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 OC23.01: Cervical pessary to prevent preterm birth in twin pregnancies with a short cervix: RCT (PECEP-twins)

2014 ◽  
Vol 44 (S1) ◽  
pp. 53-54 ◽  
Author(s):  
M.M. Goya ◽  
C. Rodo ◽  
M. De la Calle ◽  
L. Pratcorona ◽  
C. Merced ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Short Cervix ◽  
Cervical Pessary ◽  
Twin Pregnancies

Arabin cervical pessary to prevent preterm birth in twin pregnancies with short cervix

2016 ◽  
Vol 36 (6) ◽  
pp. 715-718 ◽  
Author(s):  
Mariarosaria Di Tommaso ◽  
Viola Seravalli ◽  
Silvana Arduino ◽  
Carlotta Bossotti ◽  
Giovanni Sisti ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Short Cervix ◽  
Cervical Pessary ◽  
Twin Pregnancies

scholarly journals Actual issues of prediction and prevention of preterm birth

2020 ◽  
pp. 8-13
Author(s):  
I.V. Lakhno ◽  
◽  
S.V. Коrovay ◽  
Keyword(s):  
Preterm Birth ◽  
Preterm Delivery ◽  
Premature Birth ◽  
Biochemical Markers ◽  
Cervical Insufficiency ◽  
Short Cervix ◽  
Fetal Fibronectin ◽  
Vaginal Progesterone ◽  
Prediction And Prevention ◽  
Increased Risk

Premature birth is a significant problem in modern medicine. The main aspects of its solution are the prediction and prevention of premature birth. Nowadays, among a large number of biophysical and biochemical markers of preterm birth, ultrasonic cevicometry is the most popular one. It is known that «short cervix syndrome» is not the equivalent of cervical insufficiency. The known strategies of preventive combinations are used in case of an increased risk of preterm birth. Therefore, the issue of developing a differentiated approach to the combined or separate use of progesterone, pessary, or cerclage has not been answered yet. It should be added that in most practical recommendations based on the principles of evidence-based medicine, there are no differences according to the possible pathogenesis of preterm birth. A therapeutic strategy should be set based on the possible use or misuse of any preventive combination, taking into account maternal and fetal contraindications. The combined testing on ultrasound cervicometry and biochemical markers could ameliorate the identification of patients at risk of preterm birth. The fetal fibronectin is known to be the best among all biochemical markers of preterm birth. However, the prognostic value of this test, as well as the phosphorylated transport protein insulin-like growth factor, when used separately, is limited. In pregnant women with a length of the cervix between 1.5 cm and 3 cm, it is recommended to use the analysis for placental alpha-microglobulin-1. The administration of corticosteroids should only be performed when the risk of preterm delivery is confirmed by decreased cervical length and a positive test for placental alpha-microglobulin-1 (there is a high risk of preterm delivery within 7 days). The cerclage is indicated in patients with cervical insufficiency before 16 weeks of gestation. In the presence of a «short cervix» and the lack of anamnestic data, the strategy should be individualized. The efficacy of cerclage or pessary application has not been proven. It is necessary to start with vaginal progesterone administration. In the process of the patient observation (cervicometry in dynamics) will allow you to find out an effective method: cerclage or pessary and vaginal progesterone. In the case of progredient cervical effacement in the second trimester, it is advisable to perform an urgent cerclage. In the case of incompetent cervical stitch, the additional application of a pessary is possible. In women with multiple pregnancies, there is no evidence of elective cerclage or pessary efficacy. However, it is possible to use heroic cerclage, pessary in combination with vaginal progesterone or vaginal progesterone monotherapy. Key words: preterm delivery, prediction, prevention.

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