William F. Rayburn

Double-blind comparison of intracervical and intravaginal prostaglandin E2 for cervical ripening and induction of labor

OBJECTIVEnOur purpose was to compare the safety and effectiveness of prostaglandin E2 delivered sequentially as an intracervical (0.5 mg) or intravaginal (2.5 mg) gel.nnnSTUDY DESIGNnHospitalized patients with an unfavorable cervix (Bishop score < or = 4) at > or = 35 weeks and requiring induction of labor were assigned to receive two 2.5 ml doses of gel intracervically and intravaginally in a double-blind, placebo-controlled manner. Second and third doses were given at 6-hour intervals until there were either regular uterine contractions or a Bishop score change > 3 points.nnnRESULTSnThe 100 evaluable cases received prostaglandin E2 either intracervically (n = 52) or intravaginally (n = 48). Difficulty with exact gel instillation was present with intracervical gel only, where spillage occurred in 85% of cases. Compared with intracervical therapy prostaglandin E2 given intravaginally was more likely to significantly change the Bishop score (60.4% vs 40.4%, p = 0.04) and stimulate regular contractions (72.9% vs 48.1%, p = 0.01). Uterine hyperstimulation was present in one case in each group.nnnCONCLUSIONnAlthough each was safe, instillation of prostaglandin E2 gel was better at a higher intravaginal dose than a lower intracervical dose because of its greater ease of administration and higher likelihood of cervical change.

Weekly administration of prostaglandin E2 gel compared with expectant management in women with previous cesareans

OBJECTIVEnTo compare the clinical effectiveness and safety of outpatient administration of intracervical prostaglandin (PG) E2 gel with expectant treatment for women desiring vaginal births after cesareans.nnnMETHODSnThis was a randomized, multicenter investigation involving term pregnant women who each had one previous low-transverse cesarean and an unfavorable cervix (Bishop score no more than 6), and who was a candidate for vaginal delivery. They were assigned to receive 0.5 mg of PGE2, (Prepidil; Pharmacia-Upjohn, Kalamazoo, MI) intracervically at 39 weeks gestation, repeated at weekly office visits for up to three doses, or expectant treatment. The main outcome variable was vaginal birth.nnnRESULTSnOf 294 cases, 143 received gel and 151 were treated expectantly. No differences between groups were found for maternal age, race, or Bishop score. Compared with the expectant treatment group, the PGE2 gel group was not more likely to deliver sooner or vaginally (57% versus 55%, P = .68). The onset of labor, duration of labor among those delivering vaginally, and 1- and 5-minute Apgar scores were not different between groups. No uterine ruptures occurred, and adverse effects were equally likely in both groups.nnnCONCLUSIONnAlthough its safety was confirmed for outpatient use, weekly doses of intracervical PGE2 did not improve the likelihood of vaginal births after cesareans.

Double-blind comparison of intravenous butorphanol (Stadol) and fentanyl (Sublimaze) for analgesia during labor

OBJECTIVEnOur purpose was to compare the analgesic properties, effect on labor, and maternal-fetal side effects of intravenous butorphanol and fentanyl.nnnSTUDY DESIGNnOne hundred patients with uncomplicated term pregnancies were enrolled during early active labor. Each patient received standard doses of either fentanyl (50 to 100 micrograms) or butorphanol (1 to 2 mg) hourly on request in a double-blind manner. Pain was scored independently by the nurse and patient with a 10-point visual analog scale. Categoric and measurement data were collected for comparison of the effects on uterine activity, maternal and fetal well-being, and neonatal outcomes.nnnRESULTSnThe fentanyl (n = 50) and butorphanol (n = 50) groups were identical with respect to maternal age, race, parity, and weight. Greater improvement in pain relief was found after the first dose of butorphanol than after fentanyl (p < 0.05). When fentanyl was given, either more doses were necessary (3.2 +/- 1.3 vs 2.1 +/- 1.1, p < 0.01) or epidural analgesia was requested more often (16%, 32% vs 9%, 18%, p < 0.05). Uterine contraction patterns for the first hour after dosing were unchanged, and the duration of the first and second stages of labor were not different between the two groups. No differences in maternal or newborn adverse effects were observed.nnnCONCLUSIONSnBoth drugs were equally safe and without effect on active labor. Butorphanol provided better initial analgesia than fentanyl with fewer patient requests for more medication or epidural analgesia.

Short-term effects of inhaled albuterol on maternal and fetal circulations

Short-term circulatory effects with the maximum recommended dose of inhaled albuterol (Proventil) were studied on 12 asthmatic patients between 33 and 39 weeks gestation. The mean maternal blood pressures and heart rates, systolic/diastolic ratios of the uterine arcuate and umbilical arteries, and fetal heart rates and aortic velocities were unaffected during the first 2 hours after dosing.

Refinements in performing a cesarean delivery.

Several refinements in performing a cesarean delivery have been proposed in recent years. The surgeon is now more aware of the potential of HIV virus exposure and is inclined to use techniques to minimize contact with sharp objects. Wide incisions of the skin and fascia are encouraged for greater ease in delivering the fetus. When possible, a low transverse uterine incision is attempted to allow for an improved chance of undergoing successful labor with any subsequent pregnancy. Spontaneous delivery of the placenta may reduce blood loss and decrease the chance of postoperative endometritis. Single layer closure of the uterus without closure of the peritoneum is as safe and effective as a two-layer closure. Not closing the visceral or parietal peritoneum appears to be an acceptable alternative. Superficial wound disruption may be minimized by either closing large, nondraining subcutaneous spaces or using continuous drainage. Limitations with descriptive experiences and randomized clinical trials should be appreciated when translating this information into routine surgical practice.

Attempted vaginal birth after cesarean section: a multicenter comparison of outpatient prostaglandin E2 gel with expectant management

Objective: To compare the clinical effectiveness and safety of outpatient administration of an intracervical prostaglandin (PG) E(2) gel with expectant management for women with an unfavorable cervix who wish to attempt a vaginal birth after cesarean section.Study Design: This outpatient study was a randomized, multicenter investigation involving pregnant women at term with one previous low transverse cesarean section. Each had an unfavorable cervix (Bishop score </=4) and was a candidate for vaginal delivery. Those randomly assigned to receive the gel, rather than expectant management, were given a 0.5 mg dose of PGE(2) (Prepidil) intracervically at 39 weeks gestation. This cervical ripening treatment was repeated at weekly office visits for up to 3 doses.Results: Of the 294 cases, 143 received the gel while 151 underwent expectant management. No differences between the two groups were found for maternal demographics, race, parity, or predose Bishop score. The rates of repeat cesarean section did not differ (P =.68) with use of the gel (61, 42%) or with expectant therapy (48, 45%). The onset of active labor, the duration of labor among those delivering vaginally, and the 1-minute and 5-minute Apgar scores were not different between the two groups. No uterine rupture was apparent, and adverse effects during labor were as likely to occur in the two groups.Conclusions: Although its safety was confirmed for outpatient use and for persons with a prior cesarean delivery, intracervical prostaglandin E(2) gel did not improve the chance of a vaginal birth after a cesarean delivery.

In utero drug therapy.

Drug therapy directed toward the fetus would be intended for either treating a fetal disorder or improving the capacity for later intrauterine or postnatal adaptation. Most reported trials involve single cases or small numbers of fetuses receiving the drug transplacentally after the first trimester, but before attaining maturity. Studies usually involve a single drug administered shortly before delivery. Treatments that are more direct or begun earlier in gestation are being attempted, but our limited understanding of fetal pharmacokinetics forces us to proceed cautiously. Studies to date have shown no risks to the mother and newborn infant, but long-term follow-up is necessary.

Managing Pregnancy-Related Nocturnal Nasal Congestion: The External Nasal Dilator

OBJECTIVEnTo assess the efficacy of an over-the-counter mechanical nasal dilator during sleep in pregnant women with nasal congestion.nnnSTUDY DESIGNnPregnant women with symptoms of nocturnal nasal congestion not attributed to allergies or cold symptoms were randomized in a double-blind manner to receive either a spring-loaded device or placebo device without a spring. Each patient assessed breathing and sleep quality for a three-day baseline and three-day treatment period. A 10-question diary was utilized to assess breathing, ease of falling asleep, sleep quality, and continuity and depth of sleep. Averaged scores for each question were computed for baseline and treatment periods, and differences were calculated. Statistical analyses were by the sign test, Fishers exact test and Students test.nnnRESULTSnThirty-four (21%) of 160 screened patients were enrolled into the study; 24 (15%) completed the study. All agreed to being assigned to receive either the spring-loaded device (n = 12) or a placebo (n = 12) device. Responses to 8 of the 10 questions favored the former as compared with the placebo (P = .05, sign test). Moreover, patients treated with the spring-loaded device gave more favorable responses to the question, Overall, compared with most nights, how easy was your breathing through-out last night? (P = .02, t test).nnnCONCLUSIONnUse of this drug-free external nasal dilator improved the ease of breathing among patients with pregnancy-related nocturnal congestion.