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1.
J Am Podiatr Med Assoc ; 111(6)2021 Dec 15.
Article in English | MEDLINE | ID: mdl-34137854

ABSTRACT

Background: Human amniotic membrane contains growth factors and cytokines that promote epithelial cell migration and proliferation, stimulate metabolic processes that lead to collagen synthesis, and attract fibroblasts, while also reducing pain and inflammation. Randomized studies have shown effectiveness of micronized dehydrated human amnion/chorion membrane (mdHACM) allograft injection in treatment of plantar fasciitis. We present our experience and short-term outcomes with using mdHACM injection as a treatment for Achilles tendinopathy. Methods: Retrospective case series of patients with Achilles tendinopathy treated with mdHACM by a single physician. Participants had at least two follow-up visits within 45 days of mdHACM injection. Outcomes examined included change in reported level of pain during the 45-day observation period and treatment-associated adverse events. Results: Follow-up data were available for 32 mdHACM-treated patients. At treatment initiation, 97% of patients reported severe (66%) or moderate (31%) pain. At the first follow-up visit (mean ± SD of 8.1 ± 2.7 days postinjection), 27 patients (84%) reported improvement in pain levels, although 37% of patients continued to report severe (6%) or moderate (31%) pain. At the second follow-up visit (mean ± SD of 23.1 ± 6.2 days postinjection), no patients reported severe pain and one reported moderate pain. Within 45 days of mdHACM injection, complete symptom resolution was reported by 66% of treated patients (n = 21), with the remaining 34% (n = 11) reporting symptom improvement but not complete resolution. Two patients reported calf or quadricep pain or tightness after injection. Conclusions: In our experience, mdHACM injection reduced or eliminated pain in all 32 patients with follow-up data.


Subject(s)
Achilles Tendon , Tendinopathy , Amnion/transplantation , Chorion/transplantation , Humans , Retrospective Studies , Tendinopathy/drug therapy , Treatment Outcome
2.
J Knee Surg ; 34(8): 841-845, 2021 Jul.
Article in English | MEDLINE | ID: mdl-31779034

ABSTRACT

Osteoarthritis (OA) of the knee is a leading cause of chronic pain and disability in the United States. Current treatment options primarily target OA symptoms reserving surgical intervention and knee replacement for those who fail conservative measures. With average age of patients with knee OA decreasing, regenerative treatment approaches to reduce symptoms, increase quality of life, and delay the need for surgical intervention are increasingly sought. Human amniotic membrane contains growth factors and cytokines, which promote epithelial cell migration and proliferation, stimulate metabolic processes leading to collagen synthesis, and attract fibroblasts, while also reducing pain and inflammation. Micronization of the tissue allows for suspension in normal saline and injection. We conducted a retrospective review of 100 knees treated for symptomatic OA with micronized dehydrated human amnion/chorion membrane (mdHACM) and followed for 6 months. Our purpose is to present our experience and patient outcomes. Data were abstracted from electronic medical records of 82 consecutive OA patients (100 knees) injected with 100 mg mdHACM. Patient age, gender, adverse events and routinely collected Knee Injury and Osteoarthritis Outcome Score (KOOS) were evaluated. Effectiveness of mdHACM treatment was measured by serial KOOS at baseline, and posttreatment at 6 weeks, 3, and 6 months. Overall mean KOOS for the cohort was 40 at baseline, improving to 52, 62, and 65 at 6 weeks, 3 months, and 6 months post-mdHACM injection. Percent increases were 32, 56, and 65%, respectively. Quality of life and sports/recreation domains improved by 111 and 118%, respectively, at 6 months. Pain scores improved by 67% at 6 months. All scores improved throughout the observation period. The most common adverse event was pain after injection lasting 2 to 7 days, observed in 68% of cases. This represents the largest single-physician experience with mdHACM for treatment of knee OA reported to date. Injectable mdHACM appears to be a potentially useful treatment option for knee OA patients. Controlled studies are underway to confirm these observations.


Subject(s)
Chorion/transplantation , Osteoarthritis, Knee/therapy , Pain/etiology , Adult , Aged , Aged, 80 and over , Amnion/transplantation , Female , Humans , Injections , Knee Joint/pathology , Male , Middle Aged , Pain Measurement , Quality of Life , Retrospective Studies , Treatment Outcome
3.
J Wound Care ; 28(Sup10): S10-S12, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31600100

ABSTRACT

OBJECTIVE: Over two million individuals worldwide, with end-stage renal disease (ESRD), depend on dialysis therapy or a kidney transplant for survival. Every haemodialysis patient requires vascular access. The arteriovenous fistula (AVF) is preferred for long-term hemodialysis vascular access due to long-term primary patency rates. Given the limited options for haemodialysis access and placement, preservation of existing AVF sites is always a clinical priority. This case report describes a novel approach to wound closure with the application of dehydrated amnion chorion human membrane (dHACM) at an AVF surgical site known to be complicated with issues of scarring and tissue breakdown. The patient was treated successfully with the imperative preservation of his AVF given that he had few other vascular access options.


Subject(s)
Allografts/transplantation , Amnion/transplantation , Arteriovenous Fistula/surgery , Chorion/transplantation , Dialysis/adverse effects , Kidney Failure, Chronic/complications , Wound Healing/physiology , Arteriovenous Fistula/etiology , Humans , Male , Middle Aged , Treatment Outcome
4.
Int Wound J ; 16(3): 761-767, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30864259

ABSTRACT

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention-to-treat (ITT) and/or the per-protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi-layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n = 109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12 weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant; P = 0.0473, ITT and P = 0.0128, PP. The Kaplan-Meier plot of time to heal within 12 weeks for the ITT and PP populations demonstrated a superior wound-healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.


Subject(s)
Allografts/transplantation , Amnion/transplantation , Chorion/transplantation , Data Analysis , Diabetic Foot/therapy , Treatment Outcome , Varicose Ulcer/therapy , Aged , Female , Humans , Male , Middle Aged , Models, Statistical , Prospective Studies , Wound Healing
5.
J Obes ; 2014: 563243, 2014.
Article in English | MEDLINE | ID: mdl-25405027

ABSTRACT

OBJECTIVE: Gestational diabetes (GDM) and obesity portend a high risk for subsequent type 2 diabetes. We examined maternal factors influencing the development of gestational diabetes (GDM) in obese women receiving 17-alpha-hydroxyprogesterone caproate (17OHPC) for preterm delivery prevention. MATERIALS AND METHODS: Retrospectively identified were 899 singleton pregnancies with maternal prepregnancy body mass indices of ≥30 kg/m(2) enrolled for either 17OHPC weekly administration (study group) or daily uterine monitoring and nursing assessment (control group). Patients with history of diabetes type 1, 2, or GDM were excluded. Maternal characteristics were compared between groups and for women with and without development of GDM. A logistic regression model was performed on incidence of GDM, controlling for significant univariate factors. RESULTS: The overall incidence of GDM in the 899 obese women studied was 11.9%. The incidence of GDM in the study group (n = 491) was 13.8% versus 9.6% in the control group (n = 408) (P = 0.048). Aside from earlier initiation of 17OHP and advanced maternal age, other factors including African American race, differing degrees of obesity, and use of tocolysis were not significant risks for the development of GDM. CONCLUSION: In obese women with age greater than 35 years, earlier initiation of 17OHPC may increase the risk for GDM.


Subject(s)
Diabetes, Gestational/chemically induced , Hydroxyprogesterones/adverse effects , Obesity/metabolism , Premature Birth/prevention & control , Tocolytic Agents/adverse effects , 17 alpha-Hydroxyprogesterone Caproate , Adult , Body Mass Index , Diabetes, Gestational/epidemiology , Female , Humans , Hydroxyprogesterones/administration & dosage , Injections, Intramuscular , Maternal Age , Obesity/complications , Obesity/epidemiology , Pregnancy , Retrospective Studies , Risk Factors , Tocolytic Agents/administration & dosage , United States/epidemiology
7.
J Matern Fetal Neonatal Med ; 27(1): 84-8, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23682702

ABSTRACT

OBJECTIVE: To examine the influence of nausea and vomiting of pregnancy (NVP) on pregnancy outcomes. METHODS: Outcomes were compared for primigravidas with a current singleton gestation enrolled at <20 weeks' gestation in a maternity risk screening and education program (n = 81 486). Patient-reported maternal characteristics and pregnancy outcomes were compared for women with and without NVP and within the NVP group for those with and without poor weight gain. RESULTS: 6.4% of women reported NVP as a pregnancy complication. Women reporting NVP were more likely to be younger, obese, single and smoke. They had higher rates of preterm delivery, pregnancy-induced hypertension and low birth weight <2500 g. Almost one-quarter of women with NVP had lower than recommended weight gain. Poor weight gain was associated with a higher incidence of adverse outcomes. Obesity, tobacco use and poor pregnancy weight gain independently increased the odds of an adverse outcome. CONCLUSION: NVP and subsequent poor weight gain may be associated with adverse pregnancy outcomes.


Subject(s)
Morning Sickness/epidemiology , Pregnancy Outcome , Adult , Age Factors , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Infant, Low Birth Weight , Infant, Newborn , Logistic Models , Obesity/epidemiology , Pregnancy , Premature Birth/epidemiology , Single Person/statistics & numerical data , Smoking/epidemiology , United States/epidemiology , Weight Gain
8.
Am J Perinatol ; 31(9): 795-8, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24338114

ABSTRACT

OBJECTIVE: The aim of the study was to examine pregnancy outcomes of healthy nulliparous women aged ≥ 40 years at delivery. STUDY DESIGN: The study included 53,480 nulliparous women aged 20 to 29 or ≥ 40 years delivering singleton infants, enrolled in a pregnancy risk assessment program between July 1, 2006, and August 1, 2011. Women reporting medical disorders, tobacco use, or conception with assistive reproductive technology were excluded. Data were grouped by body mass (obese or nonobese) and age (20-29 or ≥ 40 years). Pregnancy outcomes were compared within each body mass group for women aged 20 to 29 years versus ≥ 40 years and between obese and nonobese women aged ≥ 40 years. RESULTS: Within each body mass group, nulliparous women aged ≥ 40 years delivered at a significantly lower gestational age and had a greater incidence of cesarean delivery, gestational diabetes, preterm birth, and both low and very low birth weight infants, compared with controls aged 20 to 29 years. For women aged ≥ 40 years, obesity was associated with higher rates of adverse pregnancy outcomes. CONCLUSION: In healthy women, both advanced maternal age and obesity negatively influence pregnancy outcomes. Women who delay pregnancy until age 40+ years may modify their risk for cesarean section, preterm birth, and low-birth-weight infants by reducing their weight to nonobese levels before conception.


Subject(s)
Body Mass Index , Diabetes, Gestational/epidemiology , Maternal Age , Obesity/epidemiology , Pregnancy Outcome , Premature Birth/epidemiology , Adult , Body Weight , Cesarean Section , Female , Gestational Age , Humans , Incidence , Infant, Low Birth Weight , Infant, Newborn , Infant, Very Low Birth Weight , Middle Aged , Parity , Pregnancy , United States/epidemiology , Young Adult
9.
Am J Perinatol ; 31(1): 55-60, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23456908

ABSTRACT

OBJECTIVE: To determine if the rates of recurrent spontaneous preterm birth in women receiving 17α-hydroxyprogesterone caproate (17P) differ according to maternal race. STUDY DESIGN: Retrospective analysis of a cohort of women enrolled in outpatient 17P administration at < 27 weeks. Maternal characteristics, obstetric history, and rates of recurrent preterm birth were determined using chi-square and multivariable Cox proportional hazards regression at two-tailed α = 0.05. Primary study outcome was defined as having a spontaneous preterm birth < 34 weeks. RESULTS: African-American women initiated 17P injections later (19.6 versus 18.9 weeks, p < 0.001) and discontinued injections earlier (33.2 versus 34.1 weeks, p < 0.001) than Caucasian women. Spontaneous recurrent preterm birth < 34 weeks was higher in African-Americans versus Caucasians receiving 17P (odds ratio 2.1; 95% confidence interval 1.7, 2.4). After adjusting for other significant factors, African-American race retained the strongest association with recurrent spontaneous preterm birth < 34 weeks. Within each racial group, short cervical length < 25 mm before 27 weeks' gestation had the highest hazard of recurrent spontaneous preterm delivery. CONCLUSION: Despite treatment with 17P, African-American women have higher rates of recurrent preterm birth.


Subject(s)
Black or African American/statistics & numerical data , Estrogen Antagonists/therapeutic use , Hydroxyprogesterones/therapeutic use , Premature Birth/ethnology , Premature Birth/prevention & control , White People/statistics & numerical data , 17 alpha-Hydroxyprogesterone Caproate , Adolescent , Adult , Cervical Length Measurement , Cervix Uteri/anatomy & histology , Female , Gestational Age , Humans , Pregnancy , Pregnancy, High-Risk , Retrospective Studies , Secondary Prevention , Young Adult
10.
J Matern Fetal Neonatal Med ; 27(11): 1158-62, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24134662

ABSTRACT

OBJECTIVE: To examine the timing of elective delivery and neonatal intensive care unit (NICU) utilization of electively delivered infants from 2008 to 2011. METHODS: Analysis included 42,290 women with singleton gestation enrolled in a pregnancy education program, reporting uncomplicated pregnancies with elective labor induction (ELI) (n = 27,677) or scheduled cesarean delivery (SCD) (n = 14,613) at 37.0-41.9 weeks' gestation. Data were grouped by type and week of delivery (37.0-37.9, 38.0-38.9, and 39.0-41.9 weeks). ELI and SCD for each week of delivery from 2008 to 2011 and nursery utilization by delivery week were compared. RESULTS: During the 2008-2011 timeframe, a shift in timing of ELI and SCD toward ≥39.0 weeks was observed. In 2008, 80.9% of ELI occurred at ≥39.0 weeks versus 92.6% in 2011 (p < 0.001). In 2008, 60.5% of SCD occurred at ≥39.0 weeks versus 78.1% in 2011 (p < 0.001). NICU admission and prolonged nursery stays were highest at 37.0-37.9 weeks for both groups. CONCLUSIONS: We observed a shift toward later gestational age at elective delivery from 2008 to 2011 and increased NICU utilization for neonates born at <39 weeks' gestation.


Subject(s)
Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Pregnancy Outcome/epidemiology , Premature Birth/epidemiology , Term Birth , Adult , Cesarean Section/adverse effects , Cesarean Section/statistics & numerical data , Delivery, Obstetric/statistics & numerical data , Elective Surgical Procedures/adverse effects , Elective Surgical Procedures/statistics & numerical data , Female , Gestational Age , Hospitalization/statistics & numerical data , Humans , Infant, Newborn , Intensive Care Units, Neonatal/statistics & numerical data , Labor, Induced/adverse effects , Labor, Induced/statistics & numerical data , Pregnancy , Retrospective Studies , Time Factors , Young Adult
11.
Am J Perinatol ; 30(9): 751-4, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23303484

ABSTRACT

OBJECTIVE: To determine if prophylactic cerclage improves pregnancy outcomes in women with twin pregnancies without a history of cervical insufficiency. STUDY DESIGN: Women with twin pregnancies who received outpatient preterm labor surveillance services between January 1990 and May 2004 for ≥1 day beginning at < 28.0 weeks' gestation were identified from a database. Patients with previous preterm delivery or a diagnosis of cervical incompetence in a previous or in the index pregnancy were excluded. Twin pregnancies managed with prophylactic cerclage were compared with twin pregnancies in which cerclage was not placed. The primary outcome was incidence of preterm birth prior to 32 weeks. Groups were compared using Fisher exact and Mann-Whitney U test statistics. RESULTS: Overall, 8,218 twin pregnancies met inclusion criteria, of which 146 women (1.8%) received prophylactic cerclage. Patients who received prophylactic cerclage had a significantly higher incidence of preterm birth before 32 weeks and infants with lower mean birth weight and longer nursery stays. No significant difference was seen in mean gestational age at delivery. This study had 80% power to detect a 7% reduction in the primary outcome. CONCLUSION: Prophylactic cerclage was not associated with a lower risk of preterm birth and adverse neonatal outcomes in twin pregnancies without history of cervical insufficiency.


Subject(s)
Birth Weight , Cerclage, Cervical , Pregnancy, Twin , Premature Birth/prevention & control , Adult , Female , Gestational Age , Humans , Length of Stay , Pregnancy , Retrospective Studies , Young Adult
12.
J Matern Fetal Neonatal Med ; 26(9): 881-4, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23311766

ABSTRACT

OBJECTIVE: To examine the influence of maternal pre-pregnancy body mass index (BMI) on the rates of recurrent spontaneous preterm birth (SPTB) in women receiving 17α-hydroxyprogesterone caproate (17P). METHODS: Retrospective analysis of a cohort of 6253 women with a singleton gestation and prior SPTB enrolled in 17P home administration program between 16.0 and 26.9 weeks. Data were grouped by pre-pregnancy BMI (lean <18.5 kg/m(2), normal 18.5-24.9 kg/m(2), overweight 25-29.9 kg/m(2) and obese ≥30.0 kg/m(2)). Delivery outcomes were compared using χ(2) and Kruskal-Wallis tests with statistical significance set at p < 0.05. RESULTS: SPTB<28 weeks was significantly lower in normal weight women. Rates of recurrent SPTB<37 weeks were highest in the group with BMI<18.5 kg/m(2). Lean gravidas were younger, more likely to smoke, and less likely to be African-American than those with normal or increased BMI. In logistic regression, after controlling for race and prior preterm birth <28 weeks, the risk of SPTB<37 weeks decreased 2% for every additional 1 kg/m(2) increase in BMI. CONCLUSIONS: Recurrent spontaneous preterm delivery<37 weeks in patients on 17P is more common in lean women (BMI<18.5 kg/m(2)), and less common in obese women (BMI ≥30 kg/m(2)) suggesting that the current recommended dosing of 17 P is adequate for women with higher BMI.


Subject(s)
Body Mass Index , Hydroxyprogesterones/administration & dosage , Premature Birth/epidemiology , Premature Birth/prevention & control , Progesterone Congeners/administration & dosage , 17 alpha-Hydroxyprogesterone Caproate , Adult , Cohort Studies , Female , Humans , Infant, Newborn , Obesity/complications , Obesity/epidemiology , Pregnancy , Pregnancy Complications/epidemiology , Recurrence , Retrospective Studies , Young Adult
13.
Am J Perinatol ; 29(8): 635-42, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22576126

ABSTRACT

OBJECTIVE: To examine pregnancy outcomes of women receiving weekly compounded 17 α-hydroxyprogesterone caproate (17P) injections through a home nursing program compared with those reported in a multicenter trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Network. METHODS: The study sample was comprised of patients receiving compounded 17P through a home nurse administration care management program. Included were women with current singleton gestation and prior spontaneous preterm birth (SPTB) initiating 17P between 16 and 20 weeks. Maternal characteristics and pregnancy outcomes were compared between study group and NICHD Network trial patients. RESULTS: Women (n = 5493) received a mean of 16.9 ± 4.0 injections. Of the 92,700 injections, 98.4% were administered within the recommended 5- to 9-day interval. Recurrent SPTB occurred in 28.3%. The overall rate of SPTB at <37 weeks was similar for black and nonblack women (p = 0.592). Within black or nonblack groups, preterm birth rates at <37 weeks were similar regardless of gestational age at start of 17P (p = 0.894 and p = 0.374, respectively). These results were similar to those reported in the multicenter trial. Fetal and neonatal death occurred in 0.8% (46/5493). No significant difference was observed in rate of fetal or neonatal death by gestational age at initiation of 17P (p = 0.478). CONCLUSION: Home nurse administration of compounded 17P is safe and effective.


Subject(s)
Hydroxyprogesterones/therapeutic use , Pregnancy Outcome , Premature Birth/prevention & control , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Adult , Drug Packaging , Female , Fetal Death/epidemiology , Home Care Services , Humans , Hydroxyprogesterones/administration & dosage , Infant Mortality , Infant, Newborn , Pregnancy
14.
Am J Perinatol ; 29(8): 643-8, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22644829

ABSTRACT

OBJECTIVE: To examine the effect of obesity on maternal and neonatal outcomes in women diagnosed with gestational diabetes mellitus (GDM) and managed with diet only, glyburide, or insulin. STUDY DESIGN: Women with singleton gestations enrolled for outpatient services diagnosed with GDM and without history of pregnancy-related hypertension at enrollment or in a prior pregnancy were identified in a database. Women with GDM controlled by diet only (n = 3918), glyburide (n = 873), or insulin without prior exposure to oral hypoglycemic agents (n = 2229) were included. Pregnancy outcomes were compared for obese versus nonobese women within each treatment group and also compared across treatment groups within the obese and nonobese populations. RESULTS: Within each treatment group, obesity was associated with higher rates of cesarean delivery, pregnancy-related hypertension, macrosomia, and hyperbilirubinemia (all p < 0.05). Higher rates of pregnancy-related hypertension and hyperbilirubinemia were observed in women receiving glyburide. CONCLUSION: Obesity adversely affects pregnancy outcome in women with GDM. Higher rates of pregnancy-related hypertension and hyperbilirubinemia were observed in pregnant women receiving glyburide.


Subject(s)
Diabetes, Gestational/epidemiology , Diabetes, Gestational/therapy , Glyburide/therapeutic use , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Obesity/epidemiology , Pregnancy Outcome/epidemiology , Comorbidity , Diabetes, Gestational/diet therapy , Female , Humans , Logistic Models , Pregnancy , Retrospective Studies , Risk Factors
15.
Am J Perinatol ; 29(7): 489-96, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22399213

ABSTRACT

OBJECTIVE: Examine adherence to treatment guidelines and rates of recurrent spontaneous preterm birth (SPTB) in managed Medicaid patients prescribed 17 α-hydroxyprogesterone caproate (17P). STUDY DESIGN: A retrospective observational study of women receiving 17P between July 2004 and May 2010 through one of Centene's managed Medicaid programs. Included for analysis were singleton pregnancies without cerclage having SPTB history and prescribed 17P by their physician. Compounded 17P was administered through an outpatient program inclusive of patient education, weekly home nurse visits, and 24-7 telephonic nurse access. A health plan-directed pregnancy management program, Start Smart for Your Baby(®), supported the therapy with case management activities. RESULTS: Of the 790 patients studied, 58.6% initiated 17P in the recommended 16- to 20.9-week gestational age window. Elective discontinuation of 17P occurred in 18.6%. Of the 10,583 17P injections administered, 97.5% were administered within the recommended injection interval of 6 to 10 days. Recurrent SPTB occurred in 28.2% of women studied. CONCLUSION: Managed Medicaid patients enrolled in an outpatient 17P administration program supported with maternal case management have high rates of treatment compliance. Their pregnancy outcomes compare favorably to previously published reports that include both Medicaid and commercially insured patients.


Subject(s)
Home Care Services , Hydroxyprogesterones/therapeutic use , Medicaid/statistics & numerical data , Premature Birth/prevention & control , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Adolescent , Adult , Female , Gestational Age , Guideline Adherence , Humans , Infant, Newborn , Infant, Premature , Medication Adherence , Practice Guidelines as Topic , Pregnancy , Pregnancy Outcome , Retrospective Studies , United States
16.
Am J Perinatol ; 29(6): 435-40, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22399219

ABSTRACT

OBJECTIVE: To determine if current recommendations for weight gain in twin pregnancies according to maternal prepregnancy body mass index (PPBMI) influence perinatal outcomes. METHODS: We identified women with twins enrolled in a maternity risk screening and education program with initial screening and prenatal care initiated at <20 weeks and delivery at >23.9 weeks. Women with normal, overweight, or obese PPBMI were included (n = 5129). Pregnancy outcomes were compared between those women with weight gain meeting or exceeding 2009 Institute of Medicine recommendations and patients who did not meet weight gain guidelines. RESULTS: Rates of spontaneous preterm delivery at <35 weeks were higher in all PPBMI groups for those with weight gain below guidelines. In all PPBMI groups, numbers of pregnancies with both infants weighing >2500 g or >1500 g were significantly higher for women gaining weight at or above guidelines. Logistic regression analysis was utilized to assess multivariate impact on outcome of spontaneous preterm delivery at <35 weeks showing that regardless of PPBMI level, women who gain below recommended guidelines are 50% more likely to deliver spontaneously at <35 weeks. CONCLUSION: In twin pregnancies, weight gain below recommended guidelines determined by maternal PPBMI is associated with higher rates of spontaneous preterm delivery at <35 weeks.


Subject(s)
Body Composition/physiology , Body Mass Index , Body Weight/physiology , Guideline Adherence/statistics & numerical data , Pregnancy, Twin/physiology , Premature Birth/etiology , Weight Gain/physiology , Adult , Female , Guidelines as Topic , Humans , Infant, Newborn , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , Pregnancy , Pregnancy Outcome , Retrospective Studies , United States
17.
J Matern Fetal Neonatal Med ; 25(7): 1034-8, 2012 Jul.
Article in English | MEDLINE | ID: mdl-21854134

ABSTRACT

OBJECTIVE: Examine rates of recurrent, spontaneous preterm birth (PTB) in women treated prophylactically with 17 α-hydroxyprogesterone caproate (17P) when the penultimate PTB was due to preterm labor (PTL) or preterm premature rupture of the membranes (pPROM). METHODS: Retrospective, descriptive, database study of 1183 singleton gestations that initiated prophylactic 17P at <21 weeks with a penultimate PTB. Primary outcomes examined were rates of recurrent PTB at <37 and <32 weeks' gestation in the PTL (n = 939) and pPROM (n = 244) cohorts. RESULTS: Recurrent PTB <37 weeks occurred in 38% versus 28.3% of the PTL and pPROM cohorts, respectively (p <0.005). Rates of recurrent PTB <32 weeks were similar. Logistic regression revealed three risk factors increased the odds of recurrent PTB: >1 previous PTB (OR 1.8 [95% CI: 1.33-2.44]); penultimate birth at 28-33.9 weeks' gestation (OR 1.61 [95% CI: 1.22-2.13]); and, PTL as the indication for delivery in the penultimate PTB (OR 1.66 [95% CI: 1.16-2.37]). CONCLUSION: Several historical factors increase the risk for recurrent PTB in women receiving 17P. Contrary to earlier studies of PTL and pPROM recurrence, women receiving prophylactic 17P with a penultimate PTB due to pPROM are at lower risk of recurrent PTB than those with a history of PTL.


Subject(s)
Hydroxyprogesterones/therapeutic use , Premature Birth/prevention & control , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Female , Fetal Membranes, Premature Rupture/epidemiology , Humans , Logistic Models , Pregnancy , Premature Birth/epidemiology , Retrospective Studies , Risk Factors , Secondary Prevention , Treatment Outcome , United States/epidemiology
18.
Am J Obstet Gynecol ; 205(3): 269.e1-6, 2011 Sep.
Article in English | MEDLINE | ID: mdl-22071060

ABSTRACT

OBJECTIVE: The purpose of this study was to determine the role of previous term delivery on the rate of recurrent preterm birth in women with previous spontaneous preterm delivery (SPTD) who receive 17-alphahydroxyprogesterone caproate (17P) therapy. STUDY DESIGN: Women with singleton gestations who were receiving 17P therapy were studied. Rates of recurrent SPTD were compared for 1 or ≥2 SPTD with and without a previous term delivery. RESULTS: Five thousand one hundred two women had 1 previous SPTD, and 2217 women had ≥2 SPTDs. In women with 1 previous SPTD, a previous term delivery had lower rates of SPTD at <35 weeks (8.4% vs 11.2%; P = .002) and preterm delivery at <32 weeks (4.7% vs 6.2%; P = .027) compared with those women with no such history. No differences were found for SPTD at <35 weeks with ≥2 SPTDs. CONCLUSION: In patients who received 17P therapy with 1 previous SPTD, a previous term delivery confers a reduction in risk of preterm delivery at <37, <35, and <32 weeks' gestation; such reduction is not evident with ≥2 previous SPTDs.


Subject(s)
Hydroxyprogesterones/therapeutic use , Premature Birth/prevention & control , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Adult , Female , Humans , Infant, Newborn , Infant, Premature , Pregnancy , Retrospective Studies , Risk , Secondary Prevention , Term Birth
19.
Am J Obstet Gynecol ; 205(3): 275.e1-5, 2011 Sep.
Article in English | MEDLINE | ID: mdl-22071063

ABSTRACT

OBJECTIVE: We sought to compare rates of recurrent spontaneous preterm birth (SPTB) in women receiving 17-α-hydroxyprogesterone caproate (17P) with prior SPTB due to preterm labor (PTL) vs preterm premature rupture of membranes (PPROM). STUDY DESIGN: Women with singleton gestation having 1 prior SPTB enrolled at 16-24.9 weeks' gestation for weekly outpatient 17P administration were identified from a database. Rates of recurrent SPTB were compared between those with prior SPTB due to PTL or PPROM overall and by gestational age at prior SPTB. RESULTS: Records from 2123 women were analyzed. The prior PTL group vs the prior PPROM group experienced higher rates of recurrent SPTB at <37 weeks (29.7% vs 22.9%, P = .004), <35 weeks (14.0% vs 9.1%, P = .004), and <32 weeks (5.9% vs 3.3%, P = .024), respectively. CONCLUSION: Reason and gestational age of prior SPTB influence the likelihood of recurrent SPTB in women receiving 17P prophylaxis.


Subject(s)
Fetal Membranes, Premature Rupture/prevention & control , Gestational Age , Hydroxyprogesterones/therapeutic use , Premature Birth/prevention & control , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Adult , Age Factors , Female , Fetal Membranes, Premature Rupture/drug therapy , Fetal Membranes, Premature Rupture/etiology , Humans , Infant, Newborn , Infant, Premature , Pregnancy , Premature Birth/drug therapy , Premature Birth/etiology , Secondary Prevention
20.
J Womens Health (Larchmt) ; 20(9): 1363-6, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21749262

ABSTRACT

OBJECTIVE: To compare pregnancy outcomes postbariatric surgery for women who remain obese at conception to those who were not obese. METHODS: From a database of women who received outpatient perinatal services, we identified women with a history of bariatric surgery who are currently pregnant with a singleton gestation. Available maternal characteristics and pregnancy outcomes were compared between women whose prepregnancy body mass index (PPBMI) remained in the obese range (≥30 kg/m(2)) and those with a PPBMI of <30 kg/m(2) using Fisher exact test, independent Student's t test, and Mann-Whitney U test statistics. RESULTS: Of the 102 women identified, 52 (51%) were obese and 50 (49%) were not obese at conception. No differences were observed in maternal age, marital status, years from surgery to delivery, development of gestational diabetes, gestational age at delivery, neonatal intensive care unit (NICU) admission, or nursery days. Maternal obesity (≥30 kg/m(2)) postbariatric surgery was associated with higher rates of cesarean delivery (63.5% vs. 36.0%, p=0.010) and development of pregnancy-related hypertension (36.5% vs. 8.0%, p=0.001) compared to nonobese women (<30 kg/m(2)). CONCLUSIONS: Postbariatric surgery, an optimal goal should be to achieve a nonobese weight status before conception to reduce maternal complications, such as pregnancy-related hypertension and cesarean delivery.


Subject(s)
Bariatric Surgery , Pregnancy Outcome , Adult , Cesarean Section/statistics & numerical data , Female , Humans , Hypertension, Pregnancy-Induced/epidemiology , Obesity/complications , Pregnancy , Retrospective Studies
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