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The Journal of Maternal-fetal &... Dec 2022Second and early third-trimester uterine rupture in a non-laboring woman is a very rare and life-threatening condition for both mothers and newborns. However, there are...
OBJECTIVE
Second and early third-trimester uterine rupture in a non-laboring woman is a very rare and life-threatening condition for both mothers and newborns. However, there are scant epidemiologic data on this event.
STUDY DESIGN
Literature searches using Medical Subject Headings (MeSH) and non-MeSH terms were conducted in the PubMed/MEDLINE, Google Scholar and Embase databases from 1988 to 2020. Abstracts were reviewed and selected if they reported on uterine rupture in the second and third trimester. Uterine rupture was characterized as a full-thickness uterine wall defect. A total of 80 singleton intrauterine pregnancies between gestational ages of 14 and 34 weeks' gestation were included.
RESULTS
The mean gestational age at diagnosis of uterine rupture was 22.4 ± 5.4 weeks. The associated events in obstetric history for uterine rupture were: ≥1 previous cesarean section (45%; 36/80 of the cases), previous uterine rupture (10%; 8/80), previous classical uterine incision (7.5%; 6/80), myomectomy (25%; 20/80) and congenital uterine malformations (16.3%; 13/80 of the cases). Uterine ruptures were associated with a short IP interval in 13.7% (11/80) and 43.7% (35/80) were associated with abnormal placentation: placenta accreta spectrum (PAS) disorders ( = 26), placenta previa ( = 2) and placenta previa and PAS ( = 7). The rate of related prenatal ultrasound findings was 67.5%. Cesarean hysterectomy was performed in 27% of the cases. Maternal death was reported in 2.5% (2/80). For the neonates delivered ≥24 weeks' gestation ( = 27) peripartum fetal death was reported in 33.3% (9/27).
CONCLUSIONS
Midgestational pre-labor spontaneous uterine rupture is not an anecdotal event and may follow the worldwide increasing rate of cesarean sections. Health care providers should be familiar with the associated factors, presenting symptoms and complications of this obstetric emergency.
Topics: Infant, Newborn; Pregnancy; Humans; Female; Infant; Uterine Rupture; Cesarean Section; Placenta Previa; Placenta Accreta; Pregnancy Trimester, Third; Rupture, Spontaneous
PubMed: 33691570
DOI: 10.1080/14767058.2021.1875435 -
Frontiers in Global Women's Health 2023The World Health Organization (WHO) recommends treatment and management of gestational diabetes (GD) through lifestyle changes, including diet and exercise, and... (Review)
Review
INTRODUCTION
The World Health Organization (WHO) recommends treatment and management of gestational diabetes (GD) through lifestyle changes, including diet and exercise, and self-monitoring blood glucose (SMBG) to inform timely treatment decisions. To expand the evidence base of WHO's guideline on self-care interventions, we conducted a systematic review of SMBG among pregnant individuals with GD.
SETTING
Following PRISMA guidelines, we searched PubMed, CINAHL, LILACS, and EMBASE for publications through November 2020 comparing SMBG with clinic-based monitoring during antenatal care (ANC) globally.
PRIMARY AND SECONDARY OUTCOME MEASURES
We extracted data using standardized forms and summarized maternal and newborn findings using random effects meta-analysis in GRADE evidence tables. We also reviewed studies on values, preferences, and costs of SMBG.
RESULTS
We identified 6 studies examining SMBG compared to routine ANC care, 5 studies on values and preferences, and 1 study on costs. Nearly all were conducted in Europe and North America. Moderate-certainty evidence from 3 randomized controlled trials (RCTs) showed that SMBG as part of a package of interventions for GD treatment was associated with lower rates of preeclampsia, lower mean birthweight, fewer infants born large for gestational age, fewer infants with macrosomia, and lower rates of shoulder dystocia. There was no difference between groups in self-efficacy, preterm birth, C-section, mental health, stillbirth, or respiratory distress. No studies measured placenta previa, long-term complications, device-related issues, or social harms. Most end-users supported SMBG, motivated by health benefits, convenience, ease of use, and increased confidence. Health workers acknowledged SMBG's convenience but were wary of technical problems. One study found SMBG by pregnant individuals with insulin-dependent diabetes was associated with decreased costs for hospital admission and length of stay.
CONCLUSION
SMBG during pregnancy is feasible and acceptable, and when combined in a package of GD interventions, is generally associated with improved maternal and neonatal health outcomes. However, research from resource-limited settings is needed.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42021233862.
PubMed: 37293246
DOI: 10.3389/fgwh.2023.1006041 -
Journal of Gynecology Obstetrics and... Apr 2021To examine the impact of adolescent pregnancy on maternal and infant health on the basis of studies conducted in Turkey. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To examine the impact of adolescent pregnancy on maternal and infant health on the basis of studies conducted in Turkey.
MATERIAL AND METHODS
Systematic reviews and meta-analyses of cross-sectional and case-control. A systematic scan was performed in January 2020 based on the keywords "adolescent pregnancy or teenage pregnancy and Turkey" in the electronic databases PubMed, Clinical Key, Science Direct, Web of Science, Google Scholar, National Thesis Center, DergiPark, Ulakbim, Turkish Medline and Turkish Clinics. Two of the authors carried out a scan independently of each other, making a selection of articles, performing data extraction and quality assessment procedures under the supervision of the senior researcher.
RESULTS
The results of a total of 38 studies, of which twenty-three were cross-sectional and 15 were case-control, were compiled for the meta-analysis (adolescents: 20,768; control: 59,481). The results of the meta-analysis showed that the more common effects of adolescent pregnancies were preterm birth (OR: 2.12, p < 0.001), early membrane rupture (OR: 1.49, p < 0.001), anemia (OR: 2.60, p < 0.001), low birthweight/intrauterine growth retardation (OR: 2.06, p < 0.001), and fetal distress (OR: 1.78, p = 0.003). On the other hand, it was observed in the meta-analysis that childbirth by cesarean section (OR: 0.70, p < 0.001), gestational diabetes (OR: 0.35, p < 0.001), placenta previa (OR: 0.52, p = 0.01), polyhydramnios (OR: 0.52, p = 0.04) and macrosomia (OR: 0.54, p < 0.001) were less common among adolescents compared to adults.
CONCLUSION
Our review revealed that adolescent pregnancy had an adverse impact on maternal and infant health in terms of preterm childbirth, early membrane rupture, anemia, low birthweight/intrauterine growth retardation, low Apgar scores and fetal distress.
Topics: Adolescent; Anemia; Case-Control Studies; Cesarean Section; Cross-Sectional Studies; Diabetes, Gestational; Female; Fetal Distress; Fetal Growth Retardation; Fetal Macrosomia; Fetal Membranes, Premature Rupture; Humans; Infant Health; Infant, Low Birth Weight; Maternal Health; Polyhydramnios; Pregnancy; Pregnancy in Adolescence; Premature Birth; Turkey
PubMed: 33592347
DOI: 10.1016/j.jogoh.2021.102093 -
The Australian & New Zealand Journal of... Oct 2019Morbidly adherent placenta is potentially life-threatening, often requiring technically difficult surgery and large blood loss. Use of intravascular balloon occlusion...
BACKGROUND
Morbidly adherent placenta is potentially life-threatening, often requiring technically difficult surgery and large blood loss. Use of intravascular balloon occlusion with or without hysterectomy to reduce blood loss is increasing despite associated morbidity and lack of evidence of efficacy.
AIMS
To evaluate if prophylactic use of vascular balloon occlusion at the time of planned caesarean hysterectomy for antenatally diagnosed morbidly adherent placenta reduces blood loss and transfusion requirements, and determine rate of associated complications.
MATERIALS AND METHODS
A systematic review of PubMed and Medline covering January 1997 to December 2018 was conducted. Key words included placenta accreta, increta, percreta, and morbidly adherent placenta, balloon, interventional radiology, embolization, and caesarean hysterectomy.
RESULTS
Nineteen studies were included. Only three studies had appropriate controls: two with balloon placement in the internal iliac arteries and one in the common iliac arteries. One showed no difference in blood loss or transfusion requirements, the second showed a reduction in cases of percreta only and the third reported reduction in blood loss. Only few studies reported objective measures of blood loss. Blood loss and transfusion were still high (2.26 L and 3.79 units, respectively) despite use of vascular balloons. Balloon catheter use was associated with a 7.5% rate of complications; 4.5% were minor and 3.0% major.
CONCLUSIONS
There is a large body of poor data evaluating efficacy of prophylactic vascular balloon occlusion in cases of planned caesarean hysterectomy for known morbidly adherent placenta. Limited relevant data provide only scant evidence that these techniques are beneficial in reducing blood loss, despite associated significant complications.
Topics: Adult; Balloon Occlusion; Cesarean Section; Female; Humans; Hysterectomy; Placenta Accreta; Postpartum Hemorrhage; Pregnancy; Prenatal Care
PubMed: 31281966
DOI: 10.1111/ajo.13027 -
American Journal of Obstetrics &... Feb 2023Velamentous cord insertion may be identified prenatally, but the clinical implications of this diagnosis remain controversial. This meta-analysis aimed to quantitatively... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Velamentous cord insertion may be identified prenatally, but the clinical implications of this diagnosis remain controversial. This meta-analysis aimed to quantitatively summarize current data on the association of velamentous cord insertion and adverse perinatal outcomes.
DATA SOURCES
A systematic search was performed in MEDLINE, Scopus, and the Cochrane Library from inception until May 22, 2022 to identify eligible studies.
STUDY ELIGIBILITY CRITERIA
Observational studies including singleton pregnancies with velamentous cord insertion, either prenatally or postnatally identified, and comparing them with those with central/eccentric cord insertion were considered eligible.
METHODS
The quality of the studies was assessed with the Newcastle-Ottawa scale and the risk of bias with the Quality In Prognosis Studies (QUIPS) tool. The main outcome was small-for-gestational-age neonates. Heterogeneity of the studies was evaluated using a Q test and an I index. Analyses were performed using a random-effects model, with outcome data reported as relative risk or mean difference with 95% confidence interval.
RESULTS
In total, 9 cohort and 2 case-control studies, of which 4 had prenatal and 7 had postnatal velamentous cord insertion diagnosis, were included. The overall prevalence of velamentous cord insertion was estimated to be 1.4% among singleton pregnancies. Compared with the central/eccentric cord insertion control group, pregnancies with velamentous cord insertion were at higher risk of several adverse perinatal outcomes, namely small-for-gestational-age neonates (relative risk, 1.93; 95% confidence interval, 1.54-2.41), preeclampsia (relative risk, 1.85; 95% confidence interval, 1.01-3.39), pregnancy-induced hypertension (relative risk, 1.58; 95% confidence interval, 1.46-1.70), stillbirth (relative risk, 4.12; 95% confidence interval, 1.92-8.87), placental abruption (relative risk, 2.94; 95% confidence interval, 1.72-5.03), preterm delivery (relative risk, 2.14; 95% confidence interval, 1.73-2.65), emergency cesarean delivery (relative risk, 2.03; 95% confidence interval, 1.22-3.38), 1-minute Apgar score <7 (relative risk, 1.53; 95% confidence interval, 1.14-2.05), 5-minute Apgar score <7 (relative risk, 1.97; 95% confidence interval, 1.43-2.71), and neonatal intensive care unit admission (relative risk, 1.63; 95% confidence interval, 1.32-2.02). In a subgroup analysis, prenatally diagnosed velamentous cord insertion was associated with small-for-gestational-age neonates (relative risk, 1.66; 95% confidence interval, 1.19-2.32), stillbirth (relative risk, 4.78; 95% confidence interval, 1.42-16.08), and preterm delivery (relative risk, 2.69; 95% confidence interval, 2.01-3.60). In a sensitivity analysis of studies excluding cases with vasa previa, velamentous cord insertion was associated with an increased risk of small-for-gestational-age neonates (relative risk, 2.69; 95% confidence interval, 1.73-4.17), pregnancy-induced hypertension (relative risk, 1.94; 95% confidence interval, 1.24-3.01), and stillbirth (relative risk, 9.42; 95% confidence interval, 3.19-27.76), but not preterm delivery (relative risk, 1.92; 95% confidence interval, 0.82-4.54).
CONCLUSION
Velamentous cord insertion is associated with several adverse perinatal outcomes, including stillbirth, and these associations persist when only prenatally diagnosed cases are considered and when vasa previa cases are excluded. According to these findings, the exact pathophysiology should be further investigated and an effective prenatal monitoring plan should be developed.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Vasa Previa; Pregnancy Outcome; Stillbirth; Hypertension, Pregnancy-Induced; Placenta; Premature Birth; Fetal Growth Retardation
PubMed: 36379439
DOI: 10.1016/j.ajogmf.2022.100812 -
Obstetrics and Gynecology Jan 2022To assess the risk for obstetric complications in women with congenital uterine anomalies and the risk in each main class of uterine anomaly (U2 [septate], U3... (Meta-Analysis)
Meta-Analysis
Obstetric Complications in Women With Congenital Uterine Anomalies According to the 2013 European Society of Human Reproduction and Embryology and the European Society for Gynaecological Endoscopy Classification: A Systematic Review and Meta-analysis.
OBJECTIVE
To assess the risk for obstetric complications in women with congenital uterine anomalies and the risk in each main class of uterine anomaly (U2 [septate], U3 [bicorporeal], U4 [hemi-uterus]), based on the 2013 classification by the ESHRE (European Society of Human Reproduction and Embryology) and the ESGE (European Society for Gynaecological Endoscopy).
DATA SOURCES
MEDLINE, Scopus, and ClinicalTrials.gov were searched from inception until January 2021. The reference list of all included articles and previous systematic reviews were also screened to identify potential additional articles.
METHODS OF STUDY SELECTION
Comparative and noncomparative studies that investigated the obstetric outcomes of women with any type of known congenital uterine anomaly were considered eligible for inclusion. Screening and eligibility assessment was performed independently by two reviewers.
TABULATION, INTEGRATION, AND RESULTS
Forty-seven studies were included. The quality of included comparative studies was assessed using the Newcastle-Ottawa Quality Assessment Scale. Odds ratios (ORs), pooled proportions of each obstetric outcome, and 95% CIs were calculated in RevMan and Stata accordingly, using random effects models. Congenital uterine anomalies were associated with increased risk of preterm birth (OR 3.89, 95% CI 3.11-4.88); cervical insufficiency (OR 15.13, 95% CI 11.74-19.50); prelabor rupture of membranes (OR 2.48, 95% CI 1.38-4.48); fetal malpresentation (OR 11.11, 95% CI 5.74-21.49); fetal growth restriction (OR 3.75, 95% CI 1.88-7.46); placental abruption (OR 5.21, 95% CI 3.34-8.13); placenta previa (OR 4.00, 95% CI 1.87-8.56); placental retention (OR 1.71, 95% CI 1.16-2.52); and cesarean birth (OR 4.52, 95% CI 2.19-9.31); when compared with those without anomalies. Pooled estimated risks were 25% for preterm birth, 40% for fetal malpresentation, 64% for cesarean birth, 12% for prelabor rupture of membranes, 15% for fetal growth restriction, 4% for placental abruption, 5% for preeclampsia, 13% for cervical insufficiency, and 2% for placenta previa. Classes U2 (septate), U3 (bicorporeal), and U4 (hemi-uterus) were also associated independently with preterm birth, fetal malpresentation, cesarean birth, and placental abruption.
CONCLUSION
Congenital uterine anomalies are associated with obstetric complications across all examined ESHRE and ESGE classifications.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42021244487.
Topics: Delivery, Obstetric; Europe; Female; Gynecology; Humans; Obstetrics; Pregnancy; Pregnancy Complications; Societies, Medical; Urogenital Abnormalities; Uterus
PubMed: 34856567
DOI: 10.1097/AOG.0000000000004627 -
European Journal of Obstetrics,... Sep 2019Low-positioned placentas which are located in the lower uterine segment (LUS), either a low-lying placenta or a placenta previa, are associated with increased obstetric... (Meta-Analysis)
Meta-Analysis
Low-positioned placentas which are located in the lower uterine segment (LUS), either a low-lying placenta or a placenta previa, are associated with increased obstetric risks. However, most second trimester low-positioned placentas resolve during pregnancy and have a higher position in the third trimester, without posing any risks. We performed a systematic review and meta-analysis to evaluate the proportion of second trimester low-positioned placentas that have a position towards the fundus in the third trimester. Our aim was to find a cut-off value that included all women in whom the placenta will remain low in the third trimester, thus who are at increased risk of obstetric complications. Subsequently, we assessed whether an anterior or posterior placental location influenced this proportion. We searched MEDLINE and EMBASE and clinicaltrials.gov up to April 2019 for studies on the sonographic follow-up of second trimester low-positioned placentas, with a distance between the placenta and the internal os of the cervix of 20 mm or less at a gestational age of above 15 week and a follow up after 28 weeks. Studies were scored on methodological quality using the Newcastle-Ottowa Scale (NOS). A meta-analysis was conducted to summarize the proportion of second trimester low-positioned placentas with a position towards the fundus in the third trimester. We calculated the proportion at different cut-off values of the distance from the placental edge to the internal os of the cervix (0 mm, 10 mm and 20 mm). Also, anteriorly and posteriorly located placentas and women with and without a prior cesarean delivery were compared. We included 11 eligible studies which reported on 3586 women with a low-positioned placenta in the second trimester. Proportions of placentas with a position towards the fundus in the third trimester ranged between 0.63 and 1.0. Pooled proportions were 0.90 (95% CI 0.87-0.93) for IOD <10 mm and 0.80 (95% CI 0.74-0.85) for IOD < 0 mm. Due to heterogeneity between studies, the subgroup of <20 mm could not be pooled. Overall, anteriorly located placentas more often had a position towards the fundus in the third trimester, but studies did report conflicting results. Prior cesarean section had no influence except for an IOD of <0 mm, in which women without a prior cesarean delivery more often had a placenta towards the fundus. The majority of second trimester low-positioned placentas will be located towards the fundus at the time of follow-up. However, we could not determine a cut-off value for anterior and posterior placentas that included all women at high risk. The cut-off value, placental side and prior cesarean section should be assessed in a large prospective observational study.
Topics: Female; Humans; Placenta; Placenta Previa; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Second; Ultrasonography, Prenatal
PubMed: 31323500
DOI: 10.1016/j.ejogrb.2019.06.020 -
Journal of Gynecology Obstetrics and... Apr 2022To compare and evaluate the validity of the existing risk prediction models for severe postpartum hemorrhage (SPPH) in patients with placenta previa.
Systematic external evaluation of four preoperative risk prediction models for severe postpartum hemorrhage in patients with placenta previa: A multicenter retrospective study.
AIM
To compare and evaluate the validity of the existing risk prediction models for severe postpartum hemorrhage (SPPH) in patients with placenta previa.
METHODS
We conducted a systematic literature review to collect the existing risk prediction models for SPPH in patients with placenta previa, and recruited patients with placenta previa who underwent cesarean section in Tongji Hospital (Wuhan, China) and 4 cooperative hospitals from January 2018 to June 2021. We defined SPPH as total blood loss ≥1500 mL or transfusion packed red blood cell ≥4 U. The risk of SPPH of each patient was predicted by the collected models, respectively. Then we calculated the sensitivity, specificity, coincidence rate (CCR), positive predictive value (PPV), negative predictive value (NPV) and drawn the receiver operating characteristic (ROC) curve and decision curve analysis (DCA) curve of each model.
RESULTS
This external cohort contained 1172 patients of whom 284 patients (24.23%) experienced SPPH, and 4 risk prediction models were collected in this study. After evaluated by this external cohort, the area under the ROC curve (AUC), sensitivity, specificity, CCR, PPV and NPV of the four models ranged from 0.644 to 0.755, 38.38% to 86.31%, 42.75% to 86.49%, 56.23% to 74.83%, 38.68% to 47.60%, 81.15% to 87.45%, respectively. The model established by Kim JW et al. had the highest sensitivity, NPV, AUC and net benefit, the model established by Lee JY et al. had the highest specificity, CCR and PPV.
CONCLUSIONS
The four prediction models showed moderate predictive performance, the discrimination indicators and benefit indicators of each model were not simultaneously ideal in this population. The prediction models should be further optimized to improve the discrimination ability and benefit, and prospective external validation studies should also be carried out before they are applied to clinical practice.
Topics: Cesarean Section; Female; Humans; Multicenter Studies as Topic; Placenta Previa; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Retrospective Studies
PubMed: 35151929
DOI: 10.1016/j.jogoh.2022.102333 -
International Journal of Reproductive... Nov 2023Pregnancy with assisted reproductive technology (ART) is accompanied by fetal and maternal outcomes. This systematic review aimed to assess the relationship between... (Review)
Review
Pregnancy with assisted reproductive technology (ART) is accompanied by fetal and maternal outcomes. This systematic review aimed to assess the relationship between ART and maternal outcomes. In this systematic review, the electronic databases, including PubMed, MEDLINE, Web of Science, Scopus, Science Direct, Cochrane Library, Google Scholar, Magiran, Irandoc, and Scientific Information Database were searched for maternal outcomes reported from 2010-2021. The Newcastle-Ottawa Scale for cohort studies was used to assess the methodological quality of studies. A total of 3362 studies were identified by searching the databases. After screening abstracts and full-text reviews, 19 studies assessing the singleton pregnancy-related complications of in vitro fertilization/intracytoplasmic sperm injection were included in the study. The results demonstrated that singleton pregnancies conceived through ART had higher risks of pregnancy-related complications and adverse maternal outcomes, such as vaginal bleeding, cesarean section, hypertension induced by pregnancy, pre-eclampsia, placenta previa, and premature membrane rupture than those conceived naturally. In conclusion, an increased risk of adverse obstetric outcomes was observed in singleton pregnancies conceived by ART. Therefore, obstetricians should consider these pregnancies as high-risk cases and should pay special attention to their pregnancy process.
PubMed: 38292514
DOI: 10.18502/ijrm.v21i11.14651 -
Archives of Gynecology and Obstetrics Nov 2019Pernicious placenta previa induces severe hemorrhage during cesarean section. Abdominal aorta balloon occlusion (AABO) is considered as an effective operation for... (Meta-Analysis)
Meta-Analysis
Prophylactic abdominal aortic balloon occlusion in patients with pernicious placenta previa during cesarean section: a systematic review and meta-analysis from randomized controlled trials.
PURPOSE
Pernicious placenta previa induces severe hemorrhage during cesarean section. Abdominal aorta balloon occlusion (AABO) is considered as an effective operation for patients with pernicious placenta previa. The aim of this study was to investigate the clinical application of abdominal aortic balloon occlusion in the placenta previa and cesarean section by systematic review and meta-analysis.
METHODS
MEDLINE, EMBASE, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), WAN-FANG DATA and CQVIP were searched from inception to Jan. 15th, 2019. Operative time, intraoperative blood loss volume, postoperative hospitalization duration, intraoperative blood transfusion volume, hysterectomy rate, lower extremity thrombosis rate, ICU admission rate, adverse reaction rate, neonatal birth weight, Apgar 1-min and 5-min scores were regarded as the endpoints. Randomized controlled trials (RCT) were used for meta-analysis.
RESULTS
Fourteen articles were retrieved from total 650 articles, and the results of meta-analysis showed that application of intraoperative AABO had the ability to reduce the operative time (WMD = - 16.581, 95% CI - 26.690 to - 6.472; P = 0.001), the intraoperative blood loss volume (WMD = - 1202.69, 95% CI - 1732.25 to - 673.12; P < 0.001), the intraoperative blood transfusion volume (WMD = - 1202.69, 95% CI - 1732.25 to - 673.12; P < 0.001). The hysterectomy rate (RR = 0.279, 95% CI 0.164-0.474; P < 0.001), postoperative hospitalization duration (WMD = - 1.423, 95% CI - 2.070 to - 0.776; P < 0.001) and the balloon preset time (WMD = - 13.793, 95% CI - 15.341 to - 12.244; P < 0.001; I = 0.0%) were also reduced in AABO group.
CONCLUSIONS
Application of AABO in patients with pernicious placenta previa is safe and effective, which is worthy of clinical promotion.
Topics: Aorta, Abdominal; Balloon Occlusion; Blood Loss, Surgical; Blood Transfusion; Cesarean Section; Female; Humans; Hysterectomy; Infant, Newborn; Operative Time; Placenta Previa; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 31535297
DOI: 10.1007/s00404-019-05297-4