scholarly journals Prevention of spontaneous preterm birth: universal cervical length assessment and vaginal progesterone in women with a short cervix: time for action!

2018 ◽  
Vol 218 (2) ◽  
pp. 151-158 ◽  
Author(s):  
Stuart Campbell
Keyword(s):  
Preterm Birth ◽  
Cervical Length ◽  
Spontaneous Preterm Birth ◽  
Short Cervix ◽  
Vaginal Progesterone

scholarly journals Vaginal progesterone for prevention of preterm birth in asymptomatic high-risk women with a normal cervical length: a systematic review and meta-analysis protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Kimberley P. Williams ◽  
Liam McAuliffe ◽  
Rosanna Diacci ◽  
Anne-Marie Aubin ◽  
Ashad Issah ◽  
...  
Keyword(s):  
Preterm Birth ◽  
High Risk ◽  
Meta Analysis ◽  
Cervical Length ◽  
Analysis Model ◽  
Spontaneous Preterm Birth ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
High Risk Women ◽  
Vaginal Progesterone

Abstract Background Preterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8 to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronised) progesterone to prevent PTB in women with a shortened cervix (< 25 mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length. Methods Studies will be sourced from MEDLINE, Embase and Cochrane Register of Trials (CENTRAL) from their inception onwards with the search terms ‘progesterone’ and ‘preterm birth’. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB < 37 weeks, with secondary outcomes of sPTB < 34 weeks. Two independent reviewers will conduct study screening at abstract and full text level, data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals. Discussion This review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high-risk singleton pregnancies and normal cervical length. Trial registration PROSPERO CRD42020152051

scholarly journals Vaginal Progesterone for Prevention of Preterm Birth in Asymptomatic High-Risk Women with a Normal Cervical Length: A Systematic Review and Meta-Analysis Protocol

2020 ◽  
Author(s):  
Kimberley Paige Williams ◽  
Liam McAuliffe ◽  
Rosanna Diacci ◽  
Anne-Marie Aubin ◽  
Ashad Issah ◽  
...  
Keyword(s):  
Preterm Birth ◽  
High Risk ◽  
Meta Analysis ◽  
Cervical Length ◽  
Analysis Model ◽  
Spontaneous Preterm Birth ◽  
Singleton Pregnancy ◽  
Short Cervix ◽  
High Risk Women ◽  
Vaginal Progesterone

Abstract Background: Preterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8% to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronized) progesterone to prevent PTB in women with a shortened cervix (<25mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length. Methods: Studies will be sourced from MEDLINE and Embase databases with the search terms “progesterone” and “preterm birth”. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB <37 weeks, with secondary outcomes of sPTB <34 weeks. Two independent reviewers will conduct study screening at abstract and full text level, data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals.Discussion: This review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high risk singleton pregnancies and normal cervical length. Trial registration: This study has been registered on PROSPERO with the registration number CRD42020152051

Obstetric History and Risk of Short Cervix in Women with a Prior Preterm Birth

2020 ◽  
Author(s):  
Heather A. Frey ◽  
Eric M. McLaughlin ◽  
Erinn M. Hade ◽  
Matthew M. Finneran ◽  
Kara M. Rood ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Cervical Length ◽  
Spontaneous Preterm Birth ◽  
Short Cervix ◽  
Screening Guidelines ◽  
Obstetric History ◽  
History Of ◽  
Full Term Delivery

Objective We aimed to assess the relationship between obstetric history and incidence of short cervical length (CL) at <24 weeks gestational age (GA) in women with a prior spontaneous preterm birth (PTB). Study Design Women with a singleton gestation and a history of spontaneous PTB on progesterone who received prenatal care at a single center from 2011 to 2016 were included. Those who did not undergo screening or had a history-indicated cerclage were excluded. The associations between short CL (<25 mm) before 24 weeks and obstetrical factors including: number of prior PTBs, history of term birth, and GA of earliest spontaneous PTB were estimated through modified Poisson regression, adjusting for confounding factors. Multiple pregnancies for the same woman were accounted for through robust sandwich standard error estimation. Results Among 773 pregnancies, 29% (n = 224) had a CL <25 mm before 24 weeks. The number of prior PTBs was not associated with short CL, but a prior full-term delivery conferred a lower risk of short CL (absolute risk reduction or aRR 0.79, 95% CI 0.63–1.00). Earliest GA of prior spontaneous PTB was associated with short CL. The strongest association was observed in women with a prior PTB at 160/7 to 236/7weeks (aRR 1.98, 95% CI: 1.46–2.70), compared with those with deliveries at 340/7 to 366/7 weeks. Yet, even women whose earliest PTB was 340/7 to 366/7 weeks remained at risk for a short CL, as 21% had a CL <25 mm. The number of prior PTBs did not modify the effect of GA of the earliest prior PTB (interaction test: p = 0.70). Conclusion GA of earliest spontaneous PTB, but not the number of prior PTBs, is associated with short CL. Nevertheless, women with a history of later PTBs remain at sufficiently high risk of having a short CL at <24 weeks gestation that we cannot recommend modifications to existing CL screening guidelines in this group of women. Key Points

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 Reviewing short cervix in singleton pregnancies: a multicentric prospective cohort study in the Brazilian population

2021 ◽  
Author(s):  
Thaís Silva ◽  
Anderson Pinheiro ◽  
Jose Cecatti ◽  
Ben Mol ◽  
Fabrício Da Silva Costa ◽  
...  
Keyword(s):  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Cervical Length ◽  
National Council ◽  
Short Cervix ◽  
Number Needed To Screen ◽  
Vaginal Progesterone ◽  
Multicenter Randomized Controlled Trial

Objective: To identify the association between cervical length (CL) and gestational age at birth. Design: Prospective cohort study. Setting: Seventeen Brazilian reference hospitals. Population: A cohort of 3139 asymptomatic singleton pregnant women who participated in the screening phase of a Brazilian multicenter randomized controlled trial (P5 trial). Methods: Transvaginal ultrasound (TVU) to measure CL was performed from 18 to 22+6 weeks. Women with CL ≤ 30 mm received vaginal progesterone (200 mg/day) until 36 weeks’ gestation. Main Outcome Measures: Area under receive operating characteristic curve (AUC), sensitivity, specificity, Kaplan-Meier curves for preterm birth (PTB), number needed to screen (NNS). Results: CL ≤25mm was associated with extremely severe, severe, moderate and late PTB, whereas a CL 25–30mm was directly associated with late sPTB. The AUC to predict sPTB<28 weeks was 0.82 and for sPTB<34 weeks was 0.67. Almost half of the sPTB occurred in nulliparous women and CL ≤30mm was associated with sPTB <37 weeks (OR = 7.84; 95%CI = 5.5–11.1). The NNS to detect one sPTB <34 weeks in women with CL ≤25mm is 121 and 248 screening tests are necessary to prevent one sPTB <34 weeks using vaginal progesterone prophylaxis. Conclusions: CL measured by TVU is associated with sPTB <34 weeks. Women with CL ≤30mm are at increased risk for late sPTB. Funding: Bill & Melinda Gates Foundation [OPP1107597], the Brazilian Ministry of Health, and the Brazilian National Council for Scientific and Technological Development (CNPq) [401615/20138]. Keywords: cervical length; number needed to screen; preterm birth; short cervix.

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 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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