NEW YORK (Reuters Health) – Cervical ripening using misoprostol combined with a transcervical Foley bulb effectively shortens the course of induced labor, new research shows.
“When a patient undergoes induction of labor, ripening of the cervix with a combination of prostaglandin (misoprostol) and an intracervical balloon will shorten the time to delivery by approximately 4 hours, compared to ripening with prostaglandin alone,” said Dr. Barak M. Rosenn of Mt. Sinai West in New York City.
“Shortening the time to delivery has the potential to decrease the risk of maternal and neonatal complications, save costs, improve resource utilization, and increase patient satisfaction,” he told Reuters Health by email.
Dr. Rosenn and colleagues conducted a randomized controlled trial in women admitted for cervical ripening at one academic medical center. Their results appeared online December 4 in Obstetrics & Gynecology.
They included women at 37 weeks’ or greater gestational age who also had intact membranes, singleton fetus, cephalic presentation and Bishop score of 6 or lower. Among the exclusion criteria were prior uterine surgery, ruptured membranes and any contraindication to vaginal delivery.
Patients being admitted to the labor and delivery unit for labor induction were assessed for eligibility and were asked to participate in the study. Over almost 10 months, 100 women underwent cervical ripening using misoprostol alone and 100 others received misoprostol along with a transcervical Foley bulb.
The women in both groups were similar with respect to gestational age, parity, Bishop score, birth weight, body mass index and reason for induction.
Participants, health care providers and investigators were not blinded or masked to the group allocation.
Women in the misoprostol-only group were given 25 mcg of misoprostol (100-mcg tablet cut into quarters) inserted vaginally into the posterior fornix every four hours, to a maximum of six doses.
Women in the combination group received vaginal misoprostol in the same manner as the misoprostol-only group. In addition, a Foley catheter with a 30-cc balloon was inserted digitally or by direct visualization using a sterile speculum through the internal os, and the balloon was filled with 60 cc of normal saline.
The time to delivery was significantly shorter in the combined-treatment group (median, 15 hours vs. 19 hours, P=0.001); the difference remained significant in subanalysis by parity and after excluding Cesarean births.
Dr. Rosenn noted that, although other studies have shown that combining the two methods of cervical ripening shortens the time to delivery, publishing these results is important as they can help encourage clinicians to adopt evidence-based practices.
Dr. Yvonne Butler Tobah, an obstetrician and gynecologist at Mayo Clinic in Rochester, Minnesota, told Reuters Health by email that the trial was well-designed.
“The combined approach appears safe, as there were no differences between the study groups with respect to Cesarean deliveries, estimated blood loss during delivery, infection during labor (chorioamnionitis), or too-frequent uterine contractions (tachysystole),” said Dr. Tobah, who was not involved in the study.
“The combined approach was also safe for the fetus and newborn, as there were no differences between groups with respect to the newborn’s birth weight, 5-minute Apgar score, and admission to the neonatal intensive care unit,” she added.
“The induction process can be quite long, lasting on occasion 48 to 72 hours. It is often dissatisfying to the patients, and the risk of complications, such as developing chorioamnionitis and bleeding more than usual, increases when the labor process is prolonged,” Dr. Tobah explained. “An approach that shortens the course of labor would be beneficial to expectant mothers, their newborns, and their team of obstetric providers.”
The study was presented at the Society for Maternal-Fetal Medicine 37th Annual Pregnancy Meeting in Las Vegas, Nevada, in January 2017.
SOURCE: http://bit.ly/2Cb1rra
Obstet Gynecol 2017.
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