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Trial of calcium to prevent preeclampsia
latrrntliuaal kblrrnalIII
GYNECOLOGY &OBSTETRICS International
Journal
of Gynecology
& Obstetrics
60 (1YYX) 95-105
Citations from the literature This is a selection of abstracts taken from the literature in the field of gynecology and obstetrics which the Journal’s Editors feel may be of interest to our readers’ DERMATOLOGY Fetal alloimmune Bussel
thrombocytopenia
J.B.; Zahusky
M.R.:
Berkowitz
R.L.:
McFarland
J.G.
A single cervical fetal fibronectin screening test in a population at low risk for preterm delivery: An improvement on clinical indicators?
USA
Faron
NEW ENGL J MED IVY7 337/l Q-26) Background: Alloimmune thrombocytopenia is a serious fetal disorder resulting from platelet-antigen incompatibility hetwcen the mother and fetus. The diagnosis is usually made after the discovery of unexpected neonatal thromhocytopenia. Approximately lo-20% of affected fetuses have intracranial hemorrhages. one-quarter to one-half of which occur in utero. We studied the correlates of thromhocytopenia in affected fctuscs. Methods: WC studied 107 fetuses with alloimmune thrombocytopcnia at a mean ( k S.D.) gestational age of 25 k 4 weeks. bcforc their entry into one of three trcatmcnt protocols. The fctuscs were initially evaluated because an older sihling had hccn given this diagnosis at birth. We compared the initial platelet counts in utcro in these 107 fetuses with the platclct count at birth and the history of intracranial hemorrhage in the affected sibling. Results: The initial platelet count was 5 20000 per cubic millimeter in 53 of the 107 fctuscs (5O’i; ). including 21 of 46 fetuses (46%) studied before 24 weeks of gestation. The Y7 fetuses with PIcAl) incompatibility had more scvcrc thromhocytopcnia than the 10 fetuses with other antigen incompatihilitics. Among seven fetuses with platclct counts of more than SO000 per cubic millimeter that wcrc not treated initially. the counts decreased by more than 10000 per cubic millimctcr per week. Although 41 fetuscs had initial platclct counts that were lower than those measured at hirth in an older affcctcd sibling. only a history of antenatal intracranial hcmorrhagc in the sibling predicted greater severity of thromhocytopcnia in the fetus. Only one trcatcd fetus had an intracranial hcmorrhagc and the thromhocytopenia resolved after birth in all casts. Conclusions: Fetal alloimmunc thromhocytopenia occurs early in gestation, is scvcrc and is more severe in fctuscs with an older affected sihling who had an antenatal intracranial hcmorrhagc.
BEL
G.; Boulvain
M.; Lescrainier
J.-P.: Vokaer
A.
BR J OBSTET GYNAECOL lYY7 104/h (hY7-701) Objective: To assess the accuracy of a single cervical fetal fibronectin tat to predict spontaneous preterm delivery in an unselected antenatal population. Design: A prospective blind cohort study. Setting: Antcnatal clinic of H teaching hospital in a Brussels semiurban arca. Participants: An unselected group of 170 women followed at the antenatal clinic. Methods: A single cervical sample was obtained hetwecn 24 and 3.3 completed weeks of pregnancy. The tihronectin test was compared with clinical evaluation and their predictive propcrtics wcrc assessed. Results: Fifteen women were excluded from the analysis hecause of elective preterm dclivcry for medical indications or loss to follow-up. Of the 155 remaining women, nine (7%) had a spontaneous prctcrm delivery. For a single fetal fihronectin test. the sensitivity was X.7%, the specificity YS.7% and the positive and negative predictive values 40.0% and Y2.4%, rcspcctivcly. The likelihood ratio of a positive was similar to that of clinical predictors of prctcrm birth (LR = 6.2: YS% CI X-1Y.h). Sensitivities were low for both clinical criteria and the fetal fihronectin test. Conclusions: Bccausc of low sensitivity in a low risk population, screening for prctcrm delivery should not hc hascd on the result of a single fetal tihroncctin test alone. Howcvcr. due to its high specificity the test might he useful in avoiding unnecessary medical intervention.
Trial of calcium to prevent preeclampsia Lcvinc R.J.: Hauth J.C.: Curct LB.: Sihai P.M.: Morris CD.: Dcrsimonian R.: Esterlitz E.G.: Bild D.E.; Clcmcns J.D.; Cutler J.A.
B.M.: J.R.;
Cat&no Raymond
USA ‘Gcncratcd 00X)-72Y2/YX/$
PII
from
the Exccrpta
IY.00
Mcdica
Q 1998 International
SOO20-72Y2(97)00243-Y
database,
EMBASE.
Fcdcration
NEW ENGL Background:
of Gynecology
J MED Previous
and Ohstctrics
lYY7 337/l (69-76) trials have suggcstcd
that calcium
sup-
96 plementation during pregnancy may reduce the risk of preeclampsia. However, differences in study design and a low dietary calcium intake in the populations studied limit acccptance of the data. Methods: We randomly assigned 4SXY healthy nulliparous women who were 13-21 weeks pregnant to receive daily treatment with either 2 g of clcmcntal calcium or placebo for the rcmaindcr of their pregnancies. Surveillance for prccclampsia was conducted by personnel unaware of treatment-group assignments. using standardized measurements of blood pressure and urinary protein excretion at uniformly scheduled prenatal visits. protocols for monitoring these measurements during the hospitalization for delivery and reviews of medical records of unscheduled outpatient visits and all hospitalizations. Results: Calcium supplementation did not significantly reduce the incidence or severity of prceclampsia or delay its onset. Preeclampsia occurred in 15X of the 22YS women in the calcium group (6.0%‘) add 168 of the 2294 women in the placebo group (7.3%) (relative risk, O.Y4; 95% confidcncc interval. 0.76 I. 16). There were no significant diffcrenccs hetwecn the two groups in the prevalence of pregnancy-associated hypertension without preeclampsia (15.3% vs. 17.3%) or of all hypertensive disorders (22.2% vs. 24.6%). The mean systolic and diastolic blood pressures during pregnancy were similar in both groups. Calcium did not rcducc the numbers of prcterm deliveries. small-for-gcstational-age births. or fetal and neonatal deaths: nor did it increase urolithiasis during pregnancy. Conclusions: Calcium supplcmcntation during pregnancy did not prevent prceclampsia. pregnancy-rrssociatcd hypcrtcnsion. or adverse perinatal outcomes in hcalthy nulliparous wonicii.
Antioxidants in the treatment of severe pre-eclampsia: explanatory randomised controlled trial Mctin
Gulmezoglu
A.; Justus
Hofmcyr
G.: Oosthuiscn
An
M.M.J.
GBR BR J OBSTET GYNECOL 1997 104/O (689-h’)(l) Objcctivc: To dctcrminc whcthcr antioxidant therapy alters the disease process in scvcrc early oiwt prc-cclampsia. in support of the hypothesis that incrcascd lipid peroxides and rcactivc oxygen spccics production play an important role in the pathogcncsis of the discasc. Design: Randomised. double-blind. placebo controlled trial. Setting: Two tertiary cart. referral hospitals in Johannesburg. South Africa. Participants: Women with scvcrc prc-cclampsia diagnosed hctween 24 and 32 weeks of gestation. Intervention: Combined antioxidant treatment with vitamin E (SO0 IU/day). vitamin C (I000 mg/day) and allopurinol (200 mg/day). Main outcome mcasurcs Primary outcomcs: (I ) prolongation of pregnancy; and (2) biochemical assessment of lipid pcroxidcs and antioxidants. Secondary outcomes: data on maternal complications. side cffccts of trcatmcnt. infant outcomes and regular asscssmcnt of hecmatologic and renal paramctcrs. Results: The proportion of women dclivcrcd within 14 days in the antioxidant
group was 5296 (14/27) compared with 76% (22/2Y) in the placebo group (relative risk 0.68, 95% confidence interval 0.45-1.04). One woman in each group had eclampsia. Eleven women (42%) in the antioxidant and 16 (59%) in the placebo group required two antihypertensives for blood pressure control. Trial medications were well tolerated with few side effects. Lipid peroxide levels wcrc not significantly altered in the antioxidant and placebo groups. Serum uric acid levels decreased and vitamin E lcvcls increased significantly. Conclusion: The results of this explanatory randomised trial do not encourage the routine use of antioxidants against preeclampsia. However, further research with modified strategies, such as earlier initiation of therapy or different combinations seem worthwhile.
Twenty-four-hour blood pressure monitoring to evaluate the effects of nifedipine in pre-eclampsia and in chronic hypertension in pregnancy Bencdetto Carandcntc
C.: Zonca F.
M.; Giarola
M.: Maula
V.: Chiarolini
L.;
ITA BR J OBSTET GYNECOL IVY7 104/h (6X2-6%9 Objective: To investigate the effect of 7-14 days of therapy with nifedipine (sustained-release preparation) on the 24-h blood pressure patterns of pregnant women with pre-eclampsia or chronic hypertension and to test the utility of blood prcssure monitoring in modulating the timing and dosage of the drug. Design: Twenty-four-hour automatic blood pressure monitoring of pregnant women with pre-eclampsia or chronic hypertension before and after nifedipine treatment. Setting: Ccntre for Prcvcntion. Diagnosis and Treatment of Hypertension in Pregnancy. University of Turin, Italy. Population: Sixteen pregnant women with prc-eclampsia and 17 with chronic hypertension. Methods: Twenty-four-hour blood prcssure monitoring was performed before the beginning of the therapy and after 7- 14 days of trcatmcnt with sustained-relcasc nifcdipinc. Main outcome mcasurcs: Chronobiological analysis of systolic and diastolic blood pressure vaLIucs was performed: MESOR. amplitude. acrophaae. hyperbaric index. percent time elevation and significance of rhythm wcrc calculated before and after trcatmcnt. Results: A large number (6.336) of blood pressure mcasurcmcnts wcrc analyscd. Systolic and diastolic MESOR values wcrc significantly decreased after nifcdipinc trcatmcnt both in pre-cclampsia and in chronic hypertension. Howcvcr. the antihypcrtensive effect of nifcdipinc in pre-eclampsia was cspccially pronounced during evening and night, while in chronic hypertension it was more constant during the 24-h period. 24-h blood prcssurc monitoring allowed adjustment. when ncccssary. to the timing and dosage of nifcdipinc in accordance with the blood prcssurc patterns of each patient. using the hyperbaric index and pcrccnt time clcvation as objective parameters for the evaluation of trcatmcnt cfticacy. Conclusions: Twenty-four-hour blood pressure monitoring is a good method to optimise treatment and contirms that nifcdipinc ix useful for the control of maternal blood prcssurc in pregnancy.
GYNECOLOGY &OBSTETRICS International
Journal
of Gynecology
& Obstetrics
60 (1YYX) 95-105
Citations from the literature This is a selection of abstracts taken from the literature in the field of gynecology and obstetrics which the Journal’s Editors feel may be of interest to our readers’ DERMATOLOGY Fetal alloimmune Bussel
thrombocytopenia
J.B.; Zahusky
M.R.:
Berkowitz
R.L.:
McFarland
J.G.
A single cervical fetal fibronectin screening test in a population at low risk for preterm delivery: An improvement on clinical indicators?
USA
Faron
NEW ENGL J MED IVY7 337/l Q-26) Background: Alloimmune thrombocytopenia is a serious fetal disorder resulting from platelet-antigen incompatibility hetwcen the mother and fetus. The diagnosis is usually made after the discovery of unexpected neonatal thromhocytopenia. Approximately lo-20% of affected fetuses have intracranial hemorrhages. one-quarter to one-half of which occur in utero. We studied the correlates of thromhocytopenia in affected fctuscs. Methods: WC studied 107 fetuses with alloimmune thrombocytopcnia at a mean ( k S.D.) gestational age of 25 k 4 weeks. bcforc their entry into one of three trcatmcnt protocols. The fctuscs were initially evaluated because an older sihling had hccn given this diagnosis at birth. We compared the initial platelet counts in utcro in these 107 fetuses with the platclct count at birth and the history of intracranial hemorrhage in the affected sibling. Results: The initial platelet count was 5 20000 per cubic millimeter in 53 of the 107 fctuscs (5O’i; ). including 21 of 46 fetuses (46%) studied before 24 weeks of gestation. The Y7 fetuses with PIcAl) incompatibility had more scvcrc thromhocytopcnia than the 10 fetuses with other antigen incompatihilitics. Among seven fetuses with platclct counts of more than SO000 per cubic millimeter that wcrc not treated initially. the counts decreased by more than 10000 per cubic millimctcr per week. Although 41 fetuscs had initial platclct counts that were lower than those measured at hirth in an older affcctcd sibling. only a history of antenatal intracranial hcmorrhagc in the sibling predicted greater severity of thromhocytopcnia in the fetus. Only one trcatcd fetus had an intracranial hcmorrhagc and the thromhocytopenia resolved after birth in all casts. Conclusions: Fetal alloimmunc thromhocytopenia occurs early in gestation, is scvcrc and is more severe in fctuscs with an older affected sihling who had an antenatal intracranial hcmorrhagc.
BEL
G.; Boulvain
M.; Lescrainier
J.-P.: Vokaer
A.
BR J OBSTET GYNAECOL lYY7 104/h (hY7-701) Objective: To assess the accuracy of a single cervical fetal fibronectin tat to predict spontaneous preterm delivery in an unselected antenatal population. Design: A prospective blind cohort study. Setting: Antcnatal clinic of H teaching hospital in a Brussels semiurban arca. Participants: An unselected group of 170 women followed at the antenatal clinic. Methods: A single cervical sample was obtained hetwecn 24 and 3.3 completed weeks of pregnancy. The tihronectin test was compared with clinical evaluation and their predictive propcrtics wcrc assessed. Results: Fifteen women were excluded from the analysis hecause of elective preterm dclivcry for medical indications or loss to follow-up. Of the 155 remaining women, nine (7%) had a spontaneous prctcrm delivery. For a single fetal fihronectin test. the sensitivity was X.7%, the specificity YS.7% and the positive and negative predictive values 40.0% and Y2.4%, rcspcctivcly. The likelihood ratio of a positive was similar to that of clinical predictors of prctcrm birth (LR = 6.2: YS% CI X-1Y.h). Sensitivities were low for both clinical criteria and the fetal fihronectin test. Conclusions: Bccausc of low sensitivity in a low risk population, screening for prctcrm delivery should not hc hascd on the result of a single fetal tihroncctin test alone. Howcvcr. due to its high specificity the test might he useful in avoiding unnecessary medical intervention.
Trial of calcium to prevent preeclampsia Lcvinc R.J.: Hauth J.C.: Curct LB.: Sihai P.M.: Morris CD.: Dcrsimonian R.: Esterlitz E.G.: Bild D.E.; Clcmcns J.D.; Cutler J.A.
B.M.: J.R.;
Cat&no Raymond
USA ‘Gcncratcd 00X)-72Y2/YX/$
PII
from
the Exccrpta
IY.00
Mcdica
Q 1998 International
SOO20-72Y2(97)00243-Y
database,
EMBASE.
Fcdcration
NEW ENGL Background:
of Gynecology
J MED Previous
and Ohstctrics
lYY7 337/l (69-76) trials have suggcstcd
that calcium
sup-
96 plementation during pregnancy may reduce the risk of preeclampsia. However, differences in study design and a low dietary calcium intake in the populations studied limit acccptance of the data. Methods: We randomly assigned 4SXY healthy nulliparous women who were 13-21 weeks pregnant to receive daily treatment with either 2 g of clcmcntal calcium or placebo for the rcmaindcr of their pregnancies. Surveillance for prccclampsia was conducted by personnel unaware of treatment-group assignments. using standardized measurements of blood pressure and urinary protein excretion at uniformly scheduled prenatal visits. protocols for monitoring these measurements during the hospitalization for delivery and reviews of medical records of unscheduled outpatient visits and all hospitalizations. Results: Calcium supplementation did not significantly reduce the incidence or severity of prceclampsia or delay its onset. Preeclampsia occurred in 15X of the 22YS women in the calcium group (6.0%‘) add 168 of the 2294 women in the placebo group (7.3%) (relative risk, O.Y4; 95% confidcncc interval. 0.76 I. 16). There were no significant diffcrenccs hetwecn the two groups in the prevalence of pregnancy-associated hypertension without preeclampsia (15.3% vs. 17.3%) or of all hypertensive disorders (22.2% vs. 24.6%). The mean systolic and diastolic blood pressures during pregnancy were similar in both groups. Calcium did not rcducc the numbers of prcterm deliveries. small-for-gcstational-age births. or fetal and neonatal deaths: nor did it increase urolithiasis during pregnancy. Conclusions: Calcium supplcmcntation during pregnancy did not prevent prceclampsia. pregnancy-rrssociatcd hypcrtcnsion. or adverse perinatal outcomes in hcalthy nulliparous wonicii.
Antioxidants in the treatment of severe pre-eclampsia: explanatory randomised controlled trial Mctin
Gulmezoglu
A.; Justus
Hofmcyr
G.: Oosthuiscn
An
M.M.J.
GBR BR J OBSTET GYNECOL 1997 104/O (689-h’)(l) Objcctivc: To dctcrminc whcthcr antioxidant therapy alters the disease process in scvcrc early oiwt prc-cclampsia. in support of the hypothesis that incrcascd lipid peroxides and rcactivc oxygen spccics production play an important role in the pathogcncsis of the discasc. Design: Randomised. double-blind. placebo controlled trial. Setting: Two tertiary cart. referral hospitals in Johannesburg. South Africa. Participants: Women with scvcrc prc-cclampsia diagnosed hctween 24 and 32 weeks of gestation. Intervention: Combined antioxidant treatment with vitamin E (SO0 IU/day). vitamin C (I000 mg/day) and allopurinol (200 mg/day). Main outcome mcasurcs Primary outcomcs: (I ) prolongation of pregnancy; and (2) biochemical assessment of lipid pcroxidcs and antioxidants. Secondary outcomes: data on maternal complications. side cffccts of trcatmcnt. infant outcomes and regular asscssmcnt of hecmatologic and renal paramctcrs. Results: The proportion of women dclivcrcd within 14 days in the antioxidant
group was 5296 (14/27) compared with 76% (22/2Y) in the placebo group (relative risk 0.68, 95% confidence interval 0.45-1.04). One woman in each group had eclampsia. Eleven women (42%) in the antioxidant and 16 (59%) in the placebo group required two antihypertensives for blood pressure control. Trial medications were well tolerated with few side effects. Lipid peroxide levels wcrc not significantly altered in the antioxidant and placebo groups. Serum uric acid levels decreased and vitamin E lcvcls increased significantly. Conclusion: The results of this explanatory randomised trial do not encourage the routine use of antioxidants against preeclampsia. However, further research with modified strategies, such as earlier initiation of therapy or different combinations seem worthwhile.
Twenty-four-hour blood pressure monitoring to evaluate the effects of nifedipine in pre-eclampsia and in chronic hypertension in pregnancy Bencdetto Carandcntc
C.: Zonca F.
M.; Giarola
M.: Maula
V.: Chiarolini
L.;
ITA BR J OBSTET GYNECOL IVY7 104/h (6X2-6%9 Objective: To investigate the effect of 7-14 days of therapy with nifedipine (sustained-release preparation) on the 24-h blood pressure patterns of pregnant women with pre-eclampsia or chronic hypertension and to test the utility of blood prcssure monitoring in modulating the timing and dosage of the drug. Design: Twenty-four-hour automatic blood pressure monitoring of pregnant women with pre-eclampsia or chronic hypertension before and after nifedipine treatment. Setting: Ccntre for Prcvcntion. Diagnosis and Treatment of Hypertension in Pregnancy. University of Turin, Italy. Population: Sixteen pregnant women with prc-eclampsia and 17 with chronic hypertension. Methods: Twenty-four-hour blood prcssure monitoring was performed before the beginning of the therapy and after 7- 14 days of trcatmcnt with sustained-relcasc nifcdipinc. Main outcome mcasurcs: Chronobiological analysis of systolic and diastolic blood pressure vaLIucs was performed: MESOR. amplitude. acrophaae. hyperbaric index. percent time elevation and significance of rhythm wcrc calculated before and after trcatmcnt. Results: A large number (6.336) of blood pressure mcasurcmcnts wcrc analyscd. Systolic and diastolic MESOR values wcrc significantly decreased after nifcdipinc trcatmcnt both in pre-cclampsia and in chronic hypertension. Howcvcr. the antihypcrtensive effect of nifcdipinc in pre-eclampsia was cspccially pronounced during evening and night, while in chronic hypertension it was more constant during the 24-h period. 24-h blood prcssurc monitoring allowed adjustment. when ncccssary. to the timing and dosage of nifcdipinc in accordance with the blood prcssurc patterns of each patient. using the hyperbaric index and pcrccnt time clcvation as objective parameters for the evaluation of trcatmcnt cfticacy. Conclusions: Twenty-four-hour blood pressure monitoring is a good method to optimise treatment and contirms that nifcdipinc ix useful for the control of maternal blood prcssurc in pregnancy.