective caesarean section as controls. RNA sequencing showed that the progesterone response observed in the control group was impaired in the CI group. This was consistent with the finding that progesterone receptor expression was markedly downregulated in CI. Furthermore, the inhibitory effect of progesterone on lipopolysaccharide-induced inflammatory stimuli was also impaired in CI. These results suggest that abnormal cervical ripening in CI is caused by the downregulation of progesterone signalling at the receptor level, and provide a novel insight into the molecular mechanism of PTB.

Emergency cerclage using double-level versus single-level suture in the management of cervical insufficiency (Cervical Occlusion double-level Stitch Application, COSA): study protocol for a multicentre, non-blinded, randomised controlled trial.

INTRODUCTION: Cervical insufficiency accounts for 15% of recurrent pregnancy losses between 16 and 28 weeks of gestation. The aim of the study is to verify the effectiveness of emergency double-level cerclage with vaginal progesterone in cervical insufficiency treatment in terms of the prevention of preterm delivery before 34 weeks of gestation. METHODS AND ANALYSIS: This trial is a multicentre, non-blinded, randomised study with 1:1 allocation ratio. The study is conducted at tertiary perinatal care departments in Poland. It will include patients with cervical insufficiency with the fetal membranes visible in the open cervical canal or protruding into the vagina between 16+0 and 23+6 weeks of pregnancy. They will be randomised into two arms: emergency single-level cerclage with vaginal progesterone or double-level cerclage with vaginal progesterone. All will be administered antibiotics and indomethacin. The primary outcome is the rate of deliveries below 34+0 weeks of gestation, while secondary outcomes include gestational age at delivery, neonatal outcomes, maternal outcomes according to the Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth and cerclage procedure complications. The planned number of participants according to the power analysis is 78. ETHICS AND DISSEMINATION: The study protocol was written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials statement. It was created according to the requirements of the Declaration of Helsinki for Medical Research involving Human Subject. Ethical approval was obtained from the Ethics Committee of the Centre of Postgraduate Medical Education (no. 1/2022). The study protocol was approved and published by ClinicalTrials.gov (posted on 24 February 2022). All participants gave a written informed consent. After completion of the study its results will be published in a peer-reviewed English language journal. TRIAL REGISTRATION: NCT05268640.

The minimally invasive approach to abdominal cerclage: indications, complications, and techniques for placement.

PURPOSE OF REVIEW: Laparoscopic abdominal cerclage placement has become the favored approach for management of refractory cervical insufficiency. There are special considerations with respect to surgical method, management of pregnancy loss, and delivery following placement. This review addresses current literature on transabdominal cerclage with a focus on up-to-date minimally invasive techniques. RECENT FINDINGS: Recent literature on abdominal cerclage has compared laparoscopic and open approaches, evaluated the effect of preconception placement on fertility, and explored the upper gestational limit for dilation and evacuation with an abdominal cerclage in situ . SUMMARY: The objective of this article is to help minimally invasive surgeons identify candidates for transabdominal cerclage placement, understand surgical risks, succeed in their laparoscopic approach, and appropriately manage patients postoperatively.

The impact of cerclage placement on gestational length in women with premature cervical shortening.

OBJECTIVES: Cervical insufficiency (CI) is a condition consistent with painless cervical dilatation that can lead to preterm delivery. Cervical cerclage is a procedure in which cervical suture is performed for preventing preterm labor in several indications. Late emergency cerclage is technically more challenging compared to elective cerclage, performed earlier during pregnancy, prior to cervical changes. Pregnancy outcomes with emergency cerclage were found to be improved in previous reports, but there is still inconclusive data. To assess the effectiveness and safety of emergency cerclage vs. conservative management with progesterone and/or bed resting, in preventing preterm birth and improving neonatal outcomes in women with clinically evident cervical insufficiency. METHODS: This is a retrospective cohort study conducted on all women diagnosed with cervical insufficiency between the 16th and 24th gestational week who met the inclusion criteria, from January 2012 to December 2018. Obstetric and neonatal outcomes: time from diagnosis to delivery, duration of pregnancy, birth weight and Apgar score, were compared between women who underwent cerclage and those who treated conservatively. RESULTS: Twenty eight women underwent emergency cerclage (cerclage group) and 194 managed with a conservative therapy, progesterone and/or bed rest (control group). Time from diagnosis to delivery 13 weeks vs. 8 weeks and birth weight 2,418 g vs. 1914 g were significantly higher in the first cohort. Average pregnancy duration was three weeks longer in the cerclage group, but that was not significant. No complications occurred in the cerclage group and no difference in mode of delivery were found. CONCLUSIONS: Emergency cerclage is an effective and safe procedure in preventing preterm birth and prolongation of pregnancy, in women with cervical insufficiency in the late second trimester.

[Comparison of maternal-fetal outcomes between laparoscopic cervicoisthmic cerclage and McDonald cerclage in women with cervical insufficiency].

Objective: To compare the maternal and fetal outcomes of women with cervical insufficiency (CI) undergoing McDonald cerclage (MC) and laparoscopic cervicoisthmic cerclage (LCC), so as to provide evidence for the selection of cerclage methods. Methods: A retrospective trial was carried out in the First Affiliated Hospital of Sun Yat-sen University from January 2010 to December 2020. A total of 221 women who underwent the prophylactic cerclage were divided into MC group (n=54), LCC with MC history group (n=28) and LCC without MC history group (n=129) by the mode of operation and whether the pregnant women who underwent LCC had MC history. General clinical data, pregnancy complications and pregnancy outcomes were compared between the three groups. Results: (1) General clinical data: the proportion of women accepted cervical cerclage during pregnancy in MC group, LCC with MC history group and LCC without MC history group were 100.0% (54/54), 7.1% (2/28) and 27.1% (35/129), respectively (P<0.001). The indications of the three groups showed statistical significance (P=0.003), and the main indication was the history of abortion in the second and third trimester [75.9% (41/54) vs 89.3% (25/28) vs 84.5% (109/129)]. (2) Pregnancy complications: the incidence of abnormal fetal position [7.8% (4/51) vs 17.4% (4/23) vs 19.8% (24/121)], placenta accrete [5.9% (3/51) vs 13.0% (3/23) vs 11.6% (14/121)], uterine rupture [0 vs 4.3% (1/23) vs 5.8% (7/121)] in the MC group were all lower than those in LCC with MC history and LCC without MC history groups. However, there were no statistical significances (all P>0.05). Intrauterine inflammation or chorioamnionitis [15.7% (8/51) vs 0 vs 0.8% (1/121)] and premature rupture of membrane [23.5% (12/51) vs 4.3% (1/23) vs 0] were both significantly higher in MC group than those in LCC with MC history and LCC without MC history groups (all P<0.001). (3) Pregnancy outcomes: the cesarean section rate was significantly lower in MC group (41.2%, 21/51) than that in LCC with MC history group (100.0%, 23/23) and LCC without MC history group (100.0%, 121/121; P<0.001). MC group was associated with lower expenditure than LCC with MC history and LCC without MC history groups (12 169 vs 26 438 vs 27 783 yuan, P<0.001). The success rates of live birth cerclage did not differ significantly in MC (94.4%, 51/54), LCC with MC history (82.1%, 23/28) and LCC without MC history (93.8%, 121/129) groups (χ2=5.649, P=0.059). There was no significant difference in neonatal intensive care unit occupancy, neonatal birth weight and neonatal asphyxia between the three groups (all P>0.05). Conclusions: Both LCC and MC are the treatment choice for women with CI, which may get similar liver birth. However, MC has the advantages of low cesarean section rate, economical and easy operation. Therefore, MC is recommended as the first choice for CI patients, and LCC is for women with failed MC.

Tips and Tricks for Robotic-Assisted Trans-Broad Ligament Abdominal Cerclage in Pregnant Patients.

STUDY OBJECTIVE: To demonstrate the surgical techniques for improving safety in robotic-assisted abdominal cerclage via broad ligament window dissection. DESIGN: Stepwise demonstration with narrated video footage. SETTING: An academic tertiary care hospital. Our patient is a 32-year-old G8P2143, with a history of pregnancy loss at 19 and 23 weeks and 1 failed vaginal cerclage, presented to us at 13 weeks and 5 days for abdominal cerclage. We have completed a total of 5 successful procedures with this technique on pregnant patients ranging from 9 to 14 weeks. INTERVENTIONS: Abdominal cerclage during pregnancy can be very risky and challenging to perform; however, it offers an increased success rate for continuing pregnancy [1]. Excessive bleeding and the rupture of membrane during the procedure could lead to pregnancy loss and a failed abdominal cerclage [2,3]. Therefore, seeking a feasible and safer technique would be preferable for the surgeons to decrease surgical risk and complications. We have developed a trans-broad ligament technique that would allow for the bilateral uterine vessels to be clearly exposed, thereby reducing the possibility of accidental damage to a major vessel and eliminating the risk of blind needle placement piercing through the amniotic sac resulting in rupture of membrane and subsequent pregnancy loss [4,5]. A dense adhesion band from the anterior uterus to the anterior abdominal wall was carefully taken down using the monopolar scissors. The assistant gently performed a digital vaginal examination to assist with the creation of a bladder flap. The bladder was carefully dissected off the lower uterine segment and uterus using the monopolar scissors. Bilateral uterine vessels were further skeletonized and exposed anteriorly using blunt dissection and the monopolar scissors. On the right, a window was created in the broad ligament using the monopolar scissors. The right uterine vessels were then further dissected and lateralized, creating a small window medial to the uterine vessels at the level of the internal cervical os. The mersilene tape was guided through the window from anterior to posterior. In a similar fashion, a window was created on the left; the mersilene tape was then guided from posterior to anterior. The mersilene tape was completely placed around the cervix circumferentially at the level of the internal cervical os, medial to the uterine vessels. Both ends of the mersilene tape were then pulled gently, while ensuring that the tape was lying flat on the anterior of the uterus. The tape was then tied anteriorly at the 12 o'clock position in an appropriate tension. A 2-0 silk was then sutured to the tails of the tape to ensure that it would remain in the correct location and prevent the loosening of the knot of mersilene tape. The pelvis was copiously irrigated, and hemostasis was assured. The fetal heart rate was 126 bpm, and patient was discharge next day. A healthy baby, 6 pounds 14 ounces, was delivered by cesarean section at 36 weeks 5 days because of early contractions and pain (Supplemental Appendix 1-4). CONCLUSION: Robotic-assisted abdominal cerclage via broad ligament window dissection offers a possibly feasible and safe technique for surgeons seeking to reduce risks, although further research is needed.

Efficacy of ultrasound-indicated cerclage in twin pregnancies: a retrospective case-control study matched by cervical length.

BACKGROUND: Twin pregnancies with a progressively shortening cervix in the midterm pregnancy have an increasing risk for spontaneous preterm birth. Currently, there is no known effective method to prevent preterm birth among those women, and the use of an ultrasound-indicated cerclage in twin pregnancies is still controversial. OBJECTIVE: This study aimed to estimate whether a combination of ultrasound-indicated cerclage, indomethacin, and antibiotics in twin pregnancies between 18 and 26 weeks' gestation could extend the pregnancy, reduce the risk for spontaneous preterm birth, and improve perinatal and neonatal outcomes. STUDY DESIGN: A retrospective cohort study was conducted. The ultrasound-indicated cerclage group included twin pregnancies with a transvaginal cervical length <25 mm that underwent cerclage at 18 to 26 weeks of gestation in the Women's Hospital, Zhejiang University School of Medicine, from December 2015 through August 2021. Twin pregnancies in our study that underwent cerclage also received antibiotics and indomethacin. A control group of twin pregnancies that were managed expectantly were matched with the treatment group in terms of transvaginal cervical length at diagnosis (±3 mm), gestational age at presentation of diagnosis (±3 weeks), and maternal age (±5 years). An additional subanalysis was performed in which the patients were divided into 2 subgroups based on transvaginal cervical length of either <15 mm or between 15 and 24 mm. The primary outcome was gestational age at delivery. The secondary outcomes were pregnancy latency, the rate of spontaneous preterm birth at <28, <32, <34, <36 weeks' gestation, and neonatal outcomes. RESULTS: A total of 90 twin pregnancies with a transvaginal cervical length <25 mm were managed with either a cerclage (ultrasound-indicated cerclage group, n=45) or expectantly (control group, n=45). Demographic characteristics were not significantly different between the groups. When compared with the control group, the gestational age at delivery was significantly higher (33.11±3.16 vs 30.22±4.12 weeks; P=.001) and the pregnancy latency was significantly longer (72.40±22.51 vs 45.56±28.82 days; P<.001) in the ultrasound-indicated cerclage group. The rates of spontaneous preterm birth at <28, <32, <34, and <36 weeks' gestation were significantly lower in the ultrasound-indicated cerclage group than in the control group. In terms of neonatal outcomes, there were significant reductions in the overall perinatal mortality (4.4% vs 20.0%; P<.001), neonatal intensive care unit admissions (69.0% vs 92.6%; P<.001), and composite adverse neonatal outcomes (43.7% vs 64.7%; P=.010) for the ultrasound-indicated cerclage group when compared with the control group. In the subgroup of women with a transvaginal cervical length of between 15 and 24 mm (with 21 in the ultrasound-indicated cerclage group vs 21 controls), the data were adjusted for maternal age, pregestational body mass index, in vitro fertilization, operative hysteroscopy, previous cervical surgery, previous spontaneous preterm birth, white blood cell counts, C-reactive protein level, neutrophil to lymphocyte ratio, and the shortest transvaginal cervical length measured at diagnosis. In ultrasound-indicated cerclage group, gestational age at delivery was significantly higher (32.95±3.81 vs 30.24±4.01 weeks; beta, 3.34; 95% confidence interval, 0.14-6.55; P=.042), pregnancy latency was significantly prolonged (77.19±24.81 vs 48.52±29.67 days; beta, 33.81; 95% confidence interval, 12.29-55.34; P=.003), and the rates of spontaneous preterm birth <36 weeks' gestation (57.1% vs 95.2%; adjusted odds ratio, 0.03; 95% confidence interval, 0.01-0.69; P=.029) was significantly decreased, and for neonatal outcomes, there were significant reductions in neonatal intensive care unit admissions (53.7% vs 96.7%; adjusted odds ratio, 0.04; 95% confidence interval, 0.01-0.32; P=.003) and the composite adverse neonatal outcomes (39.0% vs 73.3%; adjusted odds ratio, 0.24; 95% confidence interval, 0.08-0.68; P=.008) in the ultrasound-indicated cerclage group when compared with the control group. In the subgroup of women with a transvaginal cervical length <15 mm, gestational age at delivery was higher (33.25±2.52 vs 30.00±4.33 weeks; beta, 3.96; 95% confidence interval, 1.51-6.42; P=.002), pregnancy latency was significantly prolonged (68.21±19.85 vs 42.96±28.43 days; beta, 30.11; 95% confidence interval, 12.42-47.81; P=.001), rates of spontaneous preterm birth at <32 weeks (16.7% vs 54.2%; adjusted odds ratio, 0.10; 95% confidence interval, 0.01-0.61; P=.020) and <34 weeks (54.2% vs 83.3%, adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.66; P=.019) of gestation was significantly decreased, and neonatal birthweight was significantly increased (2023.96±510.35 vs 1421.77±611.40 g; beta, 702.40; 95% confidence interval, 297.02-1107.78; P=.001) in the ultrasound-indicated cerclage group when compared with the control group. CONCLUSION: Cerclage among women with twin pregnancies with a transvaginal cervical length <25 mm may reduce the rate of spontaneous preterm birth and improve perinatal and neonatal outcomes when compared with expectant management. It is worth noting that even with a short transvaginal cervical length of 15 to 24 mm, cerclage will significantly decrease the risk of delivery at <36 weeks' gestation and prolong pregnancy latency. Among women with a short transvaginal cervical length <15 mm, cerclage will significantly decrease the risk of delivery at <32 and <34 weeks' gestation and prolong pregnancy latency.