Expectant Versus Interventionist Care in the Management of Severe Preeclampsia Remote from Term: A Systematic Review

Quintero-Ortíz, María Andrea; Grillo-Ardila, Carlos Fernando; Amaya-Guio, Jairo

doi:10.1055/s-0041-1733999

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Review Article • Rev. Bras. Ginecol. Obstet. 43 (08) • Aug 2021 • https://doi.org/10.1055/s-0041-1733999 copy

Expectant Versus Interventionist Care in the Management of Severe Preeclampsia Remote from Term: A Systematic Review

Cuidado expectante versus cuidado intervencionista no tratamento da pré-eclâmpsia grave a distância: uma revisão sistemática

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objective

To compare the effects of expectant versus interventionist care in the management of pregnant women with severe preeclampsia remote from term.

Data sources

An electronic search was conducted in the Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Cochrane Central Register of Controlled Trials (CENTRAL), Latin American and Caribbean Health Sciences Literature (LILACS, for its Spanish acronym), World Health Organization’s International Clinical Trials Registry Platform (WHO-ICTRP), and Open- Grey databases. The International Federation of Gynecology and Obstetrics (FIGO, for its French acronym), Royal College of Obstetricians and Gynaecologists (RCOG), American College of Obstetricians and Gynecologists (ACOG), and Colombian Journal of Obstetrics and Gynecology (CJOG) websites were searched for conference proceedings, without language restrictions, up to March 25, 2020.

Selection of studies

Randomized clinical trials (RCTs), and non-randomized controlled studies (NRSs) were included. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was used to evaluate the quality of the evidence.

Data collection

Studies were independently assessed for inclusion criteria, data extraction, and risk of bias. Disagreements were resolved by consensus.

Data synthesis

Four RCTs and six NRS were included. Low-quality evidence from the RCTs showed that expectant care may result in a lower incidence of appearance, pulse, grimace, activity, and respiration (Apgar) scores<7 at 5 minutes (risk ratio [RR]: 0.48; 95% confidence interval [95%CI]: 0.23%to 0.99) and a higher average birth weight (mean difference [MD]: 254.7 g; 95%CI: 98.5 g to 410.9 g). Very low quality evidence from the NRSs suggested that expectant care might decrease the rates of neonatal death (RR: 0.42; 95%CI 0.22 to 0.80), hyalinemembrane disease (RR: 0.59; 95%CI: 0.40 to 0.87), and admission to neonatal care (RR: 0.73; 95%CI: 0.54 to 0.99). Nomaternal or fetal differences were found for other perinatal outcomes.

Conclusion

Compared with interventionist management, expectant care may improve neonatal outcomes without increasing maternal morbidity and mortality.

Keywords:
preeclampsia; Apgar score; birthweight; hyaline membrane disease

Study	Design	Country	Sample size (n)	Mean age	Gestational age	Inclusion and exclusion criteria	Intervention	Comparison	Primary outcomes	Secondary outcomes
Odendaal et al. (1990) ¹⁶16 Odendaal HJ, Pattinson RC, BamR, Grove D, Kotze TJ. Aggressive or expectant management for patients with severe preeclampsia between 28-34 weeks' gestation: a randomized controlled trial. Obstet Gynecol. 1990;76(06):1070-1075	Randomized clinical trial	South Africa	38	23 years	Not mentioned	Inclusion: severe preeclampsia between 28 and 34 weeks, or fetal weight between 650 and 1,500 g; exclusion: patients who were started on oral antihypertensives before admission	Glucocorticoid (12 mg betamethasone/12 hours in 2 doses);Intravenous magnesium sulfate (4 g); intramuscular magnesium sulfate (10g) immediately, followed by another 5 g intramuscular every 4 hours for at least 24 hours); dihydralazine (6.25 mg)	Initial management similar to intervention, but delivery in 24 to 72 hours after the administration of the glucocorticoid	Placental abruption, stillbirth, neonatal death	Cesarean section, renal failure, pregnancy prolongation, birth weight
Sibai et al. (1994) ¹⁷17 Sibai BM, Mercer BM, Schiff E, Friedman SA. Aggressive versus expectant management of severe preeclampsia at 28 to 32 weeks' gestation: a randomized controlled trial. Am J Obstet Gynecol. 1994;171(03):818-822. Doi: 10.1016/0002-9378(94)90104-x https://doi.org/10.1016/0002-9378(94)901...	Randomized clinical trial	United States	95	22 years	30 weeks	Inclusion: severe preeclampsia at 28 to 32 weeks; exclusion: patients with renal disease, insulin-dependent diabetes, connective tissue disease, or obstetric complications such as bleeding, rupture of membranes, multifetal gestation, or preterm labor	Glucocorticoid (betamethasone 12 mg/24 hours in 2 doses); glucocorticoid was repeated weekly until delivery magnesium sulfate (6 g over 20 minutes, followed by 2 g/h); antihypertensive (hydralazine or oral nifedipine)	Initial management similar to intervention, but delivery in 48 hours of first dose of glucocorticoid	Eclampsia, HELLP syndrome, placental abruption, stillbirth, neonatal death, intraventricular hemorrhage, small-for-gestational age newborn	Cesarean section, pulmonary edema, renal failure, prologation of pregnancy, low Apgar score at five minutes, hyaline membrane disease, birth weight, NICU admission
Mesbah (2003) ¹⁸18 Mesbah EM. Severe preterm preeclampsia: aggressive or expectant management? Med J Cairo Univ. 2003;71(01):175-182	Randomized clinical trial	Egypt	30	24 years	31 weeks	Inclusion: severe preeclampsia at 28 to 33 weeks; exclusion: patients with renal disease, insulin-dependent diabetes, connective tissue disease, or obstetric complications such as bleeding, rupture of membranes, or pre-term labor	Glucocorticoid (dexamethasone 8 mg intramuscular/12 hours); magnesium sulfate; oral antihypertensive (nifedipine); fetal evaluation non-stress test, Doppler evaluation, and ultrasound	Initial management similar to intervention, but delivery in 48 hours of first dose of glucocorticoid	Eclampsia, HELLP syndrome, placental abruption, stillbirth, neonatal death, small-for-gestational age newborn	Cesarean section.renal failure, prolongation of pregnancy, low Apgar score at five minutes, birth weight, NICU admission
Vigil-de Gracia et al. (2013) ¹⁹19 Vigil-De Gracia P, Reyes Tejada O, Calle Miñaca A, Tellez G, Chon VY, Herrarte E, et al. Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial. AmJ Obstet Gynecol. 2013;209(05):425. e1-425.e8. Doi: 10.1016/j.ajog.2013.08.016 https://doi.org/10.1016/j.ajog.2013.08.0...	Randomized clinical trial	Panama, Guatemala, Peru, Mexico, Ecuador, and Venezuela	267	28 years	30 weeks	Inclusion: singleton or twin pregnancy and severe hypertensive disorders at 28 to 33 weeks of gestation; exclusion: < 28 weeks of gestation, eclampsia, HELLP syndrome, preeclampsia with renal failure or pulmonary edema, active vaginal bleeding, ruptured membranes, placenta previa, diabetes mellitus or gestational diabetes, preexisting renal disease or autoimmune disease, major fetal abnormalities, fetal growth restriction, oligohydramnios, and reverse umbilical artery Doppler flow	Glucocorticoid (dexamethasone 6 mg/12 hours in 4 doses, or betamethasone 12 mg/24 hours); magnesium sulfate (4 g intravenous loading dose followed by 1 g intravenous 24 to 48 hours); antihypertensive (hydralazine, labetalol, or oral nifedipine)	Initial management similar to intervention, but delivery in 24–72 hours of the admonistration of glucocorticoid	Maternal death, eclampsia.HELLP syndrome, placental abruption, stillbirth, neonatal death, intraventricular hemorrhage, small-for-gestational age newborn	Cesarean section, pulmonary edema, renal failure, prolongation of pregnancy, hyaline membrane disease, birth weight, NICU admission
Oláh et al. (1993) ²⁰20 Oláh KS, Redman CW, Gee H. Management of severe, early preeclampsia: is conservative management justified? Eur J Obstet Gynecol Reprod Biol. 1993;51(03):175-180. Doi: 10.1016/0028-2243(93)90032-8 https://doi.org/10.1016/0028-2243(93)900...	Retrospective non-randomized controlled study	England	56	23 years	29 weeks	Inclusion: blood pressure ≥ 170/110 mmHg plus proteinuria (at least 1+ on qualitative testing), and hyperuricaemia; exclusion: preexisting renal disease or essential hypertension	Glucocorticoid (2 doses of dexamethasone 12 mg/every 12 hours once a week); antihypertensive (nifedipine, methyldopa, oxprenolol)	Initial management similar, delivery at 24–48 hours. Antihypertensive. Phenytoin or diazepam. No administration of glucocorticoid	HELLP syndrome, neonatal death	Hyaline membrane disease, birth weight
Sarsam et al. (2008) ²¹21 Sarsam DS, Shamden M, AlWazan R. Expectant versus aggressive management in severe preeclampsia remote from term. Singapore Med J. 2008;49(09):698-703	Prospective non-randomized controlled study	Iraq	74	Not mentioned	29weeks	Inclusion: singleton pregnancies at 24 and 34 weeks, complicated by severe preeclampsia; exclusion: failure to control blood pressure, development of major maternal complications, non-reassuring cardiotocography	Glucocorticoid (betamethasone 12 mg in 2 doses); antihypertensive (dihydralazine and/or oral medication: methyldopa, nifidipine, or a combination); magnesium sulfate prophylaxis was not considered	Immediate delivery with or without the administration of glucocorticoid	Maternal death, eclampsia, HELLP syndrome, stillbirth, neonatal death, intraventricular hemorrhage, small-for-gestational age newborn	Cesarean section, pulmonary edema, renal failure, hyaline membrane disease, birth weight
Kumar et al. (2011) ²²22 Kumar M, Meena J, Gupta U, Singh A, Jain N. Management of early onset severe preeclampsia in a tertiary hospital in India: does expectant management alter perinatal outcome? Indian J Med Sci. 2011;65(12):535-542. Doi: 10.4103/0019-5359.109903 https://doi.org/10.4103/0019-5359.109903...	Retrospective non-randomized controlled study	India	106	25 years	32 weeks	Inclusion: blood pressure ≥ 160/110 mmHg and proteinuria > 5 g in a 24-hour urine specimen, or ≥ 3 + , or symptoms of impending preeclampsia; exclusion: not mentioned	Glucocorticoid; oral antihypertensive drugs; fetal monitoring with ultrasound and Doppler study	Immediate delivery with or without the administration of glucocorticoid	Maternal death, eclampsia, HELLP syndrome, placental abruption, stillbirth, neonatal death, intraventricular hemorrhage, Small-for-gestational age newborn	Cesarean section, pulmonary edema, birth weight, NICU admission
Suzuki et al. (2014) ²³23 Suzuki S, ShimadaM, Shibata-Hiraizumi Y. Clinical trial of expectant management of severe preeclampsia that develops at <32 weeks' gestation at a Japanese perinatal center. JMatern Fetal NeonatalMed. 2014;27(15):1568-1571. Doi: 10.3109/14767058.2013.870548 https://doi.org/10.3109/14767058.2013.87...	Retrospective non-randomized controlled study	Japan	49	34 years	29 weeks	Inclusion: early-onset severe preeclampsia; exclusion: patients with chronic hypertension, renal disease, and systemic illnesses	Glucocorticoid (betamethasone 12 mg/day for 2 days); magnesium sulfate	Immediate delivery with or without the administration of glucocorticoid	HELLP syndrome, placental abruption, stillbirth, small-for-gestational age newborn	Cesarean section, pulmonary edema, hyaline membrane disease, birth weight
Ertekin et al. (2015) ²⁴24 Ertekin AA, Kapudere B, Eken MK, Ilhan G, Dirman S, Sargin MA, et al. Does aggressive and expectant management of severe preeclampsia affect the neurologic development of the infant? Int J Clin Exp Med. 2015;8(10):19325-19331	Prospective non-randomized controlled study	Turkey	70	27 years	31 weeks	Inclusion: severe preeclampsia between 27 and 34 weeks of gestation; exclusion: multiple pregnancies	Glucocorticoid (betamethasone 12 mg/12 hours in 2 doses); magnesium sulfate; antihypertensive drugs	Initial management similar to intervention, but delivery in 24 hours of first dose of glucocorticoid	HELLP syndrome, neonatal death, intraventricular hemorrhage, small-for-gestational age newborn	Renal failure, low Apgar score at five minutes, hyaline membrane disease
Rendón-Becerra e Ortiz-Martínez (2016) ²⁵25 Rendón-Becerra CA, Ortiz-Martínez RA. Comparación de dos protocolos de manejo en preeclampsia severa, lejos del término, y resultados maternos y neonatales: una cohorte histórica Hospital Universitario San José, Popayán (Colombia). Rev Colomb Obstet Ginecol. 2016;67(01):26-5	Retrospective non-randomized controlled study	Colombia	100	26 years	32 weeks	Inclusion: singleton pregnancies at 24 and 34 weeks; exclusion: patients with eclampsia, HELLP syndrome, placental abruption, or fetal distress	Glucocorticoid (betamethasone 12 mg/day for 2 days);magnesium sulfate; antihypertensive (labetalol and nifedipine); fetal monitoring	Initial management similar to intervention, but delivery in 24–72 hours of the administration of glucocorticoid	Maternal death, eclampsia, HELLP syndrome, placental abruption, neonatal death, intraventricular hemorrhage, small-for-gestational age newborn	Pulmonary edema, renal failure, low Apgar score at five minutes, hyaline membrane disease

Patient or population: pregnant women with severe preeclampsia remote from term
Setting: high, medium and low-income countries
Intervention: expectant care
Comparison: interventionist care
Outcomes	Anticipated absolute effects* (95%CI)		Relative effect(95%CI)	N° of participants(studies)	Certainty of the evidence(GRADE)
Outcomes	Risk with interventionist care	Risk with Expectant care	Relative effect(95%CI)	N° of participants(studies)	Certainty of the evidence(GRADE)
Maternal death	0 per 1,000	0 per 1,000(0 to 0)	Not estimable	264(1 RCT)	ⴲⴲ◯◯LOW^a
Eclampsia	5 per 1,000	5 per 1,000(0 to 83)	Risk ratio: 1.02(0.06 to 16.06)	389(3 RCTs)	ⴲⴲ◯◯LOW^a
HELLP syndrome	113 per 1,000	104 per 1,000(59 to 183)	Risk ratio: 0.92(0.52 to 1.61)	389(3 RCTs)	ⴲⴲ◯◯LOW^a
Placental abruption	34 per 1,000	56 per 1,000(17 to 184)	Risk ratio: 1.65(0.50 to 5.42)	419(4 RCTs)	ⴲⴲ◯◯LOW^a
Cesarean section	850 per 1,000	850 per 1,000(731 to 995)	Risk ratio: 1.00(0.86 to 1.17)	427(4 RCTs)	ⴲⴲⴲⴲHIGH
Pulmonary edema	6 per 1,000	11 per 1,000(1 to 124)	Risk ratio: 2.03(0.19 to 22.12)	359(2 RCTs)	ⴲⴲ◯◯LOW^a
Renal failure	5 per 1,000	15 per 1,000(2 to 91)	Risk ratio: 3.13(0.50 to 19.51)	427(4 RCTs)	ⴲⴲ◯◯LOW^a
Prologation of pregnancy		Mean difference: 7.46 days higher(6.01 days higher to 8.91 days higher)	−	294(2 RCTs)	ⴲⴲⴲⴲHIGH
Patient or population: Pregnant women with severe preeclampsia remote from term
Setting: High, Medium and Low-Income Countries
Intervention: Expectant care
Comparison: interventionist care
Outcomes	*Anticipated absolute effects (95%CI)**		Relative effect (95%CI)	N° of participants (studies)	Certainty of the evidence (GRADE)
Outcomes	Risk with interventionist care	Risk with Expectant care	Relative effect (95%CI)	N° of participants (studies)	Certainty of the evidence (GRADE)
Stillbirth	5 per 1,000	8 per 1,000(1 to 61)	Risk ratio: 1.76(0.24 to 12.87)	425(4 RCTs)	ⴲⴲ◯◯LOW^a
Neonatal death	107 per 1,000	82 per 1,000(46 to 145)	Risk ratio: 0.76(0.43 to 1.35)	427(4 RCTs)	ⴲⴲ◯◯LOW^a
Intraventricular hemorrhage	39 per 1,000	11 per 1,000(2 to 52)	Risk ratio: 0.28(0.06 to 1.33)	359(2 RCTs)	ⴲⴲ◯◯LOW^a
Small-for-gestational age newborn	103 per 1,000	276 per 1,000(172 to 443)	Risk ratio: 2.68(1.67 to 4.30)	389(3 RCTs)	ⴲⴲ◯◯LOW^a
Apgar score < 7 at 5 minutes	295 per 1,000	142 per 1,000(68 to 292)	Risk ratio: 0.48(0.23 to 0.99)	125(2 RCTs)	ⴲⴲ◯◯LOW^a
Hyaline membrane disease	492 per 1,000	329 per 1,000(167 to 654)	Risk ratio: 0.67(0.34 to 1.33)	359(2 RCTs)	ⴲ◯◯◯VERY LOW^a,b
Birthweight		Mean difference: 254.7 g higher(98.5 g higher to 410.9 g higher)	−	427(4 RCTs)	ⴲ◯◯◯VERY LOW^a,b
Admission to the Neonatal Intensive Care Unit	804 per 1,000	675 per 1.000(499 to 1.000)	Risk ratio: 0.84(0.62 to 11.50)	389(3 RCTs)	ⴲ◯◯◯VERY LOW^a,b

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[1] Address for correspondence Carlos Fernando Grillo-Ardila, Assistant professor, Departmento de Obstetricia y Ginecología, Universidad Nacional de Colombia, Carrera 30 No. 45-03, Edificio 471, Oficina 205, Bogotá, Colombia (e-mail: cfgrilloa@unal.edu.co).