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Donation of blood by the pregnant patient for autologous transfusion
American Journal of Obstetrics
and Gynecology Founded in 1920
volume 159
number 5
NOVEMBER
1988
CLINICAL SECTION Clinical Opinion Donation of blood by the pregnant patient for autologous transfusion Maurice L. Druzin, MD, Carl F. W. Wolf, MD, Terri G. Edersheim, MD, J. Milton Hutson, MD, Elizabeth A. Kogut, RNC, andJ. L. Nina Salamon, MT New York, New York A study was conducted to determine the safety and utility of autologous blood donation in third trimester pregnancy. Thirty-seven obstetric patients, 32 with an obstetric risk factor, donated an average of 485 ml of blood. Twenty-one of the 37 patients were expected to undergo cesarean section. Nonstress testing was performed before and after phlebotomy. Continuous fetal heart rate monitoring was maintained throughout the donation, which lasted an average of 9 minutes. All nonstress test results were normal before and after the phlebotomy except in one case. All fetal heart rates remained stable during phlebotomy and premature labor was not precipitated. All fetal outcomes were normal. One patient delivered on the day of phlebotomy, 6 hours after the procedure. Only one of the autologous units was used, in a patient who had a pelvic infection and moderate anemia. The incidence of primary cesarean section was 35%. Phlebotomy of the mother appears to be safe for the fetus at term. Further investigation is needed to determine the safety of removal of more than 1 unit of blood and blood donation at earlier gestational ages. (AM J 0BSTET GVNECOL 1988;159:1023-7.)
Key words: Autologous transfusion, pregnancy, phlebotomy
With the current epidemic of acquired immunodeficiency syndrome in the United States, many patients facing the possibility of transfusions are concerned with receiving banked blood from random volunteer donors. Although directed donor programs are being discouraged by most major blood centers at this time,' the prior donation of blood by the patient who will subsequently undergo surgery is being encouraged.2 This support for autologous donation has not been true for the pregnant patient, despite the fact that delivery is always associated with significant hemorrhage. The estimated blood loss is approximately 1200 ml with a cesarean section and 600 ml with spontaneous vaginal delivery.' The increased blood loss with cesarean sec-
From the Department of Obstetrics and Gynecology and Blood Bank and Transfusion Service, The New York Hospital-Cornell Medical Center. Reprint requests: Maurice L. Druzin, MD, The New York HospitalCornel/Medical Center, 525 East 68th St., New York, NY 10021.
tion is accentuated by the current rise in the cesarean section rate, which is >20% in our service and was 15% in the United States in 19784 and 18.7% in 1982.' Despite this potential for needed transfusions, autologous donation has been discouraged because of concern over the possibility of inducing premature labor or causing fetal distress. 6 · 7 To determine whether this prohibition is justified, a program was established at The New York Hospital-Cornell Medical Center to monitor pregnant patients donating their own blood during pregnancy to be available, if necessary, at or after delivery. Our experience with 35 such patients is the basis for this article.
Material and methods Approval of an institutional review board was not obtained. Phlebotomy was not offered to the obstetric population as a routine service. The procedure was performed only subsequent to a patient's specifi_c request for the procedure to her physician, and only after 1023
1024 Druzin et al.
November 1988 Am J Obstet Gynecol
Table I. Antepartum data Patient No.
Estimated gestational age at donation (wk)
Change in hematocrit* (%)
Postpartum day 2 hematocrit (%)
36 38 37 38 37 38 37 37 39 38 39 38 38 37 35 36 35 38 37 36 35 37 36 36 36 38 36 36 36 39 38 38 37 36 36 37 36 37 38
-2.5 -1.3 -1.2 +0.6 +0.6 -4.3 -3.6 -2.1 -2.5 -5.7 +0.2 -0.7 -2.4 0 -3.8 -1.8 +0.5 +0.3 +3.7 -1.0 -1.5 -0.5 -6.7 -1.5 +3.3 +6.9 +0.2 +2.4 -1.8 -0.3 -1.2 + 1.5 +0.5 + 1.9 -4.6 -2.0 + 1.1 -4.3 +0.2
34.0 27.5 34.I 35.9 26.6 33.2 30.8 28.9 24.8 27.6 35.6 34.4 32.6 31.3
I 2 3 4 5 6 7 8 9 IO 11
I2 I3 I4 I5 16 17 I8 I9 20 2I 22 23 24 25 26 27 28 29 30 3I 32 33 34 35 36 37
30.4 33.6 36.7 34.3
NA 35.6 35.2 30.8 36.9 33.7 35.4 37.I 34.2 31.4 34.3 37.0 33.2 36.I 37.8 34.4 39.4
NA 39.7
Interoal from phlebotomy to delivery (days)
9 8 0 3 27 I3 20 I5 II 7 7 II 8 I5 20 I3 4 I7 I I4 I9 4 3 I5 16 9 30 2I 3 22 28 I4 2I 39 II I5 4I I5 I6
NA, Not applicable.
*Difference between predonation and admission hematocrit.
informed consent was obtained from the patient and her obstetrician and all eligibility criteria were met. A protocol was established jointly by The New York Hospital Blood Bank and Transfusion Service and the Department of Obstetrics and Gynecology to obtain donated blood from pregnant patients. The protocol required the following eligibility criteria: (1) Full informed consent for the procedure, (2) consent of the attending obstetrician and his or her availability to handle complications, (3) a hemoglobin level > 11 gm/ di or a hematocrit ;a.34% at the time of referral, and (4) gestational age ;;.35 completed weeks (with three exceptions in which blood was donated between 35 and 36 weeks' gestation). In addition, all patients had to meet the standards proposed for nonpregnant blood donors. 8 Only three candidates were rejected: one for persistent tachycardia > 100 beats/min, the second for a hematocrit <34% on
three occasions, and the third because of the occurrence of late decelerations during her prephlebotomy nonstress test. After blood donor examination, eligible patients were brought to the Antepartum Testing Unit and, after a normal nonstress test, an average of 487 ml of blood was removed with a standard CPD A- I collection set; two patients had <400 ml removed (225 ml and 262 ml, respectively) because of an unsuccessful phlebotomy. The blood was removed while the patient was attached to the fetal heart rate monitor and vital signs, blood pressure, and pulse rate were recorded. After blood donation, which lasted an average of 9 minutes, a nonstress test was repeated to determine the status of the fetus. Two patients underwent phlebotomy on two separate occasions. By our definition, a normal nonstress test (reactive test) shows at least two accelerations of the fetal heart rate, each at least 15 beats/min above baseline and as-
Volume 159 Number 5
sociated with fetal movement, during a 20-minute period. If these criteria are not met in two consecutive 20-minute monitoring periods, the test is considered nonreactive. If repeated tests are nonreactive, a contraction stress test is performed, which measures the response of the fetal heart rate to uterrne contractions (three in a 10-minute period, induced by stimulation of the breast by the patient or by oxytocin). The test is considered positive (abnormal) if each contraction is followed by a deceleration in a 10-minute period, negative (normal) if there are no late decelerations, and equivocal if one or two of the contractions is followed by decelerations. Patients were advised that they would receive transfusion only if a valid indication existed. Blood collected from patients for autologous transfusion was kept for the patient for up to 35 days after the collection date. Blood for patients who were discharged and for whom the need for blood transfusion was no longer considered to exist was salvaged for blood plasma derivative preparation. This was done provided the patient met all the requirements for protection of recipients required for a regular blood donation. That decision was made by the blood bank staff in consultation with the patient's physician. Oral iron supplementation with ferrous sulfate tablets, 300 mg three times a day, was suggested in written materials to all physicians interested in the program. If patients were not taking iron supplements at the time of phlebotomy, they were provided with written instructions to follow thereafter. Results Thirty-seven patients entered the program during the period 1983 to 1987. The mean age of the patients was 34 years. Mean gravidity and parity were 2.81 and 0.62, respectively. All but five patients had at least one complication of pregnancy. Antepartum data are presented in Table I. Pregnancy risk factors included previous cesarean section (12 patients), advanced maternal age (5), previous myomectomy (3), uterine abnormalities (3), hematologic disorders (3), and history of genital herpes (3). Twenty-five patients were delivered by cesarean section, 12 as repeat cesarean sections, 4 due to intrapartum fetal distress, 2 for cephalopelvic disproportion, 2 due to genital herpes, 2 due to previous myomectomies, 1 for breech presentation, 1 due to thrombocytopenia, and 1 because of condylomata. With one exception, all patients had a reactive nonstress test before and after phlebotomy. There were no fetal decelerations or increased uterine activity as measured by the frequency of contractions. Patient 26 had an abnormal nonreactive nonstress test before blood donation; however, this was followed by a normal negative contraction stress test, and the blood donation was allowed to proceed. After phlebotomy, the patient's non-
Donation of blood for autologous transfusion
1025
stress test was again nonreactive. Therefore, the test was repeated on the following day and was normal at that time. All neonates were delivered at term, with all Apgar scores at 1 and 5 minutes >6. The lowest birth weight was 2690 gm at 38 weeks' gestation. Only one of the autologous units was used, in a patient who had a pelvic infection and moderate anemia (patient 9). Most patients donated blood between 38 and 39 weeks' gestation. The timing of the donation was a result of when the patient approached her physician concerning the procedure. Two patients developed transient hypotension during the procedure. Patient 19 developed dizziness and mild hypotension (blood pressure 80/46 mm Hg). Blood pressure responded to position change and returned to normal within 5 minutes. Patient 35 developed severe hypotension; blood pressure dropped from 108/60 to 60/30 mm Hg at 6 minutes. The procedure was ended. Position change had no effect, and an intravenous infusion of lactated Ringer's solution was started 4 minutes after the episode developed. The fetal heart rate remained unchanged throughout the hypotensive episode. This patient had a history of "fainting" during previous blood donations, and this information had not been communicated to the health care personnel. Six patients underwent cesarean section for fetal distress. In patient 1, 9 days after phlebotomy late decelerations were noted during induction oflabor, prompting delivery. Patient 3 had uterus didelphys. She had been experiencing intermittent fetal decelerations after hyperactive uterine contractions during her daily antepartum testing. Six hours after an uncomplicated phlebotomy, fetal bradycardia occurred during the patient's daily nonstress test, leading to a primary cesarean section (which had been planned because of the didelphia). In the third case (patient 4), the woman was scheduled for a repeat cesarean section that was performed 3 days after phlebotomy because of fetal bradycardia during active labor. Twenty-seven days after phlebotomy, patient 5 underwent a cesarean section due to persistent late decelerations in labor and a closed cervix. In the fifth case (patient 11), a preplanned repeat cesarean section was performed 7 days after blood donation because of the occurrence of fetal brad ycardia during antepartum testing. Last, patient 23, 16 days after phlebotomy, underwent cesarean section because of the occurrence of fetal bradycardia during active labor. Comment
Blood transfusion has long been associated with the transmission of viruses such as hepatitis B, hepatitis nonA nonB, and cytomegalovirus, making autologous transfusion an attractive but underutilized alternative. The current epidemic of acquired immunodeficiency
1026 Druzin et al.
syndrome in this country, particularly in the city of New York, has focused greater attention on the risks of blood transfusion and increased patient willingness to participate in an autologous transfusion program. Elective surgery has prompted patients to donate their own blood. 9 -13 Donation of blood by the pregnant patient has not been encouraged because of potential complications such as precipitation of premature labor or fetal compromise. 3 • 6 There is very little information in the literature concerning fetal response to maternal phlebotomy for autologous transfusion in obstetrics. Autologous transfusion in pregnancy was addressed in March 1979 in a paper dealing with patients who were sensitized to minor blood group antigens. 14 In that series, a patient donated blood during pregnancy at 36 weeks' gestation. Two units (450 ml) of blood were withdrawn by standard techniques while an equivalent volume of 5% albumin in 0.9% sodium chloride was infused in the opposite antecubital vein. The patient seemed to tolerate the procedure well and subsequently underwent induction of labor at 38 weeks, with delivery of a 3700 gm male infant without complications. In another study6 it was suggested that donation of blood during the third trimester might precipitate premature labor. Mann et al.7 stated that, "Absolute proof of the safety of blood donation during pregnancy can be obtained only by studies which include fetal monitoring to detect clinically inapparent complications associated with phlebotomy." The main obstacle to the donation of blood in pregnancy was anemia. In these cases, the patient donated only half a unit and returned subsequently to donate the other half-unit. The two halves were pooled and then frozen as a single unit. Based on a review of the literature6 · 7 and the concerns noted, our study did not consider patients before 36 completed weeks of gestation. This narrow focus was important, because if premature labor or fetal distress were observed during or after phlebotomy, leading to delivery, we were aware that the perinatal mortality rate at 36 weeks' gestation is equivalent to that of term pregnancy. Three patients donated blood between 35 and 36 weeks' gestation. They were accepted into the study because of their high-risk factors for imminent delivery. The first patient (15) had a history of premature delivery and had previously undergone cesarean section. Because of the difficulty in controlling preterm labor and the very real possibility of requiring a cesarean section before 36 completed weeks of gestation, phlebotomy was allowed, with removal of 1 unit of blood at 35 weeks and another unit at 36 weeks. The second patient (16) had an incompetent cervix and was scheduled for removal of her cerclage at 36 weeks' gestation. The patient requested phlebotomy before removal of
November 1988 Am J Obstet Gynecol
the cerclage. The third patient (20) had previously undergone myomectomy with cavity entry. This patient was scheduled for a cesarean section and because of her history of excessive bleeding at the time of previous surgery, the patient and her physician requested the removal of 2 units of blood, 1 unit at 35 weeks and 1 unit at 37 weeks. To document the risk of placental insufficiency and precipitation of premature labor, we performed nonstress tests before and after blood donation. In addition, fetal heart and uterine activity were monitored during blood removal. There was no statistically significant change in the baseline fetal heart rate before, during, or after phlebotomy and no evidence of fetal distress directly related to blood donation. In addition, the number of uterine contractions noted before and after phlebotomy did not vary. There was no evidence that uterine activity was increased in this high-risk group of pregnant women. Of note, blood donated by these patients was used in only one case (patient 9). This reflects physician preference not to transfuse unless the patient has severe anemia (formerly defined as a hematocrit of 25% ahd now as a hematocrit of 20%) or is symptomatic at a higher hematocrit. Such practice habits were not changed by the improved safety of autologus blood donation, as even autologus transfusion is not entirely risk free because of the potential for clerical error. Autologous blood might, however, be given to some patients who have a hematocrit >25% and <30%. For example, in the single case in which donated blood was used in this series, the patient had undergone repeat low transverse cesarean section. On postoperative day 1 the patient had a temperature rise to 38.5°. After examination, the diagnosis was postpartum endomyometritis, and the hematocrit at that time was 27%. Because of the patient's anemia and pelvic infection, she was given her unit of autologous blood in addition to antimicrobial agents. She had an uneventful recovery. It is possible that in the future, other patients with anemia will be given an autologous transfusion before discharge. A majority of our patients underwent cesarean section. This, in part, is secondary to the high number of obstetric complications and the high incidence of previous cesarean sections in this group. The incidence of cesarean section for fetal distress in this group was 16%. All of these women had underlying pregnancy problems that were not thought to be due to the phlebotomy. In only one case (patient 3) did delivery occur on the day of phlebotomy, and fetal decelerations had been occurring for a number of days before the procedure. Autologous blood donation will not eliminate the need for pregnant patients to receive blood donated by random volunteer donors. Patients who suffered
Volume 159 Number 5
severe postpartum hemorrhage at The New York Hospital-Cornell Medical Center in 1985 received an average of six units of blood. The antepartum removal of 1 unit of blood from the patient would obviously not suffice in these cases of severe postpartum hemorrhage. As is true in many clinical studies, more questions are raised by our experience than are answered. Because this study demonstrates the safety of antepartum phlebotomy of 1 unit of blood under certain conditions, additional questions need to be addressed prospectively. In this study, donation was not considered before 36 weeks of gestation (with three exceptions), nor were multiple phlebotomies performed (with two exceptions). In obstetrics as practiced in the 1980s, cesarean section rates for the low-birth-weight fetus are higher than for the term fetus. 15 To deal with this high-risk group of pregnant patients, donation of blood at earlier gestation ages might be considered. In cases of severe obstetric hemorrhage, multiple units of blood products are used. Multiple donations of blood during gestation might be considered. Patients at greatest risk for requiring blood products (those with third trimester bleeding and placenta previa) were not considered for this study. Donation for autologous transfusion by this high-risk group could be studied with continuous maternal and fetal monitoring. In addition, patients at risk for uteroplacental insufficiency secondary to their disease process, such as chronic hypertension or systemic lupus, should be approached with extreme caution. Evidence of fetal growth retardation, for example, should prompt extensive fetal evaluation before phlebotomy is considered. The practice of donation for autologous transfusion before the onset of planned pregnancies or very early in gestation may also be feasible and deserves consideration. The latter practice would make preparation for delivery similar to that now advocated for elective surgical procedures that may require transfusion. However, at this time, removal of blood from a pregnant patient for autologous transfusion should be
Donation of blood for autologous transfusion
1027
restricted to a strict research protocol and is not recommended for the general population. We thank Audrey Waltner for her assistance in the preparation of this manuscript and Juan Alvarez for his technical assistance. REFERENCES 1. American Red Cross, Council of Community Blood Centers, American Association of Blood Banks. Joint Statement on Directed Donations and AIDS. AABB Newsbriefs 1983;6. 2. MMWR 1983;32:101-3. 3. Pritchard JA, MacDonald PC, Gant NF, eds. Maternal adaptation to pregnancy. In: Williams' obstetrics, 17th ed. Norwalk, Conn: Appleton-Century-Crofts, 1985:181210. 4. US Department of Health and Human Services, Public Health Service, National Institutes of Health. Cesarean childbirth. Washington, DC: US Government Printing Office, 1981 (NIH publication no 82-2067). 5. Anderson GM, Lomas J. Determination of the increasing cesarean birth rate: Ontario data 1979 to 1982. N Engl J Med 1984;311:887-92. 6. Davis R. Banked autologous blood for caesarian section. Anaesth Intens Care 1979;7:358-61. 7. Mann M, Sacks HM, Goldfinger D. Safety of autologous blood donation prior to elective surgery for a variety of potentially "high risk" patients. Transfusion l 983;23:22932. 8. American Association of Blood Banks. Standards for blood banks and transfusion services. 11th ed. Arlington, Va: American Association of Blood Banks, 1984. 9. Milles G, Langston H, Dalessandro W. Experiences with autotransfusions. Surg Gynecol Obstet 1982; 115:689-94. 10. Yomtovian R. Autologous blood transfusion.JAMA 1985; 253:2491. 11. De Ruyter E. Autologous blood transfusion. Med J Aust 1985; 143:323. 12. Nicholls MD,Janu MR, Davies VJ, Wedderburn CE. Autologous blood transfusion for elective surgery. Med J Aust 1986;144:396-9. 13. Silvergleid AJ. Autologous transfusions.JAMA 1979;241: 2724-5. 14. Sandler SG, Beyth Y, Laufer N, Levene C. Autologous blood transfusions and pregnancy. Obstet Gynecol 1979; 53(suppl):62S-6S. 15. Druzin ML, Toth M, Ledger WJ. Nonintervention in premature rupture of the amniotic membranes. Surg Gynecol Obstet 1986;163:5-10.
and Gynecology Founded in 1920
volume 159
number 5
NOVEMBER
1988
CLINICAL SECTION Clinical Opinion Donation of blood by the pregnant patient for autologous transfusion Maurice L. Druzin, MD, Carl F. W. Wolf, MD, Terri G. Edersheim, MD, J. Milton Hutson, MD, Elizabeth A. Kogut, RNC, andJ. L. Nina Salamon, MT New York, New York A study was conducted to determine the safety and utility of autologous blood donation in third trimester pregnancy. Thirty-seven obstetric patients, 32 with an obstetric risk factor, donated an average of 485 ml of blood. Twenty-one of the 37 patients were expected to undergo cesarean section. Nonstress testing was performed before and after phlebotomy. Continuous fetal heart rate monitoring was maintained throughout the donation, which lasted an average of 9 minutes. All nonstress test results were normal before and after the phlebotomy except in one case. All fetal heart rates remained stable during phlebotomy and premature labor was not precipitated. All fetal outcomes were normal. One patient delivered on the day of phlebotomy, 6 hours after the procedure. Only one of the autologous units was used, in a patient who had a pelvic infection and moderate anemia. The incidence of primary cesarean section was 35%. Phlebotomy of the mother appears to be safe for the fetus at term. Further investigation is needed to determine the safety of removal of more than 1 unit of blood and blood donation at earlier gestational ages. (AM J 0BSTET GVNECOL 1988;159:1023-7.)
Key words: Autologous transfusion, pregnancy, phlebotomy
With the current epidemic of acquired immunodeficiency syndrome in the United States, many patients facing the possibility of transfusions are concerned with receiving banked blood from random volunteer donors. Although directed donor programs are being discouraged by most major blood centers at this time,' the prior donation of blood by the patient who will subsequently undergo surgery is being encouraged.2 This support for autologous donation has not been true for the pregnant patient, despite the fact that delivery is always associated with significant hemorrhage. The estimated blood loss is approximately 1200 ml with a cesarean section and 600 ml with spontaneous vaginal delivery.' The increased blood loss with cesarean sec-
From the Department of Obstetrics and Gynecology and Blood Bank and Transfusion Service, The New York Hospital-Cornell Medical Center. Reprint requests: Maurice L. Druzin, MD, The New York HospitalCornel/Medical Center, 525 East 68th St., New York, NY 10021.
tion is accentuated by the current rise in the cesarean section rate, which is >20% in our service and was 15% in the United States in 19784 and 18.7% in 1982.' Despite this potential for needed transfusions, autologous donation has been discouraged because of concern over the possibility of inducing premature labor or causing fetal distress. 6 · 7 To determine whether this prohibition is justified, a program was established at The New York Hospital-Cornell Medical Center to monitor pregnant patients donating their own blood during pregnancy to be available, if necessary, at or after delivery. Our experience with 35 such patients is the basis for this article.
Material and methods Approval of an institutional review board was not obtained. Phlebotomy was not offered to the obstetric population as a routine service. The procedure was performed only subsequent to a patient's specifi_c request for the procedure to her physician, and only after 1023
1024 Druzin et al.
November 1988 Am J Obstet Gynecol
Table I. Antepartum data Patient No.
Estimated gestational age at donation (wk)
Change in hematocrit* (%)
Postpartum day 2 hematocrit (%)
36 38 37 38 37 38 37 37 39 38 39 38 38 37 35 36 35 38 37 36 35 37 36 36 36 38 36 36 36 39 38 38 37 36 36 37 36 37 38
-2.5 -1.3 -1.2 +0.6 +0.6 -4.3 -3.6 -2.1 -2.5 -5.7 +0.2 -0.7 -2.4 0 -3.8 -1.8 +0.5 +0.3 +3.7 -1.0 -1.5 -0.5 -6.7 -1.5 +3.3 +6.9 +0.2 +2.4 -1.8 -0.3 -1.2 + 1.5 +0.5 + 1.9 -4.6 -2.0 + 1.1 -4.3 +0.2
34.0 27.5 34.I 35.9 26.6 33.2 30.8 28.9 24.8 27.6 35.6 34.4 32.6 31.3
I 2 3 4 5 6 7 8 9 IO 11
I2 I3 I4 I5 16 17 I8 I9 20 2I 22 23 24 25 26 27 28 29 30 3I 32 33 34 35 36 37
30.4 33.6 36.7 34.3
NA 35.6 35.2 30.8 36.9 33.7 35.4 37.I 34.2 31.4 34.3 37.0 33.2 36.I 37.8 34.4 39.4
NA 39.7
Interoal from phlebotomy to delivery (days)
9 8 0 3 27 I3 20 I5 II 7 7 II 8 I5 20 I3 4 I7 I I4 I9 4 3 I5 16 9 30 2I 3 22 28 I4 2I 39 II I5 4I I5 I6
NA, Not applicable.
*Difference between predonation and admission hematocrit.
informed consent was obtained from the patient and her obstetrician and all eligibility criteria were met. A protocol was established jointly by The New York Hospital Blood Bank and Transfusion Service and the Department of Obstetrics and Gynecology to obtain donated blood from pregnant patients. The protocol required the following eligibility criteria: (1) Full informed consent for the procedure, (2) consent of the attending obstetrician and his or her availability to handle complications, (3) a hemoglobin level > 11 gm/ di or a hematocrit ;a.34% at the time of referral, and (4) gestational age ;;.35 completed weeks (with three exceptions in which blood was donated between 35 and 36 weeks' gestation). In addition, all patients had to meet the standards proposed for nonpregnant blood donors. 8 Only three candidates were rejected: one for persistent tachycardia > 100 beats/min, the second for a hematocrit <34% on
three occasions, and the third because of the occurrence of late decelerations during her prephlebotomy nonstress test. After blood donor examination, eligible patients were brought to the Antepartum Testing Unit and, after a normal nonstress test, an average of 487 ml of blood was removed with a standard CPD A- I collection set; two patients had <400 ml removed (225 ml and 262 ml, respectively) because of an unsuccessful phlebotomy. The blood was removed while the patient was attached to the fetal heart rate monitor and vital signs, blood pressure, and pulse rate were recorded. After blood donation, which lasted an average of 9 minutes, a nonstress test was repeated to determine the status of the fetus. Two patients underwent phlebotomy on two separate occasions. By our definition, a normal nonstress test (reactive test) shows at least two accelerations of the fetal heart rate, each at least 15 beats/min above baseline and as-
Volume 159 Number 5
sociated with fetal movement, during a 20-minute period. If these criteria are not met in two consecutive 20-minute monitoring periods, the test is considered nonreactive. If repeated tests are nonreactive, a contraction stress test is performed, which measures the response of the fetal heart rate to uterrne contractions (three in a 10-minute period, induced by stimulation of the breast by the patient or by oxytocin). The test is considered positive (abnormal) if each contraction is followed by a deceleration in a 10-minute period, negative (normal) if there are no late decelerations, and equivocal if one or two of the contractions is followed by decelerations. Patients were advised that they would receive transfusion only if a valid indication existed. Blood collected from patients for autologous transfusion was kept for the patient for up to 35 days after the collection date. Blood for patients who were discharged and for whom the need for blood transfusion was no longer considered to exist was salvaged for blood plasma derivative preparation. This was done provided the patient met all the requirements for protection of recipients required for a regular blood donation. That decision was made by the blood bank staff in consultation with the patient's physician. Oral iron supplementation with ferrous sulfate tablets, 300 mg three times a day, was suggested in written materials to all physicians interested in the program. If patients were not taking iron supplements at the time of phlebotomy, they were provided with written instructions to follow thereafter. Results Thirty-seven patients entered the program during the period 1983 to 1987. The mean age of the patients was 34 years. Mean gravidity and parity were 2.81 and 0.62, respectively. All but five patients had at least one complication of pregnancy. Antepartum data are presented in Table I. Pregnancy risk factors included previous cesarean section (12 patients), advanced maternal age (5), previous myomectomy (3), uterine abnormalities (3), hematologic disorders (3), and history of genital herpes (3). Twenty-five patients were delivered by cesarean section, 12 as repeat cesarean sections, 4 due to intrapartum fetal distress, 2 for cephalopelvic disproportion, 2 due to genital herpes, 2 due to previous myomectomies, 1 for breech presentation, 1 due to thrombocytopenia, and 1 because of condylomata. With one exception, all patients had a reactive nonstress test before and after phlebotomy. There were no fetal decelerations or increased uterine activity as measured by the frequency of contractions. Patient 26 had an abnormal nonreactive nonstress test before blood donation; however, this was followed by a normal negative contraction stress test, and the blood donation was allowed to proceed. After phlebotomy, the patient's non-
Donation of blood for autologous transfusion
1025
stress test was again nonreactive. Therefore, the test was repeated on the following day and was normal at that time. All neonates were delivered at term, with all Apgar scores at 1 and 5 minutes >6. The lowest birth weight was 2690 gm at 38 weeks' gestation. Only one of the autologous units was used, in a patient who had a pelvic infection and moderate anemia (patient 9). Most patients donated blood between 38 and 39 weeks' gestation. The timing of the donation was a result of when the patient approached her physician concerning the procedure. Two patients developed transient hypotension during the procedure. Patient 19 developed dizziness and mild hypotension (blood pressure 80/46 mm Hg). Blood pressure responded to position change and returned to normal within 5 minutes. Patient 35 developed severe hypotension; blood pressure dropped from 108/60 to 60/30 mm Hg at 6 minutes. The procedure was ended. Position change had no effect, and an intravenous infusion of lactated Ringer's solution was started 4 minutes after the episode developed. The fetal heart rate remained unchanged throughout the hypotensive episode. This patient had a history of "fainting" during previous blood donations, and this information had not been communicated to the health care personnel. Six patients underwent cesarean section for fetal distress. In patient 1, 9 days after phlebotomy late decelerations were noted during induction oflabor, prompting delivery. Patient 3 had uterus didelphys. She had been experiencing intermittent fetal decelerations after hyperactive uterine contractions during her daily antepartum testing. Six hours after an uncomplicated phlebotomy, fetal bradycardia occurred during the patient's daily nonstress test, leading to a primary cesarean section (which had been planned because of the didelphia). In the third case (patient 4), the woman was scheduled for a repeat cesarean section that was performed 3 days after phlebotomy because of fetal bradycardia during active labor. Twenty-seven days after phlebotomy, patient 5 underwent a cesarean section due to persistent late decelerations in labor and a closed cervix. In the fifth case (patient 11), a preplanned repeat cesarean section was performed 7 days after blood donation because of the occurrence of fetal brad ycardia during antepartum testing. Last, patient 23, 16 days after phlebotomy, underwent cesarean section because of the occurrence of fetal bradycardia during active labor. Comment
Blood transfusion has long been associated with the transmission of viruses such as hepatitis B, hepatitis nonA nonB, and cytomegalovirus, making autologous transfusion an attractive but underutilized alternative. The current epidemic of acquired immunodeficiency
1026 Druzin et al.
syndrome in this country, particularly in the city of New York, has focused greater attention on the risks of blood transfusion and increased patient willingness to participate in an autologous transfusion program. Elective surgery has prompted patients to donate their own blood. 9 -13 Donation of blood by the pregnant patient has not been encouraged because of potential complications such as precipitation of premature labor or fetal compromise. 3 • 6 There is very little information in the literature concerning fetal response to maternal phlebotomy for autologous transfusion in obstetrics. Autologous transfusion in pregnancy was addressed in March 1979 in a paper dealing with patients who were sensitized to minor blood group antigens. 14 In that series, a patient donated blood during pregnancy at 36 weeks' gestation. Two units (450 ml) of blood were withdrawn by standard techniques while an equivalent volume of 5% albumin in 0.9% sodium chloride was infused in the opposite antecubital vein. The patient seemed to tolerate the procedure well and subsequently underwent induction of labor at 38 weeks, with delivery of a 3700 gm male infant without complications. In another study6 it was suggested that donation of blood during the third trimester might precipitate premature labor. Mann et al.7 stated that, "Absolute proof of the safety of blood donation during pregnancy can be obtained only by studies which include fetal monitoring to detect clinically inapparent complications associated with phlebotomy." The main obstacle to the donation of blood in pregnancy was anemia. In these cases, the patient donated only half a unit and returned subsequently to donate the other half-unit. The two halves were pooled and then frozen as a single unit. Based on a review of the literature6 · 7 and the concerns noted, our study did not consider patients before 36 completed weeks of gestation. This narrow focus was important, because if premature labor or fetal distress were observed during or after phlebotomy, leading to delivery, we were aware that the perinatal mortality rate at 36 weeks' gestation is equivalent to that of term pregnancy. Three patients donated blood between 35 and 36 weeks' gestation. They were accepted into the study because of their high-risk factors for imminent delivery. The first patient (15) had a history of premature delivery and had previously undergone cesarean section. Because of the difficulty in controlling preterm labor and the very real possibility of requiring a cesarean section before 36 completed weeks of gestation, phlebotomy was allowed, with removal of 1 unit of blood at 35 weeks and another unit at 36 weeks. The second patient (16) had an incompetent cervix and was scheduled for removal of her cerclage at 36 weeks' gestation. The patient requested phlebotomy before removal of
November 1988 Am J Obstet Gynecol
the cerclage. The third patient (20) had previously undergone myomectomy with cavity entry. This patient was scheduled for a cesarean section and because of her history of excessive bleeding at the time of previous surgery, the patient and her physician requested the removal of 2 units of blood, 1 unit at 35 weeks and 1 unit at 37 weeks. To document the risk of placental insufficiency and precipitation of premature labor, we performed nonstress tests before and after blood donation. In addition, fetal heart and uterine activity were monitored during blood removal. There was no statistically significant change in the baseline fetal heart rate before, during, or after phlebotomy and no evidence of fetal distress directly related to blood donation. In addition, the number of uterine contractions noted before and after phlebotomy did not vary. There was no evidence that uterine activity was increased in this high-risk group of pregnant women. Of note, blood donated by these patients was used in only one case (patient 9). This reflects physician preference not to transfuse unless the patient has severe anemia (formerly defined as a hematocrit of 25% ahd now as a hematocrit of 20%) or is symptomatic at a higher hematocrit. Such practice habits were not changed by the improved safety of autologus blood donation, as even autologus transfusion is not entirely risk free because of the potential for clerical error. Autologous blood might, however, be given to some patients who have a hematocrit >25% and <30%. For example, in the single case in which donated blood was used in this series, the patient had undergone repeat low transverse cesarean section. On postoperative day 1 the patient had a temperature rise to 38.5°. After examination, the diagnosis was postpartum endomyometritis, and the hematocrit at that time was 27%. Because of the patient's anemia and pelvic infection, she was given her unit of autologous blood in addition to antimicrobial agents. She had an uneventful recovery. It is possible that in the future, other patients with anemia will be given an autologous transfusion before discharge. A majority of our patients underwent cesarean section. This, in part, is secondary to the high number of obstetric complications and the high incidence of previous cesarean sections in this group. The incidence of cesarean section for fetal distress in this group was 16%. All of these women had underlying pregnancy problems that were not thought to be due to the phlebotomy. In only one case (patient 3) did delivery occur on the day of phlebotomy, and fetal decelerations had been occurring for a number of days before the procedure. Autologous blood donation will not eliminate the need for pregnant patients to receive blood donated by random volunteer donors. Patients who suffered
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severe postpartum hemorrhage at The New York Hospital-Cornell Medical Center in 1985 received an average of six units of blood. The antepartum removal of 1 unit of blood from the patient would obviously not suffice in these cases of severe postpartum hemorrhage. As is true in many clinical studies, more questions are raised by our experience than are answered. Because this study demonstrates the safety of antepartum phlebotomy of 1 unit of blood under certain conditions, additional questions need to be addressed prospectively. In this study, donation was not considered before 36 weeks of gestation (with three exceptions), nor were multiple phlebotomies performed (with two exceptions). In obstetrics as practiced in the 1980s, cesarean section rates for the low-birth-weight fetus are higher than for the term fetus. 15 To deal with this high-risk group of pregnant patients, donation of blood at earlier gestation ages might be considered. In cases of severe obstetric hemorrhage, multiple units of blood products are used. Multiple donations of blood during gestation might be considered. Patients at greatest risk for requiring blood products (those with third trimester bleeding and placenta previa) were not considered for this study. Donation for autologous transfusion by this high-risk group could be studied with continuous maternal and fetal monitoring. In addition, patients at risk for uteroplacental insufficiency secondary to their disease process, such as chronic hypertension or systemic lupus, should be approached with extreme caution. Evidence of fetal growth retardation, for example, should prompt extensive fetal evaluation before phlebotomy is considered. The practice of donation for autologous transfusion before the onset of planned pregnancies or very early in gestation may also be feasible and deserves consideration. The latter practice would make preparation for delivery similar to that now advocated for elective surgical procedures that may require transfusion. However, at this time, removal of blood from a pregnant patient for autologous transfusion should be
Donation of blood for autologous transfusion
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restricted to a strict research protocol and is not recommended for the general population. We thank Audrey Waltner for her assistance in the preparation of this manuscript and Juan Alvarez for his technical assistance. REFERENCES 1. American Red Cross, Council of Community Blood Centers, American Association of Blood Banks. Joint Statement on Directed Donations and AIDS. AABB Newsbriefs 1983;6. 2. MMWR 1983;32:101-3. 3. Pritchard JA, MacDonald PC, Gant NF, eds. Maternal adaptation to pregnancy. In: Williams' obstetrics, 17th ed. Norwalk, Conn: Appleton-Century-Crofts, 1985:181210. 4. US Department of Health and Human Services, Public Health Service, National Institutes of Health. Cesarean childbirth. Washington, DC: US Government Printing Office, 1981 (NIH publication no 82-2067). 5. Anderson GM, Lomas J. Determination of the increasing cesarean birth rate: Ontario data 1979 to 1982. N Engl J Med 1984;311:887-92. 6. Davis R. Banked autologous blood for caesarian section. Anaesth Intens Care 1979;7:358-61. 7. Mann M, Sacks HM, Goldfinger D. Safety of autologous blood donation prior to elective surgery for a variety of potentially "high risk" patients. Transfusion l 983;23:22932. 8. American Association of Blood Banks. Standards for blood banks and transfusion services. 11th ed. Arlington, Va: American Association of Blood Banks, 1984. 9. Milles G, Langston H, Dalessandro W. Experiences with autotransfusions. Surg Gynecol Obstet 1982; 115:689-94. 10. Yomtovian R. Autologous blood transfusion.JAMA 1985; 253:2491. 11. De Ruyter E. Autologous blood transfusion. Med J Aust 1985; 143:323. 12. Nicholls MD,Janu MR, Davies VJ, Wedderburn CE. Autologous blood transfusion for elective surgery. Med J Aust 1986;144:396-9. 13. Silvergleid AJ. Autologous transfusions.JAMA 1979;241: 2724-5. 14. Sandler SG, Beyth Y, Laufer N, Levene C. Autologous blood transfusions and pregnancy. Obstet Gynecol 1979; 53(suppl):62S-6S. 15. Druzin ML, Toth M, Ledger WJ. Nonintervention in premature rupture of the amniotic membranes. Surg Gynecol Obstet 1986;163:5-10.