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Date: September 20, 1995
For Release: 6:00 PM EST
Contact: NIH/NICHD (301) 496-5133

Mixed Results for Important NICHD-Funded Study
of Actively Managed Labor and Delivery


A team of researchers supported by the National Institute of Child Health and Human Development (NICHD) has found that a highly regarded "active management" approach to labor and delivery yielded mixed results for U.S. women. The extensive clinical trial was the largest, most intensive effort yet to test the new approach.

On one hand, the researchers discovered several benefits of the approach: it decreased the average length of labor, reduced by three fold the percentage of women experiencing labor lasting longer than 12 hours, and also cut back the likelihood of maternal fever, an indication of uterine infection.

On the other hand, the method did not reduce the rate of cesarean delivery--something its proponents eagerly hoped it would.

The study appeared as the lead article in the September 21 issue of The New England Journal of Medicine. The research team was led by Fredric D. Frigoletto, Jr., MD, from the Departments of Obstetrics and Gynecology at Brigham and Women s Hospital in Boston and Harvard Medical School in Boston when the study was conducted, and now at Massachusetts General Hospital in Boston. In addition to financial support from the NICHD, the investigators also received funding from Brigham and Women s Hospital and the Harvard Community Health Foundation.

In recent years, concern has been voiced that the cesarean rate may be too high, as cesarean delivery carries an increased risk of maternal and infant illness and death. In the report Healthy People 2000: National Health Promotion and Disease Prevention Objectives, the U.S. Department of Health and Human Services recommended that the cesarean rate be reduced to no more than 15 deliveries per 100 births. Approximately 24 percent of all births now are by cesarean section.

The active management approach to labor was pioneered by physicians at the National Maternity Hospital in Dublin, Ireland, the authors explained in the article. This active approach involves strict criteria for diagnosing labor, intervention with a labor-inducing drug in the event of weak uterine contractions, and ensuring that hospital staff never leave a woman unattended during labor. Because the rate of cesarean delivery at the National Maternity Hospital has remained consistently lower than in most of the industrialized world, many practitioners of obstetrics have employed it to try to reduce cesarean rates at their facilities. Several smaller studies have also found that the approach reduced cesarean rates.

A total of 1915 women delivering their first baby participated in the U.S. study. Of these, 1009 were assigned to the active management group, and the remaining 906 were assigned to the usual care group before the 30th week of pregnancy. Women in the usual care group were observed in the hospital labor and delivery unit, which was staffed with one nurse for every two patients, until a late stage of labor, when a single nurse provided care to each patient.

Unlike the active management group, the physicians in the usual care group did not adhere to a standardized protocol for administering or stopping oxytocin, the drug used for initiating or intensifying labor. Women in the active management group were seen by nurse midwives throughout the course of their labor.

Fetal monitoring was used for both groups of women, and all the women had similar access to pain relieving methods.

All of the women received prenatal care from their own health care providers. Women in the active management group took classes that explained the active management method. Women in the usual care group received payments to allow them to take childbirth education classes they chose for themselves.

Cesarean rates did not differ significantly--10.9 percent for the active management group, versus 11.5 percent in the usual care group.

Although the results are not what was hoped for regarding cesarean section rates, the trial did identify several advantages of the active management method, said Donald McNellis, MD, a project officer with NICHD s Pregnancy and Perinatology Branch.

For example, the median duration of labor was 6.2 hours in the active management group, versus 8.9 hours in the usual care group. Furthermore, the percentage of women experiencing labor lasting longer than 12 hours was 3 times higher in the usual care group than in the active management group--26 percent versus 9 percent.

The active management group also was significantly less likely to experience maternal fever during delivery. Such fevers indicate a possible infection of the uterine lining. These infections may jeopardize a fetus life and place him or her at greater risk of neonatal infections.

The researchers found that the active management group and the usual care group experienced similar cesarean section rates in the first stage of labor. Moreover, these rates were similar to cesarean section rates in Ireland.

For the second stage of labor, the cesarean section rate was again similar for both the active management and usual care groups. However, the rates for both of these groups were much higher than typically seen in the Irish studies, suggesting that some unexplained difference may exist between obstetrical practices in America and Ireland.

This difference suggests the need for a careful assessment of practices for the management of the second stage of labor in North America, the investigators wrote.

Unlike previous studies, the current study excluded women with conditions predisposing them to higher cesarean rates, such as hypertension and diabetes.

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