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BMC Pregnancy and Childbirth May 2024The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo. (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo.
METHODS
This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by "block" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).
RESULTS
Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn's weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.
CONCLUSION
Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.
Topics: Humans; Pregnancy; Female; Probiotics; Double-Blind Method; Adult; Pregnancy Outcome; Iran; Cerclage, Cervical; Infant, Newborn; Fetal Membranes, Premature Rupture; Young Adult; Premature Birth; Obstetric Labor, Premature; Administration, Oral
PubMed: 38724897
DOI: 10.1186/s12884-024-06496-x -
Transplantation Proceedings May 2024The uterine artery pulsatility index (UtA PI) is associated with blood flow to the placenta. Its increased values imply impaired placentation. This study aimed to...
BACKGROUND
The uterine artery pulsatility index (UtA PI) is associated with blood flow to the placenta. Its increased values imply impaired placentation. This study aimed to evaluate UtA PI measurements in first-trimester ultrasound in pregnancies after kidney (KTx) or liver transplantation (LTx) and its relationship with perinatal outcome.
MATERIALS AND METHODS
A retrospective analysis of 72 pregnancies in female kidney (35) or liver (37) transplant recipients between 2017 and 2023 was performed. Data concerning UtA PI were available for 17 kidney and 19 liver recipients. Statistical analysis of variables between KTx and LTx groups and the correlation with perinatal outcomes was performed using Student's t test and Pearson's correlation with P < .05 considered statistically significant.
RESULTS
The mean UtA PI results were similar, and there were no statistical differences between the group of pregnant kidney and liver recipients with mean values of 1.46 (SD 0.44] and 1.73 (SD 0.51] respectively (P = .10). The mean neonate birth weight was lower in KTx group (2158 g ([SD 723 g]) compared with the LTx group (2780 g [SD 754g]; P =.02). In the KTx and LTx groups, mean UtA PI was in negative correlation with Apgar score in the first minute (P = .04, P = .01 respectively).
CONCLUSIONS
Uterine artery Doppler is useful in predicting perinatal outcomes in the general population and organ recipient pregnancies, even in the early stages of pregnancy, as we observed the correlation between UtA PI and Apgar score. Pregnant kidney recipients remain at higher risk for complications and more unpredictable outcomes than liver recipients.
Topics: Humans; Pregnancy; Female; Liver Transplantation; Uterine Artery; Retrospective Studies; Pulsatile Flow; Adult; Pregnancy Outcome; Kidney Transplantation; Ultrasonography, Prenatal; Infant, Newborn
PubMed: 38724404
DOI: 10.1016/j.transproceed.2024.04.005 -
The Journal of Maternal-fetal &... Dec 2024Twin pregnancy is associated with higher risks of adverse perinatal outcomes for both the mother and the babies. Among the many challenges in the follow-up of twin... (Observational Study)
Observational Study Comparative Study
BACKGROUND
Twin pregnancy is associated with higher risks of adverse perinatal outcomes for both the mother and the babies. Among the many challenges in the follow-up of twin pregnancies, the mode of delivery is the last but not the least decision to be made, with the main influencing factors being amnionicity and fetal presentation. The aim of the study was to compare perinatal outcomes in two European centers using different protocols for twin birth in case of non-cephalic second twin; the Italian patients being delivered mainly by cesarean section with those in Belgium being routinely offered the choice of vaginal delivery (VD).
METHODS
This was a dual center international retrospective observational study. The population included 843 women with a twin pregnancy ≥ 32 weeks (dichorionic or monochorionic diamniotic pregnancies) and a known pregnancy outcome. The population was stratified according to chorionicity. Demographic and pregnancy data were reported per pregnancy, whereas neonatal outcomes were reported per fetus. We used multiple logistic regression models to adjust for possible confounding variables and to compute the adjusted odds ratio (adjOR) for each maternal or neonatal outcome.
RESULTS
The observed rate of cesarean delivery was significantly higher in the Italian cohort: 85% for dichorionic pregnancies and 94.4% for the monochorionic vs 45.2% and 54.4% respectively in the Belgian center (-value < 0.001). We found that Belgian cohort showed significantly higher rates of NICU admission, respiratory distress at birth and Apgar score of < 7 after 5 min. Despite these differences, the composite severe adverse outcome was similar between the two groups.
CONCLUSION
In this study, neither the presentation of the second twin nor the chorionicity affected maternal and severe neonatal outcomes, regardless of the mode of delivery in two tertiary care centers, but VD was associated to a poorer short-term neonatal outcome.
Topics: Humans; Female; Pregnancy; Pregnancy, Twin; Cesarean Section; Retrospective Studies; Adult; Infant, Newborn; Italy; Pregnancy Outcome; Belgium; Delivery, Obstetric; Birthing Centers
PubMed: 38724257
DOI: 10.1080/14767058.2024.2350676 -
Pregnancy Hypertension Jun 2024Most guidelines recommend induction of labor after 37 weeks of gestation in preeclampsia. This study assessed the effect of interval between diagnosis of preeclampsia... (Comparative Study)
Comparative Study
OBJECTIVES
Most guidelines recommend induction of labor after 37 weeks of gestation in preeclampsia. This study assessed the effect of interval between diagnosis of preeclampsia and delivery on maternal and perinatal outcomes.
STUDY DESIGN
A cohort of 1637 women with preeclampsia recruited at five university hospitals in Finland was studied. Outcomes were compared in two groups according to the time interval between diagnosis of PE and delivery: delivery in less than 10 days (the early delivery group) and delivery at 10 days or later after the diagnosis (the delayed delivery group).
MAIN OUTCOME MEASURES
Maternal outcomes included significantly preterm delivery (delivery before 34 weeks of gestation), placental abruption, eclampsia and maternal intensive care or intensive monitoring for more than 24 h. Neonatal outcomes included small for gestational age, Apgar score of less than seven at the age of five minutes, umbilical artery pH < 7.05 and fetal death.
RESULTS
No differences in frequency of preterm deliveries or maternal need for intensive care were observed between groups. Eclampsia and fetal death were rare, and their incidence did not differ between the groups. No maternal deaths were observed. Low Apgar score at five minutes of age was reported more commonly in the early delivery group, but there was no difference in fetal acidemia between groups.
CONCLUSION
Early and delayed delivery lead to comparable outcomes in this cohort. Expectant management could be beneficial in women with an unripe cervix or preterm preeclampsia without severe features.
Topics: Humans; Female; Pregnancy; Pre-Eclampsia; Finland; Adult; Time Factors; Infant, Newborn; Premature Birth; Pregnancy Outcome; Delivery, Obstetric; Cohort Studies; Gestational Age
PubMed: 38723338
DOI: 10.1016/j.preghy.2024.101129 -
Cureus Apr 2024Background An association between renal impairment and hypertensive complications occurring during pregnancy has been shown in a limited number of studies. As a...
Background An association between renal impairment and hypertensive complications occurring during pregnancy has been shown in a limited number of studies. As a consequence of a lack of clear criteria for diagnostic certainty, acute renal failure during pregnancy is a challenging pathology to diagnose, mainly due to the physiological reduction of nitrogen retention parameters. In light of the fact that renal injury is associated with a poor maternal and fetal prognosis, this study aims to determine the maternal demographic features and the cut-off of serum creatinine that can lead to a heightened risk of prematurity, stillbirth, intrauterine growth restriction, or the necessity of neonatal intensive care. Methods We performed a study that included a cohort of 45 pregnant women with acute renal injury who delivered in the Department of Obstetrics and Gynecology of the University Emergency Hospital in Bucharest between January 1, 2017, and December 31, 2022, a cohort of 45 pregnant women with a value of serum creatinine between 0.8 and 1 mg/dL, and a cohort of 45 pregnant women, selected at random, with a value of serum creatinine under 0.8 mg/dL, who delivered in the same period in the aforementioned unit. The analysis included neonatal outcomes (preterm birth, intrauterine growth restriction, stillbirth, Apgar score calculated at one minute, the need for neonatal intensive care), maternal demographic features, medical and obstetrical history, and paraclinical parameters. Results The incidence of acute renal injury was 0.33% for the entire cohort of patients who gave birth in our hospital. Out of that lot, 65.21% of the cases of acute renal impairment associated with pregnancy were caused by hypertensive complications. The mean age of patients with acute kidney injury (AKI) was 29.4 ± 6.66, preponderantly primiparous. The majority of the neonates from patients with AKI (62.22%) were born with a birth weight under 2.500 grams. Preterm deliveries were preponderant (66.66%) in patients with AKI, while in the control group, the incidence of preterm deliveries was 48.88%. Stillbirth in the AKI group had an incidence of 13.33%, while in the control group, there were none. Due to these neonatal complications, most of the newborns in the AKI group needed neonatal intensive care. An important percentage of the patients who developed AKI (40%) did not benefit from proper medical care during pregnancy or before admission to our unit. The cutoff of 1.09 mg/dL of serum creatinine level was established following receiver operating characteristic curve analysis. Conclusion AKI during pregnancy is associated with hypertensive disorders, low birth weight, and preterm deliveries.
PubMed: 38721198
DOI: 10.7759/cureus.57849 -
PloS One 2024Neonatal Sepsis remains a significant burden globally, accounting for over 2.5 million neonatal deaths annually, with low-and middle-income countries (LMIC) including...
BACKGROUND
Neonatal Sepsis remains a significant burden globally, accounting for over 2.5 million neonatal deaths annually, with low-and middle-income countries (LMIC) including Ghana disproportionately affected. The current study sought to ascertain the prevalence of neonatal sepsis and associated factors based on analysis of institutional records from Cape Coast Teaching Hospital (CCTH) in Ghana.
METHODS
The study involved a retrospective cross-sectional review of randomly sampled medical records of 360 neonates CCTH from January 2018 to December 2021. Descriptive proportions and binary logistic regression analysis were conducted to estimate the prevalence of neonates with sepsis and associated factors.
RESULTS
The prevalence of neonates with sepsis over the period was estimated to be 59%, with early-onset neonatal sepsis (EONS) and late-onset neonatal sepsis (LONS) accounting for about 29% and 30%, respectively. Neonatal factors associated with sepsis were low Apgar score (AOR = 1.64; 95% CI:1.01-2.67, p = 0.047) and low birth weight (AOR = 2.54; 95% CI:1.06-6.09, p = 0.037), while maternal factors were maternal education (AOR = 2.65; 95% CI:1.04-6.7, p = 0.040), caesarean deliveries (AOR = 0.45; 95% CI:0.26-0.75, p = 0.003), maternal infection (AOR = 1.79; 95% CI:1.09-2.94, p = 0.020) and foul-smelling liquor (AOR = 1.84; 95% CI:1.09-3.07, p = 0.020).
CONCLUSION
The study underscores the need for improved routine care and assessment of newborns to prevent the onset of neonatal sepsis, with particular emphasis on the neonatal and maternal risk factors highlighted in the current study.
Topics: Humans; Ghana; Neonatal Sepsis; Infant, Newborn; Female; Male; Tertiary Care Centers; Cross-Sectional Studies; Retrospective Studies; Adult; Risk Factors; Prevalence; Pregnancy; Infant, Low Birth Weight; Apgar Score
PubMed: 38718061
DOI: 10.1371/journal.pone.0302533 -
Ginekologia Polska May 2024External cephalic version (ECV) is an alternative to caesarean section for abnormal fetal position. ECV is recommended by the most important scientific committees in the...
OBJECTIVES
External cephalic version (ECV) is an alternative to caesarean section for abnormal fetal position. ECV is recommended by the most important scientific committees in the world. ECV complications are rare and occur in 6.1% of cases, however severe complications requiring urgent caesarean section are found in less than 0.4%. Our aim was to demonstrate the effectiveness and safety of ECV and to present our own experience with the procedure of ECV.
MATERIAL AND METHODS
ECV was performed on 62 patients (32 nulliparas and 30 multiparas). Qualification criteria included: singleton gestation, gestational age > 36 + 6, longitudinal pelvic lie, no uterine contractions, intact membranes. Indications for immediate cesarean section within 24 hours of ECV were considered a procedural complication. In patients with complications, the condition of the newborn was checked according to the APGAR score and the day of discharge of the mother and child from the maternity ward was analyzed.
RESULTS
ECV finished successfully in 66.1% (nulliparas 56.2% and multiparas 76.7%). Patients with a successful ECV were significantly older and had higher median gestational age. ECV was more often successful when placenta was located on the posteriori wall. In our patients, there were 4 cases of complications requiring delivery at the time of ECV. No serious consequences associated with increased maternal or neonatal morbidity or mortality were reported.
CONCLUSIONS
ECV seems to be a safe alternative for women wishing to deliver vaginally, as this procedure does not increase the risk of adverse obstetric outcomes.
PubMed: 38717219
DOI: 10.5603/gpl.99736 -
BioMed Research International 2024Although neonatal sepsis is a major public health problem contributing to 30-50% of neonatal deaths in low- and middle-income countries, data on predictors of time to...
BACKGROUND
Although neonatal sepsis is a major public health problem contributing to 30-50% of neonatal deaths in low- and middle-income countries, data on predictors of time to death are limited in Eastern Ethiopia. This study is aimed at determining predictors of time to death among neonates with sepsis admitted in public hospitals in Eastern Ethiopia.
METHODS
An institutional-based retrospective cohort study was conducted among 415 neonates admitted to referral hospitals in Eastern Ethiopia with sepsis from January 1, 2021, to December 31, 2021. Data were collected from medical records by using structured checklist and entered using EpiData 3.1 and analyzed using Stata 17. The Kaplan-Meier curves and log-rank tests were used to describe survival experience among different categories. The proportional hazard assumption and goodness of fit for the Cox regression model were checked. The Cox regression model was used to identify the significant predictors. Hazard ratios (HRs) with 95% confidence intervals (CI) were calculated. Finally, statistical significance was set at a value < 0.05 in the Cox regression analysis.
RESULTS
Of the 415 neonates with neonatal sepsis, 71 (17.1%) (95% CI: 13.60-21.08) died at discharge, with a median time to death of 14 days. The overall incidence rate of mortality was 36.5 per 1000 neonate days. Low birthweight (AHR = 2.50; 95% CI: 1.15-5.44), maternal age ≥ 35 years (AHR = 3.17; 95% CI: 1.11, 9.04), low fifth-minute Apgar score (AHR: 2.32; 95% CI: 1.30-4.14), and late initiation of breastfeeding (AHR = 4.82; 95% CI: 1.40-16.65) were independent predictors of mortality among neonates with sepsis.
CONCLUSIONS
Almost one in five neonates with sepsis died at discharge. Low birthweight, maternal age ≥ 35 years, low fifth-minute Apgar score, and late initiation of breastfeeding were predictors of mortality.
Topics: Humans; Ethiopia; Infant, Newborn; Female; Male; Retrospective Studies; Neonatal Sepsis; Sepsis; Hospitalization; Proportional Hazards Models; Infant; Risk Factors; Kaplan-Meier Estimate; Infant Mortality; Infant, Low Birth Weight
PubMed: 38715713
DOI: 10.1155/2024/2594271 -
Journal of Psychosomatic Obstetrics and... Dec 2024To assess the impact of low-dose aspirin (LDA) on obstetrical outcomes through a meta-analysis of placebo-controlled randomized controlled trials (RCTs). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the impact of low-dose aspirin (LDA) on obstetrical outcomes through a meta-analysis of placebo-controlled randomized controlled trials (RCTs).
METHODS
A systematic search of the PubMed, Cochrane Library, Web of Science and Embase databases from inception to January 2024 was conducted to identify studies exploring the role of aspirin on pregnancy, reporting obstetrical-related outcomes, including preterm birth (PTB, gestational age <37 weeks), small for gestational age (SGA), low birth weight (LBW, birthweight < 2500g), perinatal death (PND), admission to the neonatal intensive care unit (NICU), 5-min Apgar score < 7 and placental abruption. Relative risks (RRs) were estimated for the combined outcomes. Subgroup analyses were performed by risk for preeclampsia (PE), LDA dosage (<100 mg vs. ≥100 mg) and timing of onset (≤20 weeks vs. >20 weeks).
RESULTS
Forty-seven studies involving 59,124 participants were included. Compared with placebo, LDA had a more significant effect on low-risk events such as SGA, PTB and LBW. Specifically, LDA significantly reduced the risk of SGA (RR = 0.91, 95% CI: 0.87-0.95), PTB (RR = 0.93, 95% CI: 0.89-0.97) and LBW (RR = 0.94, 95% CI: 0.89-0.99). For high-risk events, LDA significantly lowered the risk of NICU admission (RR = 0.93, 95% CI: 0.87-0.99). On the other hand, LDA can significantly increase the risk of placental abruption (RR = 1.72, 95% CI: 1.23-2.43). Subgroup analyses showed that LDA significantly reduced the risk of SGA (RR = 0.86, 95% CI: 0.77-0.97), PTB (RR = 0.93, 95% CI: 0.88-0.98) and PND (RR = 0.65, 95% CI: 0.48-0.88) in pregnant women at high risk of PE, whereas in healthy pregnant women LDA did not significantly improve obstetrical outcomes, but instead significantly increased the risk of placental abruption (RR = 5.56, 95% CI: 1.92-16.11). In pregnant women at high risk of PE, LDA administered at doses ≥100 mg significantly reduced the risk of SGA (RR = 0.77, 95% CI: 0.66-0.91) and PTB (RR = 0.56, 95% CI: 0.32-0.97), but did not have a statistically significant effect on reducing the risk of NICU, PND and LBW. LDA started at ≤20 weeks significantly reduced the risk of SGA (RR = 0.76, 95% CI: 0.65-0.89) and PTB (RR = 0.56, 95% CI: 0.32-0.97).
CONCLUSIONS
To sum up, LDA significantly improved neonatal outcomes in pregnant women at high risk of PE without elevating the risk of placental abruption. These findings support LDA's clinical application in pregnant women, although further research is needed to refine dosage and timing recommendations.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Abruptio Placentae; Aspirin; Infant, Low Birth Weight; Infant, Small for Gestational Age; Pre-Eclampsia; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 38712869
DOI: 10.1080/0167482X.2024.2344079 -
JAMA Network Open May 2024Although whole-body hypothermia is widely used after mild neonatal hypoxic-ischemic encephalopathy (HIE), safety and efficacy have not been evaluated in randomized... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Although whole-body hypothermia is widely used after mild neonatal hypoxic-ischemic encephalopathy (HIE), safety and efficacy have not been evaluated in randomized clinical trials (RCTs), to our knowledge.
OBJECTIVE
To examine the effect of 48 and 72 hours of whole-body hypothermia after mild HIE on cerebral magnetic resonance (MR) biomarkers.
DESIGN, SETTING, AND PARTICIPANTS
This open-label, 3-arm RCT was conducted between October 31, 2019, and April 28, 2023, with masked outcome analysis. Participants were neonates at 6 tertiary neonatal intensive care units in the UK and Italy born at or after 36 weeks' gestation with severe birth acidosis, requiring continued resuscitation, or with an Apgar score less than 6 at 10 minutes after birth and with evidence of mild HIE on modified Sarnat staging. Statistical analysis was per intention to treat.
INTERVENTIONS
Random allocation to 1 of 3 groups (1:1:1) based on age: neonates younger than 6 hours were randomized to normothermia or 72-hour hypothermia (33.5 °C), and those 6 hours or older and already receiving whole-body hypothermia were randomized to rewarming after 48 or 72 hours of hypothermia.
MAIN OUTCOMES AND MEASURES
Thalamic N-acetyl aspartate (NAA) concentration (mmol/kg wet weight), assessed by cerebral MR imaging and thalamic spectroscopy between 4 and 7 days after birth using harmonized sequences.
RESULTS
Of 225 eligible neonates, 101 were recruited (54 males [53.5%]); 48 (47.5%) were younger than 6 hours and 53 (52.5%) were 6 hours or older at randomization. Mean (SD) gestational age and birth weight were 39.5 (1.1) weeks and 3378 (380) grams in the normothermia group (n = 34), 38.7 (0.5) weeks and 3017 (338) grams in the 48-hour hypothermia group (n = 31), and 39.0 (1.1) weeks and 3293 (252) grams in the 72-hour hypothermia group (n = 36). More neonates in the 48-hour (14 of 31 [45.2%]) and 72-hour (13 of 36 [36.1%]) groups required intubation at birth than in the normothermic group (3 of 34 [8.8%]). Ninety-nine neonates (98.0%) had MR imaging data and 87 (86.1%), NAA data. Injury scores on conventional MR biomarkers were similar across groups. The mean (SD) NAA level in the normothermia group was 10.98 (0.92) mmol/kg wet weight vs 8.36 (1.23) mmol/kg wet weight (mean difference [MD], -2.62 [95% CI, -3.34 to -1.89] mmol/kg wet weight) in the 48-hour and 9.02 (1.79) mmol/kg wet weight (MD, -1.96 [95% CI, -2.66 to -1.26] mmol/kg wet weight) in the 72-hour hypothermia group. Seizures occurred beyond 6 hours after birth in 4 neonates: 1 (2.9%) in the normothermia group, 1 (3.2%) in the 48-hour hypothermia group, and 2 (5.6%) in the 72-hour hypothermia group.
CONCLUSIONS AND RELEVANCE
In this pilot RCT, whole-body hypothermia did not improve cerebral MR biomarkers after mild HIE, although neonates in the hypothermia groups were sicker at baseline. Safety and efficacy of whole-body hypothermia should be evaluated in RCTs.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03409770.
Topics: Humans; Hypothermia, Induced; Infant, Newborn; Hypoxia-Ischemia, Brain; Female; Pilot Projects; Male; Magnetic Resonance Imaging; Italy; United Kingdom; Treatment Outcome
PubMed: 38709535
DOI: 10.1001/jamanetworkopen.2024.9119