Table 3.
Study ID (setting) | Participants | Definitions | Interventions | Other medications | ||
---|---|---|---|---|---|---|
Length of pregnancy | Diagnosis N = |
Pre-eclampsia or gestational hypertension | Interventionist n= |
Expectant n= |
||
HYPITAT-I 2009 [18–20] (Netherlands) | 36–41 weeks | Pre-eclampsia or gestational hypertension N = 756 Maternal age: median 29 (26–33) years Gestational age: median 38 (37–39) weeks |
Pre-eclampsia: diastolic BP > 90 mm on two occasions at least 6 h apart; proteinuria (two or more occurrences of protein on a dipstick, >300 mg total protein within a 24-h urine collection, or ratio of protein to creatinine >30 mg/mmol) Gestational hypertension: diastolic BP ≧ 95 mmHg, on two occasions at least 6 h apart |
Delivery by induction of labour within 24 h after randomisation. Labour induced by amniotomy with a Bishop cervix score >6 at vaginal examination n = 377 |
Monitored until the onset of spontaneous delivery; monitoring of blood pressure, screening of urine for protein with dipstick specimen or with ratio of protein to creatinine (inpatient or outpatient) n = 379 |
Use of oxytocin orprostaglandins depended on local protocols |
Mesbah 2003 [21] (Egypt) | 28–33 weeks | Severe pre-eclampsia N = 30 Maternal age: mean 24.7 ± 5.9 years Gestational age: mean 31.1 ± 1.7 weeks |
Severe pre-eclampsia: BP > 180/120 mmHg on two occasions 30 min apart; or BP between 160 to 180/110 to 120 mmHg on two occasions six hours apart; > 500 mg of proteinuria on a 24 h urine collection measure | Administered dexamethasone phosphate; 48 h to lapse before either an induction of labour was attempted (50 µ, vaginal misoprostol) or caesarean section after 24 h n = 15 |
Administered dexamethasone phosphate then managed conservatively with bed rest, observations and nifedipine to control BP. Indications for delivery were imminent eclampsia, deteriorating renal function, spontaneous preterm labour, absent EDF or a non-reassuring CTG reaching 34 weeks n = 15 |
Blood pressure controlled with oral nifedipine |
MEXPRE 2013 [22] (Latin America)* | 28–33 weeks | Pre-eclampsia and severe hypertensive disorders N = 264 Maternal age: mean 28.15 ± 6.6 years Gestational age: mean 30.8 ± 1.6 |
Severe pre-eclampsia: BP > 140/90 mmHg or greater on two occasions at least 4 h apart and proteinuria >300 mg in 24 h urine specimen with 1 or more of the following additional criteria: BP > 160 mm Hg systolic or >110 mm Hg diastolic; proteinuria >5 g per 24 h; or symptoms suggesting significant end-organ involvement, such as headache, visual disturbances, epigastric pain, or tinnitus | ‘Prompt delivery’: glucocorticoid therapy followed by delivery in 24–72 h, magnesium sulphate continued until 24 h after delivery n = 133 (n = 106 with severe pre-eclampsia) |
Treated expectantly: glucocorticoid therapy followed by delivery only for specific maternal/ fetal indications or reaching 34 weeks of gestation n = 134 (n = 101 with severe pre-eclampsia) |
Corticosteroids (betamethasone or dexamethasone Oral antihypertensive used in some centers (a-methyl dopa, nifedipine, or hidralazin) |
Odendaal 1990 [23] (Africa) | 28–34 weeks | Severe pre-eclampsia N = 38 Maternal age: mean 23 ± 4 years Gestational age: range 28–34 weeks |
Severe pre-eclampsia: BP exceeding 180/120 mmHg on two occasions at least 30 min apart with 2 + or more proteinuria on dipstick Blood pressure of 160/110–180/120 mmHg on two occasions at least 6 h apart with 2 + or more proteinuria 150/100–160/110 mmHg on two occasions at least 6 h apart with 3 + or more proteinuria 140/90 mmHg or more proteinuria and clinical signs of imminent eclampsia (diagnosed in women with epigastric pain, severe headache, visual disturbances, nausea, and brisk tendon reflexes) |
Delivery by induction or caesarean section depending on obstetric circumstances 48 h after betamethasone. If cervix not favourable, prostaglandin E2 tablets. If still not favourable after 24 h, caesarean section n = 20 |
Bed rest on high-risk obstetric ward; maternal and fetal condition monitored intensively; BP controlled with prazosin; delivery at 34 weeks unless indicated earlier n = 18 |
Magnesium sulphate (4 mg IV; 10 mg IM); dihydralazine (6.25 mg IV); betamethasone (12 mg IM) |
Sibai 1994 [24] (USA) | 28–32 weeks | Severe pre-eclampsia N = 95 Maternal age: mean 22.5 ± 5.1 years Gestational age: mean 30.1 ± 1.6 weeks |
Severe pre-eclampsia: persistent elevations of blood pressure (systolic >160 mm Hg or diastolic -->- 110 mm Hg) during the initial 24 h of hospitalization. All had proteinuria (>500 mg per 24 h) and elevated serum uric acid levels (>5 mg/dl) | Delivery by caesarean section or by induction of labour, on the basis of obstetric condition, 48 h after first dose of betamethasone n = 46 |
Maternal and fetal monitoring on an antenatal ward. If either condition deteriorated, or reached 34 weeks’ gestation, delivery using the ‘most appropriate method’ n = 49 |
Betamethasone (12 mg at 24 h apart); labetalol (200 mg every 8 h, max. 2400 mg/day); nifedipine (max. 120 mg/day) |
Duvekot 2015 [25] | 28–32 weeks | Severe pre-eclampsia Maternal age: not reported Gestational age: 30 weeks |
Severe pre-eclampsia: Not reported, as only abstract is available | Delivery 48 h after admission n = 26 |
Expectant management, no more details n = 30 |
Not reported |
GRIT 2003 (Europe) [27 ] | ≤34 weeks | Fetal compromise between 24 and 36 weeks N = 548 (n = 262 relevant with severe pre-eclampsia) Maternal age: median 28 (24–32) years Gestational age: median 32 (29–34) weeks |
Not reported—gestational age between 24 and 36 weeks, umbilical artery Doppler waveform recorded | Delivery within 48 h to permit completion of a steroid course n = 141 |
Delayed delivery until obstetrician no longer uncertain n = 121 |
Not reported |
MEXPRE 2013*—additional definitions: Severe gestational hypertension defined as: BP > 140/90 mmHg or greater on two occasions at least 4 h apart and <300 mg of protein in a 24 h urine specimen with 1 or more of the following additional criteria: BP > 160 mmHg systolic greater than 110 mm Hg diastolic; or symptoms suggesting significant end-organ involvement. Chronic hypertension: hypertension present before pregnancy/ before the 20th week of gestation. Superimposed pre-eclampsia in women with chronic hypertension: development of new-onset proteinuria, with 1 or more of the following criteria: blood pressure greater than 160 mm Hg systolic or greater than 110 mm Hg diastolic; or symptoms suggesting significant end-organ involvement