Conservative management of early-onset severe preeclampsia: comparison between randomized and observational studies a systematic review

Figures & data

Figure 1. Flow diagram–summary of evidence search and analysis.

Table 1. Studies included in the review.

Study	Design	Country	Sample size (conservative management)
Odendaal 1990 [7]	RCT	South Africa	18
Sibai 1994 [9]	RCT	USA	49
Mesbah 2003 [10]	RCT	Egypt	15
Vigil-De Gracia [8]	RCT	Latin America	131
Duvekot [11]	RCT	Netherlands	30
Sibai 1990 [12]	Observational	USA	69
Moodley 1993 [13]	Observational	South Africa	50
Olah 1993 [14]	Observational	UK	28
Chammas 2000 [15]	Observational	USA	33
Hall 2000 [16]	Observational	South Africa	340
Romero 2000 [17]	Observational	Mexico	34
Murphy 2000 [18]	Observational	UK	71
Blackwell 2002 [19]	Observational	USA	63
Kobayashi 2003 [20]	Observational	Japan	29
Vigil-De Gracia 2003 [21]	Observational	Panama	129
Haddad 2004 [22]	Observational	France	239
Oettle 2005 [23]	Observational	South Africa	121
Shear 2005 [24]	Observational	Canada	59
Budden 2006 [25]	Observational	New Zeland	31
Hall 2006 [26]	Observational	South Africa	82
Gaugler-Senden 2006 [27]	Observational	Netherlands	16
Porras-Poma 2006 [28]	Observational	Peru	79
Ganzevoort 2007 [29]	Observational	Netherlands	80
Sezik 2007 [30]	Observational	Turkey	55
Bombrys 2008 [31]	Observational	USA	46
Sarsam 2008 [32]	Observational	Iraq	35
Jantasing 2008 [33]	Observational	Thailand	10
Bombrys 2009 [34]	Observational	USA	66
Abdel-Hady 2010 [35]	Observational	Egypt	211
Mogollon-Saker 2011 [36]	Observational	Colombia	24
Belghiti 2011 [37]	Observational	France	51
Kumar 2011 [38]	Observational	India	45
Swamy 2012 [39]	Observational	India	94
Astudillo 2013 [40]	Observational	Spain	33
Castellon-Pasos 2013 [41]	Observational	Mexico	27
Chen 2015 [42]	Observational	China	79
Suzuki 2014 [43]	Observational	Japan	30
Ertekin 2015 [44]	Observational	Turkey	33
Rendon-Becerra 2016 [45]	Observational	Colombia	31
Emawati 2016 [46]	Observational	Indonesia	44
Ueda 2016 [47]	Observational	Japan	41
McKinney 2016 [5]	Observational	USA	116
Deepak 2017 [48]	Observational	India	76
Vazquez-Rodríguez 2018 [49]	Observational	Mexico	40

Table 2. General information of randomized controlled trials and observational studies with conservative management of early-onset severe preeclampsia.

VARIABLE	RCT	OS	TOTAL
Number of studies n	5	39	44
Total number of patients n	243	2740	2983
Pregnancy prolongation, days (range)	8.8 (3.0–15.4)	9.5(2.3–32.7)	9.2(2.3–32.7)
Industrialized country n	2	18	20
Nonindustrialized country n	3	21	24
Years 1990–1999 n	2	3	5
Years 2000–2009 n	1	20	21
Years 2010–2018 n	2	16	18

RCT: Randomized controlled trial; OS: Observational study.

Table 3. Main maternal and perinatal outcomes of randomized controlled trials and observational studies with conservative management of early-onset severe preeclampsia.

VARIABLE	RCT (243)	OS (2740)	RR 95% CI	p
Maternal complications n(%)	47(19.3)	741(27.0)	0.71(0.54–0.93)	.009
Placental abruption n(%)	17(7.0)	211(7.7)	0.90(0.60–1.50)	.69
HELLP syndrome n(%)	22(9.0)	326(11.9)	0.76(0.50–1.15)	.18
Acute pulmonary edema n(%)	3(1.2)	65(2.3)	0.52(0.16–1.64)	.25
Renal failure n(%)	4(1.6)	110(4.0)	0.41(0.15–0.99)	.02
Eclampsia n(%)	1(0.4)	27(1.0)	0.42(0.05–3.06)	.37
Maternal death n	0	2	–	.67
Perinatal complication n(%)	150(61.7)	1900(69.3)	0.89(0.80–0.98)	.01
Respiratory distress syndrome n(%)	73(30.0)	426(15.5)	1.93(1.56–2.38)	.0001
Intraventricular hemorrhage n(%)	2(0.8)	63(2.2)	0.36(0.04–1.34)	.16
Restriction of fetal growth n(%)	54(22.2)	572(20.9)	1.06(0.83–1.36)	.62
Intrauterine death n(%)	2(0.8)	309(11.2)	0.07(0.01–0.29)	.0001
Perinatal mortality n(%)	19(7.8)	530(19.3)	0.40(0.26–0.62)	.0001
Cesarean sections n(%)	211(87.0)	1537(56.0)	1.54(1.46–1.64)	.0001

RCT: Randomized controlled trial; OS: Observational study.

Table 4. Maternal and perinatal outcomes of randomized controlled trials and observational studies with conservative management of early-onset severe preeclampsia.

VARIABLE	RCT	OS	RR 95% CI	p
Gestational age 28–34 weeks n	243	639	–	–
Total number of studies analyzed n	5	8	–	–
Total maternal complication n(%)	47(19.3)	120(18.8)	1.02(0.76–1.39)	.84
Total perinatal complication n(%)	150(61.7)	440(69.0)	0.89(0.80–1.0)	.04
Intrauterine death n(%)	2(0.8)	49(7.7)	0.10(0.02–0.43)	.0001
Perinatal mortality n(%)	19(7.8)	99(15.4)	0.50(0.31–0.80)	.002
Cesarean section n(%)	211(87.0)	351(55.0)	1.58(1.45–1.72)	.0001
Industrialized countries ≤ 34 weeks	n = 79	n = 1101	–	–
Total number of studies analyzed n	2	18	–	–
Total maternal complication n(%)	6(7.6)	356(32.3)	0.23(0.10–0.50)	.0001
Total perinatal complication n(%)	28(35.4)	775(70.3)	0.50(0.37–0.68)	.0001
Intrauterine death n(%)	0	102(9.2)	Lack	.001
Perinatal death n(%)	1(1.2)	179(16.2)	0.07(0.01–0.54)	.0003
Cesarean n(%)	63(79.7)	715(64.9)	1.22(1.08–1.38)	.007
Nonindustrialized countries ≤ 34 weeks	n = 164	n = 1639	–	–
Total number of studies analyzed n	3	21	–	–
Total maternal complication n(%)	40(24.3)	393(24.0)	1.01(0.77–1.34)	.90
Total perinatal complication n(%)	120(73.1)	816(49.8)	1.45(1.32–1.63)	.0001
Intrauterine death n(%)	2(1.2)	207(12.6)	0.10(0.02–0.38)	.0001
Perinatal death n(%)	18(11.0)	352(21.4)	0.51(0.32–0.80)	.001
Cesarean n(%)	148(90.2)	819(50.0)	1.80(1.68–1.93)	.0001

RCT: Randomized controlled trial; OS: Observational study. Subanalysis at only 28–34 weeks and subanalysis of the entire population between countries according to per capita income.

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