Misoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. The aim of this study was to compare misoprostol vaginal insert (MVI) with misoprostol vaginal tablets (MVT) for induction of labor in term pregnancies. In this retrospective cohort study we compared 200 consecutive women induced with 200-μg misoprostol 24-h vaginal insert (Misodel®) with a historical control of 200 women induced with Misoprostol 25-μg vaginal tablets (Cytotec®) every 4-6 h. Main outcomes variables included induction-to-delivery interval, vaginal delivery within 24-h, incidence of tachysystole, mode of delivery, and neonatal outcome. A subanalysis in the MVI group was performed in order to identify predictive factors for tachysistole and vaginal delivery within 24 h. The time from induction to vaginal delivery was 1048 ± 814 min in the MVI group and 1510 ± 1043 min in the MVT group (p < 0.001). Vaginal delivery within 24-h occurred in 127 (63.5%) patients of the MVI group and in 110 (55%) patients of the MVT group (p < 0.001). Tachysystole was more common in the MVI group (36% vs. 18%; p < 0.001). However, no significant predictors of uterine tachysystole in MVI group have been identified in crude and fully adjusted logistic regression models. Bishop score was the only predictor for vaginal delivery within 24 h (p < 0.001) in MVI group. Caesarean delivery rate (27% vs. 20%) and vaginal-operative deliveries (15.5% vs. 15.5%) did not differ significantly between the two groups. Neonatal outcomes were similar in both groups. MVI achieves a more vaginal delivery rate within 24 h and Tachysystole events compared to MVT. However, no differences in caesarean section, operative vaginal delivery, and neonatal outcomes are reported. No predictors of tachysistole after MVI administration have been identified. Bishop score and parity are the only predictors of vaginal delivery within 24 h after MVI administration.
31 August 2015 in Geburtshilfe und Frauenheilkunde
Background: The traditional surgical treatment for cervical insufficiency is vaginal placement of a cervical cerclage. However, in a small number of cases a vaginal approach is not possible. A transabdominal approach can become an option for these patients. Laparoscopic cervical cerclage is associated with good pregnancy outcomes but comes at the cost of a higher risk of serious surgical complications. The aim of the present study was to evaluate intraoperative and long-term pregnancy outcomes after laparoscopic cervical cerclage, performed either as an interval procedure or during early pregnancy, using a new device with a blunt grasper and a flexible tip. Methods: All women who underwent laparoscopic cervical cerclage for cervical insufficiency in our institution using the Goldfinger® device (Ethicon Endo Surgery, Somerville, NJ, USA) between January 2008 and March 2014 were included in the study. Data were collected from the patientsʼ medical records and included complications during and after the above-described procedure. Results: Eighteen women were included in the study. Of these, six were pregnant at the time of laparoscopic cervical cerclage. Mean duration of surgery was 55 ± 10 minutes. No serious intraoperative or postoperative complications occurred. All patients were discharged at 2.6 ± 0.9 days after surgery. One pregnancy ended in a miscarriage at 12 weeks of gestation. All other pregnancies ended at term (> 37 weeks of gestation) with good perinatal and maternal outcomes. Summary: Performing a laparoscopic cervical cerclage using a blunt grasper device with a flexible tip does not increase intraoperative complications, particularly in early pregnancy. We believe that use of this device, which is characterized by increased maneuverability, could be an important option to avoid intraoperative complications if surgical access is limited due to the anatomical situation. However, because of the small sample size, further studies are needed to confirm our findings. Hintergrund: Die Therapie einer Zervixinsuffizienz besteht aktuell in der vaginalen Cerclage. In einigen wenigen Fällen ist dies nicht möglich, sodass die laparoskopische zervikale Cerclage eine Therapieoption sein kann, die aber mit einem höheren Risiko intraoperativer Komplikationen assoziiert ist. Das Ziel unserer Studie besteht darin, sowohl die intraoperative Sicherheit als auch die Langzeitergebnisse der mit einem „neuen“ Instrument durchgeführten laparoskopischen zervikalen Cerclage – präkonzeptionell oder in der Frühschwangerschaft durchgeführt – zu evaluieren. Methoden: Eingeschlossen wurden alle Frauen, bei denen zwischen Januar 2008 und März 2014 eine laparoskopische zervikale Cerclage mittels dem Goldfinger®-Instrument (Ethicon Endo Surgery, Somerville, NJ, USA) aufgrund einer Zervixinsuffizienz durchgeführt wurde. Es wurden alle Daten der Patientinnen inklusive der peri- und postoperativen Komplikationen der oben beschriebenen Operationstechniken gesammelt. Ergebnisse: Achtzehn Frauen wurden in unsere Studie eingeschlossen. Zum Zeitpunkt der durchgeführten laparoskopischen zervikalen Cerclage waren 6 Patientinnen schwanger. Die mittlere Operationsdauer betrug 55 ± 10 Minuten. Es traten keine ernsthaften peri- und postoperativen Komplikationen auf. Alle Patientinnen konnten nach 2,6 ± 0,9 Tagen aus dem Spital entlassen werden. Bei einer Patientin kam es zu einem Abort in der 12. SSW. Bei allen anderen Schwangerschaften kam es zur Geburt am Termin (> 37. SSW) mit gutem perinatalen und maternalen Outcome. Zusammenfassung: Das Durchführen einer laparoskopischen zervikalen Cerclage mit diesem flexiblen Instrument scheint die intraoperative Komplikationsrate – insbesondere in der Frühschwangerschaft – nicht zu erhöhen. Die Verwendung des flexiblen und sehr gut manövrierbaren Instruments ist eine interessante Möglichkeit bei Patientinnen mit anatomisch schwierigen Verhältnissen und der Notwendigkeit einer zervikalen Cerclage. Um die guten Resultate zu bestätigen sind weitere Studien notwendig.
3 March 2017 in Archives of Gynecology and Obstetrics