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Purpose: To evaluate patients' acceptance of a universal transvaginal ultrasound cervical length (CL) screening program and the feasibility of initiating treatment with progesterone in a clinical setting in women found to have a short cervix. Methods: An observational, pragmatic cohort study was conducted at one tertiary care facility from 2012–2015, involving eligible women with singleton pregnancies who accepted and underwent second-trimester CL screening. The primary outcomes were the percentage of women who were eligible and accepting of screening, compliance with progesterone treatment, and the screening value of TVCL in predicting SPTB. Secondary outcomes were the number of women who received progesterone treatment and the rates of SPTB. Results: Overall cervical length screening acceptance rate was found to be 82.5%. Of the 797 women that underwent screening, 21 women (2.6%) had a TVCL < 25 mm, of whom nine had a TVCL < 20.0 mm. Nineteen of the 21 women with a TVCL < 25 mm were treated with progesterone, with a 94.7% compliance rate. Delivery outcomes were obtained for 767 women. Of those with a TVCL < 25 mm, there was a 35% rate of SPTB as opposed to a 6.3% SPTB rate in those with TVCL > 25 mm. The negative predictive value for SPTB with a TVCL 25 mm or greater was 94.0%. Conclusion: Universal cervical length screening was successfully implemented in 82.5% of the patient population with a high compliance rate with progesterone treatment. Furthermore, there was a higher rate of SPTB in those with a shorter cervix. Based on our outcomes obtained in an observational and pragmatic manner, we showed that incorporating second trimester transvaginal cervical length screening into routine clinical practice is readily accepted and, with the addition of vaginal progesterone treatment, may reduce the rate of prematurity. [ABSTRACT FROM AUTHOR]

Background: Cervical pessary placement as an intervention for preterm birth prevention in women with a short cervix is a simple, painless procedure with few complications and a reasonable cost. Its efficacy depends on the expertise of the obstetrician performing the procedure. Therefore, it is reasonable to assume that untrained obstetricians with no expertise in pessary placement are more likely to insert the pessary incorrectly, thereby reducing its efficacy. Nevertheless, the impact of pessary placement expertise and training, as well as the accuracy of cervival length measurements, has never been evaluated.Objective: To evaluate the impact of providing training for pessary placement to obstetricians with no expertise in this intervention. To this end, the percentage of correct pessary placements and accuracy of cervical length measurements after pessary placement achieved by obstetricians who received such training was compared with the results achieved by obstetricians who did not receive any training.Methods: This prospective, double-blind, randomized clinical trial included 91 pregnant women requiring a cervical pessary due to a short cervix. Patients were assigned at random to a group treated by untrained obstetricians with no expertise in pessary placement (untrained group, n = 45) or to a group treated by trained obstetricians with no expertise in pessary placement (trained group, n = 46). The primary outcomes were the quality of pessary placement and the accuracy of cervical length measurements after pessary placement.Results: Obstetricians in the trained group achieved a significantly higher percentage of correct pessary placements than obstetricians in the untrained group (97.8 % and 65.2 %, respectively; p < 0.001). No significant differences were observed between groups in terms of the accuracy of cervical length measurements after pessary placement (p = 0.661), and both groups showed moderate to good agreement with the expert's measurements (intraclass correlation coefficient 0.840 and 0.749, respectively). No differences in pregnancy outcomes were observed between groups.Conclusion: This study showed that providing training in pessary placement to obstetricians with no expertise in this procedure increases the quality of pessary placement. Furthermore, the inconsistent results found in pessary studies may be explained, in part, by a lack of training in pessary placement. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study is to compare pregnancy and neonatal results with regards to the thickness of the suture material used in the transvaginal cerclage operation. Materials and Methods: Patients who were subject to transvaginal cervical cerclage due to cervical insufficiency were evaluated in a secondary care center between 2103 and 2021 retrospectively. The demographic data, cerclage indications (ultrasound induced, prophylactic, or physical examination induced), number of pregnancy weeks at cerclage, type of cerclage suture (prolene, mersilene), type of cerclage (McDonald, Shirodkar), total pregnancy weeks, delivery method (cesarean (C/S), normal spontaneous vaginal delivery) of each patient were recorded. Additionally, birth weight, 1st and 5th minute APGAR scores, and neonatal intensive care unit (NICU) requirements were recorded as neonatal parameters. Patients were divided into two groups with regard to the type of cerclage suture (mersilene or prolene) and maternal, neonatal and pregnancy results were compared between these groups. Results: The study included 151 patients in total. Prolene sutures were used for 69 of the patients (45.7%) and mersilene sutures for 82 patients (54.3%) Cerclage was applied for 18 patients (11.9%) depending on the ultrasound findings, 121 patients (80.1%) depending on emergency and 12 patients (7.9%) depending on history. Gravida increased significantly in the prolene suture group (p=0.021). Pregnancy week was found to be significantly lower in the mersilene suture group [32.5 w (15-40)] compared to the prolene suture group [37.0 w (15-41)] [37.0 w (15-41)](p<0.001). Ratios of birthing below 34 weeks and 37 weeks for the mersilene suture group were found as 57.3% and 80.5%, and for the prolene suture group 11.6% and 40.6% respectively, and a statistically significant difference was observed (p<0.001). Fetal weight, 1st and 5th minute APGAR scores in the mersilene suture group were significantly lower (p<0.05). Ratios of newborn intensive care requirements and preterm premature rupture of membranes (PPROM) in the mersilene suture group were found to be significantly higher compared to the prolene suture group (p=0.016, p<0.001 respectively). Conclusion: Although mersilene suture is more preferred, its supply is not always possible in emergency situations. Therefore, the prolene suture should be kept in mind as an even stronger cerclage suture option. [ABSTRACT FROM AUTHOR]

Purpose: To identify patient perspectives of barriers to cervical length screening to prevent preterm births. Methods: In Phase I of this prospective descriptive implementation study, 40 pregnant women of up to 24 week gestation were interviewed. Phase II comprised questionnaire development and data validation. The questionnaire was subsequently administered to 400 participants in Phase III. Results: Most participants (74.3%) realised preterm babies have complications and high care costs (53%). They recognised that premature-birth risk identification enables appropriate pregnancy care (93.8%), but they were unaware that cervical length measurements indicate the risk (59.5%). The participants who were aware wanted to be examined (63.5%) because of concern about preterm birth (95.8%). Husbands were reported to influence decision-making about screening (81.3%) and subsequent treatment (42.5%). If the associated costs were subsidised, the majority of participants (67.3%) would undergo screening. Conclusion: Physicians do not explain ways to prevent preterm births. Government policy on preventing preterm births is not well established. Screening and treatment costs are major barriers. Trial registration: Thai Clinical Trials Registry (TCTR) number: TCTR20190813003 [ABSTRACT FROM AUTHOR]

Background: Progesterone is widely used in prenatal care. However, long‐term effects of prenatal progesterone treatment on child development are unclear. Objectives: To evaluate long‐term outcomes in children after prenatal progesterone treatment. Search strategy: MEDLINE, Embase and Cochrane Central Register of Controlled Trials from inception to 24 May 2020. Selection criteria: Randomised controlled trials (RCTs) reporting outcomes in children born to women who received progesterone treatment (compared with placebo or another intervention) during any trimester in pregnancy. Data collection and analysis: Two authors independently selected and extracted data. We used the Cochrane Risk of Bias tool for randomised trials and Quality In Prognosis Studies. Main results: Of 388 papers, we included seven articles based on five RCTs, comprising 4222 measurements of children aged 6 months to 8 years. All studies compared progesterone to placebo in second and/or third trimester for the prevention of preterm birth. Meta‐analysis (two studies, n = 890 children) showed no difference in neurodevelopment as assessed by the Bayley‐III Cognitive Composite score at 2 years between children exposed to progesterone versus placebo (Standardised Mean Difference −0.04, 95% Confidence Interval −0.26 to 0.19), I2 = 22%. Heterogeneity prohibited additional meta‐analyses. Other long‐term outcomes showed no differences. Conclusions: Our systematic review comprising a multitude of developmental measurements with a broad age range did not find evidence of benefit or harm in offspring prenatally exposed to progesterone treatment for the prevention of preterm birth. We identified an urgent need for follow‐up studies of prenatal progesterone administration in early pregnancy and effects in offspring beyond early childhood. Progesterone to prevent preterm birth: no effect on child development. Outcomes after first trimester progesterone are unclear. Progesterone to prevent preterm birth: no effect on child development. Outcomes after first trimester progesterone are unclear. [ABSTRACT FROM AUTHOR]

Background: Premature birth is responsible for approximately 38% of infant deaths as well as a host of complications, including abnormal lung development, infection, and long-term disabilities. For women with a history of spontaneous preterm birth in a singleton pregnancy, use of 17 alpha-hydroxyprogesterone caproate (17-OHP) can reduce the risk of a recurrent preterm birth by up to 42%. However, less than half of eligible women currently receive 17-OHP.Objectives: The purpose of this study was to understand the barriers to access and acceptability of 17-OHP use from the patient perspective.Study design: A qualitative study was conducted of women with a history of a prior spontaneous, singleton preterm birth who were eligible for 17-OHP during a subsequent singleton pregnancy. Researchers recruited 118 eligible women during the Spring and Summer of 2018 from a safety-net hospital in Denver, CO, USA, a hospital that provides healthcare for individuals regardless of their insurance status or ability to pay. Responses from 35 participants were analyzed, looking at themes surrounding knowledge of and counseling received regarding 17-OHP, hesitations, and barriers toward receiving the treatment.Results: Among respondents (34.0% response rate), the mean age was 31.5 years and mean gestational age at delivery was 32.1 weeks. Major themes from interviews included reasons that encouraged women to use 17-OHP, such as the desire to do anything for the health of their baby and reasons that women felt discouraged from using 17-OHP, including unknown complications and lack of information. Other barriers to this treatment method included the time commitment, specifically the length of clinic appointments and concerns about the safety of the 17-OHP injection.Conclusions: One of the strongest reasons for women choosing to use 17-OHP was a desire to do anything possible to support their babies. Somewhat surprisingly, there was not a significant relationship with the participants between gestational age of prior preterm deliveries and subsequent use of 17-OHP. There were two important reasons women cited most frequently for choosing not to use 17-OHP. One was feeling that they lacked information or knowledge about 17-OHP to make an informed decision, which is crucial because the study also showed that all eligible women are not being appropriately counseled on the option of 17-OHP. In terms of time commitment, it was the length of individual appointments, rather than frequency that was a barrier to receiving weekly injections. [ABSTRACT FROM AUTHOR]

Preterm birth prevention is multifaceted and produces many nuanced questions. This review addresses six important clinical questions about preterm birth prevention as voted for by members of the UK Preterm Clinical Network. The questions cover the following areas: preterm birth prevention in 'low‐risk' populations; screening for asymptomatic genital tract infection in women at high risk of preterm birth; cervical length screening with cerclage or vaginal pessary in situ; cervical shortening whilst using progesterone; use of vaginal progesterone in combination with cervical cerclage; and optimal advice about intercourse for women at high risk of preterm birth. What stumps preterm birth experts? Evidence summary and expert opinion on the top six clinical controversies as voted by members of the UK Preterm Clinical Network. This article includes Author Insights, a video abstract available at https://vimeo.com/rcog/authorinsights16544. [ABSTRACT FROM AUTHOR]

The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018. [ABSTRACT FROM AUTHOR]

Objective This article aims to evaluate whether midtrimester cervical length (CL) is associated with improved prediction of preterm delivery in women presenting with preterm labor. Study Design This is a retrospective cohort study of women with a singleton gestation who underwent routine CL screening between 18 and 24 weeks of gestation between 2010 and 2014 who were later evaluated for preterm labor. Women were stratified by midtrimester CL quartile. Bivariable and multivariable analyses were performed to identify factors independently associated with preterm birth <37 weeks, <34 weeks, and delivery within 7 days of evaluation. Receiver operating characteristic (ROC) curves were created for multivariable equations with and without CL quartile to determine whether addition of CL improved the predictive capacity of the model for predicting preterm birth. Results A total of 460 women were evaluated for preterm labor and had midtrimester CL measurements available. When CL quartile was incorporated into a regression model including demographic and clinical characteristics associated with preterm birth, the area under the ROC curve was not improved (0.775 vs. 0.786, p = 0.20). Conclusion While a shorter midtrimester CL quartile is associated with an increased incidence of preterm delivery in women evaluated for preterm labor, the addition of this variable to an existing model does not improve prediction of preterm birth. [ABSTRACT FROM AUTHOR]

Background: Although there is a call for patient-centred prenatal care, women's preferences for and concerns about preterm birth (PTB) prevention have not been well-studied. Therefore, we conducted a cross-sectional survey to determine women's preferences for PTB prevention and their likelihood of following their healthcare provider's recommendations for PTB prevention, as well as factors associated with these responses.Methods: A piloted self-administered questionnaire was completed by pregnant women who could read English. Data were collected about their preferences for and concerns about PTB prevention, and the likelihood of following their healthcare provider's recommendations, using multivariable logistic regression to control for other factors.Results: Three hundred and eleven women at a median of 32-weeks of gestation completed the survey, a response rate of 85.2%. Most women reported that if they were told they were at increased risk for PTB, they preferred not to use PTB prevention (65.8%), of whom almost all (93.4%) reported they preferred close-monitoring and 6.6% preferred neither monitoring nor prevention. A much smaller proportion of women reported that they would not follow their healthcare provider's recommendation for progesterone (10.9%) compared to pessary (28.7%) or cerclage (50.2%). Women who were neither married nor in a common-law relationship were more likely to report that they would not follow recommendations for progesterone (aOR = 5.88 [95% CI: 1.72, 20.00]). Most women (84.5%) reported they would use other sources of information other than their main healthcare provider to learn more about PTB prevention, with the most popular source being the internet.Conclusions: Most women reported that if they were told they were at increased risk of PTB, they preferred close-monitoring over using PTB prevention. Their reported likelihood of not following their healthcare provider's recommendations for PTB prevention varied from 10.9% for progesterone to 50.2% for cerclage. These findings suggest that more education about the risk of PTB, PTB preventions, as well as compliance with progesterone is needed and that the internet would be an important source of information. However as our study was completed by women at a median of 32 weeks of gestation, future surveys targeted at women earlier in their pregnancy are needed. [ABSTRACT FROM AUTHOR]

Background: Preterm birth complicates almost all triplet pregnancies and no preventive strategy has proven effective.Objective: To determine, using individual patient data (IPD) meta-analysis, whether the outcome of triplet pregnancy is affected by prophylactic administration of 17-hydroxyprogesterone caproate (17OHPc).Search Strategy: We searched literature databases, trial registries and references in published articles.Selection Criteria: Randomised controlled trials (RCTs) of progestogens versus control that included women with triplet pregnancies.Data Collection and Analysis: Investigators from identified RCTs collaborated on the protocol and contributed their IPD. The primary outcome was a composite measure of adverse perinatal outcome. The secondary outcome was the rate of birth before 32 weeks of gestation. Other pre-specified outcomes included randomisation-to-delivery interval and rates of birth at <24, <28 and <34 weeks of gestation.Main Results: Three RCTs of 17OHPc versus placebo included 232 mothers with triplet pregnancies and their 696 offspring. Risk-of-bias scores and between-study heterogeneity were low. Baseline characteristics were comparable between 17OHPc and placebo groups. The rate of the composite adverse perinatal outcome was similar among those treated with 17OHPc and those treated with placebo (34 and 35%, respectively; risk ratio [RR] 0.98, 95% confidence interval [95% CI] 0.79-1.2). The rate of birth at <32 weeks was also similar in the two groups (35 and 38%, respectively; RR 0.92, 95% CI 0.55-1.56). There were no significant between-group differences in perinatal mortality rate, randomisation-to-delivery interval, or other specified outcomes.Conclusion: Prophylactic 17OHPc given to mothers with triplet pregnancies had no significant impact on perinatal outcome or pregnancy duration.Tweetable Abstract: 17-Hydroxyprogesterone caproate had no significant impact on the outcome or duration of triplet pregnancy. [ABSTRACT FROM AUTHOR]

The number of multiple gestations has increased over the last several decades and preterm birth is one of the leading causes of perinatal morbidity and mortality for these pregnancies. While screening and treatment strategies have achieved moderate success in singleton gestations, screening strategies are less effective in multiple gestations. In addition, to date no intervention aimed at preventing preterm birth has been conclusively shown to either prolong gestation or improve neonatal outcomes for multiple gestations. As in singleton gestations, cervical length is one of the strongest predictors of preterm birth. While not conclusive, emerging data suggest that vaginal progesterone or cervical pessary may be able to prevent preterm birth in twin gestations with a short cervix. [ABSTRACT FROM AUTHOR]

Objective To determine whether 17-α-hydroxyprogesterone caproate (17P) reduces the incidence of preterm birth in women with a history-indicated cerclage. Study Design Retrospective cohort study of women who received a cerclage for a prior preterm birth, analyzed based on exposure to 17P. The primary outcome variable was delivery < 35 weeks. Secondary outcomes were preterm birth < 37, 32, 28, and 24 weeks; interval between cerclage placement and delivery; gestational age at delivery; and infant birth weight. Results Fourteen women received 17P and 80 did not. Baseline characteristics did not differ between these two groups. Preterm delivery at < 35 weeks did not differ between those who received 17P and those who did not (29% versus 15%, p = 0.46). There were no significant differences between the groups for any other outcome. Conclusion 17P does not appear to have an effect on preterm birth < 35 weeks in women with a history-indicated cerclage. [ABSTRACT FROM AUTHOR]

Objective To determine whether transabdominal cervical length screening could identify women at high risk for having a short cervix on transvaginal ultrasound. Design Retrospective cohort study. Setting Tertiary referral center. Population A total of 703 patients with a singleton pregnancy at 18 to 23+6 weeks of gestation who underwent transabdominal and transvaginal cervical length assessment during anatomy ultrasound at a single institution between January 2007 and October 2011. Methods Electronic medical records were reviewed to identify women who met the study criteria. Main outcome measures The primary outcome was the number of women with a short transabdominal cervical length (defined as ≤30 mm) who needed to undergo transvaginal ultrasound to detect one woman with a short transvaginal cervical length of ≤20 mm. Results In all, 703 patients were included in the primary analysis; 3.42 women with transabdominal cervical length ≤30 mm needed to undergo transvaginal ultrasound to detect one woman with transvaginal ultrasound cervical length ≤20 mm. Of women with short transvaginal cervical length ≤20 mm, 89.8% had a transabdominal measurement ≤30 mm and 96.7% had a transabdominal measurement ≤33 mm. Conclusions Screening of transabdominal cervical length may represent a useful strategy for detecting women with short cervix on transvaginal ultrasound. [ABSTRACT FROM AUTHOR]

Objective: To assess whether type of suture material affects cerclage efficacy for preterm birth (PTB) prevention. Methods: Secondary analysis of a multicenter trial of ultrasound-indicated cerclage for short cervical length (CL), in which women with prior spontaneous PTB at 16-33 6/7 weeks, a singleton gestation and CL < 25 mm between 16-22 6/7 weeks, were randomized to McDonald cerclage or no cerclage. Outcomes of women who underwent cerclage were analyzed by type of suture material, comparing polyester braided thread (Mersilene™ or Ethibond™) to Mersilene tape™. Primary outcome was PTB < 35 weeks. Results: 138 women underwent McDonald cerclage: 84 (61%) received polyester braided thread and 46 (33%) Mersilene tape™. Eight (6%) received monofilament suture and were excluded from analysis. Rates of PTB < 35 weeks were similar, 35% for polyester braided thread vs 24% for Mersilene tape™ ( p = .24). Birth gestational age was also similar among the 2 groups ( p = .18). Conclusion: Type of suture material may not affect ultrasound-indicated cerclage efficacy in high-risk women with short CL, but further study is needed. Polyester braided thread (Mersilene™ or Ethibond™) and polyester braided Mersilene tape™ seem to have similar efficacy. [ABSTRACT FROM AUTHOR]

Objective: To examine pregnancy outcomes of women receiving weekly compounded 17 αhydroxyprogesterone caproate (17P) injections through a home nursing program compared with those reported in a multicenter trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Network. Methods: The study sample was comprised of patients receiving compounded 17P through a home nurse administration care management program. Included were women with current singleton gestation and prior spontaneous preterm birth (SPTB) initiating 17P between 16 and 20 weeks. Maternal characteristics and pregnancy outcomes were compared between study group and NICHD Network trial patients. Results: Women (n = 5493) received a mean of 16.9 ± 4.0 injections. Of the 92,700 injections, 98.4% were administered within the recommended 5- to 9-day interval. Recurrent SPTB occurred in 28.3%. The overall rate of SPTB at <37 weeks was similar for black and nonblack women (p = 0.592).Within black or nonblack groups, preterm birth rates at <37 weeks were similar regardless of gestational age at start of 17P (p = 0.894 and p = 0.374, respectively). These results were similar to those reported in the multicenter trial. Fetal and neonatal death occurred in 0.8% (46/5493). No significant difference was observed in rate of fetal or neonatal death by gestational age at initiation of 17P (p = 0.478). Conclusion: Home nurse administration of compounded 17P is safe and effective. [ABSTRACT FROM AUTHOR]

Objective. Evaluation of an outpatient 17 α-hydroxyprogesterone caproate (17P) administration programme. Methods. A retrospective analysis of data collected from patients with a history of preterm birth (PTB) and current singleton gestation enrolled between 16.0 and 20.9 weeks' gestational age (GA) for weekly outpatient 17P administration and nursing assessment between 7/2004 and 12/2007 was conducted ( n = 3139). Results. The population was mostly white (50.3%), 18–35 years old (77.7%), and married (67.0%). Median GA at 17P initiation and stop was 17.4 (16.0, 20.9) weeks and 35.1 (18.6, 37.4) weeks. Mean injections per patient were 16.5 ± 4.9, at an interval of 7.2 days. Median GA at delivery was 37.3 (18.6, 44.0) weeks. Rate of recurrent spontaneous PTB was 29.8%, with 15.5% and 7.0% with PTB at <35 and <32 weeks. Conclusions. This represents the largest cohort reported to date of patients prescribed 17P therapy in clinical practice to prevent recurrent spontaneous PTB. [ABSTRACT FROM AUTHOR]

Objective. To compare rates of recurrent preterm birth between women starting treatment with 17a-hydroxyprogesterone caproate (17P) at 16-20.9 weeks of gestation versus 21-26.9 weeks. Methods. Women enrolled in an outpatient program of education, nursing assessment and weekly 17P injections beginning at 16-26.9 weeks were eligible. Included were patients with singleton pregnancies and a history of preterm delivery (PTD). Pregnancy outcome was compared between women starting 17P at 16-20.9 weeks (n=156) and those starting 17P at 21-26.9 weeks (n=119) using Fisher's exact and Mann-Whitney U test statistics (p<0.05 considered significant). Results. Mean gestational age at delivery (36.8±3.0 vs. 36.7±2.5) and rates of PTD at <37 weeks (40.4% vs. 48.7%), <35 weeks (16.7% vs. 16.8%) and <32 weeks (5.1% vs. 5.0%) were similar between the groups; all p<0.05. Conclusions. Rates of preterm delivery were similar in patients initiating 17P at 16-20.9 or 21-26.9 weeks. A larger sample size is warranted in order to confirm our findings. [ABSTRACT FROM AUTHOR]