Antenatal interventions for fetomaternal alloimmune thrombocytopenia

Rachel Rayment; Susan J Brunskill; Peter W Soothill; David J Roberts; James B Bussel; Michael F Murphy

doi:10.1002/14651858.CD004226.pub3

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Analysis 1.1

Comparison 1 Corticosteroid vs IVIG alone, Outcome 1 Fetal/neonatal death.

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Analysis 1.2

Comparison 1 Corticosteroid vs IVIG alone, Outcome 2 Platelet count at birth.

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Analysis 1.3

Comparison 1 Corticosteroid vs IVIG alone, Outcome 3 Satisfactory response to therapy.

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Analysis 1.4

Comparison 1 Corticosteroid vs IVIG alone, Outcome 4 Mean change between pre‐treatment and birth fetal platelet count.

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Analysis 1.5

Comparison 1 Corticosteroid vs IVIG alone, Outcome 5 Mean change in fetal platelet count between 1st and 2nd fetal blood sampling.

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Analysis 2.1

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 1 Intracranial haemorrhage.

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Analysis 2.2

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 2 Platelet count at birth.

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Analysis 2.3

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 3 Premature birth.

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Analysis 2.4

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 4 Satisfactory response to therapy.

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Analysis 2.5

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 5 Mean change between pre‐treatment and birth fetal platelet count.

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Analysis 2.6

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 6 Mean change in fetal platelet count at 2nd from 1st fetal blood sampling.

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Analysis 2.7

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 7 Mean change in fetal platelet count at birth from first fetal blood sampling.

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Analysis 2.8

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 8 Number of ICHs in previous sibling.

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Analysis 2.9

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 9 Adverse outcomes associated with FBS.

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Analysis 2.10

Comparison 2 IVIG with a corticosteroid vs IVIG alone, Outcome 10 Adverse events associated with treatment.

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Table 1. Results from observational studies of antenatal treatment for fetomaternal alloimmune thrombocytopenia with IVIG

Study	No. fetuses treated	IvIg admin	Steroid admin(daily)	IUT	Second‐line Rx‐nonrespon	No. with ICH	*No.plt ct <30x109/l**	No. deaths	Comments
Daffos 1984	1	Nil	Nil	IUT prior to delivery	Nil	0	0	0
Bussel 1988	7	1 g/kg/week (n = 7)	Dexamethasone 5 mg/day (n = 3), 3 mg/day (n = 2)	Nil	Nil	0	0	0
Mir 1988	1	0.8 mg/kg at 30 weeks, then 0.4 mg/kg/week from 31 weeks	Nil	Nil	Nil	0	0	0
Kaplan 1988	7	0.4 g/kg/5 days weekly from 35 weeks if plt < 20 x 10*9/l (n = 1)		1 IUT 38 weeks. Serial IUT x 3 (n = 1)	Nil	0	0	0
Nicolini 1988	1	Nil	Nil	Weekly IUT from 26 weeks	Nil	0	0	0
Daffos 1988	1	Nil	Prednisolone 10 mg from 23 weeks	Nil	Nil	0	0	0
Murphy 1990	1	Nil	Nil	Weekly IUT from 29 weeks until delivery 34 weeks	Nil	0	0	0
Nicolini 1990	2	Nil	Nil	Weekly IUT from 26 and 27 weeks until delivery	IVIG from week 25, with persistent thrombocytopenia (n = 1)	0	0	0
Kaplan 1991	6	Nil	Prednisone 10 mg from 22 to 26 weeks until delivery at 37 to 38 weeks (n = 4). 25 mg from 21 weeks (n = 2)	Nil	IVIG 1 g/kg/week from 26 weeks until delivery at 38 weeks (n = 1)	0	1	0
Lynch 1992	18	1 g/kg/week from diagnosis of thrombocytopenia at 20 to 22 weeks (one case received 0.5 mg/kg/week)	9 also received dexamethasone 1.5 to 5 mg or prednisolone 10 mg	Nil	Nil	0	2	0
Wenstrom 1992	6	1 g/kg/week	3 received dexamethasone 1.5 mg	Nil	Prednisone 60 mg/day (n = 2)	0	1	0
Marzusch 1992	1	1 g/kg/week from 17 to 34 weeks	Nil	Nil	Failed IUT prior to delivery (n = 1)	0	1	0
Kroll 1994	1	1 g/kg/week from 20 weeks	Nil	Nil	Weekly IUT from time of ICH at 32 weeks until delivery at 35 weeks	1	0	0
Zimmermann 1992	1	Intrauterine transfusion to fetus	Nil	Nil	Single IUT given prior to delivery	0	0	0
Bowman 1992	1	Intrauterine transfusion to fetus	Nil	Nil	IVIG 1 g/kg/week given to mother	0	0	0
Murphy 1994	15	1 g/kg/week beginning at 21 to 34 weeks to 31 to 38 weeks (n = 4) Prednisone 20 mg/day plus IVIG 1 g/kg/week beginning 14 to 20 weeks up to 16 to 33 weeks (n = 3)**	Prednisone 20 mg/day from 16 to 26 weeks to 25 to 36 weeks (n = 2).**	Weekly IUT from 18 to 29 weeks until delivery at 33 to 35 weeks, apart from one case 2 (n = 4) *	Prednisone alone (n = 1) Prednisone + IVIG (n = 2) weekly IUTs were commenced at from 26 to 34 weeks until delivery at 33 to 36 weeks.	1	0	3	Severely affected babies with initial fetal platelet count < 20 x 109/l were treated with fetal platelet transfusions. *Mildly affected fetuses with initial fetal platelet count > 50 x 109/l were initially treated either with steroids or IvIgG alone or a combination of both.
Kanhai 1996	19	1 g/kg/week (n = 8) Intrauterine transfusion to fetus (n = 1)		IUT schedule based on previous obstetric history (n = 19)	Prednisone 60 mg/day for 3 weeks (n = 1)	0	0	1 following cordocentesis an ELSCS. 1 fetus: non fatal sagittal sinus thrombosis 1 following cordocentesis an ELSCS. 1 fetus: non fatal sagittal sinus thrombosis
Kaplan 1998	37	From diagnosis of thrombocytopenia (n = 27)1 g/kg/week	Corticosteroids 0.5 mg/kg/day	Nil	Nil	2	Not stated	3
Mackenzie 1999	14	1 g/kg/week (n = 11)	Nil	IUT weekly from 27 weeks until delivery (n = 3)	Nil	0	1 (IUT treatment), 1 (IVIG treatment)	2 related to cordocentesis
Sainio 1999	15	1 g/kg/week from 25 to 32 weeks to 35 to 39 weeks (n = 7) IVIG Plus prednisone (30 mg/day 24 to 29 weeks (n = 1)	Prednisone 20 mg/day from 22 to 35 weeks (n = 1). IVIG ‐1 g/kg for one week only at 35 weeks	Weekly IUT from 25 to 29 weeks to 33 to 36 weeks, apart from 2 cases*	7 cases receiving IVIG +/‐ prednisone required IUT prior to delivery	0	3	0	* 2 pregnancies were managed with a single transfusion: one immediately prior to delivery at 34 weeks, and the other at 28 weeks prior to delivery at 37 weeks.
Dawkins 1999	17	1 g/kg/week (n = 11)	Nil	Nil	Nil	Not stated	2	0
Silver 2000	18	1 g/kg/week (n = 8). Intrauterine transfusion (n = 2)	Nil	Nil	Nil	0	Not stated	0
Radder 2001	56	1 g/kg/week			Weekly IUT	0	25 had platelet count < 50 prior to delivery/IUT	1
Overton 2002	12	1 g/kg/week (n = 3) Intrauterine transfusion in addition (n = 2)	Nil	Weekly IUT from 22 to 24 weeks until delivery	Nil	0	Not stated	2 (1 procedure related)
Lucas 2002	2 (in 1 woman)	0.4 g/kg x 3/week (n = 1) and 0.5 g/kg x 2/week (n = 1)	Nil	Weekly IUT x 5 (n = 1) X1 (n = 1)	Nil	0	0	0
Birchall 2003	56	1 g/kg/week (n = 16)	Prednisone 0.5 mg/kg/day plus IVIG (n = 2 )	Weekly IUT (n = 33)		2 (both before 1st FBS)	Not stated	3 (2 related to FBS)
van den Akker 2006	32	1g/kg from weeks 32 to 38 followed by induction of labour	Nil	Nil	Nil	0	4	0
ELSCS: elective lower section caesarean section FBS: fetal blood sampling IUT: intrauterine transfusion

Table 1. Results from observational studies of antenatal treatment for fetomaternal alloimmune thrombocytopenia with IVIG

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Table 2. Complications of treatment ‐ Berkowitz 2007

Complication	IVIG alone (n = 22)	IVIG + prednisone (n =28)	Second‐line (n = 13)
Gastrointestinal diabetes mellitus	0	4 (14)	3 (23)
Fluid retention	1 (5)	9 (32)	4 (31)
Mood swings	2 (9)	7 (25)	5 (38)
Moderate to severe fatigue	7 (32)	5 (18)	6 (46)
Joint pain	3 (14)	6 (21)	3 (23)
Moderate to severe headache	9 (41)	10 (36)	6 (46)
Rash	2 (9)	3 (11)	1 (8)
Insomnia/jitteriness	0	2 (7)	4 (31)
TOTAL number of complications	24	46	32
Data on complications experienced were not obtained from 6 women receiving IVIG alone and 4 women receiving IVIG and prednisone
Complications of treatment data presented as number of women (%) of events. IVIG: intravenous immunoglobulin

Table 2. Complications of treatment ‐ Berkowitz 2007

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Comparison 1. Corticosteroid vs IVIG alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Fetal/neonatal death Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2 Platelet count at birth Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3 Satisfactory response to therapy Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4 Mean change between pre‐treatment and birth fetal platelet count Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5 Mean change in fetal platelet count between 1st and 2nd fetal blood sampling Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

Comparison 1. Corticosteroid vs IVIG alone

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Comparison 2. IVIG with a corticosteroid vs IVIG alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intracranial haemorrhage Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.07, 15.82]
2 Platelet count at birth Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 IVIG 1g/kg/week plus dexamethasone 1.5 mg/day versus IVIG 1 g/kg/week	1	54	Mean Difference (IV, Fixed, 95% CI)	14.10 [‐30.26, 58.46]
2.2 1g/kg/week plus prednisone 1.0 mg/kg/day versus IVIG 1g/kg/week	1	36	Mean Difference (IV, Fixed, 95% CI)	28.00 [‐11.47, 67.47]
2.3 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	73	Mean Difference (IV, Fixed, 95% CI)	‐35.40 [‐258.66, 187.86]
3 Premature birth Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 IVIG 1g/kg/week plus dexamethasone 1.5 mg/day versus IVIG 1 g/kg/week	1	54	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐2.69, 1.69]
3.2 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	73	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐5.71, 5.31]
4 Satisfactory response to therapy Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 IVIG 1g/kg/week plus prednisone 1 mg/kg/day versus IVIG 1 g/kg/week alone	1	38	Risk Ratio (M‐H, Fixed, 95% CI)	2.54 [1.37, 4.72]
5 Mean change between pre‐treatment and birth fetal platelet count Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 IVIG 1g/kg/week plus prednisone 1 mg/kg/day versus IVIG 1 g/kg/week alone	1	35	Mean Difference (IV, Fixed, 95% CI)	10.83 [‐28.99, 50.65]
5.2 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	58	Mean Difference (IV, Fixed, 95% CI)	‐21.95 [‐57.96, 14.06]
6 Mean change in fetal platelet count at 2nd from 1st fetal blood sampling Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 IVIG 1g/kg/week plus dexamethasone 1.5 mg/day versus IVIG 1 g/kg/week	1	54	Mean Difference (IV, Fixed, 95% CI)	‐3.5 [‐24.62, 17.62]
6.2 IVIG 1g/kg/week plus prednisone 1 mg/kg/day versus IVIG 1 g/kg/week alone	1	36	Mean Difference (IV, Fixed, 95% CI)	42.0 [18.91, 65.09]
7 Mean change in fetal platelet count at birth from first fetal blood sampling Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 IVIG 1g/kg/week plus dexamethasone 1.5 mg/day versus IVIG 1 g/kg/week	1	54	Mean Difference (IV, Fixed, 95% CI)	24.40 [‐14.17, 62.97]
8 Number of ICHs in previous sibling Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 IVIG 1g/kg/week plus prednisone 1 mg/kg/day versus IVIG 1 g/kg/week alone	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.21, 3.24]
9 Adverse outcomes associated with FBS Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	79	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.14, 6.58]
10 Adverse events associated with treatment Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 IVIG 1g/kg/week plus prednisone 0.5 mg/kg/day versus IVIG 2g/kg/week	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.88, 1.27]

Comparison 2. IVIG with a corticosteroid vs IVIG alone

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