Biomedical subjects

DE Soper

Publications and source records attributed to DE Soper.

At least 19 recordsLinked to original sources

PubMed1999

Gynecologic Complications of Bacterial Vaginosis: Fact or Fiction?

Bacterial vaginosis is a complex alteration of vaginal flora causing mild symptoms in women characterized by a milky vaginal discharge associated with a fishy odor worsened after unprotected vaginal coitus. It is the most common cause of vaginitis. It is now clear that this seemingly harmless disorder causing nuisance symptoms is linked to a number of important adverse reproductive tract sequelae, including the obstetrical sequelae of preterm labor and delivery. Literature published over the past year continue to support the association of bacterial vaginosis with adverse gynecologic sequelae in women.

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PubMed1998

Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.

Objective: To compare the safety and efficacy of 0.75% metronidazole vaginal gel (MGV) administered QD for 5 days to MGV administered BID for 5 days for the treatment of bacterial vaginosis (BV).Methods: Nonpregnant women 18 years or older with a diagnosis of BV were enrolled into this trial. Patients were determined to have BV if their vaginal discharge had >/=20% clue cells and if they had at least 2 of the following criteria: homogeneous discharge, positive KOH amine odor test, or vaginal pH >/=4.7. In addition, microbiologic confirmation of BV at baseline was required to be evaluable. Patients were evaluated at baseline and at 7-12 days after completion of therapy. If patients remained free of BV after therapy, they were evaluated at a follow-up visit 28-35 days after therapy.Results: A total of 514 patients were enrolled in the trial; 252 in the QD treatment group and 262 in the BID treatment group. Clinical cure rates based on patients considered evaluable at first return visits were 77% and 80% for QD and BID dosing regimens, respectively. Clinical cure rates based on patients considered evaluable at the final visit were 58% and 61% for QD and BID dosing regimens, respectively. Clinical cure rates at the final return visit based on intent-to-treat analysis were 53% and 57% for the QD and BID regimens, respectively. Two adverse events in two patients were reported as serious. Both adverse events resolved and neither event was judged to be related to therapy.Conclusion: MetroGel-Vaginal administered QD for 5 days was found to be as effective as MetroGel-Vaginal administered BID for 5 days in the treatment of bacterial vaginosis 28-35 days after therapy. The number of patients reporting adverse events judged to be related to therapy was also statistically comparable in both treatment groups.

Journal Article↗

PubMed1998

Safety and cost-effectiveness of managing patients at risk for immediate preterm delivery on a minimum care unit.

Objective: To evaluate the safety and effectiveness of managing pregnant women with 1) preterm, premature rupture of the membranes, 2) preterm labor with advanced cervical dilitation and effacement, and 3) complete placenta previa on a minimum care unit obviating the need for routine hospitalization.Methods: After obtaining informed consent, patients with the above noted diagnoses were placed in a minimum care unit with close proximity to labor and delivery (Perinatal Access and Support Services [PASS Program]). Physicians saw the patients on a regular weekly basis, while nurses saw the patients daily. The majority of each patient's care and daily assessment was performed by the patient, herself, much as if the patient was discharged to home. Neonatal outcome was assessed and a cost comparison between routine hospitalization and utilization of the minimum care unit was calculated.Results: Sixty-one patients consented to participate in the PASS program. The mean gestational age on admission vs delivery was 30 4/7 weeks vs 31 5/7 weeks for patients with premature rupture of the membranes and 29 3/7 weeks vs 34 4/7 weeks for patients with preterm labor and advanced cervical dilatation. All complaints resulting in a transfer to labor and delivery were initiated by the patient and not the nurse or physician provider. All four neonatal deaths were due to complications of immaturity (gestational ages <24 weeks). There were no intrauterine fetal demises on the minimum care unit. Utilization of this program saved over $220,000 in hospital costs.Conclusion: The PASS program is a safe, cost-effective alternative to routine hospitalization for patients who do not need routine hospitalization but who must have immediate access to labor and delivery.

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PubMed1996