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PubMed2002

Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications.

Oral mucosal drug delivery is an alternative method of systemic drug delivery that offers several advantages over both injectable and enteral methods. Because the oral mucosa is highly vascularised, drugs that are absorbed through the oral mucosa directly enter the systemic circulation, bypassing the gastrointestinal tract and first-pass metabolism in the liver. For some drugs, this results in rapid onset of action via a more comfortable and convenient delivery route than the intravenous route. Not all drugs, however, can be administered through the oral mucosa because of the characteristics of the oral mucosa and the physicochemical properties of the drug. Several cardiovascular drugs administered transmucosally have been studied extensively. Nitroglycerin is one of the most common drugs delivered through the oral mucosa. Research on other cardiovascular drugs, such as captopril, verapamil and propafenone, has proven promising. Oral transmucosal delivery of analgesics has received considerable attention. Oral transmucosal fentanyl is designed to deliver rapid analgesia for breakthrough pain, providing patients with a noninvasive, easy to use and nonintimidating option. For analgesics that are used to treat mild to moderate pain, rapid onset has relatively little benefit and oral mucosal delivery is a poor option. Oral mucosal delivery of sedatives such as midazolam, triazolam and etomidate has shown favourable results with clinical advantages over other routes of administration. Oral mucosal delivery of the antinausea drugs scopolamine and prochlorperazine has received some attention, as has oral mucosal delivery of drugs for erectile dysfunction. Oral transmucosal formulations of testosterone and estrogen have been developed. In clinical studies, sublingual testosterone has been shown to result in increases in lean muscle mass and muscle strength, improvement in positive mood parameters, and increases in genital responsiveness in women. Short-term administration of estrogen to menopausal women with cardiovascular disease has been shown to produce coronary and peripheral vasodilation, reduction of vascular resistance and improvement in endothelial function. Studies of sublingual administration of estrogen are needed to clarify the most beneficial regimen. Although many drugs have been evaluated for oral transmucosal delivery, few are commercially available. The clinical need for oral transmucosal delivery of a drug must be high enough to offset the high costs associated with developing this type of product. Drugs considered for oral transmucosal delivery are limited to existing products, and until there is a change in the selection and development process for new drugs, candidates for oral transmucosal delivery will be limited.

Absorption↗

PubMed2004

Current status of delivery systems to improve target efficacy of oligonucleotides.

The tragic failure of gene therapy resulted in rolling back the research of gene-based medicine. Because of the poor delivery of gene-based medicines, such as antisense oligonucleotides, ribozyme, triplex, or gene both in vitro and in vivo, further development of gene-based medicines as therapeutic agents have stagnated. Although the delivery system plays a critical role in the overall efficacy of oligonucleotides, inappropriate target selection, improper evaluation methods and misinterpretation of results often caused the pessimistic view. Still, the decoding of the whole human genome has rekindled the enthusiastic development of delivery tools for gene-based medicine. We would like to focus on the newly developed delivery systems mainly for antisense oligonucleotides in this article. There are two ways to improve delivery efficacy of antisense oligonucleotides: One is the chemical modification of the antisense oligonucleotide backbone. The other way is by means of delivery vehicles, such as cationic liposomes, synthetic polymers, or non-viral vectors. We will review the current status of delivery vehicles both in vitro and in vivo. Delivery efficiency depends on the oligonucleotides' chemistry, length, size, net charge, cell/tissue type and administration route. It is difficult to deduce a common rule that affects delivery efficiency. Some cells like keratinocytes rapidly internalize oligonucleotides without a delivery system, which is contrary to common belief. Although we cannot extensively cover all reports, we will summarize several experiments with delivery system in vitro and in vivo. We will then address the possible factors promoting the efficient delivery of oligonucleotides.

Animals↗

PubMed2002

Assisted breech delivery, is the art fading?

OBJECTIVE: To review the modes of breech delivery over a 5 year period in Khamis Civil Hospital, Khamis Mushayt, Kingdom of Saudi Arabia, and to evaluate the trend and associated complications. METHODS: Relevant data was extracted from the delivery room records of all women delivered in Khamis Civil Hospital, Khamis Mushayt, Kingdom of Saudi Arabia, from 1st January 1996 through 31st December 2000. Available data was analyzed. RESULTS: There were 375 breech deliveries, constituting 2.8% of the entire deliveries in the hospital. Eighty-two percent of the breeches were delivered by cesarean section while 18% had assisted vaginal delivery (p=0.0193). Amongst 72 primigravidae breeches, 68 (94.4%) were delivered by cesarean section while 238 (78.5%) out of 303 multigravidae were delivered by cesarean section. There were 2 unexplained neonatal deaths among the vaginal delivery group in multigravidae. Cesarean delivery was associated with less morbidity compared to vaginal delivery. CONCLUSION: This study has demonstrated a significant increase in delivery of breeches by cesarean section and the resultant drop, in the number available for assisted breech delivery. Less obstetricians will therefore be exposed practically to the art of assisted breech delivery. Most practicing obstetricians seem to be more inclined towards delivering breeches by cesarean section. If this trend continues, the art of assisted breech delivery may fade.

Breech Presentation↗

PubMed2002

[Comparison of the risk of fetal hypoxia in active and expectant management of post-term delivery].

OBJECTIVE: Evaluation and comparison of risk of intrapartum foetal hypoxia in expectative and active approach after term of delivery. DESIGN: Retrospective analysis. SETTING: Gynaecological and Obstetric Clinic Medical Faculty, Masaryk University Brno. METHODS: The authors compared retrospectively two groups. Group A comprised 1906 deliveries in 1996, group B 2008 deliveries in 1999. In group A 194 deliveries after the 41st week term was applied. In group B there were 373 deliveries with an expectative approach, with inductions after the 42nd week of pregnancy. The authors evaluated the number of surgical and induced deliveries in after-term pregnancy in both groups and analyzed in indications. The post-delivery condition of neonates was evaluated in both groups according to the Apgar score during the 1st, 5th and 10th minute, In group B the authors had for the blood from the umbilical artery. The condition of neonates delivered by a surgical approach in group B was made more accurate by the base excess (BE) blood from the umbilical artery. The statistical significance of results was evaluated by the U-test and chi 2 test. RESULTS: The differences in the condition of neonates after delivery between the two groups are insignificant. In the expectative approach in 1999 there was a significant decline of the total number of induced deliveries and the total number of surgical deliveries. The difference in the number of surgical deliveries on account of imminent foetal hypoxia in group A and B are statistically insignificant. The number of hypoxic neonates is the same in both groups. CONCLUSION: Based on the results of comparison of the two groups it is obvious that the expectative approach is safe and medically justified. It is not associated with a greater risk of intrauterine foetal hypoxia. It does not lead to deterioration of perinatal results and leads to a marked reduction of induced deliveries.

Apgar Score↗

PubMedDate not supplied

Pharmaceutical approaches to colon targeted drug delivery systems.

PURPOSE: Although oral delivery has become a widely accepted route of administration of therapeutic drugs, the gastrointestinal tract presents several formidable barriers to drug delivery. Colonic drug delivery has gained increased importance not just for the delivery of the drugs for the treatment of local diseases associated with the colon but also for its potential for the delivery of proteins and therapeutic peptides. To achieve successful colonic delivery, a drug needs to be protected from absorption and /or the environment of the upper gastrointestinal tract (GIT) and then be abruptly released into the proximal colon, which is considered the optimum site for colon-targeted delivery of drugs. Colon targeting is naturally of value for the topical treatment of diseases of colon such as Chron's diseases, ulcerative colitis, colorectal cancer and amebiasis. Peptides, proteins, oligonucleotides and vaccines pose potential candidature for colon targeted drug delivery. METHODS: The various strategies for targeting orally administered drugs to the colon include covalent linkage of a drug with a carrier, coating with pH-sensitive polymers, formulation of timed released systems, exploitation of carriers that are degraded specifically by colonic bacteria, bioadhesive systems and osmotic controlled drug delivery systems. Various prodrugs (sulfasalazine, ipsalazine, balsalazine and olsalazine) have been developed that are aimed to deliver 5-amino salicylic acid (5-ASA) for localized chemotherapy of inflammatory bowl disease (IBD). Microbially degradable polymers especially azo crosslinked polymers have been investigated for use in targeting of drugs to colon. Certain plant polysaccharides such as amylose, inulin, pectin and guar gum remains unaffected in the presence of gastrointestinal enzymes and pave the way for the formulation of colon targeted drug delivery systems. The concept of using pH as a rigger to release a drug in the colon is based on the pH conditions that vary continuously down the gastrointestinal tract. Times dependent drug delivery systems have been developed that are based on the principle to prevent release of drug until 3-4 h after leaving the stomach. Redox sensitive polymers and bioadhesive systems have also been exploited to deliver the drugs into the colon. RESULTS: The approach that is based on the formation of prodrug involves covalent linkage between drug and carrier. The type of linkage that is formed between drug and carrier would decide the triggering mechanism for the release of drug in colon. The presence of azo reductase enzymes play pivotal role in the release of drug from azo bond prodrugs while glycosidase activity of the colonic microflora is responsible for liberation of drugs from glycosidic prodrugs. Release of drugs from azo polymer coated dosage forms is supposed to take place after reduction and thus cleavage of the azo bonds by the azoreductase enzymes present in the colonic microflora. Natural polysaccharides have been used as tools to deliver the drugs specifically to the colon. These polysaccharides remain intact in the physiological environment of stomach and small intestine but once the dosage form enters into colon, it is acted upon by polysaccharidases, which degrades the polysaccharide and releases the drug into the vicinity of bioenvironment of colon. However, they should be protected while gaining entry into stomach and small intestine due to enormous swelling and hydrophilic properties of polysaccharides. This has been achieved either by chemical crosslinking or by addition of a protective coat. Formulation coated with enteric polymers releases drug when pH move towards alkaline range while as the multicoated formulation passes the stomach, the drug is released after a lag time of 3-5 h that is equivalent to small intestinal transit time. Drug coated with a bioadhesive polymer that selectively provides adhesion to the colonic mucosa may release drug in the colon. CONCLUSIONS: Improved drug delivery systems are required for drugs currently in use to treat localized diseases of the colon. The advantages of targeting drugs specifically to the diseased colon are reduced incidence of systemic side effects, lower dose of drug, supply of the drug to the biophase only when it is required and maintenance of the drug in its intact form as close as possible to the target site.

Animals↗

PubMed2003

Cohort study of operative delivery in the second stage of labour and standard of obstetric care.

OBJECTIVE: To assess the maternal and neonatal morbidity following operative delivery in the second stage of labour in relation to the standard of obstetric care. DESIGN: Cohort study. SETTING: Maternity units in two teaching hospitals in Bristol, United Kingdom. Three hundred and ninety-three women with term, singleton, cephalic pregnancies who required operative delivery in theatre at full dilatation between February 1999 and February 2000. METHODS: Morbidity was compared for completed instrumental delivery, failed instrumental delivery and immediate caesarean section in relation to duration of second stage of labour, number of pulls at attempted instrumental delivery, number of instruments used and operator experience. MAIN OUTCOME MEASURES: Maternal trauma, admission to special care baby unit, neonatal trauma. RESULTS: Failed instrumental delivery after a long second stage of labour was associated with increased maternal trauma (adjusted odds ratios [OR] 4.1, 95% confidence interval [CI] 1.1, 16.5). More than three pulls at attempted instrumental delivery was associated with increased neonatal trauma for completed (adjusted OR 4.2, 95% CI 1.6, 9.5) and failed deliveries (adjusted OR 7.2, 95% CI 2.1, 24.0). Babies delivered after failed instrumental delivery with more than three pulls were at increased risk of admission to special care baby unit (adjusted OR 6.2, 95% CI 1.6, 22.8) The use of multiple instruments was associated with increased neonatal trauma (adjusted OR 3.1, 95% CI 1.5, 6.8; adjusted OR 4.4, 95% CI 1.3, 14.4, for completed and failed deliveries, respectively). Excessive pulls and multiple instrument use were associated with an initial attempt at vaginal delivery by an inexperienced operator, 25/48 (52%) and 34/75 (45%). CONCLUSIONS: Guidelines for safe operative delivery in the second stage of labour should be developed and adhered to in order to reduce morbidity, particularly neonatal trauma.

Cesarean Section↗

PubMed2005

Incidence of vaginal breech delivery in singleton in Siriraj Hospital.

OBJECTIVE: To determine the incidence of vaginal breech delivery at Siriraj Hospital and to evaluate factor affecting mode of delivery. DESIGN: Cross-sectional study. SETTING: Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University. SUBJECT: A total of 317 women with singleton breech presentation, > or =28 weeks of gestation, who had their deliveries at Siriraj Hospital during January 1st to December 31st 2003. MATERIAL AND METHOD: The medical records of these women were reviewed to determine the incidence of vaginal breech delivery. Characteristics regarding current pregnancy and delivery and maternal and fetal outcomes were evaluated, including parity, gestational age, estimate fetal weight, cervical dilation, membranes status, maternal complications, types of breech presentation, and being a private case. RESULTS: The incidence of vaginal breech delivery among these women was 17.7%. Univariate analysis showed that multiparity, gestational age of <32 weeks, estimate fetal weight of < or =2500 grams, advanced cervical dilatation, ruptured membranes, and not being a private case increased the risk of vaginal breech delivery. Multiple logistic regression analysis demonstrated that only advanced cervical dilatation (4-7 cm, adjusted OR 10.7, 95% CI 3.5-33.0; >7 cm adjusted OR 40.4, 95% CI 12.6-129.2), ruptured membranes (adjusted OR 2.9, 95% CI 1.3-6.3), multiparity (adjusted OR 6.4, 95% CI 2.6-15.7), and gestational age <32 weeks (adjusted OR 9.7, 95% CI 2.7-35.7) were independently associated with vaginal breech delivery. However, lower apgar scores and neonatal complications, especially prematurity, were more frequent in vaginal than cesarean delivery. CONCLUSION: Vaginal breech delivery was found in 17.7% of singleton breech presentation in Siriraj Hospital. Certain characteristics during labor and delivery were associated with mode of delivery including advanced cervical dilatation, ruptured membranes, multiparity, and preterm gestational age.

Adult↗

PubMed2006

Impact of deliveries on the office practice of family medicine.

INTRODUCTION: To prospectively evaluate the frequency of late-night deliveries and the cost of lost office hours, physicians serving mainly uninsured and Medicaid patients in an urban area established databases tracking office demographics and detailed information on each delivery. SUBJECTS AND METHODS: Time needed in the hospital during routine office hours and late night was tabulated for each delivery. Complete calendar years 2000-2003 were tabulated separately and in total. Overhead and opportunity costs were calculated using historical norms and actual costs. RESULTS: During the study, there were 490 deliveries, with 113 (23%) occurring late at night. Physicians retrospectively self-reported an average of 2.8 hours in the hospital for the average delivery, which included 105 (21%) Cesarean deliveries. There were an average of 9.5 prenatal visits with each delivery, and 23% of deliveries occurred late at night (11 p.m.-6 a.m.). The average delivery produced a net revenue of dollar 1,339. Deliveries caused physicians to be absent from the office for 371.5 hours over the four years. After deducting opportunity cost and continuing overhead, net revenue for the 48-month study period was dollar 646,858. Ancillary revenues were beyond the scope of the study design. CONCLUSION: These data suggest that delivery services in this community of urban underserved minorities can be self-supporting. This is the first study in the medical literature to provide data describing the impact of deliveries on physician practices outside of residency. Loss of physician sleep and revenue lost secondary to time away from the office were successfully measured. These data suggest that common beliefs frequently overestimate lifestyle interruptions and underestimate the financial losses of failure to deliver babies in this region. Future studies are suggested.

Adolescent↗

PubMed1996

Induction of thrombolysis and prevention of thrombus formation by local drug delivery with a double-occlusion balloon catheter.

The efficacy of the local delivery of an antithrombotic drug in preventing thrombosis and enabling thrombolysis was investigated in 29 dogs. An antithrombotic drug (heparin, 25 U/kg), or an antithrombin (argatroban, 0.05 mg/kg) was infused into injured canine iliac arteries, using a double-occlusion balloon catheter, and the preventive effect of the drug was evaluated. Local delivery of low-dose tissue-type plasminogen activator (t-PA; Tisokinase, 50,000 U; Kowa, Nagoya and Asahi Chemical Industries, Fuji, Japan) into thrombosed canine iliac arteries, using the same catheter, or intravenous infusion of low-dose or high-dose t-PA (30,000 U/kg) was also performed. Angiographically, stenotic thrombosis was 2% by local delivery of argatroban and 7% by local delivery of heparin (P < 0.01 vs each control; 47% and 51% respectively). Thrombotic stenosis, as observed by angiography, decreased from 91% to 9% after local delivery of t-PA, and from 94% to 52% in controls. Local delivery of t-PA effectively reduced the thrombus size (P < 0.01 vs control). After systemic intravenous delivery of low-dose t-PA, no reduction of residual thrombotic stenosis, was observed. Reduction of residual thrombotic stenosis after intravenous delivery of high-dose t-PA, was similar to that achieved by local delivery of the drug. Angioscopy demonstrated a similar trend. High-dose drug delivery reduced systemic coagulability. Local delivery of an antithrombotic drug, using a double-occlusion balloon catheter, effectively prevented thrombus formation, and local delivery of t-PA induced thrombolysis without exerting a significant influence on coagulability.

Angioscopy↗

PubMed1995

An objective definition of shoulder dystocia: prolonged head-to-body delivery intervals and/or the use of ancillary obstetric maneuvers.

OBJECTIVE: To generate an objective definition of shoulder dystocia by timing the events of the second and third stages of labor, and to define the true incidence of shoulder dystocia. METHODS: In 34 arbitrarily selected 24-hour time periods, a nonparticipating observer prospectively timed intervals of the second stage of labor in all vaginal deliveries and recorded the use of obstetric maneuvers (McRoberts, episiotomy after delivery of the fetal head, intentional extension of initial episiotomy after delivery of the fetal head, suprapubic pressure, posterior arm rotation to an oblique angle, rotation of the infant by 180 degrees, delivery of the posterior arm, and general anesthesia) and whether the obstetric attendant identified a delivery with shoulder dystocia. All data are reported as mean +/- standard error of the mean. RESULTS: Two hundred fifty deliveries were timed and recorded prospectively. Mean intervals (in seconds) in nonmaneuver patients were as follows: head to anterior shoulder 14.8 +/- 1.0, anterior to posterior shoulder 3.9 +/- 0.6, posterior shoulder to body 5.4 +/- 0.8, and total head-to-body time 24.2 +/- 1.3. Three groups of patients were defined after delivery. The maneuver group consisted of 27 patients requiring any of the aforementioned obstetric maneuvers, although the obstetric attendant identified only 16 of these as shoulder dystocia. The prolonged delivery group included 29 patients with the head-to-body delivery interval exceeding the mean plus two standard deviations (60 seconds) of nonmaneuver patients. Sixteen of the 27 maneuver patients were identified as prolonged. The 210 not identified as maneuver or prolonged were considered to be normal. Normal patients had a significantly lower newborn birth weight (3269 +/- 38 g), and a lower proportion of 1-minute Apgar scores of 7 or less (11%) than did the maneuver (4247 +/- 86 g, 41%) and prolonged groups (3952 +/- 118 g, 34%). Defining shoulder dystocia as a prolonged head-to-body delivery time and/or the use of obstetric maneuvers identified 40 patients who had birth weights and 1-minute Apgar scores significantly different from the normal patients. CONCLUSION: The incidence of shoulder dystocia, as defined by the use of ancillary obstetric maneuvers, is higher than that reported previously, and the reporting of shoulder dystocia appears to be unreliable. The interval from head-to-body delivery is delayed significantly in patients with shoulder dystocia, despite the lack of recognition of shoulder dystocia. We propose defining shoulder dystocia as a prolonged head-to-body delivery time (eg, more than 60 seconds) or the need for ancillary obstetric maneuvers.

Adult↗

PubMed1999

Prediction of preterm delivery with transvaginal ultrasonography of the cervix in patients with high-risk pregnancies: does cerclage prevent prematurity?

OBJECTIVES: We sought to determine the predictive accuracy for preterm delivery of transvaginal ultrasonography of the cervix between 14 and 24 weeks' gestation in high-risk patients and to determine whether cerclage prevents preterm delivery in patients with ultrasonographic cervical changes. STUDY DESIGN: Patients with asymptomatic singleton pregnancies at high risk for preterm delivery were followed prospectively from 14 weeks' to 23 weeks 6 days' gestation with transvaginal ultrasonography of the cervix. The subgroup of patients with either a cervical length of <25 mm or funneling of >25% or both was offered McDonald salvage cerclage, which was performed at the discretion of the patient and the obstetrician. The 2 groups (with and without cerclage) were compared for the primary outcome of preterm delivery at <35 weeks' gestation. RESULTS: One hundred sixty-eight women were followed, including 97 (58%) with >/=1 prior 14- to 34-week preterm deliveries. Of 63 (37. 5%) patients identified as having cervical changes, 23 (37%) had preterm delivery; of 105 patients with no cervical changes, 8 (8%) had preterm delivery (relative risk, 4.8; 95% confidence interval, 2. 3-10.1). The sensitivity, specificity, and positive and negative predictive values of either a short cervix of <25 mm or funneling of >25% or both were 74%, 70%, 37%, and 92%, respectively. Of 63 pregnancies in which there were cervical changes, 39 underwent cerclage and 24 did not. These 2 groups were similar for demographic characteristics, risk factors, and transvaginal ultrasonographic cervical length and funneling but dissimilar for gestational age at identification of cervical changes (18.3 vs 21.2 weeks' gestation in the groups with and without cerclage, respectively; P <.001). Multivariate logistic regression analysis after adjustment for gestational age at cervical changes showed no difference in the rate of preterm delivery between the groups with and without cerclage (odds ratio, 1.1; 95% confidence interval, 0.3-4.6). Stratified analysis of patients identified between 18 and 24 weeks revealed 22 pregnancies with cerclage and 22 pregnancies without cerclage, which was similar for all characteristics studied. The incidence of preterm delivery remained similar (27% vs 23%, respectively; P =.7), as did days from cervical changes to delivery (111 vs 96, respectively; P =.2). CONCLUSIONS: Transvaginal ultrasonography of the cervix between 14 and 24 weeks' gestation is a good predictor of preterm delivery in high-risk pregnancies. Cerclage may not prevent preterm delivery in patients identified to be at high risk for this outcome by transvaginal ultrasonography.

Cervix Uteri↗

PubMed2003

Maternal morbidity associated with cesarean delivery without labor compared with spontaneous onset of labor at term.

OBJECTIVE: To estimate the maternal morbidity associated with cesarean deliveries performed at term without labor compared with morbidity associated with spontaneous labor. METHODS: A 14-year, population-based, cohort study (1988-2001) using the Nova Scotia Atlee Perinatal Database compared maternal outcomes in nulliparous women at term undergoing spontaneous labor for planned vaginal delivery with singleton, cephalic presentation and nulliparous women delivering by cesarean without labor. RESULTS: From a total of 18,435 pregnancies, which satisfied inclusion and exclusion criteria, 721 were cesarean deliveries without labor. There were no maternal deaths or transfers for intensive care. There was no difference in wound infection, blood transfusion, or intraoperative trauma. Women undergoing cesarean deliveries without labor were more likely to have puerperal febrile morbidity (relative risk [RR] 2.2; 95% confidence interval [CI] 1.1, 4.5; P=.03), but were less likely to have early postpartum hemorrhage (RR 0.6; 95% CI 0.4, 0.9; P=.01) compared with women entering spontaneous labor. Subgroup analyses of maternal outcomes in women delivering by spontaneous and assisted vaginal delivery and cesarean delivery in labor were also performed. The highest morbidity was found in the assisted vaginal delivery and cesarean delivery in labor groups. CONCLUSION: The increased maternal morbidity in elective cesarean delivery compared with spontaneous onset of labor is limited to puerperal febrile morbidity. Maternal morbidity is increased after assisted vaginal delivery and cesarean delivery in labor compared with cesarean delivery without labor.

Adult↗

PubMed1998

Transverse arrest: a review of outcomes of rotational forceps and cesarean delivery at a single center.

Objective: To assess whether Kielland forceps rotational delivery causes a significant increase in maternal or perinatal morbidity in comparison with cesarean delivery in the clinical situation of transverse arrest. Rotational forceps delivery has been reported to have unacceptably high maternal and neonatal complication rates when compared with either spontaneous vaginal delivery or non-rotational forceps delivery. Clinically, however, we considered the more relevant comparison between Kielland rotational forceps delivery and cesarean delivery as these are generally the two modes of delivery for the fetus in transverse arrest.Study Design: The charts of all the mothers delivered by Kielland forceps or cesarean delivery for the main indication of transverse arrest between July 1995 and June 1996 were reviewed. The following were evaluated: Apgar scores at 1 and 5 minutes, cord pH, birth weight, neonatal superficial facial laceration or bruising, bone or nerve injuries, maternal injuries, 3rd and 4th degree perineal or vaginal lacerations, post-partum fever. Statistical analysis was by chi(2) (for Apgar scores), two-tailed Fisher Exact test (for post-partum fever), and t test (for birth weight and cord pH). A P value <.05 was considered statistically significant.Results: Fifty-two Kielland forceps and 30 cesarean deliveries were performed. One-minute Apgar scores of less than or equal to 7 were noted in 11.5% and 6.7% of the forceps and cesarean section groups, respectively (P = NS); mean arterial cord pH was 7.26 for both groups; no cases of post-partum fever were noted in the forceps versus 16% in the cesarean group (P <.05); the mean weight was 3,316 and 3,569 g for the forceps and cesarean group, respectively (P <.05). The Kielland group was also characterized by the following: 19 facial bruising and 2 temporary facial nerve injury (resolved by the time of discharge), 3 perineal lacerations, and 3 vaginal tears. No blood transfusions were required for either group.Conclusions: To our knowledge, this is the first study that compares rotational forceps delivery for transverse arrest with its true clinical alternative, cesarean delivery.No significant difference in cord pH and Apgar scores were noted between the two groups. The birth weight was greater and post-partum fever was more common in the cesarean section group. Neonatal facial bruising, temporary facial nerve palsy, and maternal perineal and vaginal lacerations were more common in the forceps groups. This study suggests that rotational forceps may be a reasonable alternative to cesarean delivery in the management of transverse arrest.

Journal Article↗

PubMed1998

Elective repeat cesarean delivery vs trial of labor: a comparison of morbidities in a community hospital setting.

Objective: In an attempt to reduce the cesarean delivery rate nationally, many obstetricians are offering a trial of labor to their patients who have had a prior low transverse cesarean delivery. Many studies have demonstrated the success and safety of a vaginal birth after cesarean. However, few studies have actually compared elective repeat cesareans with a trial of labor. Recent articles suggest that the morbidities associated with a failed trial of labor (TOL) may be more serious than that associated with an elective repeat cesarean delivery (RC/D). Our objective was to review and compare the morbidities and complications of repeat elective cesarean delivery versus patients attempting a trial of labor in our institution.Methods and Materials: A retrospective or nonconcurrent cohort study was conducted. Inclusion criteria included all women at our institution who had delivered from July 1993 through March 1997 and had a prior cesarean delivery. Patients were eligible for a trial of labor according to the recommendations of ACOG Practice Patterns. Exclusion criteria were nonvertex presentation, prior classical or T-incision, placenta previa, previous myomectomy, or multiple gestation. The patients were divided into those who underwent an elective repeat delivery and those who consented to a trial of labor. Outcomes studied included major complications (uterine rupture or operative injury) and minor complications (puerperal fever, postpartum hemorrhage requiring transfusion or operative intervention, or abdominal wound infection). Data were ascertained from medical records, the delivery log book, and the Quality Improvement data base. Prior to performing this study, a power analysis was conducted using an alpha of 0.05 and beta of 0.20. The required number in each arm was 2,280 to determine a 50% difference in outcome.Results: There were 1,148 women who had a repeat cesarean delivery during the study time period. Of that, 174 were excluded by the criteria, leaving 973 eligible. There were 1,030 women who underwent a trial of labor. Seven hundred seventy-three women successfully delivered vaginally (75%). The overall maternal morbidity was 2.4%; 0.8% had a major complication and 1.5% had a minor complication. The total complication rate was similar for both the trial of labor group (TOL) and the elective repeat cesarean delivery group (RC/D): 2.33% and 2.57%, respectively. However, major complications were more frequent among those that attempted a trial of labor than those who underwent an elective repeat cesarean delivery; 1.65% versus 0.1% (relative risk 16.08 with a 95% CI of 2.14-120.57; P =.00024). The relative risk for minor complications in the TOL group compared to the RC/D group was 0.28 with a 95% CI 0.12-0.64 (P =.001). Stratified analysis of the TOL group was performed. Compared to the RC/D group, those who failed VBAC had a relative risk for major complications of 56.85 using a 95% CI of 7.45-428.37. The successful VBAC group did not have statistically higher major complication rate (RR = 2.52, CI 0.23-27.74, P =.4).Conclusions: At our institution, there is a trend that major maternal complications are more frequent among those who have a trial of labor compared to those who have an elective repeat cesarean delivery. This trend was even more evident in those who failed a VBAC trial. When VBAC was successful, complications did not seem to be higher than repeat cesarean delivery. Our study did not have the power because of insufficient numbers in each arm. However, data collection is continuing to achieve the power to this study. This prompted us to reconsider the safety for a trial of labor. Perhaps more stringent criteria for selection of VBAC candidates and determination of when a trial of labor should be abandoned need to be defined. Ongoing study is warranted in this area.

Journal Article↗

PubMed2001

Psychosocial predictors of disappointment with delivery and puerperal depression. A longitudinal study.

BACKGROUND: To examine the extent to which personality characteristics, depression, fear and anxiety about pregnancy and delivery, and socio-economic background, predict disappointment with delivery and the risk of puerperal depression. METHODS: Two hundred and eleven women filled in questionnaires measuring personality traits, socio-economic factors, and marital satisfaction once before and once after the 30th week of pregnancy, and 2 3 months after delivery, when obstetric data about pregnancy and delivery was also collected. RESULTS: The women who were disappointed with their delivery or suffered from puerperal depression had been more depressed already in early pregnancy. Regression analysis showed that the strongest predictors of disappointment with delivery were labor pain (increase in R2 = 0.14, p<0.001) and emergency Cesarean (increase in R2 = 0.18, p<0.001). Puerperal depression was predicted by depression (increase in R2 = 0.16, p<0.001), and by personal traits such as general anxiety, vulnerability and neuroticism (increase in R2 = 0.32, p<0.001), both before 30 weeks of pregnancy and prior to the delivery (for depression increase in R2 = 0.05, p<0.001, and for anxiety and vulnerability increase in R2 = 0.04, p<0.01). The strongest predictors were depression at both time points before delivery (beta = 0.51, p<0.001, and beta = 0.39, p<0.001). Pregnancy- and delivery-related anxiety prior to the delivery also predicted puerperal depression, but complications of the pregnancy and delivery did not. CONCLUSIONS: Depression in early pregnancy predicts disappointment with the delivery and is a strong predictor of puerperal depression.

Adolescent↗

PubMed2002

Maternal second-trimester serum ferritin concentrations and subsequent risk of preterm delivery.

We studied the relationship between maternal second-trimester serum ferritin concentrations and preterm delivery. The 312 preterm delivery cases, studied in aggregate and in subgroups [spontaneous preterm labour, preterm premature rupture of membranes, medically induced preterm delivery, moderate preterm delivery (gestational age at delivery 34-36 weeks) and very preterm delivery (gestational age at delivery <34 weeks)] were compared with 424 randomly selected women who delivered at term. Maternal ferritin concentrations, measured in serum collected at 17 weeks gestation on average, was determined using a two-site chemiluminometric immunoassay. Using multiple logistic regression, we derived maximum likelihood estimates of adjusted odds ratios (OR) and 95% confidence intervals [CI]. Elevation in maternal second-trimester ferritin was weakly associated with the risk of preterm delivery overall. After adjusting for possible confounding by maternal age, race/ethnicity, parity, Medicaid payment status and smoking during the index pregnancy, the OR for extreme quartiles (>64.5 vs. <26.0 ng/mL) of ferritin was 1.3 [95% CI 0.8, 2.1]. Stratified analyses indicated that elevated maternal serum ferritin was associated with an increased risk of preterm premature rupture of membranes (OR = 2.1; 95% CI 1.1, 4.1), but not with spontaneous preterm labour (OR = 0.9; 95% CI 0.4, 1.7) or medically induced preterm delivery (OR = 1.1; 95% CI 0.6, 2.0). The relationship between elevated maternal second-trimester serum ferritin concentrations and preterm delivery was strongest for spontaneous very preterm deliveries (<34 weeks gestation). Women with ferritin concentrations in the highest decile (>96 ng/mL) experienced a 2.7-fold increased risk of delivering before 34 completed weeks, compared with women with concentrations <26.0 ng/mL. These results are consistent with some previous reports, and further underline the potential for heterogeneity in the aetiology of preterm delivery.

Adult↗

PubMed2006

Does hospitalization prevent preterm delivery in the patient with a short cervix?

This study considers whether admission to the hospital of a patient diagnosed with a short cervix delayed delivery, prevented preterm delivery, and/or decreased the rate of change in the cervical length (CL) on follow-up measurements. The design was a retrospective cohort study of women carrying singleton pregnancies with cervical lengths <or= 25 mm at gestational ages 16 to 28 weeks managed expectantly from July 2002 through July 2005. Eighty-two patients met criteria for inclusion, 26 (32%) of whom were hospitalized. On univariate analysis, hospitalization correlated with delivery < 34 weeks ( p=0.027), an earlier gestational age (GA) at delivery ( p=0.046), and a shorter time from diagnosis to delivery ( p< .001). Multivariate regression analysis of significant factors (age, prior preterm births, initial CL, GA at diagnosis, and hospitalization) showed a correlation between hospitalization and increased rate of cervical shortening ( p=0.005), and a trend toward hospitalization as an independent risk factor for delivery less than 34 weeks ( p=0.066), an earlier GA at delivery ( p=0.058), and a shorter time from diagnosis to delivery ( p=0.078). There also was no benefit seen from hospitalization when the initial CL was < 15 mm, although we were underpowered for this analysis. Admission to the hospital was not associated with a decreased rate of preterm delivery and there was a trend toward hospitalization as an independent risk factor for delivery at < 34 weeks, an earlier GA at delivery, and a shorter time from diagnosis to delivery. Hospitalization was independently associated with an increased rate of cervical shortening.

Adult↗

PubMed2004

Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery.

BACKGROUND: The proportion of women who attempt vaginal delivery after prior cesarean delivery has decreased largely because of concern about safety. The absolute and relative risks associated with a trial of labor in women with a history of cesarean delivery, as compared with elective repeated cesarean delivery without labor, are uncertain. METHODS: We conducted a prospective four-year observational study of all women with a singleton gestation and a prior cesarean delivery at 19 academic medical centers. Maternal and perinatal outcomes were compared between women who underwent a trial of labor and women who had an elective repeated cesarean delivery without labor. RESULTS: Vaginal delivery was attempted by 17,898 women, and 15,801 women underwent elective repeated cesarean delivery without labor. Symptomatic uterine rupture occurred in 124 women who underwent a trial of labor (0.7 percent). Hypoxic-ischemic encephalopathy occurred in no infants whose mothers underwent elective repeated cesarean delivery and in 12 infants born at term whose mothers underwent a trial of labor (P<0.001). Seven of these cases of hypoxic-ischemic encephalopathy followed uterine rupture (absolute risk, 0.46 per 1000 women at term undergoing a trial of labor), including two neonatal deaths. The rate of endometritis was higher in women undergoing a trial of labor than in women undergoing repeated elective cesarean delivery (2.9 percent vs. 1.8 percent), as was the rate of blood transfusion (1.7 percent vs. 1.0 percent). The frequency of hysterectomy and of maternal death did not differ significantly between groups (0.2 percent vs. 0.3 percent, and 0.02 percent vs. 0.04 percent, respectively). CONCLUSIONS: A trial of labor after prior cesarean delivery is associated with a greater perinatal risk than is elective repeated cesarean delivery without labor, although absolute risks are low. This information is relevant for counseling women about their choices after a cesarean section.

Adolescent↗