scholarly journals CERVICAL PESSARY PLUS VAGINAL PROGESTERONE IN A SINGLETON PREGNANCY WITH A SHORT CERVIX: AN ANALYSIS OF EFFICACY BASED ON THE LEARNING CURVE AND CUMULATIVE SUM ANALYSIS (LC-CUSUM) IN A QUASI-RANDOMIZED CLINICAL TRIAL

2020 ◽  
Author(s):  
Marcelo Franca ◽  
Alan Hatanaka ◽  
Jader Cruz ◽  
Valter Andrade Jr ◽  
Tatiana Hamamoto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Learning Curve ◽  
Randomized Clinical Trial ◽  
Cumulative Sum ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
Cumulative Sum Analysis ◽  
Cervical Pessary ◽  
Vaginal Progesterone

Safety and efficacy of the cervical pessary combined with vaginal progesterone for the prevention of spontaneous preterm birth

2018 ◽  
Vol 46 (5) ◽  
pp. 531-537 ◽  
Author(s):  
Georgios Daskalakis ◽  
Dimitrios Zacharakis ◽  
Marianna Theodora ◽  
Panagiotis Antsaklis ◽  
Nikolaos Papantoniou ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Combined Treatment ◽  
Primary Outcome Measure ◽  
Perinatal Complications ◽  
Spontaneous Preterm Birth ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
Safety And Efficacy ◽  
Cervical Pessary ◽  
Vaginal Progesterone

AbstractIntroduction:The aim of this study was to evaluate the safety and efficacy of the combined treatment of cervical pessary and endovaginal progesterone for the prevention of spontaneous preterm birth (SPB) in women with a short cervical length (CL) between 20 and 24 weeks of gestation.Materials and methods:This is a prospective study of women with a singleton pregnancy and a sonographically detected mid-trimester CL ≤25 mm. The primary outcome measure was spontaneous delivery before 34 weeks (238 days) of gestation.Results:The study sample consisted of 90 women with a mean CL of 14.2 mm (SD=6.5 mm). Of the women, 34.4% had at least one risk factor for SPB; 7.8% delivered preterm before 34 weeks of gestation, and 25.6%, before 37 weeks. Neonatal death occurred in two (2.2%) cases due to respiratory distress syndrome. Lower body mass index values, history of preterm delivery and number of second trimester miscarriages were independently associated with delivery before 34 weeks.Conclusion:The combination of vaginal progesterone and cervical pessary for the prevention of SPB in women with a short cervix is safe and well tolerated. This therapy was associated with pregnancy prolongation, reduced prematurity rate and a low rate of perinatal complications.

Cervical pessary plus vaginal progesterone in a singleton pregnancy with a short cervix: an experience-based analysis of cervical pessary’s efficacy

2021 ◽  
pp. 1-11
Author(s):  
Marcelo Santucci França ◽  
Alan Roberto Hatanaka ◽  
Jader de Jesus Cruz ◽  
Valter Lacerda de Andrade Júnior ◽  
Tatiana Emy Kawanami Hamamoto ◽  
...  
Keyword(s):  
Singleton Pregnancy ◽  
Short Cervix ◽  
Cervical Pessary ◽  
Vaginal Progesterone

Combined treatment with cervical pessary and vaginal progesterone for the prevention of preterm birth: A randomized clinical trial

2016 ◽  
Vol 42 (12) ◽  
pp. 1673-1679 ◽  
Author(s):  
Niloofar Karbasian ◽  
Mahdi Sheikh ◽  
Reihaneh Pirjani ◽  
Shahla Hazrati ◽  
Fatemeh Tara ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Randomized Clinical Trial ◽  
Combined Treatment ◽  
Cervical Pessary ◽  
Vaginal Progesterone

scholarly journals Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036587
Author(s):  
Vinh Q Dang ◽  
Yen TN He ◽  
Ha NH Pham ◽  
Tuyen TT Trieu ◽  
Trung Q Bui ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Randomised Clinical Trial ◽  
Cervical Cerclage ◽  
Short Cervix ◽  
Cervical Pessary ◽  
Vaginal Progesterone ◽  
Increased Risk ◽  
Patient Consent ◽  
Twin Pregnancies

IntroductionWomen with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.Methods and analysisThis multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16–22 weeks’ gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks’ gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions.Ethics and disseminationEthical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03863613 (date of registration: 4 March 2019).

scholarly journals Evaluation of the learning curve for external cephalic version using cumulative sum analysis

2017 ◽  
Vol 60 (4) ◽  
pp. 343 ◽  
Author(s):  
So Yun Kim ◽  
Jung Yeol Han ◽  
Eun Hye Chang ◽  
Dong Wook Kwak ◽  
Hyun Kyung Ahn ◽  
...  
Keyword(s):  
Learning Curve ◽  
External Cephalic Version ◽  
Cumulative Sum ◽  
Cumulative Sum Analysis

scholarly journals O12 OPEN PREPERITONEAL INGUINAL HERNIA REPAIR, TREPP VERSUS TIPP IN A RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Willem Bökkerink ◽  
Giel Koning ◽  
Patrick Vriens ◽  
Roland Mollen ◽  
Willem Akkersdijk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Learning Curve ◽  
Randomized Clinical Trial ◽  
Inguinal Hernia Repair ◽  
Recurrence Rates ◽  
Significant Difference ◽  
Related Quality

Abstract Aim The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding Chronic Postoperative Inguinal Pain (CPIP) with low recurrence rates. Two open preperitoneal techniques, the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal (TIPP) technique, were compared in a randomized clinical trial with the hypothesis of less patients with CPIP after TREPP due to complete avoidance of nerve contact. Materials and Methods Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Prior to the trial’s start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events and Health related Quality of Life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months and 1 year. Results Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but the CPIP at rest at 1 year was comparable 1.9% after TREPP vs 1.4% after TIPP, p = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, p = 0.591). Conclusions both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1 year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.

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