Delivery Birth Research Articles

Birth Order, Caesarean Section, or Daycare Attendance in Relation to Child- and Adult-Onset Type 1 Diabetes: Results from the German National Cohort.

(1) Background: Global incidence of type 1 diabetes (T1D) is rising and nearly half occurred in adults. However, it is unclear if certain early-life childhood T1D risk factors were also associated with adult-onset T1D. This study aimed to assess associations between birth order, delivery mode or daycare attendance and type 1 diabetes (T1D) risk in a population-based cohort and whether these were similar for childhood- and adult-onset T1D (cut-off age 15); (2) Methods: Data were obtained from the German National Cohort (NAKO Gesundheitsstudie) baseline assessment. Self-reported diabetes was classified as T1D if: diagnosis age ≤ 40 years and has been receiving insulin treatment since less than one year after diagnosis. Cox regression was applied for T1D risk analysis; (3) Results: Analyses included 101,411 participants (100 childhood- and 271 adult-onset T1D cases). Compared to “only-children”, HRs for second- or later-born individuals were 0.70 (95% CI = 0.50–0.96) and 0.65 (95% CI = 0.45–0.94), respectively, regardless of parental diabetes, migration background, birth year and perinatal factors. In further analyses, higher birth order reduced T1D risk in children and adults born in recent decades. Caesarean section and daycare attendance showed no clear associations with T1D risk; (4) Conclusions: Birth order should be considered in both children and adults’ T1D risk assessment for early detection.

Frequency of cerclage in consecutive pregnancies of women with history of preterm birth.

Serial cervical length screening is performed in women with a history of preterm birth to determine indication for cerclage placement. Our aim is to evaluate the frequency of cerclage placement in consecutive pregnancies with preterm birth history to determine whether performing serial cervical length screening for women with a history of late (34-36 6/7 weeks) spontaneous preterm birth (SPTB) should be reconsidered. Retrospective evaluation of cerclage frequency and gestational age of delivery for consecutive singleton births for 69,671 women whose first birth was a SPTB. History of late SPTB was associated with a lower frequency of cerclage than history of early SPTB (0.83% vs 4.88%, OR 0.16, 95% CI 0.14-0.18). Rates of recurrent SPTB were lower for women with history of late SPTB than those with history of early SPTB (13.45%, 3.74% early, 9.71% late vs 20.69%, 9.12% early, 11.57% late). Women with a history of late PTB have a lower risk of recurrent PTB than those with a history of early PTB but constitute most of those undergoing serial cervical length screening for potential cerclage placement. Practice guidelines for screening women with a history of late PTB should be re-evaluated.

The effectiveness of a behavioral science and design intervention for family savings on use of maternal health services and male involvement: study protocol for a randomized controlled trial

BackgroundLack of financial preparedness for pregnancy can lead to adverse outcomes during childbirth. Behavioral science interventions have been shown to influence savings behavior. Financial savings interventions can be adapted for the purpose of encouraging individuals to save towards maternal healthcare costs. This article describes a protocol to assess the effectiveness of an intervention formulated with a behavioral science approach for encouraging use of maternal health services through increased financial savings for birth preparedness and maternal healthcare costs among pregnant women or their partners in Uganda.MethodsA randomized controlled trial will be conducted to assess the effectiveness of the intervention among pregnant women or their partners in Uganda’s central region, including the capital of Kampala. Seven hundred pregnant women (12–35 gestational weeks) or their partners will be recruited. All participants will receive access to a committed mobile money health savings account provided by a local organization that also offers savings targets and reminders for antenatal care appointments and health tips as part of a “Mamas Program” offered to expectant mothers. The time period in the intervention is from the day of enrollment until two weeks after the delivery date. The control group will receive the standard Mama Program offering. The intervention group will receive the standard Mama Program offering plus behavioral designs encouraging savings behavior through short-message service (SMS) text messages. The primary outcome is usage of maternal health services measured by level of birth preparedness and delivery at a health facility. Secondary outcomes include male involvement in maternal healthcare, measured by financial support, as well as total savings for healthcare, assessed using the validated amount of savings accrued in participants’ clinicPesa accounts from the day of enrollment plus any withdrawals for healthcare expenditures during the intervention period.DiscussionThe study will contribute to a better understanding of the effectiveness of behavioral designs encouraging financial savings during pregnancy into committed mobile money health savings accounts. The study could contribute to demonstrating the effectiveness of savings on birth preparedness, usage of maternal health services, and male involvement in maternal healthcare.Trial registrationUMIN-CTR Clinical Trial, UMIN000046472. Registered on 19 January 2022. https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053008

Factors associated with health facility delivery in Kitui County: a cross sectional study

Background: High maternal mortality rate is a major public health concern in developing countries. Skilled birth delivery is central to reducing maternal mortality, yet health facility delivery remains low in Kitui County, Kenya. Our study estimated prevalence of unskilled delivery and identified factors associated with health facility delivery in Kitui County. Methods: A cross-sectional study was conducted December 2017-February 2018. 245 women from five administrative wards were interviewed. A structured questionnaire was used to collect data. Variables that had p value ≤0.05 in bivariate analysis were included in multivariable regression model to assess for confounders. Variables with a p value of ≤0.05 in multivariate analysis were considered statistically significant at 95% CI. Results: We interviewed 245 (240 analyzed) women from the five wards; the majority were 16-25 years age group (45.5%; 110/240). Mean age was 27±6.6 years. Prevalence of health facility delivery was 50.4%. Distance from a health facility, number of children in a household, occupation of the respondent’s partner, number of antenatal clinic (ANC) visits and means of transport were significant factors for not delivering in a health facility. On multivariate analysis, women who lived >5km from health facility were less likely to deliver in a health facility (AOR =0.36; 95% CI 0.15- 0.86). Women who attended ≥ 4 ANC visits were 4 times more likely to deliver in a health facility (95% CI 2.01-8.79). Conclusions: More than half of the respondents delivered in a health facility. A long distance from the health facility is a hindrance to accessing ANC services. Inadequate ANC visits was associated with home delivery. Improving accessibility of health care services and health education on family planning would increase delivery at a health facility. We recommend Kitui County introduce five satellite clinics/ambulatory services for expectant women to access ANC and maternal services.

Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System.

It is a priority of the US Food and Drug Administration (FDA) to monitor the safety of medications used during pregnancy. Pregnancy exposure registries and cohort studies utilizing electronic health record data are primary sources of information but are limited by small sample sizes and limited outcome assessment. TreeScan™, a statistical data mining tool, can be applied within the FDA Sentinel System to simultaneously identify multiple potential adverse neonatal and infant outcomes after maternal medication exposure. We implemented TreeScan using the Sentinel analytic tools in a cohort of linked live birth deliveries and infants nested in the IBM MarketScan® Research Database. As a case study, we compared first trimester fluoroquinolone use and cephalosporin use. We used the Bernoulli and Poisson TreeScan statistics with compatible propensity score-based study designs for confounding control (matching and stratification) and used multiple propensity score models with various strategies for confounding control to inform best practices. We developed a hierarchical outcome tree including major congenital malformations and outcomes of gestational length and birth weight. A total of 1791 fluoroquinolone-exposed and 8739 cephalosporin-exposed mother-infant pairs were eligible for analysis. Both TreeScan analysis methods resulted in single alerts that were deemed to be due to uncontrolled confounding or otherwise not warranting follow-up. In this implementation of TreeScan using Sentinel analytic tools, we did not observe any new safety signals for fluoroquinolone use in the first trimester. TreeScan, with tailored or high-dimensional propensity scores for confounding control, is a valuable tool in addition to current safety surveillance methods for medications used during pregnancy.

A systematic review of home-based records in maternal and child health for improving informational continuity, health outcomes, and perceived usefulness in low and middle-income countries.

BackgroundEvidence shows that a gap in the documentation of patients’ past medical history leads to errors in, or duplication of, treatment and is a threat to patient safety. Home-based or patient-held records (HBR) are widely used in low and middle-income countries (LMIC) in maternal and childcare. The aim is to systematically review the evidence on HBRs in LMICs for (1) improving informational continuity for providers and women/families across health care visits and facilities, (2) to describe the perceived usefulness by women/families and healthcare providers, and (3) maternal and child health outcomes of using HBRs for maternal and child health care.MethodsThe protocol was registered in PROSPERO (CRD42019139365). We searched MEDLINE, EMBASE, CINAHL, and Global Index Medicus databases for studies with home-based records from LMICs. Search terms pertained to women or parent-held records and LMICs. Two reviewers assessed studies for inclusion using a priori study selection criteria- studies explaining the use of HBRs in LMIC for maternal and child health care. The included study quality was appraised using the Mixed Methods Appraisal Tool (MMAT). Results from all study designs were summarised narratively.ResultsIn total, 41 papers were included in the review from 4514 potential studies. Included studies represented various study designs and 16 countries. The least evaluated function of HBR was information continuity across health care facilities (n = 6). Overall, there were limited data on the usefulness of HBRs to providers and mothers/families. Home-based records were mostly available for providers during health care visits. However, the documentation in HBRs varied. The use of HBRs is likely to lead to improved antenatal visits and immunisation uptake, and skilled birth delivery in some settings. Mothers’ knowledge of breastfeeding practices and danger signs in pregnancy improved with the use of HBRs. One randomised trial found the use of HBRs reduced the risk of cognitive development delay in children and another reported on trial lessened the risk of underweight and stunted growth in children.ConclusionThere is limited literature from LMICs on the usefulness of HBRs and for improving information transfer across healthcare facilities, or their use by women at home. Current HBRs from LMICs are sub-optimally documented leading to poor informational availability that defeats the point of them as a source of information for future providers.

Hospital-level variation in rates of postpartum hemorrhage in California.

To examine the extent of hospital-level variation in risk-adjusted rates of postpartum hemorrhage (PPH). We performed a cross-sectional study examining live births in 257 California hospitals between 2011 and 2015 using linked birth certificate and maternal discharge data. PPH was measured using International Classification of Diseases Codes version 9. Mixed-effects logistic regression models were used to examine the presence and extent of hospital-level variation in PPH before and after adjustment for patient-level risk factors and select hospital characteristics (teaching status and annual delivery volume). Risk-adjusted rates of PPH were estimated for each hospital. The extent of hospital variation was evaluated using the median odds ratio (MOR) and intraclass correlation coefficient (ICC). Our study cohort comprised 1,904,479 women who had a live birth delivery hospitalization at 247 hospitals. The median, lowest, and highest hospital-specific rates of PPH were 3.48%, 0.54%, and 12.0%, respectively. Similar rates were observed after adjustment for patient and hospital factors (3.44%, 0.60%, and 11.48%). After adjustment, the proportion of the total variation in PPH rates attributable to the hospital was low, with a MOR of 2.02 (95% confidence interval [CI]: 1.89-2.15) and ICC of 14.3% (95% CI: 11.9%-16.3%). Wide variability exists in the rate of PPH across hospitals in California, not attributable to patient factors, hospital teaching status, and hospital annual delivery volume. Determining whether differences in hospital quality of care explain the unaccounted-for variation in hospital-level PPH rates should be a public health priority.

COVID-19 and vaccination during pregnancy: a systematic analysis using Korea National Health Insurance claims data.

This study systematically analyzed coronavirus disease 2019 (COVID-19) and vaccination details during pregnancy by using the national health insurance claims data. Population-based retrospective cohort data of 12,399,065 women aged 15-49 years were obtained from the Korea National Health Insurance Service claims database between 2019 and 2021. Univariate analysis was performed to compare the obstetric outcomes of pregnant women (ICD-10 O00-O94) and their newborns (ICD-10 P00-P96) with and without COVID-19. Univariate analysis was also performed to compare the age and obstetric outcomes of pregnant women receiving different types of vaccines. The percentage of pregnant women with COVID-19 during pregnancy was 0.11%. Some obstetric outcomes of pregnant women with COVID-19, including the rates of preterm birth or cesarean delivery, were significantly better than those of pregnant women without COVID-19. The rate of miscarriage was higher in pregnant women with COVID-19 than without COVID-19. However, the outcomes of newborns of women with and without COVID-19 were not significantly different. Regarding vaccination type, obstetric outcomes of pregnant women appeared to be worse with the viral vector vaccine than with the mRNA vaccine. To the best of our knowledge, this is the first study to systematically analyze COVID-19 and vaccination details during pregnancy using the national health insurance claims data in Korea. The obstetric outcomes in pregnant women with and without COVID-19 and their newborns were similar.

Human leukocyte antigen HLA-C, HLA-G, HLA-F, and HLA-E placental profiles are altered in early severe preeclampsia and preterm birth with chorioamnionitis

The extravillous trophoblast expresses each of the nonclassical major histocompatibility complex class I antigens-human leukocyte antigens E, F, and G-and a single classical class I antigen, human leukocyte antigen C. We recently demonstrated dynamic expression patterns of human leukocyte antigens C, G, and F during early extravillous trophoblast invasion and placentation. This study aimed to investigate the hypothesis that the immune inflammatory mediated complications of pregnancy such as early preeclampsia and preterm labor may show altered expression profiles of nonclassical human leukocyte antigens. Real-time quantitative polymerase chain reaction, western blot, and immunohistochemistry were performed on placental villous tissues and basal plate sections from term nonlaboring deliveries, preterm deliveries, and severe early-onset preeclampsia, both with and without small-for-gestational-age neonates. Human leukocyte antigen G is strongly and exclusively expressed by the extravillous trophoblast within the placental basal plate, and its levels increase in pregnancies complicated by severe early-onset preeclampsia with small-for-gestational-age neonates relative to those of healthy term controls. Human leukocyte antigen C shows a similar profile in the extravillous trophoblast of preeclamptic pregnancies, but significantly decreases in the villous placenta. Human leukocyte antigen F protein levels are decreased in both extravillous trophoblast and villous placenta of severe early-onset preeclamptic pregnancies, both with and without small-for-gestational-age neonates, compared with those found in term and preterm birth deliveries. Human leukocyte antigen E decreases in blood vessels in placentas from preeclamptic pregnancies relative to its levels in term and preterm birth deliveries. Placental levels of human leukocyte antigens F and C are increased in cases of preterm birth with chorioamnionitis relative to those of cases of idiopathic preterm birth. Dysregulation of placental human leukocyte antigen expression at the maternal-fetal interface may contribute to compromised maternal tolerance in preterm birth with chorioamnionitis and excessive maternal systemic inflammation associated with severe early-onset preeclampsia.

Effects of letrozole co-treatment on outcomes of gonadotropin-releasing hormone antagonist cycles in POSEIDON groups 3 and 4 expected poor responders.

To evaluate the effects of adjuvant letrozole administration on outcomes of gonadotropin-releasing hormone (GnRH) antagonist cycles with intra-cytoplasmic sperm injection in POSEIDON groups 3 and 4 expected poor responder women. This study was conducted by retrospective analysis of patients with expected poor ovarian response (POSEIDON groups 3 and 4) that underwent GnRH antagonist cycles with intra-cytoplasmic sperm injection between 2010 and 2020. A total of 488 patients with letrozole co-administration and 2564 patients without any adjuvant treatment that underwent GnRH antagonist cycles within the selected period of time were included in the study. Implantation rates, clinical pregnancy rates and live birth delivery rates were significantly higher in letrozole administered patients in comparison to controls among POSEIDON group 3 women (0.39 ± 0.46 vs 0.27 ± 0.40, p = 0.01; 46.1% vs 33%, p = 0.014; 42.7% vs 31.5%, p = 0.034, respectively). Mean total doses of gonadotropins required per cycle were significantly lower in letrozole administered patients among both POSEIDON groups 3 and 4 women (2864.65 ± 878.47IU vs 3757.27 ± 1088.89IU, p < 0.001; 3286.06 ± 770.16IU vs 3666.48 ± 959.66IU, p < 0.001, respectively). Adjuvant letrozole co-administration in intra-cytoplasmic sperm injection cycles following GnRH antagonist protocol appears to improve implantation, clinical pregnancy and live birth delivery rates in women with POSEIDON group 3 expected poor ovarian response.

Mode of Delivery Is Associated with Postpartum Depression: Do Women with and without Depression History Exhibit a Difference?

Whether the mode of birth delivery correlates with the incidence of postpartum depression (PPD) is still under debate. This study seeks to clarify such a correlation and to further investigate if there are any differences in the likelihood of PPD medical care use among women with and without a history of depression. A logistic regression at two assessment points (6-month and 12-month postpartum) on the National Health Insurance Database in Taiwan is performed. In total, 32,729 women were included who gave first birth from 2007 to 2011 via cesarean section (CS), elective CS, and vaginal delivery, of whom 3580 (10.9%) were diagnosed with a history of depression. Findings show that CS was associated with a higher likelihood of PPD doctor visits regardless of whether the women have a history of depression or not, but elective CS tended to have different impacts for these two groups of women. Mentally healthy women who experienced elective CS had 1.36- and 1.64-times higher risk of PDD medical care use than those who delivered vaginally, whereas previous depressive women undertaking an elective cesarean birth had no significant difference observed in incidences. A notably higher risk of elective CS delivery versus vaginal delivery for mentally healthy women suggests that elective CS is not clinically appropriate, yet it might be an alternative to vaginal delivery with careful counseling for pregnant women who experience a history of depression.

Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin improves live birth rates in POSEIDON group 3 and 4 expected poor responders

Objective Aim of this study was to evaluate the effects of dual triggering with gonadotropin releasing hormone agonist and human chorionic gonadotropin (hCG) on outcomes of fresh embryo transfers following gonadotropin antagonist cycles in POSEIDON group 3 and group 4 low prognosis women and to compare the outcomes with hCG-only triggering. Methods This study was conducted by retrospective analysis of patients with expected poor ovarian response (POSEIDON group 3 and 4) that underwent fresh embryo transfers following in-vitro fertilization/intracytoplasmic sperm injection cycles with either dual triggering or hCG-only triggering between January 2010 and April 2020. A total of 1068 women that underwent dual triggering and 1931 that underwent hCG-only triggering were included in the study. Results Number of retrieved oocytes, M2 oocytes, oocyte maturation rate, fertilization rate, obtained 2PN embryos, implantation rate, clinical pregnancy rate and live birth delivery rates were found significantly higher in dual-triggering group in comparison to hCG-only group (p < 0.001, p < 0.001, p < 0.001, p < 0.001, p < 0.001, p < 0.001, p = 0.02, p < 0.001 respectively). Conclusion Dual trigger with concomitant injections of GnRH agonist and hCG in GnRH antagonist cycles appears to improve IVF outcomes, increase quality of embryos, reduce miscarriage rates and consequently increase live birth delivery rates in POSEIDON groups 3/4 poor responders.

Understanding Etiologic Pathways Through Multiple Sequential Mediators: An Application in Perinatal Epidemiology.

Causal mediation analysis facilitates decomposing the total effect into a direct effect and an indirect effect that operates through an intermediate variable. Recent developments in causal mediation analysis have clarified the process of evaluating how-and to what extent-different pathways via multiple causally ordered mediators link the exposure to the outcome. Through an application of natural effect models for multiple mediators, we show how placental abruption might affect perinatal mortality using small for gestational age (SGA) birth and preterm delivery as two sequential mediators. We describe methods to disentangle the total effect into the proportions mediated via each of the sequential mediators, when evaluating natural direct and natural indirect effects. Under the assumption that SGA births causally precedes preterm delivery, an analysis of 16.7 million singleton pregnancies is consistent with the hypothesis that abruption exerts powerful effects on perinatal mortality (adjusted risk ratio = 11.9; 95% confidence interval = 11.6, 12.1). The proportions of the estimated total effect mediated through SGA birth and preterm delivery were 2% and 58%, respectively. The proportion unmediated via either SGA or preterm delivery was 41%. Through an application of causal mediation analysis with sequential mediators, we uncovered new insights into the pathways along which abruption impacts perinatal mortality.

Placental location and obstetrical-neonatal outcomes: A retrospective study.

To explore the potential association of lateral placentation with pregnancy outcome. The database of a tertiary medical center was searched for women who gave birth to a singleton neonate from 2012 to 2020 for whom placental location was documented during antepartum sonographic examination. Clinical data were compared between patients with a central (anterior/posterior/fundal) or lateral placenta using standard statistics. The primary outcome measure was neonatal birthweight, and secondary outcome measures were pregnancy complications and mode of delivery. The cohort included 12 306 women: 11 608 (94%) with a central placenta and 698 (5.6%) with a lateral placenta. The lateral placenta group had higher rates (P <0.05) of prior and current cesarean delivery, assisted delivery, and preterm birth. On multivariate regression analyses, placental location (adjusted odds ratio [aOR], 1.36; 95% confidence interval [CI], 1.11-1.66) and maternal age (aOR, 1.02; 95% CI, 1.01-1.03) were associated with risk of preterm birth. Lateral placenta (aOR, 1.22; 95% CI, 1.02-1.47), maternal age (aOR, 1.07; 95% CI, 1.06-1.08), parity (aOR, 0.32; 95% CI, 0.28-0.35), and prior cesarean delivery (aOR, 12.00; 95% CI, 10.60-13.60) were associated with risk of current cesarean delivery. The findings suggest that lateral placentation may pose a risk of preterm birth and cesarean delivery compared with central placentation.

Quality improvement initiative to address bed shortage in the maternity ward at the National Referral Hospital.

Background and AimsThe shortage of beds at the maternity ward is ever increasing with an increasing trend in total birth and cesarean section deliveries thereby increasing the daily number of obstetric patients awaiting admission. This quality improvement (QI) project was conducted to mitigate the problem of bed shortage by implementing modified enhanced recovery after surgery in low‐risk cesarean section mothers. We aimed to increase the process measure of second day postoperative discharge in low‐risk cesarean section mothers admitted in the maternity ward from 0% to 25% over 2 months period. Simultaneously, the outcome measure of daily number of obstetric patients awaiting admission was assessed.MethodsThe study was conducted at the maternity ward, Jigme Dorji Wangchuck National Referral Hospital, Thimphu Bhutan. Fishbone analysis was used to analyze problems leading to delayed discharge. Interventions were discussed, implemented, and reviewed using Plan, Do, Study, and Act (PDSA) cycle over 8 week period from June 1 to July 31, 2021. Data were collected using the EXCEL sheet and analyzed using STATA 13. Process and outcome measures during the pre and postintervention period were analyzed. Descriptive statistics were used to express the results. Wilcoxon Signed‐Rank test was used to determine the statistical significance at p < 0.05.ResultsThe postintervention second day postoperative discharge increased to a median value of 65.5% (interquartile range [IQR]: 45–80) compared to the preintervention value of zero. The number of daily waiting obstetric patients decreased from the preintervention median value of 6.0 (IQR: 0–7) to the postintervention median value of 1.0 (IQR: 0–2) which was statistically significant at p = 0.0001.ConclusionQI initiative can address bed shortages by increasing the early postoperative discharge, thereby reducing the number of obstetric patients awaiting admissions. The outcome of this QI initiative can be used to provide evidence to modify the existing Standard Operating Procedures in our setup.

A Descriptive Study of Maternal Choices for Labor Pain Relief.

In a setting with a wider than usual variety of available labor pain relief methods, a prospective, descriptive study was conducted of labor pain relief methods desired by low-risk women prenatally, during labor, and at delivery. Of all women registering for care between 2017 and 2020, a total of 2562 women were screened for low-risk status and then offered study participation, if eligible. Of 1185 eligible women, 512 remained at low risk until admission in labor and completed the study. Pain relief methods chosen were compared with the type of labor, type of delivery, and between delivery sites. Hydrotherapy and a "none/unmedicated" labor were favored by a majority of subjects, regardless of ultimate method used. Multiple labor pain relief methods were used by 54.5% of subjects. Epidural analgesia most often occurred with augmented labor. Hydrotherapy was used more by those with spontaneous labors, water birth deliveries, and birth center births. Effectiveness of all pain relief measures was rated above average. Differences between planned hospital and planned birth center births were clear on most variables. Results can be used by childbirth educators, health professionals, and administrators to respect and improve the individualization of care and satisfaction of laboring women.

The effect of performance-based financing interventions on out-of-pocket expenses intended to improve access to and utilization of maternal health services in sub-Saharan Africa: protocol for a systematic review and meta-analysis

BackgroundOut-of-pocket expenses have been reported as a major barrier to accessing antenatal care and skilled birth delivery in most of sub-Saharan Africa. Performance-based financing (PBF) is one of several strategies introduced in lower- and middle-income countries to strengthen a weak health system. This review aims to synthesize evidence on the effectiveness of PBF interventions implemented with the objective of reducing out-of-pocket expenses and improving access to and utilization of ANC and skilled birth delivery and family planning in sub-Saharan Africa. It will consider evidence across health sectors and identify gaps in the evidence.Methods and analysisThis protocol is reported according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guideline. The systematic review will apply a three-step strategy to search five databases (CINAHL, PubMed, Ovid Medline, EMBASE, Cochrane.) and grey literature with the help of a librarian. Two independent reviewers will conduct screening to determine eligibility and critical appraisal of selected studies using the risk of bias criteria developed by the Cochrane EPOC Group and the New Castle Ottawa Scale for observational studies. The certainty of evidence for the outcomes will be assessed using “Grades of Recommendation, Assessment, Development, and Evaluation” (GRADE) approach. This review will consider experimental and quasi-experimental study designs and observational studies. Studies published in English and French language(s) will be included. Studies published since the introduction of PBF in sub-Saharan Africa will be included. Data will be collected on each item that contributes to out-of-pocket expenses. This review will adopt the Multiple Dimensions of Access Framework to organize the findings.DiscussionThis systematic review will support evidence-informed data for the performance-based financing community and government by identifying, describing, and assessing the impact of performance-based financing interventions on out-of-pocket expenses in promoting access and utilization of ANC, skilled birth delivery, and family planning across health sectors.Systematic review registrationThis review has been registered with PROSPERO, Registration number CRD42020222893.

P-064 Clinical outcomes of 127 patients with recurrent implantation failure treated with testicular sperm aspiration (TESA)

Abstract Study question Are the embryological, clinical and newborn outcomes using aspirated testicular sperm improved in cases with recurrent implantation failure previously treated with ejaculated sperm? Summary answer Aspirated testicular sperm enabled to obtain significant higher embryological, clinical and newborn outcomes in cases with recurrent implantation failure previously treated with ejaculated sperm. What is known already High levels of sperm DNA fragmentation (SDF) were associated to poor clinical outcomes (1-Simon et al., 2017). Testicular sperm display lower SDF than ejaculated sperm (2-Sakas and Alvarez, 2010), improving clinical outcomes in cases with abnormal semen parameters (3-Awaga et al., 2018; 4-Kang et al., 2018), recurrent implantation failure (RIF) and pregnancy loss (RPL) (5-Esteves et al., 2017), and elevated SDF (6-Ambar et al., 2021). As only a few studies are specifically dedicated to RIF, we expanded the number of cases and first provided full demographic, stimulation, embryological, clinical and newborn outcomes. References 1-(https://doi.org/10.4103/1008-682X.182822); 2-(https://doi.org/10.1016/j.fertnstert.2009.10.046); 3-(https://doi.org/10.1016/j.rbmo.2018.08.017); 4-(https://doi.org/10.1038/s41598-018-26280-0); 5-(https://doi.org/10.1016/j.fertnstert.2017.06.018); 6-(https://doi.org/10.5534/wjmh.200084 Study design, size, duration We retrospectively evaluated during consecutive years (2010-2020) 63 patients with recurrent implantation failure, which accepted to perform testicular sperm aspiration (TESA) as an alternative treatment. These patients presented a long history of failed treatments (153 cycles) using ejaculated sperm. From these cycles, no pregnancy ensued. The present study compares 127 treatment cycles, 80 with testicular sperm (17 cases repeated TESA) and 47 with ejaculated sperm from the same patients performed at the present IVF clinic. Participants/materials, setting, methods Patients were screened for karyotype abnormalities, for Y-chromosome microdeletions (7-Gonçalves et al., 2016), and for SDF with the TUNEL assay (8-Sá et al., 2015). Conventional semen analysis was performed according to World Health Organization guidelines (9-WHO, 2010). Male evaluation and TESA was performed by the same experienced urologist (LF) according to established protocols (10-Madureira et al 2014). The procedure was performed entirely on an outpatient basis, with no complications reported. References 7-(https://doi.org/10.4103/1008-682X.172827); 8-(https://doi.org/10.1016/j.rbmo.2015.06.019); 9-(https://apps.who.int/iris/handle/10665/44261); 10-(https://doi.org/10.1111/j.2047-2927.2014.00231.x). Main results and the role of chance The mean ages were 35.5±3.4 (26-42)-female and 38.1±5.7 (29-59)-male. There were 4 abnormal karyotypes (3-female, 1-male), all without known relevance. Most cases had asthenozoospermia and teratozoospermia (65.1%), or oligoasthenoteratozoospermia (41.8%). Of the 19 cases with &amp;lt;5M/ml, none presented Y-chromosome microdeletions. Although we do not routinely perform SDF testing, 15 patients had previous SDF values (12, &amp;gt;20%; 8, &amp;gt;36%). Female basal characteristics and testicular evaluation were under normal values. The TESA procedure took about 15-20 min, and the time of laboratorial search around 30-60 min. Cases using testicular sperm showed significant higher rates of fertilization (64% vs 73%-p=0.005), blastocyst development (47% vs 62%-p=0.010), implantation (6% vs 27%-p=0.000), clinical pregnancy (10% vs 39%-p=0.001), live birth delivery (5% vs 28%-p=0.005) and newborn (5% vs 32%-p=0.000) than ejaculated sperm. No significant differences were observed regarding the rates of embryo cleavage (95% vs 94.8%) and high quality embryos (89.4% vs 94%), in the mean number of transferred embryos (1.8±0.4 vs 1.9±0.4), or in the abortion rate (2 cases-50% vs 7 cases-25.9%). Cases using testicular sperm had 22 frozen-thawed embryo transfer cycles, enabling per initiated cycle a cumulative pregnancy rate of 45%, live birth delivery rate of 31.3% and newborn rate of 37.5% (32 newborn). Limitations, reasons for caution Although presenting the higher number of cycles using TESA in the treatment of RIF, this number needs to be increased for drawing more definitive conclusions, as these women present a diversity of conditions, rendering subgrouping difficult. In the future, it would also be important to evaluate SDF in all cases. Wider implications of the findings In conclusion, the present results gave further evidence for the superiority of using testicular sperm instead of ejaculated sperm in cases with recurrent implantation failure. Data also evidences the security of using testicular sperm aspiration, as there were no pregnancy or delivery complications, or congenital anomalies among the 32 newborn. Trial registration number Not Applicable

Sleep During Pregnancy.

This article will provide a brief review of most recent findings of sleep, insomnia, obstructive sleep apnea, and restless leg syndrome during pregnancy. Recent meta-analyses have found that 38.2% of pregnant women experience insomnia, 15% experience obstructive sleep apnea, and 20% experience restless leg syndrome. Poor sleep during pregnancy is associated with increased odds of preterm birth, cesarean section, hypertension, gestational diabetes, and longer deliveries. OSA is also associated with poor outcomes such as maternal hypertension, gestational diabetes, preterm birth, and low infant Apgar score. Incidence of new-onset RLS increases with parity, gestational age, maternal age, and increased maternal adiposity. Typical treatments have been found to be effective for treating sleep disorders in pregnant women. Obtaining sufficient sleep quality and quantity in addition to assessing and treating sleep disorders should be a priority for pregnant women and their providers.

Predictive value of new onset versus primary meconium-stained amniotic fluid.

Transition of clear amniotic fluid to meconium-stained fluid is a relatively common occurrence during labor. However, data regarding the clinical significance and the prognostic value of the presence of meconium-stained amnionic fluid (MSAF) are scarce. This study aimed to investigate delivery and neonatal outcomes according to the presence of MSAF and the timing of the meconium passage. We used an historical cohort study at a single tertiary medical center in Israel between the years 2011 and 2018. Women were divided into two groups according to timing of meconium passage: primary MSAF (MSAF present at membrane rupture) and secondary MSAF (clear amnionic fluid that transitioned to MSAF during labor). Neonatal complication rates were compared between groups. Composite adverse neonatal outcome was defined as arterial cord blood pH &lt;7.1, 5 min Apgar score ≤7, and/or neonatal intensive care unit admission. The study cohort included 56 863 singleton term births. Of these, 9043 (15.9%) were to women who had primary MSAF, and 1484 (2.6%) to those with secondary MSAF. Secondary MSAF compared with primary MSAF increased the risks of cesarean birth and operative vaginal delivery, increased the risks of low one- and five-minute Apgar scores and low arterial cord blood pH, and increased hospital stay duration. Multivariate analysis revealed that secondary MSAF was independently associated with an increased risk of composite adverse neonatal outcome (OR1.68, 95% CI 1.25-2.24, p&lt; 0.001) compared with primary MSAF. In this sample, secondary MSAF was associated with more adverse neonatal outcomes than primary MSAF. Closer monitoring of fetal well-being may be prudent in these cases.