Table 8.
Studies with bradycardia as outcome measure.
| Article | Study Groups | Bradycardia | Heart Rate (Beats per Minute) |
Definition of Bradycardia | Time of Control of Bradycardia |
|---|---|---|---|---|---|
| Kayser A, 2020 [30] | ß-blocker vs. methyldopa ß-blocker vs. non-hypertensive mother |
5/252 (2.0%) vs. 5/199 (2.5%) (NS) 5/252 (2.0%) vs. 5/588 (0.8%) (NS) |
Diagnosis of bradycardia was retrieved from medical reports | N | |
| Mazkereth R, 2019 [32] | ß-blocker vs. control | 6/153 (3.9%) vs. 0/153 (0%) p = 0.030 |
Heart rate < 100 bpm | In the first 48 h after birth | |
| Easterling T, 2019 [33] | Labetalol vs. nifedipine Labetalol vs. methyldopa |
0/280 (0%) vs. 0/297 (0%) 0/280 (0%) vs. 0/298 (0%) |
Heart rate < 110 bpm | N | |
| Thewissen L, 2017 [34] | Labetalol vs. control | 0/22 vs. 0/22 vs. 0/22 | N | In the first 24 h after birth | |
| Bateman BT, 2016 [35] | ß-blocker vs. control Labetalol vs. control Metoprolol vs. control Atenolol vs. control Propensity-score 1 corrected available |
165/10,585 (1.6%) vs. 11,659/2,281,531 (0.5%) 124/6748 (1.8%) vs. 11,659/2,281,531 (0.5%) 12/1485 (0.8%) vs. 11,659/2,281,531 (0.5%) 12/1121 (1.1%) vs. 11,659/2,281,531 (0.5%) |
Heart rate ≤ 100 bpm | N | |
|
Heida KY, 2012 [37] |
Labetalol vs. control Labetalol i.v. vs. labetalol oral |
4/55 (7.3%) vs. 1/54 (1.9%) p = 0.18 5.4 vs 11.1% p = 0.39 |
Heart rate < 100 bpm | In the first minutes after birth and during the first 48 h | |
| Verma R, 2012 [38] | Labetalol vs. methyldopa | 1/45 (2.22%) vs. 0/45 (0%) (NS) | N | N | |
| Vigil-De Gracia P, 2006 [40] | Labetalol vs. hydralazine | 11/103 (10.6%) vs. 2/102 (1.9%) (p = 0.008) | Heart rate < 110 bpm | N | |
| Munshi UK, 1992 [43] | Labetalol vs. control | 6/48 (12.5%) vs 4/81 (5%) (NS) | Heart rate < 100 bpm | At 5-min as part of Apgar scoring | |
| Bott-Kanner G, 1992 [44] | Pindolol vs. placebo | 2 | Heart rate < 100 bpm | During the first 24 h after birth | |
| Pickles CJ, 1989 [45] | Labetalol vs. placebo | 4/70 (5.7%) vs. 4/74 (5.4%) | Heart rate < 120 bpm | At five minutes | |
| Ramanathan J, 1988 [28] | Labetalol vs. control | 0/15 (0%) vs. 0/10 (0%) | 138.2 ± 2.5 vs. 144 ± 3.2 (NS) | N | During 10–20 min after birth and thereafter for 12 to 24 h |
| Mabie WC, 1987 [47] | Labetalol vs. hydralazine | 0/13 (0%) vs. 0/6 (0%) | Heart rate < 110 bpm | N | |
| Macpherson M, 1986 [49] | Labetalol vs. control | No difference between the two groups | N | At 2, 4, 8,16, 24, 48 and 72 h after birth | |
| Boutroy MJ, 1986 [48] | 3 | ||||
| Högstedt S, 1985 [50] | Metoprolol and hydralazine vs. control (intended-to-treat) 4
Metoprolol and hydralazine vs. control (cause–effect) |
1/82 (1.2%) vs. 4/79 (5.1%) 1/69 (1.4%) vs. 3/66 (4.5%) |
N | N | |
| Reynolds B, 1984 [51] | 5 | ||||
| Williams ER, 1983 [52] | Acebutolol vs. methyldopa | 0/9 vs. 0/11 | N | N | |
| Rubin PC, 1983 [53] | Atenolol vs. placebo | 18/46 (39.1%) vs. 4/39 (10.3%) (p < 0.01) | Heart rate < 120 bpm | Continuously recorded in the first 24 h after birth | |
| Liedholm H, 1983 [27] | Atenolol (no control group) | 6 | N | N | |
| Livingstone I, 1983 [55] | Propranolol vs. methyldopa | 0/14 (0%) vs. 0/14 (0%) | N | During 48 h after birth | |
| Boutroy MJ, 1982 [56] | Acebutolol (no control group) | 12/31 (38.7%) | Basal heart rate < 120 beats per minute and lasting longer than 1 h | During 72 h after birth | |
| Sandström B, 1982 [58] | Bendroflumethiazide + metoprolol vs. metoprolol + hydralazine vs. Bendroflumethiazide + hydralazine | 7/101 vs. 1/83 vs. 16/97 (8/184 vs. 16/97) | Heart rate < 100 bpm | At birth | |
| Garden A, 1982 [59] | Labetalol vs. hydralazine | 3/3 (100%) vs. 0/3 (0%) | Heart rate < 100 bpm | Immediately after birth | |
| Rubin PC, 1982 [57] | Atenolol (no control group) | 0/9 (0%) | Heart rate < 120 bpm | During 24 h after birth | |
| Dumez Y, 1981 [60] | Acebutolol vs. methyldopa | Day 1: 118 ± 19 vs. 132 ± 9 (p < 0.05) Day 2: 123 ± 18 vs. 139 ± 10 (p < 0.05) Day 3: 126 ± 21 vs. 148 ± 12 (p < 0.02) |
N | Daily during the 3 first days after birth, when the babies were sleeping | |
| O’Hare MF, 1980 [62] | Sotalol (no control group) | 6/12 (50%) | Heart rate < 120 bpm | Four-hourly for at least 24 h | |
| Pruyn SC, 1979 [64] | Propranolol (no control group) | 1/12 (8.3%) | N | N |
Abbreviations: N: is not described in article; NS: not significant; bpm: beats per minute. 1 PS-matched: Propensity scores were estimated using a logistic regression model in which exposure was the dependent variable and was estimated on the basis of 5 groups of potential confounders of the planned analysis: demographic characteristics, medical conditions, obstetrical conditions, maternal medications, and measures of healthcare use [35]. 2 As regards other outcome variables, namely, the Apgar score, respiratory and heart rate at delivery, hypoglycemia and jaundice during the first 24 h—the differences between the two treatment groups were inconsistent and non-significant [44]. 3 Hypotension, bradycardia and transient tachypnea were observed in one infant. The article does not describe if there were any other cases of bradycardia. 4 For the analyses, the material was divided into two categories. The first group gives data for all the 161 patients whom it was the intention to treat. In the calculation of cause-and-effect, 26 patients were withdrawn from the original group of 161: in 5 patients of C-group, DBP exceeded 110 mmHg and they were then treated with antihypertensive drugs; one patient in T-group admitted that she had not taken the prescribed drugs; 6 patients gave birth to malformed or stillborn children and their data were not used for the calculation of Apgar scores, birth weights or other vitality signs. Eight patients in the T-group and 6 in the C-group gave birth within 2 weeks after admission to the study, and these 14 women were excluded from the cause-and-effect analyses because of the short treatment period [50]. 5 One infant in the placebo group had a bradycardia in the first 12 h of life. The article does not describe if there were any other cases of bradycardia. 6 Bradycardia was only investigated in one of the seven infants [27]. At no time did this infant have bradycardia or any other clinical sign of beta-blockade [27].