Cerclage for prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination: a randomized trial

2005 ◽  
Vol 105 (2) ◽  
pp. 435
Keyword(s):  
Preterm Birth ◽  
Randomized Trial ◽  
Ultrasound Examination ◽  
Transvaginal Ultrasound ◽  
Short Cervix

The Length of the Cervix and the Risk of Spontaneous Preterm Delivery

2021 ◽  
pp. 32-37
Author(s):  
Julie Stone ◽  
Michael House
Keyword(s):  
Preterm Birth ◽  
Inverse Relationship ◽  
Clinical Case ◽  
Transvaginal Ultrasound ◽  
Cervical Length ◽  
Central Component ◽  
Current Clinical Practice ◽  
Short Cervix ◽  
Spontaneous Preterm Delivery ◽  
Increased Risk

Measurement of the cervical length has become a central component of prenatal care. Mid-trimester cervical shortening is associated with preterm birth. This article summarizes a key study that established a strong correlation between cervical shortening and an increased risk of preterm birth. Transvaginal ultrasound was used to measure cervical length at 22 to 24 weeks’ gestation. The study showed that a short cervix was associated with an increased risk of preterm birth before 35 weeks. In addition, the shortest cervix conferred the highest risk, suggesting an inverse relationship. This article concludes by summarizing how cervical length is incorporated into current clinical practice. Also, a clinical case is presented.

scholarly journals Vaginal progesterone in risk reduction of preterm birth in women with short cervix

2019 ◽  
Vol 8 (7) ◽  
pp. 2695
Author(s):  
Shubhi Srivastava ◽  
D. Borgohain
Keyword(s):  
Preterm Birth ◽  
Transvaginal Ultrasound ◽  
Perinatal Outcomes ◽  
Cervical Length ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
Mortality And Morbidity ◽  
Medical College ◽  
Vaginal Progesterone ◽  
Adverse Neonatal Outcomes

Background: Preterm birth is a global health problem affecting the neonate, family and country in general. It is the leading cause of perinatal mortality and morbidity. Short cervical length detected on transvaginal ultrasound is the most practical risk factor for prediction of preterm birth. The aim of this study was to determine the efficacy and safety of vaginal progesterone in reducing the rate of preterm birth in women with a short cervix and to determine its effect on neonatal mortality and morbidity.Methods: The study was carried out in the Department of Obstetrics and Gynaecology at Assam Medical College, Dibrugarh for a period of one year. It included 128 asymptomatic women with a singleton pregnancy and a sonographic short cervix. Women were randomly divided into two groups, one of which was given placebo and the other was given vaginal progesterone and a comparative study was conducted.Results: It was observed that delivery before 37 weeks of gestation was less frequent in the progesterone group than in the placebo group (60.94% vs. 90.63%). Vaginal progesterone was also associated with a significant reduction in adverse neonatal outcomes like the rate of sepsis (6.25% vs. 18.75%), requirement of ventilator (12.5% vs. 26.56%), admission to NICU (10.94% vs. 26.56%) and birth weight ≤1.5kg (7.81% vs. 21.88%).Conclusions: Vaginal progesterone reduces the risk of preterm birth and adverse perinatal outcomes in pregnant women without any deleterious effects on the foetus or mother.

scholarly journals A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rodolfo C. Pacagnella ◽  
◽  
Ben W. Mol ◽  
Anderson Borovac-Pinheiro ◽  
Renato Passini ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Cervical Length ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Vaginal Progesterone

Abstract Background Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. Methods This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. Discussion In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. Trial registration Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111–1164-2636, 2014/11/18.

scholarly journals Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study

PLoS ONE ◽  
2020 ◽  
Vol 15 (9) ◽  
pp. e0238748
Author(s):  
Joan T. Price ◽  
Chileshe M. Mabula-Bwalya ◽  
Bethany L. Freeman ◽  
Jessica Carda-Auten ◽  
Winifreda M. Phiri ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Preterm Birth ◽  
Randomized Trial ◽  
Clinic Visit ◽  
Short Cervix ◽  
Women Living With Hiv ◽  
Vaginal Progesterone ◽  
Study Product ◽  
Study Staff ◽  
Maternal Hiv

Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.

scholarly journals CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Naomi Carlisle ◽  
Agnieszka Glazewska-Hallin ◽  
Lisa Story ◽  
Jenny Carter ◽  
Paul T. Seed ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Subsequent Pregnancy ◽  
Spontaneous Preterm Birth ◽  
Short Cervix ◽  
Fetal Fibronectin ◽  
Increased Risk ◽  
Late Miscarriage

Abstract Background Full dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown. Methods There are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG). CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section. CRAFT-IMG: Imaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche. Discussion The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies. Trial registration CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry (10.1186/ISRCTN15068651).

Cervical Cerclage versus Vaginal Progesterone for Management of Short Cervix in Low-Risk Women

2018 ◽  
Vol 36 (02) ◽  
pp. 111-117 ◽  
Author(s):  
Sarah Dotters-Katz ◽  
Brenna Hughes ◽  
Amber Wood
Keyword(s):  
Preterm Birth ◽  
Transvaginal Ultrasound ◽  
Cervical Length ◽  
Low Risk ◽  
Prior History ◽  
Short Cervix ◽  
Vaginal Progesterone ◽  
History Of ◽  
Secondary Outcomes ◽  
Low Risk Women

Objective To evaluate the risk of preterm birth in low-risk women with cervical length (CL) ≤25 mm on transvaginal ultrasound (TVUS) managed with vaginal progesterone (VagP) therapy versus cerclage. Study Design This is a retrospective cohort of women with no prior history of preterm birth or cervical insufficiency and CL ≤ 25 mm on TVUS, managed with either VagP therapy alone or cerclage (with or without VagP). The primary outcome was rate of preterm delivery < 37 weeks gestational age (GA). Secondary outcomes included delivery at ≤ 32 or ≤ 28 weeks GA, premature preterm rupture of membranes, pregnancy latency, GA at delivery, and composite neonatal outcome. Results Women undergoing cerclage placement (n = 31) were older and had an earlier GA at the time of diagnosis of short cervix compared with women receiving VagP (n = 62). Delivery at < 37 weeks occurred in 21/62 (33.9%) in the VagP group and 14/31 (45.2%) in the cerclage group (adjusted odds ratio: 1.72, 95% confidence interval: 0.52, 5.66). There were no differences in secondary outcomes. Conclusion Cerclage compared with VagP therapy did not decrease risk of preterm birth in women with CL ≤ 25 mm. Further research is needed to determine optimal management in such women given a residual 40% risk of preterm birth despite optimal therapy.

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