Prevention Of Preterm Birth In Women Research Articles

Implications of training for pessary placement and accuracy of cervical length measurements after pessary placement: A prospective, double-blind, randomized clinical trial

BackgroundCervical 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. ObjectiveTo 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. MethodsThis 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. ResultsObstetricians 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. ConclusionThis 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.

The role of vaginal progesterone for preterm birth prevention in women with threatened labor and shortened cervix diagnosed after 24 weeks of pregnancy.

To determine whether vaginal progesterone treatment for women with a short cervix, diagnosed after 24 weeks of pregnancy, reduces preterm birth rates. A retrospective cohort study that included women with a singleton pregnancy, threatened preterm labor, and a short cervix measured between 24+0 and 33+6 weeks. Women who received vaginal progesterone were compared with women who did not receive progesterone. The primary outcome was spontaneous preterm birth before 37 weeks of pregnancy. Patients who received vaginal progesterone had a lower rate of preterm delivery at less than 37 weeks of pregnancy (18.2% [22/121] versus 28.9% [73/253]; adjusted hazard ratio 0.50; 95% confidence interval 0.28-0.73, P= 0.001). The diagnosis-to-delivery interval was significantly greater in patients who received progesterone than in those who did not-median time to delivery in weeks: 8.2 (interquartile range [IQR] 6.2-9.8) versus 6.6 (4.8-8.8), (P< 0.001). The frequency of neonatal intensive care unit admission was significantly lower in patients who received progesterone than in those who did not (8.3% [10/121] versus 16.2% [41/253], P= 0.04). The administration of vaginal progesterone to patients with an episode of threatened premature labor and a short cervix presenting after 24 weeks of pregnancy was associated with lower rates of premature births.

Vaginal progesterone for preterm birth prevention in women with arrested preterm labor

Objective We tested the hypothesis that administration of vaginal progesterone in women with arrested preterm labor would result in lower rates of preterm birth <37 weeks compared to placebo. Study design We performed a randomized, placebo-controlled trial comparing vaginal progesterone to placebo in women with arrested preterm labor. Our trial included women with a singleton or twin gestation at 240 /7–336/7 weeks’ gestation who presented with preterm labor with cervical dilation ≥1 centimeter but remained undelivered. Participants were randomized to receive vaginal progesterone 200 mg daily or an identical placebo. The primary outcome was preterm birth <37 weeks. We performed an updated systematic review and meta-analysis of clinical trials, including our results. We searched MEDLINE, EMBASE, CINHAL, Scopus, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov using the key terms to identify relevant trials. The risk of bias was appraised using the Cochrane risk-of-bias tool. Data were synthesized using random-effects models. Heterogeneity was assessed using Higgins I 2. Results The randomized trial was prematurely terminated due to slow recruitment. There were 18 women randomized to receive vaginal progesterone who had complete follow-up data and 18 women in the placebo group. The risk of preterm birth <37 weeks was not significantly different in the groups (RR 1.10, 95% CI 0.63–1.19). Secondary outcomes were also similar. Thirteen trials with 1658 women (835 in the vaginal progesterone and 823 in the control groups) were included in the meta-analysis. Risk of preterm birth <37 weeks was similar in women who received progesterone and those in the control group (pooled RR 1.06, 95% CI 0.83–1.35). Latency was significantly longer among women with arrested preterm labor who received vaginal progesterone (weighted mean difference: 9.2 d, 95% CI 3.2–15.1), but further analysis showed that prolonged latency was only observed in the subgroup of studies that were not placebo-controlled. Conclusions This randomized controlled trial and meta-analysis do not support the use of vaginal progesterone for the prevention of preterm birth in women who present in preterm labor.

Ultrasound-Indicated Cerclage Placement in Early Preterm Birth Prevention in Women Without Prior Preterm Birth [15S

INTRODUCTION: To determine if cervical cerclage placement plus vaginal progesterone for short cervix decreased the risk for preterm birth in singleton gestations without prior spontaneous preterm birth. METHODS: This was a retrospective cohort study. Electronic charts of patients with singleton gestations with short cervix between 2007-2017 at the University of Kentucky were reviewed. Those without prior preterm birth with cervical length &lt;25 mm between 16 0/7 and 23 6/7 weeks of gestation were eligible. All women received vaginal progesterone. A subgroup also undergoing cervical cerclage were compared to those on vaginal progesterone alone. Those receiving cerclage and progesterone at a cervical length &lt;15 mm were also compared to the medication only group. The primary outcomes were mid-trimester and early preterm birth. Secondary outcomes included mean gestational age of delivery, birth weight, 1 and 5-minute APGARS. RESULTS: Out of the 55 eligible patients, 20 cases who underwent cerclage and vaginal progesterone were compared with 35 women who received vaginal progesterone alone. Rates of preterm birth &lt;28 weeks (OR, 1.73, 95% CI 0.22-13.60) and &lt;34 weeks (OR, 2.77, 95% CI, 0.40-18.74) were similar in both groups. No difference in the rates of preterm birth &lt;28 weeks and &lt;34 weeks of gestation in the sub-group with a cervix &lt;15 mm was observed as well. Mean gestational age at delivery (36.2±4.9 weeks vs. 36.7±4.3, P=0.76), mean birth weights (2907±1198 grams vs. 2929±733 grams, P=0.94), 1-minute APGAR and 5-minute APGAR scores were also similar. CONCLUSION: Cervical cerclage placement in addition to vaginal progesterone does not appear to be beneficial for short cervix in low risk population in the prevention of spontaneous preterm birth.

A randomised trial to compare 200 mg micronised progesterone effervescent vaginal tablet daily with 250 mg intramuscular 17 alpha hydroxy progesterone caproate weekly for prevention of recurrent preterm birth

For prevention of a recurrent preterm birth (PTB), intramuscular 17-α-hydroxy progesterone caproate (IM 17 OHPC) weekly is recommended. Vaginal progesterone is preferred for women at risk for PTB due to a short cervical length, but may be useful in women with a prior PTB. However, there is no consensus about the optimal vaginal formulation or its efficacy as compared to 17 OHPC to prevent recurrent PTB. We randomised 100 women with a singleton pregnancy between 16 and 24 weeks of gestation and ≥ one prior spontaneous PTB, of a singleton (>16 to <37 weeks of gestation) to receive the 200 mg vaginal progesterone effervescent tablet daily (Group A) or IM 17-OHPC, 250 mg weekly (Group B) till 37 weeks of gestation or delivery. The spontaneous PTB rate of <37 weeks was similar (20% in Group A and 20.8% in Group B, p = .918). The PTB rate of <34 weeks or <28 weeks were also comparable. The mean birth weight and other neonatal outcomes were similar in the two groups. Two neonates in Group A and four neonates in Group B required NICU admission, one of whom (Group B) died due to prematurity. Twenty percent of women in Group A and 29.2% in Group B reported adverse effects from their respective study medications (p = .408, NS). Thus, there did not appear to be a difference between vaginal progesterone and 17-OHPC when used for the prevention of a recurrent PTB.Impact statementWhat is already known on this subject? Progesterone administration is useful for prevention of a recurrent preterm birth (PTB) and these women are prescribed the intramuscular 17-α-hydroxy progesterone caproate (IM 17 OHPC), 250 mg, weekly. Some studies found that vaginal progesterone (once daily) is also beneficial in these women, but there is no consensus regarding its efficacy when compared to 17 OHPC, or its optimal formulation and dose.What do the results of this study add? In the present study, 100 women with a singleton pregnancy between 16 and 24 weeks of gestation and ≥ one prior spontaneous singleton PTB or mid-trimester abortion were randomised to receive 200 mg of vaginal progesterone effervescent tablet daily (Group A) or 250 mg IM 17-OHPC weekly (Group B) till 37 weeks of gestation or delivery. The spontaneous PTB rate <37 weeks was similar in the two groups (20% in Group A and 20.8% in Group B, p = .918). The PTB rate <34 weeks or <28 weeks were also comparable. The mean birth weight and other neonatal outcomes were similar. Twenty percent of women in Group A and 29.2% of women in Group B reported adverse effects from their respective study medications (p = .408, NS). Thus, there did not appear to be a difference between the vaginal progesterone effervescent tablet and 17-OHPC when used for the prevention of a recurrent PTB.What are the implications of these findings for clinical practice and/or further research? The vaginal progesterone effervescent tablet may be a suitable alternative to IM 17 OHPC to prevent recurrent PTB. Future studies should identify the most appropriate route (IM or vaginal) and vaginal progesterone formulation for PTB prevention in women at risk for a recurrent PTB and in women with a short cervical length.

377: Vaginal progesterone for preterm birth prevention in women with a short intepregnancy interval: a cost-effectiveness analysis

377: Vaginal progesterone for preterm birth prevention in women with a short intepregnancy interval: a cost-effectiveness analysis

Racial and ethnic disparities in use of 17-alpha hydroxyprogesterone caproate for prevention of preterm birth

Racial/ethnic disparities in preterm birth remain a major public health challenge in the United States. While 17-alpha hydroxyprogesterone caproate (17OHP-C) is recommended for preterm birth prevention in women with a prior preterm birth, non-Hispanic black women continue to experience higher rates of recurrent preterm birth than white women receiving the same treatment. Further investigation of disparities in 17OHP-C use and adherence is warranted. We sought to evaluate whether racial and ethnic disparities exist in the use of and adherence to 17OHP-C within a population of eligible women. This was a retrospective cohort study of women with a prior spontaneous, singleton preterm birth who were eligible for 17OHP-C for preterm birth prevention and received care at a single institution from 2010 through 2014. Associations between self-identified race/ethnicity (non-Hispanic black vs women in all other racial/ethnic groups) and documented counseling about 17OHP-C, receipt of any 17OHP-C, and adherence to 17OHP-C administration were each estimated by bivariable analysis and multivariable logistic regression. Adherence to 17OHP-C was defined as not >1 missed dose, initiation <20 weeks' gestational age, and continuation until 37 weeks or delivery. Of 472 women who were clinically eligible for 17OHP-C, 72% (N = 296) had documented 17OHP-C counseling and 48.9% (N = 229) received 17OHP-C. There were no differences in likelihood of 17OHP-C counseling or receipt of 17OHP-C based on race/ethnicity. While overall 83% (N = 176) of women were adherent to 17OHP-C, only 70% (N = 58) of non-Hispanic black women were adherent, compared to 91% (N = 118) of all other women (P < .001). Non-Hispanic black women had more missed doses (2.4 vs 0.4 doses, P < .001) and later initiation of care (12.0 vs 10.2 weeks, P < .001) than women in other racial/ethnic groups. After adjustment for potential confounders, non-Hispanic black women were significantly less likely to be adherent to 17OHP-C (adjusted odds ratio, 0.16; 95% confidence interval, 0.04-0.65). A significant interaction between non-Hispanic black race/ethnicity and public insurance was identified (adjusted odds ratio, 0.16; 95% confidence interval, 0.05-0.52). In a diverse cohort of women eligible for preterm birth prevention, non-Hispanic black women are at an increased risk of nonadherence to 17OHP-C. Non-Hispanic black women with public insurance are at a particularly increased risk of nonadherence.

Mycoplasma, bacterial vaginosis–associated bacteria BVAB3, race, and risk of preterm birth in a high-risk cohort

Genital tract infection accounts for approximately 25-40% of all preterm births. We sought to assess the relationship between preterm birth and selected vaginal bacterial taxa associated with preterm birth either directly or through their association with bacterial vaginosis (BV). Vaginal fluid for Gram stain was collected between 17 and 22 weeks' gestation as part of a randomized trial of ultrasound-indicated cerclage for preterm birth prevention in women at high risk for recurrent spontaneous preterm birth. Bacterial deoxyribonucleic acid was extracted from the Gram stain slides and analyzed using quantitative polymerase chain reaction. Among the 499 participants, Mycoplasma was positively correlated with increased risk of preterm (risk ratio [RR], 1.83; 95% confidence interval [CI], 1.52-2.22) as was Mobiluncus (RR, 1.36; 95% CI, 1.07-1.73) and Atopobium (RR, 1.44; 95% CI, 1.1-1.87). However, there were strong interactions between the race/ethnic group and the presence of these and other individual taxa on risk of preterm birth. By contrast, bacterial vaginosis-associated bacteria (BVAB)-3 was consistently associated with a reduction in the risk of preterm birth for all racial/ethnic groups (0.55; 95% CI, 0.39-0.78). BV is characterized by a reduction of Lactobacillus, and lactic acid-producing bacteria and the presence of Mobiluncus; we found these factors and the presence of Mycoplasma to be associated with an increased risk of preterm birth. By contrast, the presence of a recently identified organism sufficient to cause BV, BVAB3, decreased the risk of preterm birth. These findings give insight into why treating BV has mixed impact on risk of preterm birth.

Effectiveness of 17-α-Hydroxyprogesterone Caproate on Preterm Birth Prevention in Women with History-Indicated Cerclage

To determine whether 17-α-hydroxyprogesterone caproate (17P) reduces the incidence of preterm birth in women with a history-indicated cerclage. 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. 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. 17P does not appear to have an effect on preterm birth < 35 weeks in women with a history-indicated cerclage.

Progesterone and preterm birth prevention: translating clinical trials data into clinical practice

We sought to provide evidence-based guidelines for using progestogens for the prevention of preterm birth (PTB). Relevant documents, in particular randomized trials, were identified using PubMed (US National Library of Medicine, 1983 through February 2012) publications, written in English, which evaluate the effectiveness of progestogens for prevention of PTB. Progestogens evaluated were, in particular, vaginal progesterone and 17-alpha-hydroxy-progesterone caproate. Additionally, the Cochrane Library, organizational guidelines, and studies identified through review of the above were utilized to identify relevant articles. Data were evaluated according to population studied, with separate analyses for singleton vs multiple gestations, prior PTB, or short transvaginal ultrasound cervical length (CL), and combinations of these factors. Consistent with US Preventive Task Force suggestions, references were evaluated for quality based on the highest level of evidence, and recommendations were graded. Summary of randomized studies indicates that in women with singleton gestations, no prior PTB, and short CL ≤ 20 mm at ≤ 24 weeks, vaginal progesterone, either 90-mg gel or 200-mg suppository, is associated with reduction in PTB and perinatal morbidity and mortality, and can be offered in these cases. The issue of universal CL screening of singleton gestations without prior PTB for the prevention of PTB remains an object of debate. CL screening in singleton gestations without prior PTB cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners, following strict guidelines. In singleton gestations with prior PTB 20-36 6/7 weeks, 17-alpha-hydroxy-progesterone caproate 250 mg intramuscularly weekly, preferably starting at 16-20 weeks until 36 weeks, is recommended. In these women with prior PTB, if the transvaginal ultrasound CL shortens to < 25 mm at < 24 weeks, cervical cerclage may be offered. Progestogens have not been associated with prevention of PTB in women who have in the current pregnancy multiple gestations, preterm labor, or preterm premature rupture of membranes. There is insufficient evidence to recommend the use of progestogens in women with any of these risk factors, with or without a short CL.

458: Recurrent preterm birth prevention in women receiving prophylactic 17P experiencing symptoms of preterm labor

458: Recurrent preterm birth prevention in women receiving prophylactic 17P experiencing symptoms of preterm labor

17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length

We sought to evaluate 17-alpha-hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25 mm. We conducted planned secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored randomized trial evaluating cerclage for women with singleton gestations, prior SPTB (17-33 6/7 weeks), and CL <25 mm between 16-22 6/7 weeks. Women were stratified at randomization to intent to use or not use 17P. The effect of 17P was analyzed separately for cerclage and no-cerclage groups. Primary outcome was PTB <35 weeks. In 300 women, 17P had no effect on PTB <35 weeks in either cerclage (P = .64) or no-cerclage (P = .51) groups. Only PTB <24 weeks (odds ratio, 0.08) and perinatal death (odds ratio, 0.14) were significantly lower for those with 17P in the no-cerclage group. 17P had no additional benefit for prevention of PTB in women who had prior SPTB and got ultrasound-indicated cerclage for CL <25 mm. In women who did not get cerclage, 17P reduced previable birth and perinatal mortality.