Reduction In Preterm Birth Research Articles

Fetoscopic Multilayer, Dural Patch Closure Technique for Intrauterine Myelomeningocele Repair: 2-Dimensional Operative Video.

Myelomeningocele (MMC) is the most common open neural tube defect associated with long-term survival. In 2011, The Management of Myelomeningocele Study (MOMS) trial demonstrated that fetal repair for MMC reduced the rate of shunted hydrocephalus and improved developmental, motor, and ambulation outcomes at 30 mo compared to postnatal intervention.1 Recent studies have demonstrated the safety and feasibility of fetoscopic MMC repair as well as reduction in preterm birth, lower risk of uterine dehiscence, and the option of vaginal delivery with this approach compared to open fetal repair.2-4 The patient is a 25-yr-old female, G4 P2, who presented at 20 wk's gestation with ultrasound findings concerning for MMC and Chiari II malformation. These findings were further corroborated with fetal magnetic resonance imaging. After extensive prenatal counseling in a multidisciplinary fashion and discussion regarding risks and benefits of prenatal closure of the MMC, the patient chose to undergo prenatal repair and surgical consent was obtained. At 25 wk's gestation, the patient underwent a fetoscopic multilayer closure with dural patch repair using a standardized, 3-port, carbon dioxide insufflation technique for the intrauterine treatment of MMC without any postoperative complications. The duration of the entire procedure was 275 min. At 36 wk's and 1 d's gestational age, the patient had a spontaneous vaginal delivery, resulting in a healthy male newborn. The surgical site was well healed without complications, and follow-up radiographic imaging was reassuring. This edited, 2-dimensional operative video highlights the key steps of the fetoscopic closure with follow-up postnatal clinical and radiographic outcomes.

Modest reduction in adverse birth outcomes following the COVID-19 lockdown

BackgroundWidespread lockdowns imposed during the coronavirus disease 2019 crisis may impact birth outcomes.ObjectiveThis study aimed to evaluate the association between the COVID-19 lockdown and the risk of adverse birth outcomes in Botswana.Study DesignIn response to the coronavirus disease 2019 crisis, Botswana enforced a lockdown that restricted movement within the country. We used data from an ongoing nationwide birth outcomes surveillance study to evaluate adverse outcomes (stillbirth, preterm birth, small-for-gestational-age fetuses, and neonatal death) and severe adverse outcomes (stillbirth, very preterm birth, very-small-for-gestational-age fetuses, and neonatal death) recorded prelockdown (January 1, 2020–April 2, 2020), during lockdown (April 3, 2020–May 7, 2020), and postlockdown (May 8, 2020–July 20, 2020). Using difference-in-differences analyses, we compared the net change in each outcome from the prelockdown to lockdown periods in 2020 relative to the same 2 periods in 2017–2019 with the net change in each outcome from the prelockdown to postlockdown periods in 2020 relative to the same 2 periods in 2017–2019.ResultsIn this study, 68,448 women delivered a singleton infant in 2017–2020 between January 1 and July 20 and were included in our analysis (mean [interquartile range] age of mothers, 26 [22–32] years). Across the included calendar years and periods, the risk of any adverse outcome ranged from 27.92% to 31.70%, and the risk of any severe adverse outcome ranged from 8.40% to 11.38%. The lockdown period was associated with a 0.81 percentage point reduction (95% confidence interval, −2.95% to 1.30%) in the risk of any adverse outcome (3% relative reduction) and a 0.02 percentage point reduction (95% confidence interval, −0.79% to 0.75%) in the risk of any severe adverse outcome (0% relative reduction). The postlockdown period was associated with a 1.72 percentage point reduction (95% confidence, −3.42% to 0.02%) in the risk of any adverse outcome (5% relative reduction) and a 1.62 percentage point reduction (95% confidence interval, −2.69% to −0.55%) in the risk of any severe adverse outcome (14% relative reduction). Reductions in adverse outcomes were largest among women with human immunodeficiency virus and among women delivering at urban delivery sites, driven primarily by reductions in preterm birth and small-for-gestational-age fetuses.ConclusionAdverse birth outcomes decreased from the prelockdown to postlockdown periods in 2020, relative to the change during the same periods in 2017–2019. Our findings may provide insights into associations between mobility and birth outcomes in Botswana and other low- and middle-income countries.

Recurrent Preterm Birth Reduction by 17-Hydroxyprogesterone Caproate in Dichorionic/Diamniotic Twin Gestation.

The study aimed to evaluate the impact of 17-hydroxyprogesterone caproate (17-OHPC) on recurrent preterm birth (PTB) in women with a prior PTB and a current dichorionic/diamniotic twin gestation. We combined individual patient-level data from two prospective randomized placebo-controlled trials of prophylactic 17-OHPC in twin gestation and compared the rates of recurrent spontaneous PTB in those women with a prior singleton PTB randomized to placebo or 17-OHPC (250 mg weekly). Only 7.4% of women with dichorionic/diamniotic twin gestation experienced a prior PTB. Among these 66 women, spontaneous delivery prior to 34 weeks occurred significantly less often (p = 0.03) in those randomized to 17-OHPC (20.6%) than in those randomized to placebo (46.9%). However, mean gestational length was not significantly different, and there was no statistically significant difference in composite neonatal outcome. 17-OHPC may be beneficial to women with a prior PTB and a current dichorionic/diamniotic twin gestation. These findings along with those reported by the Maternal Fetal Medicine Units Network in singletons suggest a common mechanism of action and a specific target population, those with a prior PTB, that may benefit from 17-OHPC treatment. A large prospective trial is needed to validate these findings. · 17-OHPC reduces recurrent PTB in women with dichorionic/diamniotic twins.. · PTB risk and response to 17-OHPC may differ according to the type of twinning.. · 17-OHPC may affect a common pathway in twins and singletons with a prior PTB..

COMPARISON OF THE PREDICTIVE VALUE OF TRANSVAGINAL CERVICAL LENGTH AT 11-14 WEEKS AND AT 20-22 WEEKS OF GESTATION IN PRETERM LABOUR

Background: Preterm labour is defined as the onset of labour before 37 weeks of gestation, in pregnancy beyond 20 weeks of gestation, and is responsible for nearly 75% of all neonatal mortality and neurological morbidity. Cervical length (CL) is one of the major determinants of preterm delivery. Several studies have been able to conclude that transvaginal CL assessment may be a useful tool for the prediction of preterm delivery. The risk of preterm birth varies inversely with CL measured by ultrasound in low-risk women. Objective: To evaluate and compare the predictive value of transvaginal cervical length between 11-14 weeks and 20- 22 weeks of gestation in preterm labour. Material and Methods: A total of 264 pregnant women who were primigravida, singleton pregnancy, and women at gestational age 11-14 weeks and 20-22 weeks were included in the study. They were subjected for CL measurement at 11-14 and 20-22 weeks of gestation using transvaginal ultrasonography with the standard longitudinal view of the cervix while the patient’s bladder was empty. GEL VOLUSON 730 PRO Trans Vaginal Ultrasound (TVS) probe IC 5-9 H instrument with 5-9 MHz was used to measure CL. Results: The variables analyzed were the mean cervical length at 11-14 weeks and 20-22 weeks, the rate of shortening of cervical length in those who deliver at term and preterm and the cervical length at 11-14 weeks 20-22 weeks was correlated with gestational age at delivery and the predictive value of the same was determined. Cut-off of cervical length at 11-14 and 20-22 weeks of gestation was 3.73 cm and 2.89 and was statistically significant for the prediction of pre-term labour. Reduction in cervical length from 11-14 weeks to 20-22 weeks of gestation of more than 0.7 cm is predictive of preterm labour with statistical significance (p<0.001). Conclusion: Routine mid-pregnancy cervical length assessment in low-risk women can be a cost-effective method of preterm birth reduction but the implementation of such a policy is highly dependent upon local factors. If it is to be undertaken, cervical length assessment should be performed according to a standardized technique.

Association between omega-3 fatty acid supplementation and lower risk of preterm delivery: a systematic review and meta-analysis

Objective To explore whether omega-3 fatty acid supplementation is associated with lower risk of preterm delivery. Methods Searching the RCTs which were compared preterm birth between women with omega-3 fatty acid supplementation and without before December 2019 on Medline, EMBASE and Cochrane’s Library, then performing a meta-analysis. Results 26 trials were identified, included 20124 women. There was almost no association between omega-3 fatty acid supplementation and lower risk of preterm delivery (risk ratio 0.92, 95% confidence interval 0.85 to 1.01, I 2 = 9%), gestational duration (0.30, −0.05 to 0.64, I 2 = 48%). In subgroup analyses, preterm delivery lower rate occurred in groups with mixed DHA and EPA supplementation not only DHA supplementation groups (P for interaction = 0.02); The dose of equivalent greater than 1 g made a higher reduction in preterm birth significantly. Conclusions Omega-3 fatty acid supplementation was not associated with reduced risk of preterm delivery compared with placebo or no treatment during pregnancy. Relationship between Omega-3 fatty acid supplementation and other pregnant outcomes need more evidence and clinical studies.

Incidence, risk factors and consequences of preterm birth \u2013 findings from a multi-centric observational study for 14\u2009months in Nepal

BackgroundPreterm birth is a worldwide epidemic and a leading cause of neonatal mortality. In this study, we aimed to evaluate the incidence, risk factors and consequences of preterm birth in Nepal.MethodsThis was an observational study conducted in 12 public hospitals of Nepal. All the babies born during the study period were included in the study. Babies born < 37 weeks of gestation were classified as preterm births. For the association and outcomes for preterm birth, univariate followed by multiple regression analysis was conducted.ResultsThe incidence of preterm was found to be 93 per 1000 live births. Mothers aged less than 20 years (aOR 1.26;1.15–1.39) had a high risk for preterm birth. Similarly, education of the mother was a significant predictor for preterm birth: illiterate mothers (aOR 1.41; 1.22–1.64), literate mothers (aOR 1.21; 1.08–1.35) and mothers having basic level of education (aOR 1.17; 1.07–1.27). Socio-demographic factors such as smoking (aOR 1.13; 1.01–1.26), use of polluted fuel (aOR 1.26; 1.17–1.35) and sex of baby (aOR 1.18; 1.11–1.26); obstetric factors such as nulliparity (aOR 1.33; 1.20–1.48), multiple delivery (aOR 6.63; 5.16–8.52), severe anemia during pregnancy (aOR 3.27; 2.21–4.84), antenatal visit during second trimester (aOR 1.13; 1.05–1.22) and third trimester (aOR 1.24; 1.12–1.38), < 4 antenatal visits during pregnancy (aOR 1.49; 1.38–1.61) were found to be significant risk factors of preterm birth. Preterm has a risk for pre-discharge mortality (10.60; 9.28–12.10).ConclusionIn this study, we found high incidence of preterm birth. Various socio-demographic, obstetric and neonatal risk factors were associated with preterm birth. Risk factor modifications and timely interventions will help in the reduction of preterm births and associated mortalities.Trial registrationISRCTN30829654.

The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial

BackgroundThe rate of multiple pregnancies in IVF/ICSI ranges from 20 to 30%. The incidence of preterm birth in multiple pregnancies is as high as 60% and is even higher in pregnancies conceived after IVF & ICSI. The effect of progesterone on prevention of preterm birth in twins is controversial. Our group has proven a positive effect in reduction of preterm birth, by starting progesterone from the mid-trimester, in exclusively IVF/ICSI singleton pregnancies but not twins. The purpose of our current study was to explore the effect of earlier administration of natural progesterone, in IVF/ICSI twin pregnancies starting at 11–14 weeks for prevention of preterm birth.MethodsThis is a double-blind, placebo controlled, single center, randomized clinical trial. Women with dichorionic twin gestations, having an IVF/ICSI trial were randomized to receive natural rectal progesterone (800 mg daily) vs placebo, starting early from 11 to 14 weeks. They also received oral and vaginal antimicrobial agents as part of our routine treatment for vaginitis and urinary tract infection. They were randomized regardless of cervical length and had no previous history of preterm birth or known Mullerian anomalies. The primary outcome was spontaneous preterm birth rate before 37 weeks. The secondary outcome was; spontaneous preterm birth before 34, 32, 28 weeks and neonatal outcome.ResultsA total of 203 women were randomized to both groups, final analysis included 199 women as 4 were lost to follow up. The base line characteristics as well as gestational age at delivery were not significantly different between the study and the placebo group (34.7 ± 3.6 vs 34.5 ± 4.5, P = 0.626). Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks.ConclusionsRectal natural progesterone starting from the first trimester in IVF/ICSI twin pregnancies did not reduce spontaneous preterm birth.Trial registrationThe trial was registered on 31 January 2014 at www.ISRCTN.com, number 69810120.

The elements of success in a comprehensive state-wide program to safely reduce the rate of preterm birth.

In 2014, a whole-of-population and multi-faceted preterm birth prevention program was introduced in Western Australia with the single aim of safely lowering the rate of preterm birth. The program included new clinical guidelines, print and social media, and a dedicated new clinic. In the first full calendar year the rate of preterm birth fell by 7.6% and the reduction extended from the 28-31 week gestational age group upwards. The objective of this study was to evaluate outcomes in greater depth and to also include the first three years of the program. This was a prospective population-based cohort study of perinatal outcomes in singleton pregnancies before and after commencement of the program. There was a significant reduction in preterm birth in the tertiary center which extended from 28 weeks gestation onwards and was ongoing. In non-tertiary centers there was an initial reduction, but this was not sustained past the first year. The greatest reduction was observed in pregnancies classified at first attendance as low risk. No benefit was observed in the private sector, but a significant reduction was seen in the remote region of the Kimberley where the program was first launched and vaginal progesterone had been made free-of-charge. Preterm birth rates can be safely reduced by a multi-faceted and whole-of-population program but the effectiveness requires continuing effort and will be greatest where the strategies are most targeted.

Comparison of the Predictive Value of Transvaginal Cervical Length at 11-14 Weeks and at 20-22 Weeks of Gestation in Preterm Labour

Background: Preterm labour is defined as the onset of labour before 37 weeks of gestation, in pregnancy beyond 20 weeks of gestation, and is responsible for nearly 75% of all neonatal mortality and neurological morbidity. Cervical length (CL) is one of the major determinants of preterm delivery. Several studies have been able to conclude that transvaginal CL assessment may be a useful tool for the prediction of preterm delivery. The risk of preterm birth varies inversely with CL measured by ultrasound in low-risk women. Objective: To evaluate and compare the predictive value of transvaginal cervical length between 11-14 weeks and 20-22 weeks of gestation in preterm labour. Material and Methods: A total of 264 pregnant women who were primigravida, singleton pregnancy, and women at gestational age 11-14 weeks and 20-22 weeks were included in the study. They were subjected for CL measurement at 11-14 and 20-22 weeks of gestation using transvaginal ultrasonography with the standard longitudinal view of the cervix while the patient’s bladder was empty. GEL VOLUSON 730 PRO Trans Vaginal Ultrasound (TVS) probe IC 5-9 H instrument with 5-9 MHz was used to measure CL. Results: The variables analyzed were the mean cervical length at 11-14 weeks and 20-22 weeks, the rate of shortening of cervical length in those who deliver at term and preterm and the cervical length at 11-14 weeks 20-22 weeks was correlated with gestational age at delivery and the predictive value of the same was determined. Cut-off of cervical length at 11-14 and 20-22 weeks of gestation was 3.73 cm and 2.89 and was statistically significant for the prediction of pre-term labour. Reduction in cervical length from 11-14 weeks to 20-22 weeks of gestation of more than 0.7 cm is predictive of preterm labour with statistical significance (p<0.001). Conclusion: Routine mid-pregnancy cervical length assessment in low-risk women can be a cost-effective method of preterm birth reduction but the implementation of such a policy is highly dependent upon local factors. If it is to be undertaken, cervical length assessment should be performed according to a standardized technique.

The Potential Impact of Aspirin Prophylaxis on Pregnancy Outcomes for Women With Severe Preeclampsia [37L

INTRODUCTION: Preeclampsia affects 3-5% of pregnancies with significant morbidity and mortality. Aspirin may reduce the risk of developing preeclampsia by up to 24%. Several organizations have created guidelines for initiation of aspirin therapy, each using different criteria. This study was designed to assess the impact of differing guidelines for aspirin use on maternal and fetal outcomes. METHODS: A retrospective cohort study of women who delivered between January 2009 and September 2010 with a diagnosis of preeclampsia with severe features was performed. Guidelines from six different OBGYN societies were applied to these patients to identify the percentage who met criteria for aspirin administration. Published risk reduction rates for preeclampsia, intrauterine growth restriction (IUGR), and preterm birth were applied to estimate adjusted maternal and fetal outcomes. RESULTS: Of 153 deliveries with 173 neonates, 31 cases of IUGR (20%) and 107 cases of preterm births (70%) were identified. The Canadian society (SOGC) guideline identified 97% of our patients for aspirin therapy, while the remaining guidelines identified between 4-46% (P&lt;.001) The SOGC was the only guideline to meet the published 24% reduction in cases of preeclampsia and 14% reduction of preterm birth with 35.3% and 14.3% reduction respectively. None of the guidelines reduced IUGR by the published 20% rate. CONCLUSION: The Canadian society’s guideline is comprehensive and captures more women who should start aspirin therapy. While these guidelines are beneficial for initiation of aspirin therapy, few of the published guidelines will effectively reduce rates of preeclampsia. Development of a more effective preventive treatment remains essential.

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.

Antibiotics for asymptomatic bacteriuria in pregnancy.

Asymptomatic bacteriuria is a bacterial infection of the urine without any of the typical symptoms that are associated with a urinary infection, and occurs in 2% to 15% of pregnancies. If left untreated, up to 30% of mothers will develop acute pyelonephritis. Asymptomatic bacteriuria has been associated with low birthweight and preterm birth. This is an update of a review last published in 2015. To assess the effect of antibiotic treatment for asymptomatic bacteriuria on the development of pyelonephritis and the risk of low birthweight and preterm birth. For this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) on 4 November 2018, and reference lists of retrieved studies. Randomised controlled trials (RCT) comparing antibiotic treatment with placebo or no treatment in pregnant women with asymptomatic bacteriuria found on antenatal screening. Trials using a cluster-RCT design and quasi-RCTs were eligible for inclusion, as were trials published in abstract or letter form, but cross-over studies were not. Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach. We included 15 studies, involving over 2000 women. Antibiotic treatment compared with placebo or no treatment may reduce the incidence of pyelonephritis (average risk ratio (RR) 0.24, 95% confidence interval (CI) 0.13 to 0.41; 12 studies, 2017 women; low-certainty evidence). Antibiotic treatment may be associated with a reduction in the incidence of preterm birth (RR 0.34, 95% CI 0.13 to 0.88; 3 studies, 327 women; low-certainty evidence), and low birthweight babies (average RR 0.64, 95% CI 0.45 to 0.93; 6 studies, 1437 babies; low-certainty evidence). There may be a reduction in persistent bacteriuria at the time of delivery (average RR 0.30, 95% CI 0.18 to 0.53; 4 studies; 596 women), but the results were inconclusive for serious adverse neonatal outcomes (average RR 0.64, 95% CI 0.23 to 1.79, 3 studies; 549 babies). There were very limited data on which to estimate the effect of antibiotics on other infant outcomes, and maternal adverse effects were rarely described. Overall, we judged only one trial at low risk of bias across all domains; the other 14 studies were assessed as high or unclear risk of bias. Many studies lacked an adequate description of methods, and we could only judge the risk of bias as unclear, but in most studies, we assessed at least one domain at high risk of bias. We assessed the quality of the evidence for the three primary outcomes with GRADE software, and found low-certainty evidence for pyelonephritis, preterm birth, and birthweight less than 2500 g. Antibiotic treatment may be effective in reducing the risk of pyelonephritis in pregnancy, but our confidence in the effect estimate is limited given the low certainty of the evidence. There may be a reduction in preterm birth and low birthweight with antibiotic treatment, consistent with theories about the role of infection in adverse pregnancy outcomes, but again, the confidence in the effect is limited given the low certainty of the evidence. Research implications identified in this review include the need for an up-to-date cost-effectiveness evaluation of diagnostic algorithms, and more evidence to learn whether there is a low-risk group of women who are unlikely to benefit from treatment of asymptomatic bacteriuria.

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI 'syndromic' management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.

Omega-3 fatty acids to prevent preterm birth: Australian pregnant women\u2019s preterm birth awareness and intentions to increase omega-3 fatty acid intake

BackgroundPreterm birth is the leading cause of death in children under five. A recent Cochrane review found a 42% reduction in early preterm birth (< 34 weeks’ gestation) and 11% reduction in preterm birth (< 37 weeks’ gestation) with omega-3 fatty acid supplementation. To assist in the development of implementation strategies to increase pregnant women’s omega-3 fatty acid intake, we assessed the awareness of Australian pregnant women about preterm birth, their nutrition and supplementation behaviours during pregnancy, and intentions to increase omega-3 fatty acid intake.MethodsA ten-minute survey was conducted online to assess the knowledge, attitudes, behaviours, and intentions of Australian pregnant women across three domains: (1) preterm birth; (2) nutrition and supplementation during pregnancy; and (3) omega-3 fatty acid consumption to prevent preterm birth. Participants were recruited from Survey Sampling International’s research panels.ResultsOf the 763 women who completed the survey, less than two-thirds had heard of preterm birth. Over 55% of respondents had changed their diet during pregnancy and a prenatal dietary supplement was consumed by 82% of the women surveyed. Respondents’ main source of information about preterm birth and nutrition during pregnancy was from a health professional. When asked about their intentions to increase their omega-3 fatty acid intake following a health professional’s recommendation, the vast majority of participants indicated they would increase their omega-3 fatty acid intake (90%). When a hypothetical scenario was presented of an omega-3 fatty acid supplement being offered from a health service at no cost, the number of respondents who selected they would increase their intake through supplementation increased from 54 to 79%.ConclusionsThe main information source for women about preterm birth and dietary supplementation recommendations during pregnancy is their health professional. Therefore, informing women about ways to prevent preterm birth, including the role of omega-3 fatty acids, should occur during antenatal visits. The results from our study are useful for clinicians caring for pregnant women and for the next stage of translation of the Cochrane review findings – the design of implementation strategies to increase the intake of omega-3 fatty acids during pregnancy where needed.

17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial

Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due to a large treatment benefit. This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation. This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (clinicaltrials.gov: NCT01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 160/7 to 206/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250 mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB < 35 weeks and a neonatal morbidity composite index. The composite included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB < 35 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%-11%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal/early infant death assuming a 4% fetal/early infant death rate. Analysis was performed according to the intention-to-treat principle. Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71-1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68-1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4-1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (n = 391; 23% of all patients), although the rate of PTB < 35 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk = 0.88 [95% CI: 0.55, 1.40]. In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death.

PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

BackgroundPreeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB.MethodsThis is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded.DiscussionThe PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries.Trial registrationClinicalTrials.gov: NCT03073317.

Association Between Sexual and Genital Hygiene Habits With the Urinary Tract Infection During Pregnancy: A Case-Control Study

Objectives: Urinary tract infections (UTIs) are the most common type of infection during pregnancy, which cause serious complications for the mother and baby. The present study was conducted to investigate the relationship between sexual and genital hygiene habits and UTIs in pregnant women. Materials and Methods: This case-control study was conducted on 187 pregnant women including 97 pregnant women with symptomatic bacteriuria (case) and 90 healthy pregnant women (control). Controls were frequency matched with the cases with respect to the number of pregnancy and trimesters of pregnancy. Both groups were compared for the presence of UTI. Finally, the binary multivariate unconditional logistic regression approach was used to evaluate the association between UTI and the confounding variables. Results: The results of this study showed a significant association between UTI in pregnancy and sexual and genital hygiene habits (P&lt;0.05). Based on the binary multivariate logistic regression analysis, attributable risks for UTI included having sexual intercourse &gt;3 times/week (adjusted odds ratio [AOR] =3.68, 95% CI = 2.09-5.41, P=0.001), changing the underwear per week (AOR =1.39, 95% CI=1-1.76, P=0.012), not voiding post-coitus (AOR=2.01, 95% CI=1.34-2.69, P=0.01), washing genitalia from back to the front (AOR=1.96, 95% CI=1.06-2.78, P=0.01), and not washing genitals pre-coitus by the husband (AOR=1.20, 95% CI=0.54-1.9, P=0.024) were among the sexual and hygiene habit variables associated with UTI in pregnant women in this model. Conclusions: In general, sexual and genital hygiene habits are vital preventive actions for controlling the UTI in pregnant women. These actions may lead to UTI complications and a preterm birth reduction. Thus, informing spouses about these practices is highly suggested.

Measurement of birth outcomes in analyses of the impact of maternal influenza vaccination.

BackgroundThe estimated association of maternal influenza vaccination and birth outcomes may be sensitive to methods used to define preterm birth or small‐for‐gestational age (SGA).MethodsIn a cohort of pregnant women in Lao People's Democratic Republic, we estimated gestational age from: (a) date of last menstrual period (LMP), (b) any prenatal ultrasound, (c) first trimester ultrasound, (d) Ballard Score at delivery, and (e) an algorithm combining LMP and ultrasound. Infants were classified as SGA at birth using a Canadian, global, and equation‐based growth reference. We estimated the association of maternal influenza vaccination and birth outcomes, by influenza activity, using multivariable log‐binomial regression and Cox proportional hazards regression with vaccination as a time‐varying exposure.ResultsThe frequency of preterm birth in the cohort varied by method to estimate gestational age, from 5% using Ballard Score to 15% using any ultrasound. Using LMP, any ultrasound, or the algorithm, we found statistically significant reductions in preterm birth among vaccinated women during periods of high influenza activity and statistically significant increases in SGA, using a Canadian growth reference. We did not find statistically significant associations with SGA when using global or equation‐based growth references.ConclusionsThe association of maternal influenza vaccination and birth outcomes was most affected by the choice of a growth reference used to define SGA at birth. The association with pre‐term birth was present and consistent across multiple statistical approaches. Future studies of birth outcomes, specifically SGA, should carefully consider the potential for bias introduced by measurement choice.

Time trends and sociodemographic determinants of preterm births in pregnancy cohorts in Matlab, Bangladesh, 1990–2014

IntroductionPreterm birth is the major cause of under-five mortality. Population-based data on determinants and proportions of children born preterm are limited, especially from low-income countries. This study aimed at assessing...

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery &lt;37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (&lt;2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.