Preterm Birth and Multiple Gestation

Transcription

Preterm Birth and Multiple Gestation
Is Planned Cesarean Birth for
Twin Pregnancy Justified?
Jon FR Barrett MBBCh, MD, FRCOG FRCSC
Sunnybrook Health Science Centre
University of Toronto
Objectives
• To review current practice guidelines for delivery of
term twins
• To discuss the influence of mode of delivery on
perinatal outcome in the second twin
• To evaluate available evidence for planned
cesarean birth for twins ≥ 32 weeks
• To present the current status of the Twin Birth
Study (TBS)
Delivery of Twin A
Breech
– Cesarean section
– Vaginal delivery
Cephalic
– Spontaneous vaginal delivery
– Vacuum or forceps
– Cesarean section
Delivery of Twin B
Cephalic
– Await descent, amniotomy, deliver
– Vacuum or forceps
– Internal podalic version, breech
extraction
– Cesarean section
Delivery of Twin B
Breech
– Await descent (amniotomy) deliver
– Breech extraction
– Cesarean section
Transverse
– Breech extraction
– Cesarean section
Clinical Practice Guidelines
SOGC (No. 91, 2000)
• Indications for elective Cesarean section
• Monoamniotic twins
• Conjoined twins
• Vaginal delivery of Twin B if 1500-4000g
ACOG (No. 56, 2004)
• Twin A vertex, B vertex … Vaginal delivery
• Twin A nonvertex … Cesarean section
• Twin A vertex, B nonvertex … Controversial
Clinical Practice Guidelines
French College (CNGOF 2011)
• Optimal MOD unclear
• Active delivery of second twin
• Breech extraction for breech, transverse or
high cephalic presentation
RCOG (2006)
• Optimal MOD>32 weeks unclear
NICE (2011)
• CS when first twin non-cephalic
What are we doing?
Delivery of Twins < 32 Weeks
Delivery of Twins 32-38 Weeks
500
500
450
450
400
400
350
350
300
300
250
250
200
200
150
150
100
100
50
50
0
0
Vtx /Vtx
Vtx /Breech
Breech/Vtx
Planned vaginal delivery
Vtx /Vtx
Vtx /Breech
Breech/Vtx
Planned Cesarean section
Hutton et al. (2002) JOGC
Cesarean Rates for Twins in USA
The Second Twin
Determinants of Perinatal Mortality
and Serious Neonatal Morbidity
in the Second Twin
B. Anthony Armson
Vidia Persad
KS Joseph
Colleen O’Connell
David Young
Thomas Baskett
Obstet Gynecol 2006; 108:556-64
Methods
• Retrospective cohort study of twins  500 gm
• NS Atlee Perinatal Database 1988-1992.
• Exclusions: Birthweight < 500 gm
Monoamniotic/conjoined twins
Major congenital anomalies
Prelabor fetal death of either twin
• Matched pair analysis
Obstet Gynecol 2006; 108:556-64
Primary Outcome
•
•
•
•
•
Perinatal Death
Birth Asphyxia
Respiratory Distress Syndrome
Neonatal Infection
Birth Trauma
Obstet Gynecol 2006; 108:556-64
Composite Perinatal Morbidity
by Gestational Age
Gestational
Age (N)
All (1542)
Twin 1
n (rate/1000)
Twin 2
n (rate/1000)
RR (95% CI)
p
108 (70.0)
175 (113.5)
1.6(1.38-1.90)
<0.001
37 weeks (876)
11 (12.6)
29 (33.1)
2.6(1.36-5.09)
0.003
34-36 weeks (478)
20 (41.8)
48 (100.4)
2.4(1.56-3.69)
<0.001
<34 weeks (188)
77(409.6)
98 (521.3)
1.3(1.10-1.48)
<0.001
Obstet Gynecol 2006; 108:556-64
Perinatal Mortality and Serious Neonatal
Morbidity (n = 1542)
Morbidity
Twin 1
n (rate/1000)
Twin 2
n (rate/1000)
RR (95% CI)
p
Birth Asphyxia
28 (18.2)
48 (31.1)
1.74(1.14-2.58)
0.009
Respiratory
Distress
75 (48.6)
131(84.9)
1.75(1.44-2.11)
<0.001
Neonatal
Infection
31 (20.1)
28 (18.2)
0.84(0.56-1.25)
0.38
3 (1.9)
7 (4.5)
2.33(0.69-7.82)
0.16
10 (6.5)
13 (8.4)
1.3 (0.82-2.05)
0.26
Birth Trauma
Perinatal Death
Composite
Morbidity
108 (70.0)
175 (113.5)
1.62(1.38-1.90) <0.001
Obstet Gynecol 2006; 108:556-64
Determinants of Morbidity
in the Second Twin
YES
NO
• Planned VD
• Birthweight discordance
T1 < T2 by > 20%
• Prolonged interdelivery
interval
• Combined VD/CS
• Presentation
• Chorionicity
• Infant Sex
Obstet Gynecol 2006; 108:556-64
Mode of Delivery
Gestational Age (N)
37 weeks (876)
Mode of
Delivery (N)
Twin 1
n (rate/1000)
Twin 2
n (rate/1000)
RR (95% CI)
p
Planned CS (183)
Planned VD (693)
2 (10.9)
9 (13.0)
2 (10.9)
27 (39.0)
1.0 (0.14-7.10)
3.0 (1.47-6.11)
1
<0.001
34-36 weeks (478) Planned CS (83)
Planned VD (395)
4 (48.2)
16 (40.5)
14 (168.7)
34 (86.8)
3.5 (1.31-9.32)
2.1 (1.32-3.42)
0.006
<0.001
< 34 weeks (188)
Planned CS (28)
Planned VD(160)
15 (535.7)
62 (387.5)
15 (535.7)
83 (518.8)
1.0 (0.73-1.38)
1.3 (1.13-1.58)
1
<0.001
All (1542)
Planned CS (294)
Planned Vag(1248)
21 (71.4)
87 (69.7)
31 (105.4)
144 (115.4)
1.5 (1.01-2.15)
1.7 (1.39-1.97)
0.04
<0.001
Obstet Gynecol 2006; 108:556-64
Delivery-related Perinatal Death
among Term Twins
•
•
•
•
Retrospective cohort study
Scotland (1985-2001, n=8073)
Perinatal Deaths: T1 – 6; T2 – 30 (OR 5 for T2)
Risk of death due to intrapartum anoxia
- OR 21 for 2nd twin
• PMR with planned CS = 0.14%
• PMR with planned VB = 0. 52% (p=0.05)
• Planned CS may reduce perinatal death in twins
by 75% by reducing risk of intrapartum anoxia in
the 2nd twin
Smith GS, BJOG 2005
RCT of Vaginal vs Cesarean Birth for
Nonvertex Second Twin
Rabinovici:
• 60 Vtx/Nvtx twins > 33 weeks
• Planned vaginal (33); planned cesarean (27)
• No difference in Apgar scores or neonatal
morbidity between groups
• For nonvertex second twin, outcome not
influenced by mode of delivery
Am J Obstet Gynecol 1987;156:52-6
Systematic Reviews
•
•
•
•
Planned cesarean vs planned vaginal birth
≥ 32weeks gestation
13 cohort studies; 7396 newborns
Neonatal mortality and morbidity measures
Armson, Barrett – unpublished data
Systematic Reviews
Hogle K:
• 4 studies (1932 infants)
• Low 5-minute Apgar score less likely with
cesarean
• Longer LOS for twins delivered by cesarean
Conclusions:
• Planned cesarean birth may reduce risk of low
5-minute Apgar, especially if Twin A is breech
• No evidence to support planned cesarean birth
for twins
Am J Obstet Gynecol 2003;188:220-7
Vaginal vs Cesarean Birth?
• Conflicting evidence from observational trials
• Planned CS may reduce risk of adverse perinatal
outcome (Smith 2002, 2007; Armson 2006; Yang 2005)
• No evidence of benefit (Zhang 1996; Usta 2002; Sibony
2003)
• Vaginal/cesarean birth associated with increased
risk of perinatal death (Persad 2001, Wen 2004)
Systematic Reviews
Steins CN:
• 1 RCT (60); 16 cohort studies (3,167)
• No difference neonatal outcome between VD
and CS in T1 or T2
• T1 in cephalic or non-cephalic presentation
– No difference
• T2 in non-cephalic presentation:
– No difference in neonatal outcome
– VD associated with ↑incidence of 5-minute
Apgar < 5 in one study
Arch Gynecol Obstet 2012;286:237-47
Systematic Reviews
Rossi AC:
• 18 studies (39,571 twin pregnancies)
• Neonatal mortality/morbidity less for T1 than T2
• T1 - ↓ morbidity with VD vs CS (OR=2)
– Planned VD vs planned CS → No difference
• T2 - ↑ morbidity with combined VD/CS
– Planned VD vs planned CS → No difference
BJOG 2011;118:523-532
Systematic Reviews
Steins CN:
• 1 RCT (60); 16 cohort studies (3,167)
• No difference neonatal outcome between VD
and CS in T1 or T2
• T1 in cephalic or non-cephalic presentation
– No difference
• T2 in non-cephalic presentation:
– No difference in neonatal outcome
– VD associated with ↑incidence of 5-minute
Apgar < 5 in one study
Arch Gynecol Obstet 2012;286:237-47
Systematic Reviews
Hofmeyr, Barrett, Crowther 2011:
•
•
•
•
•
One study – Rabinovici
60 Vtx/Nvtx twins
No difference in neonatal outcome
Sample size too small to inform practice
Large RCT required
Cochran Review, Dec, 2011
Neonatal Death
Armson, Barrett – unpublished data
Neonatal Morbidity
Armson, Barrett – unpublished data
5 Minute Apgar < 4
Armson, Barrett – unpublished data
Umbilical Cord pH < 7.0
Armson, Barrett – unpublished data
Severe Respiratory Distress
Armson, Barrett – unpublished data
Birth Trauma
NICU Admission
Armson, Barrett – unpublished data
Fetal perspective
Cohort
Meta-analysis
Equipoise
The Twin Birth Study
RCT of planned cesarean (CS) vs planned
vaginal birth (VB) for twins 32-38 weeks
gestation
Research Questions
For twin pregnancies of 32-38 weeks gestation, where
twin A is presenting vertex, does a policy of planned
CS compared to a policy of planned VB:
• Primary:
 decrease the likelihood of stillbirth or neonatal mortality
or serious morbidity, during the first 28 days after birth?
• Secondary:
 decrease the risk of death or poor neurodevelopmental
outcome of the children at 2 years corrected age?
 decrease the risk of problematic urinary or faecal/flatal
incontinence for the mother at 2 years postpartum?
Inclusion Criteria
• Gestational age 32 - 38 weeks
 Estimated weight of each fetus is 1,500g
– 4,000g by ultrasound within 7 days of
randomization
 Twin A vertex
 Twin B any presentation
• 20% change
• clinical impression
 Both twins alive
Exclusion Criteria
 Mono-amniotic twins
 Lethal fetal anomaly of either fetus
 Contraindication to labour or vaginal delivery
of either twin
− IUGR
− twin B substantially larger than twin A
 Previous participation in TBS
Perinatal/neonatal mortality or
serious neonatal morbidity
• Death before 28 days of life
• Birth trauma: subdural or intracerebral haemorrhage, spinal cord injury, basal or
depressed skull fracture, or long bone fracture, peripheral nerve injury present at
discharge from hospital
•
•
•
•
•
•
•
•
Apgar < 4 at 5 minutes
Coma, stupor or decreased response to pain
Neonatal seizures within 72 hours of birth
Assisted ventilation via ET-tube for  24 hours within 72 hours after birth
Septicemia or meningitis within 72 hrs of birth
Necrotising enterocolitis
BPD
IVH (grade 3 or 4) or cystic PVL
Sample Size
Total sample = 2800 (1400/group)
80% power
2 - sided  error = 0.05
Reduction in risk of perinatal/neonatal
mortality or serious neonatal morbidity from
4% (0.04) with planned VB to 2% (0.02)
with planned CS
Statistical Analysis
 Interim analyses
• after first 1000 and 1800 women
recruited
• p < 0.002 (2 sided) to stop trial early
 Final analysis
• Intention-to-treat
• methods of Donner and Klar (a baby will
be the unit of analysis; pregnancy will be
treated as a cluster)
• p < 0.05 for primary and secondary
outcomes
• p < 0.01 for other outcomes
First twin pair recruited, December 2003
RECRUITMENT GRAPH
Twin Birth Study Recruitment Graph
2800
2600
2400
2200
2000
1800
1600
1400
1200
1000
800
600
400
200
0
RECRUITMENT TABLE
(projected sample size of 2800)
April 30, 2011
COUNTRY
ARGENTINA
BRAZIL
CANADA
ISRAEL
POLAND
UK
CHILE
SPAIN
EGYPT
AUSTRALIA
THE NETHERLANDS
SERBIA
USA
JORDAN
JAMAICA
ESTONIA
QATAR
HUNGARY
OMAN
ROMANIA
GERMANY
BELGIUM
URUGUAY
CROATIA
GREECE
Total
Jan Annual Dec Dec
Goal 2003 2004
67
73
84
46
15
68
16
32
20
32
10
11
31
9
4
3
22
4
7
3
9
0
13
0
0
579
3
60
2
25
21
4
2
8
2
19
2
7
65
44
53
27
28
2
11
6
14
15
9
96
71
46
16
18
15
13
10
15
12
17
107
54
41
14
44
18
8
9
6
17
6
4
5
13
5
10
8
5
12
5
11
2
5
3
Jan - Jan - Jan - Jan - Jan - Jan Dec Dec Dec Dec Dec
Jun
2005 2006 2007 2008 2009 2010
5
3
7
4
3
182
333
8
8
9
23
7
122
63
29
32
35
16
16
8
12
14
6
27
5
8
14
7
125
97
40
42
25
31
25
7
20
8
5
24
11
6
7
7
6
3
5
5
2
4
3
2
1
373
4
4
3
385
3
3
425
63
43
7
20
10
19
13
10
3
8
4
4
3
7
5
5
10
2
9
1
1
487
245
Jul Dec Jan Feb Mar Apr Grand
2010 2011 2011 2011 2011 Total
60
26
9
19
9
7
1
1
11
7
39
4
4
8
2
9
2
3
7
3
2
25
1
8
1
13
3
3
5
1
4
3
5
9
4
3
4
2
4
6
3
3
1
1
1
1
2
3
2
2
4
3
3
238
43
43
2
1
1
1
42
5
732
414
260
201
167
126
114
108
89
79
63
58
57
56
54
53
42
39
21
18
15
15
10
9
4
2804
2804 Women
Randomized
1406 women allocated to
planned VB
(2812 fetuses)
1398 women allocated to
planned CS
(2795 fetuses)
6 women (12 fetuses)
lost to follow-up
1392 women (2783 fetuses)
13 women (26 fetuses)
lost to follow-up
643 had labour
(140 delivered
vaginally)
2 infants/fetuses
lost to follow-up
1393 women (2786 fetuses)
4 infants/fetuses
lost to follow-up
1 woman lost to
follow-up
2782 infants/fetuses
contributed to
primary outcome
2781 infant/fetuses
contributed to primary
outcome
21 neonatal
deaths/stillbirths
2760 infants/fetuses
contributed to neonatal
morbidity
1195 had labour
(842 delivered
vaginally)
17 neonatal
deaths/stillbirths
2765 infants/fetuses
contributed to neonatal
morbidity
1392 women
contributed to
maternal
outcome
Mode of delivery
Planned Caesarean Section
Planned Vaginal Birth
N=1392
N=1393
n (%)
n (%)
Caesarean section for
both
1250 (89.93%)
551 (39.55%)
Vaginal delivery for
both
129 (9.28%)
783 (56.21%)
Vaginal/Caesarean
(all Cephalic Twin A)
11 (0.79%)
59 (4.24%)
Thank you

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