- Email: [email protected]
Celeste Phillips, The Mother of Family-Centered Maternity Care
Use of Cytotec (misoprostol) for Labor Induction
T
he following letter concerns unapproved use of misoprostol for labor induction and is published as a follow-up to “The Nurse’s Role in Misoprosto1 Induction: A Proposal Protocol, by C. Wilson, (NovemberlDecember 2000 JOGNN): ”
Dear Health Care Provider: The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion. Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. The uterotonic effect of Cytotec is an inherent property of prostaglandin E,(PGE,), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy. Serious adverse events reported following offlabel use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain. Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is
January I February 2001
used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established. Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec. Further information may be obtained by calling 1-800-323-4204.
Michael Cullen, M D Medical Director, U.S. Searle Skokie, IL
Celeste Phillips, The Mother of FamilyCentered Maternity Care T h a n k s to Celeste Phillips and all the other nurses who have made family-centered maternity care (FCMC) possible (“Trendsetter: Celeste Phillips, The Mother of Family-Centered Maternity Care,” JanuarylFebruary 2000 JOGNN}. As a young nurse, I have known maternity care only this way, but I have heard stories and read about the care provided to past generations. I am grateful that my experience has been much different. I have seen Phillips’s principles applied to maternity care in both my professional and personal life. As the mother of a 19-month-old, I remember the support of my family and friends during the time of her birth. This would not have been possible without FCMC. Fathers can now be involved in the birth of their children, an important experience for both parents, thanks to FCMC. The principle of FCMC has affected the medical industry more than any other philosophy. It has transformed the way that nurses deliver health care to the childbearing family and changed the safety and quality of care given to the mother and newborn. Most important, it has promoted family unity (Sherwen, Scoloveno, & Weingarten, 1995).
JOGNN 11
I agree with Phillips’s 10 principles, which I experienced with the care of my daughter. She was born prematurely and air-transported to a neonatal intensivecare unit (NICU) o u t b f town. I saw firsthand these principles applied to the initial care, helicopter transport, and the subsequent care in the NICU. The fact that I was able to be closely involved and had access to her at all times made this stressful situation easier to endure. I further agree with Phillips’s beliefs regarding critical challenges to maternity and newborn care brought about by the growing technology of the 21st century. Through the use of FCMC, the human element of child-
12 JOGNN
birth has been maintained. Therefore, with this foundation we should be able to meet the challenges that technology will bring in this century.
Michelle Ham, RN, BSN The University of Texas Southwestern Medical School
1
REFERENCE Sherwen, L. N., Scoloveno, M. A., & Weingarten, c. T. (199.5). Nursing care of the childbearing family. (3rd ed.). East Norwalk, CT: Appleton & Lange.
Volume 30, Number 1
T
he following letter concerns unapproved use of misoprostol for labor induction and is published as a follow-up to “The Nurse’s Role in Misoprosto1 Induction: A Proposal Protocol, by C. Wilson, (NovemberlDecember 2000 JOGNN): ”
Dear Health Care Provider: The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion. Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. The uterotonic effect of Cytotec is an inherent property of prostaglandin E,(PGE,), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy. Serious adverse events reported following offlabel use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain. Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is
January I February 2001
used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established. Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec. Further information may be obtained by calling 1-800-323-4204.
Michael Cullen, M D Medical Director, U.S. Searle Skokie, IL
Celeste Phillips, The Mother of FamilyCentered Maternity Care T h a n k s to Celeste Phillips and all the other nurses who have made family-centered maternity care (FCMC) possible (“Trendsetter: Celeste Phillips, The Mother of Family-Centered Maternity Care,” JanuarylFebruary 2000 JOGNN}. As a young nurse, I have known maternity care only this way, but I have heard stories and read about the care provided to past generations. I am grateful that my experience has been much different. I have seen Phillips’s principles applied to maternity care in both my professional and personal life. As the mother of a 19-month-old, I remember the support of my family and friends during the time of her birth. This would not have been possible without FCMC. Fathers can now be involved in the birth of their children, an important experience for both parents, thanks to FCMC. The principle of FCMC has affected the medical industry more than any other philosophy. It has transformed the way that nurses deliver health care to the childbearing family and changed the safety and quality of care given to the mother and newborn. Most important, it has promoted family unity (Sherwen, Scoloveno, & Weingarten, 1995).
JOGNN 11
I agree with Phillips’s 10 principles, which I experienced with the care of my daughter. She was born prematurely and air-transported to a neonatal intensivecare unit (NICU) o u t b f town. I saw firsthand these principles applied to the initial care, helicopter transport, and the subsequent care in the NICU. The fact that I was able to be closely involved and had access to her at all times made this stressful situation easier to endure. I further agree with Phillips’s beliefs regarding critical challenges to maternity and newborn care brought about by the growing technology of the 21st century. Through the use of FCMC, the human element of child-
12 JOGNN
birth has been maintained. Therefore, with this foundation we should be able to meet the challenges that technology will bring in this century.
Michelle Ham, RN, BSN The University of Texas Southwestern Medical School
1
REFERENCE Sherwen, L. N., Scoloveno, M. A., & Weingarten, c. T. (199.5). Nursing care of the childbearing family. (3rd ed.). East Norwalk, CT: Appleton & Lange.
Volume 30, Number 1