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1.
Am J Perinatol ; 39(5): 539-545, 2022 04.
Article in English | MEDLINE | ID: mdl-33003227

ABSTRACT

OBJECTIVE: This study was aimed to evaluate the relationship between cesarean skin incision length and wound complications. STUDY DESIGN: Planned secondary analysis of a multicenter double-blind randomized trial of adjunctive azithromycin versus placebo (in addition to standard cefazolin) in women ≥24 weeks undergoing cesarean delivery during labor or ≥4 hours after membrane rupture. Skin incision length (cm) was measured just prior to skin closure. The primary outcome was a composite of wound complications (wound infection, separation, seroma, hematoma, or dehiscence) up to 6 weeks of postpartum. Individual components of the composite were examined as secondary outcomes. Outcomes were compared between groups defined by the lowest (≤25th), middle (25-75th) and highest (>75th) incision length quartiles. Logistic regression was used to adjust for potential confounding variables. RESULTS: Of the 2,013 women enrolled in the primary trial, 1,916 had recorded incision lengths and were included in this secondary analysis. The overall rate of composite wound complications was 7.8%. Median incision length was 15.0 cm (interquartile range: 14.0-16.5) with the lowest quartile defined as ≤14, middle as >14 to ≤16.5, and highest as >16.5 cm. Mean BMI, parity, use of staples, and duration of surgery differed significantly between the three incision length groups. In unadjusted analysis, the longest incision lengths were associated with an increased risk of the wound composite and wound infections (odds ratio [OR] = 2.27, 95% confidence interval [CI]: 1.43-3.60 and OR = 2.30, 95% CI: 1.27-4.15, respectively) compared with the shortest incision lengths. However, after multivariable adjustments, these associations were nullified. Additional analyses considering incision length as a continuous variable and using 10th/90th percentile cut-offs still did not suggest any associations with outcomes. CONCLUSION: Increasing skin incision length is not independently associated with an increased risk of postoperative wound complications. KEY POINTS: · After multivariable adjustments, skin incision length was not independently associated with an increased risk of postoperative wound complications.. · A reasonable incision length needed to safely perform the procedure should be used..


Subject(s)
Postoperative Complications , Surgical Wound Infection , Cesarean Section/adverse effects , Cesarean Section/methods , Female , Humans , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Pregnancy , Seroma/epidemiology , Seroma/etiology , Surgical Wound Dehiscence/epidemiology , Surgical Wound Dehiscence/etiology , Surgical Wound Infection/epidemiology , Surgical Wound Infection/etiology , Sutures/adverse effects
2.
Am J Perinatol ; 39(10): 1042-1047, 2022 07.
Article in English | MEDLINE | ID: mdl-35253125

ABSTRACT

OBJECTIVE: Despite legislation and hospital policies (present in some institutions) mandating a minimum length of stay in an effort to decrease the frequency of hospital readmissions, the effectiveness of this approach remains uncertain.We hypothesized that following cesarean delivery (CD), the rates of maternal readmission or unscheduled health care visits are lower in patients discharged on postoperative day (POD) 3 or ≥4 as compared with those discharged earlier on POD 2. METHODS: This is a secondary analysis of a multicenter randomized trial comparing adjunctive azithromycin for unscheduled CD to prevent infection. Groups were compared based on the duration of hospitalization measured in days from delivery (POD 0) to day of discharge and categorized as POD 2, 3, and ≥4. The primary outcome was the composite of any maternal postpartum readmission, unscheduled clinic, or emergency room (ER) visit, within 6 weeks of delivery. Secondary outcomes included components of the primary outcome and neonatal readmissions. We excluded women with hypertensive disorders of pregnancy and infections diagnosed prior to POD 2. RESULTS: A total of 1,391 patients were included. The rate of the primary outcome of any readmission increased with POD at discharge: 5.9% for POD 2, 9.4% for POD 3, and 10.9% for POD ≥4 group (trend for p = 0.03). The primary outcome increased with later discharge (POD ≥4 when compared with POD 2). Among components of the composite, ER and unscheduled clinic visits, but not maternal readmissions, increased with the timing of discharge for patients discharged on POD ≥4 when compared with POD 2. Using logistic regression, discharge on POD 3 and on POD ≥4 was significantly associated with the composite (adjusted odds ratios [aOR] 2.6, 95% confidence interval [CI] [1.3-5.3]; aOR 2.9, 95% CI [1.3-6.4], respectively) compared with POD 2. CONCLUSION: The risk of maternal readmission composite following uncomplicated but unscheduled CD was not lower in patients discharged home on POD 3 or ≥4 compared with patients discharged earlier (POD 2). KEY POINTS: · Risk of maternal readmission is higher in patients discharged on POD 3 or 4 compared with POD 2.. · No significant differences by the timing of discharge were observed for any neonatal readmissions.. · Timing of discharge should include an individualized approach with the option of discharge by POD 2..


Subject(s)
Patient Discharge , Patient Readmission , Azithromycin , Cesarean Section , Female , Humans , Infant, Newborn , Logistic Models , Pregnancy , Retrospective Studies
3.
Am J Obstet Gynecol ; 223(5): 739.e1-739.e13, 2020 11.
Article in English | MEDLINE | ID: mdl-32780999

ABSTRACT

BACKGROUND: Despite expectant management, preeclampsia remote from term usually results in preterm delivery. Antithrombin, which displays antiinflammatory and anticoagulant properties, may have a therapeutic role in treating preterm preeclampsia, a disorder characterized by endothelial dysfunction, inflammation, and activation of the coagulation system. OBJECTIVE: This randomized, placebo-controlled clinical trial aimed to evaluate whether intravenous recombinant human antithrombin could prolong gestation and therefore improve maternal and fetal outcomes. STUDY DESIGN: We performed a double-blind, placebo-controlled trial at 23 hospitals. Women were eligible if they had a singleton pregnancy, early-onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks' gestation, and planned expectant management. In addition to standard therapy, patients were randomized to receive either recombinant human antithrombin 250 mg loading dose followed by a continuous infusion of 2000 mg per 24 hours or an identical saline infusion until delivery. The primary outcome was days gained from randomization until delivery. The secondary outcome was composite neonatal morbidity score. A total of 120 women were randomized. RESULTS: There was no difference in median gestational age at enrollment (27.3 weeks' gestation for the recombinant human antithrombin group [range, 23.1-30.0] and 27.6 weeks' gestation for the placebo group [range, 23.0-30.0]; P=.67). There were no differences in median increase in days gained (5.0 in the recombinant human antithrombin group [range, 0-75] and 6.0 for the placebo group [range, 0-85]; P=.95). There were no differences between groups in composite neonatal morbidity scores or in maternal complications. No safety issues related to recombinant human antithrombin were noted in this study, despite the achievement of supraphysiological antithrombin concentrations. CONCLUSION: The administration of recombinant human antithrombin in preterm preeclampsia neither prolonged pregnancy nor improved neonatal or maternal outcomes.


Subject(s)
Antithrombin Proteins/therapeutic use , Cesarean Section/statistics & numerical data , Gestational Age , Pre-Eclampsia/drug therapy , Administration, Intravenous , Adolescent , Adult , Delivery, Obstetric/statistics & numerical data , Double-Blind Method , Female , Fetal Distress/epidemiology , Humans , Infant, Premature, Diseases/epidemiology , Infant, Small for Gestational Age , Middle Aged , Neonatal Sepsis/epidemiology , Perinatal Mortality , Pre-Eclampsia/blood , Pre-Eclampsia/physiopathology , Pregnancy , Pregnancy Trimester, Second , Pregnancy Trimester, Third , Prospective Studies , Recombinant Proteins , Young Adult
4.
Ann Intern Med ; 171(11): 837-842, 2019 12 03.
Article in English | MEDLINE | ID: mdl-31610550

ABSTRACT

Cardiovascular disease is the leading cause of death among women in the United States, and stroke is third. This article uses a case scenario to examine female sex-specific cardiovascular risk factors across the lifespan and describes a precision medicine-based approach to risk factor modification and primary prevention. It also presents recent updates to the role of genetic testing and polygenic risk scores for the prediction of stroke and cardiovascular disease.


Subject(s)
Cardiovascular Diseases/prevention & control , Precision Medicine , Risk Assessment/methods , Stroke/prevention & control , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Evidence-Based Medicine , Female , Genetic Techniques , Humans , Medical History Taking , Middle Aged , Primary Prevention , Risk Factors , Stroke/epidemiology , Stroke/mortality , United States/epidemiology
5.
N Engl J Med ; 375(13): 1231-41, 2016 09 29.
Article in English | MEDLINE | ID: mdl-27682034

ABSTRACT

BACKGROUND: The addition of azithromycin to standard regimens for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin-based extended-spectrum prophylaxis in women undergoing nonelective cesarean section. METHODS: In this trial conducted at 14 centers in the United States, we studied 2013 women who had a singleton pregnancy with a gestation of 24 weeks or more and who were undergoing cesarean delivery during labor or after membrane rupture. We randomly assigned 1019 to receive 500 mg of intravenous azithromycin and 994 to receive placebo. All the women were also scheduled to receive standard antibiotic prophylaxis. The primary outcome was a composite of endometritis, wound infection, or other infection occurring within 6 weeks. RESULTS: The primary outcome occurred in 62 women (6.1%) who received azithromycin and in 119 (12.0%) who received placebo (relative risk, 0.51; 95% confidence interval [CI], 0.38 to 0.68; P<0.001). There were significant differences between the azithromycin group and the placebo group in rates of endometritis (3.8% vs. 6.1%, P=0.02), wound infection (2.4% vs. 6.6%, P<0.001), and serious maternal adverse events (1.5% vs. 2.9%, P=0.03). There was no significant between-group difference in a secondary neonatal composite outcome that included neonatal death and serious neonatal complications (14.3% vs. 13.6%, P=0.63). CONCLUSIONS: Among women undergoing nonelective cesarean delivery who were all receiving standard antibiotic prophylaxis, extended-spectrum prophylaxis with adjunctive azithromycin was more effective than placebo in reducing the risk of postoperative infection. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; C/SOAP ClinicalTrials.gov number, NCT01235546 .).


Subject(s)
Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Azithromycin/therapeutic use , Cesarean Section , Endometritis/prevention & control , Puerperal Infection/prevention & control , Surgical Wound Infection/prevention & control , Adult , Anti-Bacterial Agents/adverse effects , Azithromycin/adverse effects , Female , Humans , Infant, Newborn , Pregnancy , Sepsis/epidemiology , Sepsis/prevention & control , Survival Analysis , Young Adult
6.
Am J Perinatol ; 36(11): 1115-1119, 2019 09.
Article in English | MEDLINE | ID: mdl-30877684

ABSTRACT

OBJECTIVE: Hospital readmissions are increasingly tracked and assessed for value-based compensation. Our objective was to determine the incidence and risk factors associated with post-cesarean delivery (CD) readmissions or unexpected visits, defined as unexpected office or emergency room visits. STUDY DESIGN: This is a secondary analysis of a multicenter randomized controlled trial of adjunctive azithromycin prophylaxis for CD performed in laboring patients with viable pregnancies. Patients were followed up to 6 weeks postpartum. Our primary outcome was a composite of hospital readmission or unexpected visit, defined as unscheduled clinic or emergency department visits. Data of hospital readmissions, unexpected visits, and their reasons were collected. Demographics, antepartum, intrapartum, and postpartum risk factors were evaluated in bivariate analyses and multivariable logistic regression modeling. RESULTS: A total of 1,019 women were randomized to azithromycin and 994 to placebo. The prevalence of readmission or unexpected visit was 10.2% (95% confidence interval [CI]: 8.9-11.6), with rates of 3.8% (95% CI: 3.0-4.7%) hospital readmissions, 6.9% (95% CI: 5.8-8.0%) emergency room visits, and 4.2% (95% CI: 3.4-5.2%) unexpected clinic visits. The most common causes were infectious disease and hypertensive disorder. Women with readmissions or unexpected visits were more likely to be obese and diabetic, as well as experience longer length of ruptured membranes, intrauterine pressure catheter placement, and postpartum fevers. On multivariable analysis, diabetes (adjusted odds ratio [aOR]: 1.6, 95% CI: 1.1-2.4), prolonged ruptured membranes (aOR: 1.9, 95% CI: 1.3-2.8), and postpartum fevers (aOR: 4.6, 95% CI: 3.0-7.0) were significantly positively associated with readmission or unscheduled visit, while azithromycin was a protective (aOR: 0.6, 95% CI: 0.5-0.9). CONCLUSION: Women who had postpartum fever were at especially high risk for readmission or unexpected visits. Diabetes, prolonged ruptured membranes, and postpartum fevers were significantly associated with the adverse outcome, and azithromycin was associated with lower rates of readmission and unexpected visits.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Cesarean Section , Patient Readmission/statistics & numerical data , Adult , Antibiotic Prophylaxis , Emergency Service, Hospital/statistics & numerical data , Female , Fever/epidemiology , Fever/prevention & control , Humans , Incidence , Pregnancy , Puerperal Infection/epidemiology , Puerperal Infection/prevention & control , Risk Factors
7.
Am J Perinatol ; 36(9): 886-890, 2019 07.
Article in English | MEDLINE | ID: mdl-30780190

ABSTRACT

OBJECTIVE: Adding azithromycin to standard antibiotic prophylaxis for unscheduled cesarean delivery has been shown to reduce postcesarean infections. Because wound infection with ureaplasmas may not be overtly purulent, we assessed the hypothesis that azithromycin-based extended-spectrum antibiotic prophylaxis also reduces wound complications that are identified as noninfectious. STUDY DESIGN: This is a secondary analysis of the C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) randomized controlled trial, which enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean. Women were randomized to adjunctive azithromycin or identical placebo up to 1 hour preincision. All wound complications occurring within 6 weeks were adjudicated into infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown). The primary outcome for this analysis is the composite of noninfectious wound complications. RESULTS: At a total of 14 sites, 2,013 women were randomized to adjunctive azithromycin (n = 1,019) or placebo (n = 994). Groups were similar at baseline. Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant (p = 0.22). CONCLUSION: While adding azithromycin to usual antibiotic prophylaxis for nonelective cesarean delivery does reduce the risk of postcesarean infections, it did not significantly reduce the risk of postcesarean noninfectious wound complications.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Azithromycin/therapeutic use , Cesarean Section/adverse effects , Postoperative Complications/prevention & control , Surgical Wound Infection/prevention & control , Adult , Cellulitis/etiology , Cellulitis/prevention & control , Female , Hematoma/etiology , Hematoma/prevention & control , Humans , Pregnancy , Risk , Seroma/etiology , Seroma/prevention & control
9.
Curr Hypertens Rep ; 20(12): 101, 2018 10 25.
Article in English | MEDLINE | ID: mdl-30361886

ABSTRACT

PURPOSE: Hypertensive disorders of pregnancy are increasing in prevalence and associated with significant maternal and perinatal morbidity and mortality. RECENT FINDINGS: Increased emphasis has been placed recently on the use of out-of-office (i.e., home and ambulatory) blood pressure (BP) monitoring to diagnose and manage hypertension in the general population. Current guidelines offer limited recommendations on the use of out-of-office BP monitoring during pregnancy and postpartum. This review will discuss the recent literature on BP measurement outside of the office and its use for screening, diagnosis, and treatment in pregnancy and postpartum, and will illuminate areas for future research.


Subject(s)
Blood Pressure Monitoring, Ambulatory/methods , Hypertension , Postpartum Period/physiology , Pre-Eclampsia , Pregnancy Complications, Cardiovascular , Disease Management , Female , Humans , Hypertension/diagnosis , Hypertension/physiopathology , Pre-Eclampsia/diagnosis , Pre-Eclampsia/etiology , Pre-Eclampsia/prevention & control , Pregnancy , Pregnancy Complications, Cardiovascular/diagnosis , Pregnancy Complications, Cardiovascular/physiopathology
10.
Am J Obstet Gynecol ; 214(6): 720.e1-720.e17, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26723196

ABSTRACT

BACKGROUND: Preeclampsia complicates approximately 3-5% of pregnancies and remains a major cause of maternal and neonatal morbidity and mortality. It shares pathogenic similarities with adult cardiovascular disease as well as many risk factors. Pravastatin, a hydrophilic, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor, has been shown in preclinical studies to reverse various pathophysiological pathways associated with preeclampsia, providing biological plausibility for its use for preeclampsia prevention. However, human trials are lacking. OBJECTIVE: As an initial step in evaluating the utility of pravastatin in preventing preeclampsia and after consultation with the US Food and Drug Administration, we undertook a pilot randomized controlled trial with the objective to determine pravastatin safety and pharmacokinetic parameters when used in pregnant women at high risk of preeclampsia. STUDY DESIGN: We conducted a pilot, multicenter, double-blind, placebo-controlled, randomized trial of women with singleton, nonanomalous pregnancies at high risk for preeclampsia. Women between 12(0/7) and 16(6/7) weeks' gestation were assigned to daily pravastatin 10 mg or placebo orally until delivery. Primary outcomes were maternal-fetal safety and pharmacokinetic parameters of pravastatin during pregnancy. Secondary outcomes included rates of preeclampsia and preterm delivery, gestational age at delivery, birthweight, and maternal and cord blood lipid profile (clinicaltrials.gov identifier NCT01717586). RESULTS: Ten women assigned to pravastatin and 10 to placebo completed the trial. There were no differences between the 2 groups in rates of study drug side effects, congenital anomalies, or other adverse or serious adverse events. There was no maternal, fetal, or neonatal death. Pravastatin renal clearance was significantly higher in pregnancy compared with postpartum. Four subjects in the placebo group developed preeclampsia compared with none in the pravastatin group. Although pravastatin reduced maternal cholesterol concentrations, umbilical cord cholesterol concentrations and infant birthweight were not different between the groups. The majority of umbilical cord and maternal pravastatin plasma concentrations at the time of delivery were below the lower limit of quantification of the assay. Pravastatin use was associated with a more favorable pregnancy angiogenic profile. CONCLUSION: This study provides preliminary safety and pharmacokinetic data regarding the use of pravastatin for preventing preeclampsia in high-risk pregnant women. Although the data are preliminary, no identifiable safety risks were associated with pravastatin use in this cohort. This favorable risk-benefit analysis justifies using pravastatin in a larger clinical trial with dose escalation.


Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacokinetics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Pravastatin/pharmacokinetics , Pravastatin/therapeutic use , Pre-Eclampsia/prevention & control , Pregnancy, High-Risk , Adult , Birth Weight , Cholesterol/blood , Double-Blind Method , Female , Fetal Blood/chemistry , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/blood , Infant, Newborn , Pilot Projects , Pravastatin/blood , Pregnancy , Pregnancy Trimester, First , Pregnancy Trimester, Second
11.
Am J Perinatol ; 29(4): 273-6, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22135154

ABSTRACT

We compared maternal and neonatal outcomes in women who received prophylactic antibiotics prior to skin incision to those who received antibiotics at cord clamp. We performed a randomized clinical trial at two sites. Eligible women included those undergoing nonemergency cesarean at 36 weeks' gestation or greater. Subjects were randomized (permuted blocks) into one of two treatments: "preoperative antibiotics" (cefazolin 1 g given <30 minutes prior to skin incision) or "intraoperative antibiotics" (cefazolin 1 g at cord clamping). Patients who reported an allergy to penicillin received clindamycin 900 mg. The trial primary outcome was a composite of maternal infectious morbidities, defined as having any one of the following: (1) postoperative fever (defined as oral temperature >38°C on two separate occasions more than 6 hours apart, after the initial 24-hour postoperative period); (2) wound infection (defined as purulent discharge from the incision); (3) endomyometritis (defined as fundal tenderness and fever malodorous lochia, fever); (4) urinary tract infection (defined as fever, positive urine culture). We enrolled a total of 434 subjects in this study, with 217 in each group. Overall, we found no difference in composite maternal infectious morbidity between those who received antibiotics preoperatively and those who received antibiotics at cord clamp (relative risk = 1.2, 95% confidence interval 0.7 to 1.5). Neonatal outcomes were also similar between the two intervention arms. The rate of suspected sepsis was similar between the two groups. There were no cases of antibiotic resistance in the neonates. Either preoperative antibiotic therapy or antibiotic administration after cord clamp is a reasonable clinical method for reducing the risk of postcesarean infectious morbidity.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis , Cefazolin/administration & dosage , Cesarean Section/methods , Clindamycin/administration & dosage , Surgical Wound Infection/prevention & control , Adult , Anti-Bacterial Agents/therapeutic use , Cefazolin/therapeutic use , Clindamycin/therapeutic use , Drug Administration Schedule , Endometritis/prevention & control , Female , Fever/drug therapy , Fever/prevention & control , Humans , Infant, Newborn , Pregnancy , Sepsis/prevention & control , Urinary Tract Infections/prevention & control
12.
Obstet Gynecol ; 139(6): 1043-1049, 2022 06 01.
Article in English | MEDLINE | ID: mdl-35675601

ABSTRACT

OBJECTIVE: To estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity. METHODS: We conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was applied to assess differences in association by antibiotic timing. RESULTS: Of 2,013 participants, antibiotics were initiated after skin incision (median 3 minutes, range 0-229 minutes) in 269 (13.4%), 0-30 minutes before skin incision in 1,378 (68.5%), more than 30-60 minutes before skin incision in 270 (13.4%), and more than 60 minutes before skin incision (median 85 minutes, range 61-218 minutes) in 96 (4.8%). The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66). Risks were not significantly different in patients who received azithromycin more than 60 minutes before skin incision (RR 0.59, 95% CI 0.10-3.36). Results were similar when endometritis and wound infections were analyzed separately. Neonatal outcomes were not significantly different for azithromycin compared with placebo across all timing groups. CONCLUSION: Adjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01235546.


Subject(s)
Azithromycin , Endometritis , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/methods , Azithromycin/therapeutic use , Endometritis/prevention & control , Female , Humans , Infant, Newborn , Pregnancy , Surgical Wound Infection/prevention & control
13.
J Matern Fetal Neonatal Med ; 35(14): 2690-2694, 2022 Jul.
Article in English | MEDLINE | ID: mdl-32727231

ABSTRACT

OBJECTIVE: To compare the frequency of postoperative surgical site infection (SSI) by type of skin preparation used for unscheduled cesarean in the setting of adjunctive azithromycin prophylaxis. METHODS: Secondary analysis of a multi-center randomized controlled trial of adjunctive azithromycin (500 mg intravenous) versus placebo in women who were ≥24 weeks gestation and undergoing unscheduled cesarean (i.e. during labor or ≥4 h after membrane rupture). Type of skin preparation used was identified based on the protocol at the hospital at the time of delivery: iodine-alcohol, chlorhexidine, chlorhexidine-alcohol, or the combination of chlorhexidine-alcohol and iodine. The primary outcome of this analysis was incidence of post-operative SSI, as defined by CDC criteria. Multivariable logistic regression was applied for adjustments. RESULTS: All 2013 women in the primary trial were included in this analysis. Women were grouped according to type of skin preparation received: iodine-alcohol (n = 193), chlorhexidine (n = 733), chlorhexidine-alcohol (n = 656), and chlorhexidine-alcohol and iodine combined sequentially (n = 431). The unadjusted rates of wound infection ranged from 2.9% to 5.7%. Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. CONCLUSION: In women undergoing unscheduled cesarean delivery in a trial of adjunctive azithromycin, the type of skin preparation used did not appear to be associated with the frequency of wound SSI.


Subject(s)
Anti-Infective Agents, Local , Iodine , Anti-Infective Agents, Local/therapeutic use , Azithromycin/therapeutic use , Chlorhexidine , Female , Humans , Povidone-Iodine , Pregnancy , Preoperative Care/methods , Surgical Wound Infection/drug therapy , Surgical Wound Infection/epidemiology , Surgical Wound Infection/prevention & control
14.
BMJ Open ; 11(1): e043052, 2021 01 07.
Article in English | MEDLINE | ID: mdl-33414149

ABSTRACT

INTRODUCTION: Cardiovascular and cerebrovascular diseases (CCVDs) are the leading cause of maternal mortality in the first year after delivery. Women whose pregnancies were complicated by pre-eclampsia are at particularly high risk for adverse events. In addition, women with a history of pre-eclampsia have higher risk of CCVD later in life. The physiological mechanisms that contribute to increased CCVD risk in these women are not well understood, and the optimal clinical pathways for postpartum CCVD risk reduction are not yet defined. METHODS AND ANALYSIS: The Motherhealth Study (MHS) is a prospective cohort study at Columbia University Irving Medical Center (CUIMC), a quaternary care academic medical centre serving a multiethnic population in New York City. MHS began recruitment on 28 September 2018 and will enrol 60 women diagnosed with pre-eclampsia with severe features in the antepartum or postpartum period, and 40 normotensive pregnant women as a comparison cohort. Clinical data, biospecimens and measures of vascular function will be collected from all participants at the time of enrolment. Women in the pre-eclampsia group will complete an additional three postpartum study visits over 12-24 months. Visits will include additional detailed cardiovascular and cerebrovascular phenotyping. As this is an exploratory, observational pilot study, only descriptive statistics are planned. Data will be used to inform power calculations for future planned interventional studies. ETHICS AND DISSEMINATION: The CUIMC Institutional Review Board approved this study prior to initiation of recruitment. All participants signed informed consent prior to enrolment. Results will be disseminated to the clinical and research community, along with the public, on completion of analyses. Data will be shared on reasonable request.


Subject(s)
Pre-Eclampsia , Blood Pressure , Cohort Studies , Female , Humans , New York City , Observational Studies as Topic , Pre-Eclampsia/epidemiology , Pregnancy , Prospective Studies
15.
J Perinatol ; 41(1): 24-31, 2021 01.
Article in English | MEDLINE | ID: mdl-32669643

ABSTRACT

OBJECTIVE: Determine incidence and risk factors for readmissions in early infancy. STUDY DESIGN: Secondary analysis of data from the Cesarean Section Optimal Antibiotic Prophylaxis trial. All unplanned revisits (unplanned clinic, ER visits, and hospital readmissions) and hospital readmissions (initial discharge to 3-month follow-up) were analyzed. RESULTS: 295 (15.9%) of 1850 infants had revisits with risk factors being ethnicity (adjusted odds ratio (aOR): 0.6 for Hispanic), maternal postpartum antibiotics (1.89), azithromycin treatment (1.22), small for gestational age (1.68), apnea (3.82), and hospital stay after birth >90th percentile (0.49). 71 (3.8%) of 1850 infants were readmitted with risk factors being antenatal steroids (aOR 2.49), elective repeat C/section (0.72), postpartum maternal antibiotics (2.22), O2 requirement after delivery room (2.82), and suspected/proven neonatal sepsis (0.55). CONCLUSION(S): Multiple risk factors were identified, suggesting potential impact on the neonatal microbiome (maternal postpartum antibiotics) or issues related to access/cost of care (Hispanic ethnicity associated with fewer revisits).


Subject(s)
Cesarean Section , Patient Readmission , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Cesarean Section, Repeat , Female , Humans , Infant , Infant, Newborn , Pregnancy
16.
J Am Heart Assoc ; 9(3): e014775, 2020 02 04.
Article in English | MEDLINE | ID: mdl-31973601

ABSTRACT

Background Racial disparities contribute to maternal morbidity in the United States. Hypertension is associated with poor maternal outcomes, including stroke. Disparities in hypertension might contribute to maternal strokes. Methods and Results Using billing data from the Healthcare Cost and Utilization Project's National Inpatient Sample, we analyzed the effect of race/ethnicity on stroke during delivery admission in women aged 18 to 54 years delivering in US hospitals from January 1, 1998, through December 31, 2014. We categorized hypertension as normotensive, chronic hypertension, or pregnancy-induced hypertension. Adjusted risk ratios (aRRs) and 95% CIs were calculated using log-linear Poisson regression models, testing for interactions between race/ethnicity and hypertensive status. A total of 65 286 425 women were admitted for delivery during the study period, of whom 7764 were diagnosed with a stroke (11.9 per 100 000 deliveries). Hypertension modified the effect of race/ethnicity (P<0.0001 for interaction). Among women with pregnancy-induced hypertension, black and Hispanic women had higher stroke risk compared with non-Hispanic whites (blacks: aRR, 2.07; 95% CI, 1.86-2.30; Hispanics: aRR, 2.19; 95% CI, 1.98-2.43). Among women with chronic hypertension, all minority women had higher stroke risk (blacks: aRR, 1.71; 95% CI, 1.30-2.26; Hispanics: aRR, 1.75; 95% CI, 2.32-5.63; Asian/Pacific Islanders: aRR, 3.62; 95% CI, 2.32-5.63). Among normotensive women, only blacks had increased stroke risk (aRR, 1.17; 95% CI, 1.07-1.28). Conclusions Pregnant US women from minority groups had higher stroke risk during delivery admissions, compared with non-Hispanic whites. The effect of race/ethnicity was larger in women with chronic hypertension or pregnancy-induced hypertension. Targeting blood pressure management in pregnancy may help reduce maternal stroke risk in minority populations.


Subject(s)
Black or African American , Blood Pressure , Hispanic or Latino , Hypertension, Pregnancy-Induced/ethnology , Hypertension/ethnology , Parturition/ethnology , Patient Admission , Stroke/ethnology , White People , Adolescent , Adult , Cross-Sectional Studies , Databases, Factual , Female , Humans , Hypertension/diagnosis , Hypertension/mortality , Hypertension/physiopathology , Hypertension, Pregnancy-Induced/diagnosis , Hypertension, Pregnancy-Induced/mortality , Hypertension, Pregnancy-Induced/physiopathology , Inpatients , Maternal Mortality/ethnology , Middle Aged , Pregnancy , Race Factors , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Stroke/physiopathology , United States/epidemiology , Young Adult
17.
J Am Heart Assoc ; 8(19): e013092, 2019 10.
Article in English | MEDLINE | ID: mdl-31564189

ABSTRACT

Background Identifying pregnancy-associated risk factors before the development of major cardiovascular disease events could provide opportunities for prevention. The objective of this study was to determine the association between outcomes in first pregnancies and subsequent cardiovascular health. Methods and Results The Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-be Heart Health Study is a prospective observational cohort that followed 4484 women 2 to 7 years (mean 3.2 years) after their first pregnancy. Adverse pregnancy outcomes (defined as hypertensive disorders of pregnancy, small-for-gestational-age birth, preterm birth, and stillbirth) were identified prospectively in 1017 of the women (22.7%) during this pregnancy. The primary outcome was incident hypertension (HTN). Women without adverse pregnancy outcomes served as controls. Risk ratios (RR) and 95% CIs were adjusted for age, smoking, body mass index, insurance type, and race/ethnicity at enrollment during pregnancy. The overall incidence of HTN was 5.4% (95% CI 4.7% to 6.1%). Women with adverse pregnancy outcomes had higher adjusted risk of HTN at follow-up compared with controls (RR 2.4, 95% CI 1.8-3.1). The association held for individual adverse pregnancy outcomes: any hypertensive disorders of pregnancy (RR 2.7, 95% CI 2.0-3.6), preeclampsia (RR 2.8, 95% CI 2.0-4.0), and preterm birth (RR 2.7, 95% CI 1.9-3.8). Women who had an indicated preterm birth and hypertensive disorders of pregnancy had the highest risk of HTN (RR 4.3, 95% CI 2.7-6.7). Conclusions Several pregnancy complications in the first pregnancy are associated with development of HTN 2 to 7 years later. Preventive care for women should include a detailed pregnancy history to aid in counseling about HTN risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov Unique identifier: NCT02231398.


Subject(s)
Blood Pressure , Hypertension/epidemiology , Pregnancy Complications/epidemiology , Adult , Birth Weight , Female , Gestational Age , Humans , Hypertension/diagnosis , Hypertension/physiopathology , Incidence , Infant, Newborn , Infant, Premature , Infant, Small for Gestational Age , Pregnancy , Pregnancy Complications/diagnosis , Pregnancy Outcome , Prognosis , Prospective Studies , Risk Assessment , Risk Factors , Time Factors , United States/epidemiology , Young Adult
18.
Hypertension ; 71(2): 326-335, 2018 02.
Article in English | MEDLINE | ID: mdl-29229741

ABSTRACT

The accurate measurement of blood pressure (BP) in pregnancy is essential to guide medical decision making that affects both mother and fetus. The aim of this systematic review was to determine the accuracy of ambulatory, home, and clinic BP measurement devices in pregnant women. We searched Ovid MEDLINE, The Cochrane Library, EMBASE, CINAHL EBSCO, ClinicalTrials.gov, International Clinical Trials Registry Platform, and dabl from inception through August 3, 2017 for articles that assessed the validity of an upper arm BP measurement device against a mercury sphygmomanometer in pregnant women. Two independent investigators determined eligibility, extracted data, and adjudicated protocol violations. From 1798 potential articles identified, 41, that assessed 28 devices, met the inclusion criteria. Most articles (n=32) followed a standard or modified American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization, British Hypertension Society, or European Society of Hypertension validation protocol. Several articles described the results of validation studies performed on >1 device (n=7) or in >1 population of pregnant women (n=12), comprising 64 pairwise validity assessments. The device was validated in 61% (32 of 52) of studies which used a standard or modified protocol. Only 34% (11 of 32) of the studies wherein the device was successfully validated were performed without a protocol violation. Given the implications of inaccurate BP measurement in pregnant women, healthcare providers should be aware of and try to use the BP measurement devices which have been properly validated in this population.


Subject(s)
Blood Pressure Determination/instrumentation , Blood Pressure , Equipment Design/standards , Blood Pressure Determination/methods , Blood Pressure Determination/standards , Female , Humans , Hypertension/diagnosis , Pregnancy , Reference Standards , Reproducibility of Results , Validation Studies as Topic
19.
Obstet Gynecol ; 131(3): 441-450, 2018 03.
Article in English | MEDLINE | ID: mdl-29420396

ABSTRACT

OBJECTIVE: To evaluate temporal trends in use of antihypertensive medications during delivery hospitalizations complicated by preeclampsia and risk of maternal stroke over the same time period. METHODS: The Perspective database was used to perform a retrospective cohort study evaluating antihypertensive drugs dispensed during delivery hospitalizations complicated by preeclampsia from 2006 to the first quarter of 2015. Medications evaluated included nifedipine, hydralazine, and oral and intravenous labetalol. Adjusted models for receipt of antihypertensive agents accounting for demographic and hospital factors were created. Hospital-level rates of antihypertensive administration for women with severe preeclampsia were analyzed. Risk of stroke during delivery hospitalization was evaluated. RESULTS: A total of 239,454 patients with preeclampsia were included in the analysis including 126,595 women with mild, 31,628 with superimposed, and 81,231 with severe preeclampsia. Overall, 105,409 women received a hypertensive agent. From 2006 to 2014, for all patients with preeclampsia, receipt of oral labetalol increased from 20.3% to 31.4%, intravenous labetalol from 13.3% to 21.4%, hydralazine from 12.8% to 16.9%, nifedipine from 15.0% to 18.2%, and more than one medication from 16.5% to 25.8%. The proportion of patients with preeclampsia receiving any antihypertensive medication rose from 37.8% in 2006 to 49.4% in 2015. In adjusted models, temporal trends retained significance. Rates of antihypertensive administration for severe preeclampsia varied significantly by hospital. For severe preeclampsia, the risk for stroke decreased from 13.5 per 10,000 deliveries in 2006-2008 (n=27) to 9.7 in 2009-2011 (n=25) to 6.0 in 2012-2014 (n=20) (P=.02). CONCLUSION: Use of multiple antihypertensive agents to treat preeclamptic women increased over the study period for women with mild, superimposed, and severe preeclampsia. There was substantial hospital variation in use of antihypertensive agents. This trend was associated with decreased risk of maternal stroke.


Subject(s)
Antihypertensive Agents/therapeutic use , Delivery, Obstetric , Hospitalization , Practice Patterns, Physicians'/trends , Pre-Eclampsia/drug therapy , Adolescent , Adult , Female , Humans , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Pregnancy , Retrospective Studies , Risk Factors , Stroke/etiology , Stroke/prevention & control , United States , Young Adult
20.
Obstet Gynecol ; 132(1): 185-192, 2018 07.
Article in English | MEDLINE | ID: mdl-29889742

ABSTRACT

OBJECTIVE: To estimate whether the diagnosis of asthma is associated with the use of specific uterotonic and antihypertensive medications during delivery hospitalizations. METHODS: We used Perspective, an administrative database, to determine whether women hospitalized for delivery complicated by postpartum hemorrhage or preeclampsia received uterotonics and antihypertensive medications differentially based on the absence or presence of asthma from 2006 to 2015. Given that carboprost and intravenous (IV) labetalol may be associated with asthma exacerbation, adjusted models for receipt of these medications were created with adjusted risk ratios with 95% CIs as measures of effect. Risk for status asthmaticus based on receipt of carboprost and IV labetalol was analyzed. RESULTS: Over the study period, a total of 5,691,178 women were analyzed, of whom 239,915 (4.2%) had preeclampsia and 139,841 postpartum hemorrhage (2.5%). Carboprost was used less frequently in patients with asthma compared with patients with no asthma (11.4% vs 18.0%) in comparison with IV labetalol, which was used more commonly when a diagnosis of asthma was present (18.5% vs 16.7%). In unadjusted analysis, the presence of asthma was associated with a 37% decrease in likelihood of carboprost use and an 11% increase in likelihood of labetalol use. In adjusted analysis, the presence of asthma was associated with a 32% decrease in likelihood of carboprost use (adjusted risk ratio 0.68, 95% CI 0.62-0.74) compared with a 7% decrease in labetalol use (adjusted risk ratio 0.93, 95% CI 0.90-0.97). Risk for status asthmaticus was significantly increased with use of IV labetalol compared with other antihypertensive medications (6.5 vs 1.7/1,000 delivery hospitalizations, P<.01). CONCLUSION: There may be an opportunity to reduce use of ß-blockers and carboprost among patients with asthma. Given their association with status asthmaticus, these drugs should be used cautiously in women with asthma.


Subject(s)
Antihypertensive Agents/adverse effects , Asthma/drug therapy , Delivery, Obstetric/adverse effects , Oxytocics/adverse effects , Pregnancy Complications/drug therapy , Adult , Asthma/chemically induced , Carboprost/adverse effects , Contraindications, Drug , Databases, Factual , Drug Therapy, Combination/adverse effects , Female , Hospitalization/statistics & numerical data , Humans , Labetalol/adverse effects , Odds Ratio , Oxytocin/adverse effects , Postpartum Hemorrhage/chemically induced , Postpartum Hemorrhage/drug therapy , Pre-Eclampsia/drug therapy , Pregnancy
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