Less-Tight Versus Tight Control of Hypertension in Pregnancy

Abstract

A note on versions:The version presented here may differ from the published version or from the version of record. If you wish to cite this item you are advised to consult the publisher's version. Please see the repository url above for details on accessing the published version and note that access may require a subscription. BACKGROUNDThe effects of less-tight versus tight control of hypertension on pregnancy complications are unclear. METHODSWe performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later. RESULTSIncluded in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (P<0.001). CONCLUSIONSWe found no significant between-group differences in the risk of pregnancy loss, high-level neonatal care, or overall maternal complications, although less-tight control was associated with a significantly higher frequency of severe maternal hypertension. (Funded by the Canadian Institutes of Health Research; CHIPS Current Controlled Trials number, ISRCTN71416914; ClinicalTrials.gov number, NCT01192412.) a bs tr ac t

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial

“…Of the 987 women enrolled in the CHIPS Trial, six women were lost to follow up for the primary and secondary outcomes, leaving 981 women (99.4%) who were included in this predictive modeling analysis. Among these, 305 (31.1%) had primary outcomes, 175 (17.9%) babies with birthweight <10th percentile, 334 (34.0%) developed severe hypertension and 464 (47.3%) preeclampsia, 138 (14.1%) delivered at <34 weeks, and 328 (33.4%) at <37 weeks, as previously reported .…”

“…Severe hypertension was associated with “less tight” BP control [as reported ], Black/Hispanic ethnicity (vs. Caucasian/Asian/other), conception by ART, higher BP, prior severe hypertension in the index pregnancy, and antihypertensive therapy other than labetalol or methyldopa (as previously reported)] (Figure c). Sensitivity analysis revealed one interaction – increasing sBP at enrolment had a greater impact on the likelihood of severe hypertension among women who were not on any antihypertensive at enrolment compared with the effect on those who were on antihypertensives (Table S4).…”

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial

“…Of the 987 women enrolled in the CHIPS Trial, six women were lost to follow up for the primary and secondary outcomes, leaving 981 women (99.4%) who were included in this predictive modeling analysis. Among these, 305 (31.1%) had primary outcomes, 175 (17.9%) babies with birthweight <10th percentile, 334 (34.0%) developed severe hypertension and 464 (47.3%) preeclampsia, 138 (14.1%) delivered at <34 weeks, and 328 (33.4%) at <37 weeks, as previously reported .…”

“…Severe hypertension was associated with “less tight” BP control [as reported ], Black/Hispanic ethnicity (vs. Caucasian/Asian/other), conception by ART, higher BP, prior severe hypertension in the index pregnancy, and antihypertensive therapy other than labetalol or methyldopa (as previously reported)] (Figure c). Sensitivity analysis revealed one interaction – increasing sBP at enrolment had a greater impact on the likelihood of severe hypertension among women who were not on any antihypertensive at enrolment compared with the effect on those who were on antihypertensives (Table S4).…”

Pharmacogenetics in the Treatment of Pre-Eclampsia: Current Findings, Challenges and Perspectives

“…Further studies are required to improve our understanding of the HDP. However, some of the parameters included in our criteria are in agreement with the clinical criteria observed in a study regarding the effects of less-tight versus tight control of hypertension on pregnancy [99]. In this study, the pregnant women in the less-tight control group were associated with a significantly higher frequency of severe maternal hypertension and target-organ lesions [99,100].…”

Timing is everything: snoring onset and blood pressure trajectories in pregnancyCommentary on Dunietz GL, Hao W, Shedden K, et al. Maternal habitual snoring and blood pressure trajectories in pregnancy. J Clin Sleep Med . 2022;18(1):31–38. doi:10.5664/jcsm.9474

“…In addition, the Control of Hypertension In Pregnancy Study (CHIPS) trial that demonstrated a difference of 5.8 mmHg systolic and 4.6 mmHg diastolic pressures between the tight and less tight BP target groups in pregnancy did not show any difference in perinatal outcomes, except for differences in the frequency of severe maternal hypertension. 11 Further, ambulatory monitoring data for 48 consecutive hours every 4 weeks in women with normotensive and complicated pregnancies demonstrated an average 8% BP increase starting in midgestation in normotensive women and a 9-13% increase in complicated pregnancies, 12 many-fold higher than the cutoff proposed in the present study.…”

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial

“…Of the 987 women enrolled in the CHIPS Trial, six women were lost to follow up for the primary and secondary outcomes, leaving 981 women (99.4%) who were included in this predictive modeling analysis. Among these, 305 (31.1%) had primary outcomes, 175 (17.9%) babies with birthweight <10th percentile, 334 (34.0%) developed severe hypertension and 464 (47.3%) preeclampsia, 138 (14.1%) delivered at <34 weeks, and 328 (33.4%) at <37 weeks, as previously reported .…”

“…Severe hypertension was associated with “less tight” BP control [as reported ], Black/Hispanic ethnicity (vs. Caucasian/Asian/other), conception by ART, higher BP, prior severe hypertension in the index pregnancy, and antihypertensive therapy other than labetalol or methyldopa (as previously reported)] (Figure c). Sensitivity analysis revealed one interaction – increasing sBP at enrolment had a greater impact on the likelihood of severe hypertension among women who were not on any antihypertensive at enrolment compared with the effect on those who were on antihypertensives (Table S4).…”

Pharmacogenetics in the Treatment of Pre-Eclampsia: Current Findings, Challenges and Perspectives

“…Further studies are required to improve our understanding of the HDP. However, some of the parameters included in our criteria are in agreement with the clinical criteria observed in a study regarding the effects of less-tight versus tight control of hypertension on pregnancy [99]. In this study, the pregnant women in the less-tight control group were associated with a significantly higher frequency of severe maternal hypertension and target-organ lesions [99,100].…”

Timing is everything: snoring onset and blood pressure trajectories in pregnancyCommentary on Dunietz GL, Hao W, Shedden K, et al. Maternal habitual snoring and blood pressure trajectories in pregnancy. J Clin Sleep Med . 2022;18(1):31–38. doi:10.5664/jcsm.9474

“…In addition, the Control of Hypertension In Pregnancy Study (CHIPS) trial that demonstrated a difference of 5.8 mmHg systolic and 4.6 mmHg diastolic pressures between the tight and less tight BP target groups in pregnancy did not show any difference in perinatal outcomes, except for differences in the frequency of severe maternal hypertension. 11 Further, ambulatory monitoring data for 48 consecutive hours every 4 weeks in women with normotensive and complicated pregnancies demonstrated an average 8% BP increase starting in midgestation in normotensive women and a 9-13% increase in complicated pregnancies, 12 many-fold higher than the cutoff proposed in the present study.…”

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial

“…Of the 987 women enrolled in the CHIPS Trial, six women were lost to follow up for the primary and secondary outcomes, leaving 981 women (99.4%) who were included in this predictive modeling analysis. Among these, 305 (31.1%) had primary outcomes, 175 (17.9%) babies with birthweight <10th percentile, 334 (34.0%) developed severe hypertension and 464 (47.3%) preeclampsia, 138 (14.1%) delivered at <34 weeks, and 328 (33.4%) at <37 weeks, as previously reported .…”

“…Severe hypertension was associated with “less tight” BP control [as reported ], Black/Hispanic ethnicity (vs. Caucasian/Asian/other), conception by ART, higher BP, prior severe hypertension in the index pregnancy, and antihypertensive therapy other than labetalol or methyldopa (as previously reported)] (Figure c). Sensitivity analysis revealed one interaction – increasing sBP at enrolment had a greater impact on the likelihood of severe hypertension among women who were not on any antihypertensive at enrolment compared with the effect on those who were on antihypertensives (Table S4).…”

Pharmacogenetics in the Treatment of Pre-Eclampsia: Current Findings, Challenges and Perspectives

“…Further studies are required to improve our understanding of the HDP. However, some of the parameters included in our criteria are in agreement with the clinical criteria observed in a study regarding the effects of less-tight versus tight control of hypertension on pregnancy [99]. In this study, the pregnant women in the less-tight control group were associated with a significantly higher frequency of severe maternal hypertension and target-organ lesions [99,100].…”

Timing is everything: snoring onset and blood pressure trajectories in pregnancyCommentary on Dunietz GL, Hao W, Shedden K, et al. Maternal habitual snoring and blood pressure trajectories in pregnancy. J Clin Sleep Med . 2022;18(1):31–38. doi:10.5664/jcsm.9474

“…In addition, the Control of Hypertension In Pregnancy Study (CHIPS) trial that demonstrated a difference of 5.8 mmHg systolic and 4.6 mmHg diastolic pressures between the tight and less tight BP target groups in pregnancy did not show any difference in perinatal outcomes, except for differences in the frequency of severe maternal hypertension. 11 Further, ambulatory monitoring data for 48 consecutive hours every 4 weeks in women with normotensive and complicated pregnancies demonstrated an average 8% BP increase starting in midgestation in normotensive women and a 9-13% increase in complicated pregnancies, 12 many-fold higher than the cutoff proposed in the present study.…”