James E. Maher

Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial.

OBJECTIVE Our purpose was to determine whether chlorhexidine vaginal irrigation prevents maternal peripartal infection. STUDY DESIGN A double-blinded, placebo-controlled, randomized trial was performed. Single 200 ml irrigations of either 0.2% chlorhexidine solution or sterile water placebo were given in active labor or before planned cesarean delivery. The primary outcome measure was the combined rate of chorioamnionitis and endometritis (which were mutually exclusive diagnoses). RESULTS A total of 1024 patients were enrolled: 508 in the chlorhexidine group and 516 in the placebo group. The two groups were generally well balanced on important clinical factors but differed (p < 0.05) in rates of nulliparity (chlorhexidine 42%, placebo 52%), intrauterine pressure catheter usage (chlorhexidine 65%, placebo 72%), and presence of meconium (chlorhexidine 17%, placebo 22%). There were no recognized adverse maternal or neonatal reactions to irrigation. Rates of infection (chorioamnionitis + endometritis) did not differ significantly between the groups, chlorhexidine 10% versus placebo 13% (relative risk 0.8, 95% confidence interval 0.5 to 1.1). Stratified and logistic regression analyses supported the primary univariate analysis. Neonatal outcomes, including sepsis rates of 0.4%, were equivalent for the groups. CONCLUSION As used in this trial, chlorhexidine lacked efficacy in the prevention of maternal peripartal infection.

Characteristics of successful claims for payment by the Florida Neurologic Injury Compensation Association Fund

OBJECTIVES Our purpose was to examine the obstetric characteristics of claims paid by the State of Florida after the birth of a neurologically impaired child. STUDY DESIGN The Florida Birth Related Neurological Injury Compensation plan is a no-fault alternative to litigation for compensation after a catastrophic neurologic birth injury. The plan has specific criteria for inclusion. We retrospectively analyzed claims for compensation that were accepted and paid (n = 64) after a birth-related neurologic injury. Simple description statistics were compiled for the relative frequencies of various obstetric correlates found in successful claims for payment. RESULTS Seventy percent of infants (45) were delivered by cesarean section and 15 of 19 vaginal deliveries (79%) were operative (forceps or vacuum), yielding a 94% operative delivery rate. A persistent nonreassuring fetal heart rate tracing was seen before delivery in all cases. The 5-minute Apgar score was < or = 6 in 91% of deliveries and the 10-minute Apgar score was < 6 in 86% of deliveries. When first examined in the labor and delivery suite, 17 women had a nonreassuring fetal heart rate, and a nonreassuring tracing developed in labor in 47. Nine attempts at vaginal birth after a cesarean section led to a uterine rupture. Seven of these deliveries were either inductions or augmentations against an unfavorable cervix. Forty-five percent (27) of deliveries were associated with meconium-stained amniotic fluid, including 17 infants with meconium aspiration syndrome. There were three shoulder dystocias and four infants with group B streptococcal sepsis. In eight cases (12.5%), there appeared to be a breach of the published standard of care, which contributed to the poor outcome. CONCLUSION Most of these cases should not have been eligible for compensation in a traditional tort-based system because the applicable standard of care was not breached. Meeting the published standard for perinatal care failed to prevent these devastating neurologic injuries. Obviously, not all intrapartum injuries can be prevented; however, if we are to prevent similar injuries in the future, we will need to examine the clinical management in these or similar case for clues to develop novel strategies to respond to intrapartum emergencies. An unexpected finding was the frequency of catastrophic birth injuries after an attempted vaginal birth after cesarean section with the predominance of these deliveries associated with oxytocin stimulation against an unripe cervix. It is apparent that the push to lower cesarean section rates is not without some risk.

The construction and utility of an amniocentesis trainer

OBJECTIVE Our goal was to design an inexpensive amniocentesis trainer for instruction and practice with ultrasonography-assisted needle guidance and the freehand technique. STUDY DESIGN The amniocentesis trainer was constructed from a commercially available 5.3-L storage box (No. 5805; Rubbermaid Incorporated, Wooster, Ohio). Sonodense sperical targets 2.3 cm in diameter were taped to the bottom, and the box was filled with a gelatin mixture. The box was covered with a rubber membrane from a pelviscopy trainer (United States Surgical Corp, Norwalk, Conn). After the gelatin mixture set overnight at 40 degreesF, the amniocentesis trainer was ready for use. RESULTS When a needle is introduced through the membrane into the gelatin, the ultrasonographic image is a reasonable simulation of an amniocentesis. The trainer improved the ability of an operator to perform a freehand amniocentesis, orient the ultrasound transducer, follow a needle with continuous ultrasonographic guidance, and hit a 2-cm target. The gelatin also allows for evaluation of improvement between amniocentesis attempts because a faint image of the needle track from prior attempts remains visible. Once basic amniocentesis skills are mastered, the trainer is easily modifiable so that obstacles can be added that could simulate umbilical cord and fetal extremities. CONCLUSIONS We were able to construct an inexpensive amniocentesis trainer that facilitates instruction in the freehand amniocentesis technique. This trainer enables an operator to master the skills necessary to perform the technique of freehand ultrasonography-guided amniocentesis under direct ultrasonographic visualization without putting a patient through the discomfort of participating in the learning curve.

The predictive value of umbilical artery Doppler studies for preeclampsia or fetal growth retardation in a preeclampsia prevention trial.

Objective: To determine the clinical utility of longitudinal Doppler umbilical artery systolic‐diastolic ratios (S/D) to predict the occurrence of either preeclampsia or fetal growth retardation (FGR) in a low‐risk population. Methods: Healthy nulliparas with singleton gestations were enrolled in a double‐blind trial of low‐dose (60 mg) aspirin for preeclampsia prevention. Treatment was initiated at 24 weeks and continued until delivery. Continuouswave Doppler studies were scheduled before assignment to treatment and at 27‐31, 32‐36, and 37‐42 weeks. Preeclampsia was defined as a persistent diastolic blood pressure of at least 90 mmHg with proteinuria, and FGR was defined as birth weight below the tenth percentile. Doppler values were considered abnormal if they exceeded the 90th percentile for the gestational age range in the study population. Summary predictive values were computed for the abnormal S/D at each gestational age interval. To assess the potential effect of the administration of low‐dose aspirin, logistic regression was used to model the relation between the Doppler indices, aspirin use, and these abnormal pregnancy outcomes. Results: A total of 1665 Doppler examinations were performed on 565 women. Forty‐four fetuses developed FGR and 21 women were diagnosed with preeclampsia. The positive predictive values of an abnormal S/D for the subsequent development of FGR were 13‐17% across the gestational age ranges studied, and the positive predictive values for preeclampsia were 0‐5%. Aspirin treatment did not affect the relation between the Doppler indices and these outcomes in the logistic regression model. Conclusion: Elevated umbilical artery S/D is not a clinically useful predictor of either FGR or preeclampsia in a low‐risk population. (Obstet Gynecol 1994;83:609‐12)