Docstoc

AMPHIA Postpartum hemorrhage

Document Sample
AMPHIA Postpartum hemorrhage Powered By Docstoc
					                            Hypertension and Preeclampsia
ISSHP 16th WORLD CONGRESS


                               Intervention Trial At Term:

                                     The HYPITAT-trial

                              Corine M Koopmans, Ben W J Mol, Jan G Aarnoudse, Paul P
                              Van Den Berg Henk Groen, Christine Willekes, Anneke Kwee,
                              Kitty WM Bloemenkamp, Joris AM Van Der Post, Hubertina CJ
                                         Scheepers and Maria MG Van Pampus,

                                         On behalf of the HYPITAT study group
                                                            Background
                                                              PIH & PE
ISSHP 16th WORLD CONGRESS


                            • In The Netherlands the most important
                              causes of maternal mortality and
                              morbidity
                            • 10-15% of all pregnancies are
                              complicated by PIH or PE
                            • Maternal mortality
                              4.0 per 100.000 pregnancies1,2
                            • The majority declare after 32 weeks
                            • The only causal treatment is termination of
                              pregnancy

                               1 Schuitemaker,      et al
                               2   Schutte, et al
                                                  Background
                                                    PIH & PE
ISSHP 16th WORLD CONGRESS




                                    In pre-term pregnancies
                                    conservative expectant
                                  management is advocated in
                                order to improve fetal maturity, as
                                 long as the risk for the mother is
                                          acceptable3,4


                            3 Sibai,et al
                            4   Odendaal, et al
                                    Background
                                       PIH & PE
ISSHP 16th WORLD CONGRESS




                             In term pregnancies there is no
                            evidence which treatment would
                                      be the best...
                              Induction of Labour or
                            Expectant Management?
ISSHP 16th WORLD CONGRESS
                                                            Background
                                                       Induction of labour
ISSHP 16th WORLD CONGRESS


                            • Decrease of severe maternal and neonatal
                              complications
                            • Increase the risk of instrumental vaginal
                              delivery and caesarean section 5
                                                                                Emergency Caesarean
                                                                                       Section
                                                                                     RR (95% BI)
                                             Spontaneous labour                          ref
                                             Amniotomy                             1.9 (1.3 to 2.9)
                                             Oxytocine                             1.5 (1.2 to 1.8)
                                             Prostaglandins                        3.0 (2.5 to 3.5)

                             5Data   of Dutch national perinatal registration
                                          Aim
ISSHP 16th WORLD CONGRESS




                            To investigate whether in women
                               with PIH or mild PE induction of
                             labour at term will reduce severe
                            maternal morbidity compared with
                                 expectant management.
                                          Methods
ISSHP 16th WORLD CONGRESS




                            • Randomized controlled clinical trial
                            • 38 Dutch hospitals
                            • Inclusion period: October 2005 to
                              March 2008
                                           Methods
                                        Inclusion criteria
ISSHP 16th WORLD CONGRESS



                            •   Singleton pregnancy (N=720)
                            •   Child in cephalic presentation
                            •   PIH or mild PE
                                 • PIH: DBP ≥ 95 mmHg
                                 • PE: DBP ≥ 90 mmHg and proteinuria
                            •   GA: 36+0 to 41+0 weeks
                                        Methods
                                     Exclusion criteria
ISSHP 16th WORLD CONGRESS


                            •   Previous caesarean section
                            •   Pre-existing diseases, as hypertension,
                                diabetes and renal disease
                            •   Severe hypertension
                            •   Proteinuria ≥ 5 gram/ 24 hours
                            •   Intravenous anti-hypertensive medication
                            •   HELLP-syndrome
                            •   Oliguria < 500 ml in 24 hours
                            •   Small for gestational age fetus
                                    Interventions
ISSHP 16th WORLD CONGRESS



                            • Induction of labour
                               Labour was induced within 24 hours
                               after randomization.


                            • Expectant management
                               Monitoring of mother and child until
                               the onset of spontaneous delivery.
                                      Methods
                                   Primary Outcome
ISSHP 16th WORLD CONGRESS


                            Composite adverse maternal outcome:
                            • Maternal mortality
                            • Severe hypertension
                            • Severe proteinuria
                            • Eclampsia
                            • HELLP-syndrome
                            • Major postpartum hemorrhage
                            • Thromboembolic disease
                            • Pulmonary edema
                            • Placental abruption
                                       Methods
                                Secondary Outcomes
ISSHP 16th WORLD CONGRESS



                            • Neonatal mortality & morbidity
                            • Mode of delivery
                                 •spontaneously
                                 •vaginal instrumental delivery
                                 •caesarean section
                            • Quality of life
                            • Costs
                                       Methods
                                     Power Analysis
ISSHP 16th WORLD CONGRESS


                            • The maternal complication rate in the
                              expectant management group was
                              thought to be 12% based on data
                              from the Dutch national delivery
                              registries.
                            • In total, 720 patients had to be
                              randomized to show a reduction from
                              12% to 6% in adverse maternal
                              outcome (two-sided test, alpha .05;
                              beta .80)
                                        Methods
                                         Analysis
ISSHP 16th WORLD CONGRESS




                            • Intention-to-treat
                            • Relative risk and 95%
                              confidence intervals
                            • Chi-square statistics
ISSHP 16th WORLD CONGRESS                                    1154 women were eligible


                                                                              397 refused randomization:

                                                                               73 induction of labour
                                                                              324 expectant management


                                                              756 randomly assigned




                                   377 were assigned to                          379 were assigned to expectant
                                    induction of labour                                   management



                            11 delivered spontaneously                        199 delivered spontaneously
                             1 primary caesarean section                       7 primary caesarean section
                            365 induction of labour                           172 induction of labour



                                  0 were lost to follow-up                              1 was lost to follow-up



                                 377 women were analyzed                              378 women were analyzed
                                Baseline Characteristics
ISSHP 16th WORLD CONGRESS


                                                                    Induction       Expectant
                                                                      (n=377)      management
                                                                                     (n=378)
                            Maternal age (yrs)                        30 ± 5.1       30 ± 5.1
                            Caucasion                                 317 (90)       298 (86)
                            Maternal smoking                          52 (13)        49 (14)
                            Nulliparous                               269 (71)       272 (72)
                            Body mass index at booking (kg/m2)        27 ± 5.7       27 ± 5.1
                            Gestational age (wks)                     38 ± 1.2       39 ± 1.2
                            Systolic BP (mmHg)                       144 ± 12        144 ± 12
                            Diastolic BP (mmHg)                       97 ± 6.4       97 ± 5.5
                            Number of women with PIH                  241 (66)       244 (67)
                            Number of women with PE                   125 (34)       123 (34)
                            Missing                                    11 (3)         12 (3)
                            Proteinuria in women with PE            445 (0-5900)   565 (2-5680)
                            [median (range),mg/24 hr]

                            Values expressed in n(%) or mean ± SD
                            Expectant Management (n=378)
                                                        Reasons for induction
ISSHP 16th WORLD CONGRESS


                                                                                Induction in expectant
                                                                                  management group
                                                                                     (n=172 (46%))
                             Maternal indications                                      91 (53)
                             •Systolic BP ≥ 170 mmHg
                             •Diastolic BP ≥ 110 mmHg
                             •Proteinuria ≥ 5 gram/24 hours
                             •Eclampsia
                             •HELLP-syndrome
                             •Use of intravenous anti-hypertensive medication
                             •Use of anti-convulsive medication
                             Suspected fetal distress                                  18 (10)
                             Prelabour rupture of membranes > 48 hours                  9 (5)
                             Gestational age > 41 weeks                                24 (14)
                             Unknown or elective induction                             49 (28)

                             Values expressed in n(%)
                                                                    Results
ISSHP 16th WORLD CONGRESS



                                                                    Induction     Expectant     P
                                                                     (n=377)     management
                                                                                   (n=378)
                            Gestational age at                       39 ± 1.2      40 ± 1.2   <0.001
                            delivery (weeks)
                            Time between                             0.5 ± 1.6    7.4 ± 6.0   <0.001
                            randomization and start
                            of delivery (days)

                            Values expressed in n(%) or mean ± SD
                                                       Primary Outcome
                                             Severe maternal complications
ISSHP 16th WORLD CONGRESS


                                                            Induction    Expectant     RR (95%CI)
                                                             (n=377)    management        or P
                                                                          (n=378)
                            Maternal death                      0            0

                            Systolic BP ≥ 170mmHg            55 (15)      85 (23)    0.64 (0.47 to 0.87)

                            Diastolic BP ≥ 110mmHg           61 (16)      99 (27)    0.61 (0.46 to 0.81)

                            Proteinuria ≥ 5 g/ 24 hours       3 (2)        4 (2)     0.91 (0.21 to 4.0)

                            HELLP - syndrome                  3 (1)        9 (2)     0.46 (0.14 to 1.5)

                            Eclampsia                           0            0

                            Pulmonary edema                     0            2

                            Postpartum hemorrhage > 1 L      35 (10)      40 (11)    0.88 (0.57 to 1.3)

                            Thromboembolic disease              1            0

                            Placental abruption                 0            0

                            Composite adverse maternal       116 (31)     159 (42)   0.73 (0.61 to 0.89)
                            outcome                                                        <0.001

                            Values expressed in n(%)
                                                       Primary Outcome
                                             Severe maternal complications
ISSHP 16th WORLD CONGRESS


                                                            Induction    Expectant     RR (95%CI)
                                                             (n=377)    management        or P
                                                                          (n=378)
                            Maternal death                      0            0

                            Systolic BP ≥ 170mmHg            55 (15)      85 (23)    0.64 (0.47 to 0.87)

                            Diastolic BP ≥ 110mmHg           61 (16)      99 (27)    0.61 (0.46 to 0.81)

                            Proteinuria ≥ 5 g/ 24 hours       3 (2)        4 (2)     0.91 (0.21 to 4.0)

                            HELLP - syndrome                  3 (1)        9 (2)     0.46 (0.14 to 1.5)

                            Eclampsia                           0            0

                            Pulmonary edema                     0            2

                            Postpartum hemorrhage > 1 L      35 (10)      40 (11)    0.88 (0.57 to 1.3)

                            Thromboembolic disease              1            0

                            Placental abruption                 0            0

                            Composite adverse maternal       116 (31)     159 (42)   0.73 (0.61 to 0.89)
                            outcome                                                        <0.001

                            Values expressed in n(%)
                                                       Primary Outcome
                                             Severe maternal complications
ISSHP 16th WORLD CONGRESS


                                                            Induction    Expectant     RR (95%CI)
                                                             (n=377)    management        or P
                                                                          (n=378)
                            Maternal death                      0            0

                            Systolic BP ≥ 170mmHg            55 (15)      85 (23)    0.64 (0.47 to 0.87)

                            Diastolic BP ≥ 110mmHg           61 (16)      99 (27)    0.61 (0.46 to 0.81)

                            Proteinuria ≥ 5 g/ 24 hours       3 (2)        4 (2)     0.91 (0.21 to 4.0)

                            HELLP - syndrome                  3 (1)        9 (2)     0.46 (0.14 to 1.5)

                            Eclampsia                           0            0

                            Pulmonary edema                     0            2

                            Postpartum hemorrhage > 1 L      35 (10)      40 (11)    0.88 (0.57 to 1.3)

                            Thromboembolic disease              1            0

                            Placental abruption                 0            0

                            Composite adverse maternal       116 (31)     159 (42)   0.73 (0.61 to 0.89)
                            outcome                                                        <0.001

                            Values expressed in n(%)
                                               Secondary Outcome
                                                       Neonatal Outcome
ISSHP 16th WORLD CONGRESS



                                                         Induction     Expectant     RR (95%CI)
                                                           (n=377)    management        or P
                                                                        (n=378)
                            Birth weight (g)             3245 ± 508   3446 ± 557        <0.001
                            Perinatal death                  0            0
                            Apgar Score after 5            7 (2)         9 (2)     0.79 (0.30 to 2.1)
                            minutes < 7
                            Arterial pH < 7.05             9 (3)        18 (6)     0.48 (0.22 to 1.1)
                            Admission to neonatal          10 (3)        8 (3)     1.2 (0.48 to 3.0)
                            IC unit
                            Composite adverse              24 (9)       31 (13)    0.75 (0.46 to 1.2)
                            neonatal outcome

                            Values expressed in n(%)
                                      Secondary Outcome
                                                       Mode of delivery
ISSHP 16th WORLD CONGRESS



                                                           Induction    Expectant     RR (95%CI)
                                                            (n=377)    management        or P
                                                                         (n=378)
                            Spontaneously                  273 (72)      253 (67)   1.1 (0.98 to 1.2)
                            Vaginal instrumental            50 (13)      53 (14)    0.95 (0.66 to 1.4)
                            delivery
                            Caesarean section               54 (14)      72 (19)    0.75 (0.55 to 1.0)

                            Values expressed in n(%)
                                      Secondary Outcome
                                                       Mode of delivery
ISSHP 16th WORLD CONGRESS



                                                           Induction    Expectant     RR (95%CI)
                                                            (n=377)    management        or P
                                                                         (n=378)
                            Spontaneously                  273 (72)      253 (67)   1.1 (0.98 to 1.2)
                            Vaginal instrumental            50 (13)      53 (14)    0.95 (0.66 to 1.4)
                            delivery
                            Caesarean section               54 (14)      72 (19)    0.75 (0.55 to 1.0)

                            Values expressed in n(%)
ISSHP 16th WORLD CONGRESS




                            Induction better   Expectant management
                                                      better
ISSHP 16th WORLD CONGRESS




                            Induction better   Expectant management
                                                      better
                                     Summary
ISSHP 16th WORLD CONGRESS



                            Induction of labour gives
                            • a lower maternal complication
                              rate than expectant management
                            • a reduction in caesarean section
                              rate
                            • a trend towards a better neonatal
                              outcome
                                 Conclusion
                                 Hypitat trial
ISSHP 16th WORLD CONGRESS




                              Induction of labour in
                            pregnancies complicated
                            by PIH or mild PE at term is
                              better than expectant
                                  management.
                            •   University Medical Centre Groningen   •   Medical Centre Haaglanden Den
                                Maria G van Pampus,                       Haag
                                Jan G Aarnoudse,                          Christianne JM de Groot
ISSHP 16th WORLD CONGRESS
                                Paul P van den Berg,
                                Henk Groen.                           •   Gelre Hospital Apeldoorn
                                                                          Anjoke JM Huisjes
                            •   Academic Medical Centre Amsterdam
                                Ben WJ Mol,                           •   University Medical Centre Utrecht
                                Sylvia Vijgen,                            Anneke Kwee
                                Denise Bijlenga,
                                Joris AM van der Post.                •   Martini Hospital Groningen
                                                                          Aren J van Loon
                            •   Onze Lieve Vrouwen Gasthuis
                                Amsterdam                             •   Spaarne Hospital Hoofddorp
                                Dick J Bekedam                            Annemiek Lub

                            •   Hospital Rijnstate Arnhem             •   Amphia Hospital Breda
                                Karin de Boer                             Dimitri NM Papatsonis

                            •   Scheper Hospital Emmen                •   Atrium Medical Centre Heerlen
                                Jan M Burggraaff                          Frans JME Roumen

                            •   Leiden University Medical Centre      •   University Medical Centre Nijmegen
                                Kitty WM Bloemenkamp                      Hubertina CJ Scheepers

                            •   Twee Steden Hospital Tilburg          •   University Hospital Maastricht
                                Addi P Drogtrop                           Christine Willekes

                            •   Sint Elisabeth Hospital Tilburg
                                Arie Franx
ISSHP 16th WORLD CONGRESS
                        Research nurses…
                                Relation between maternal
                            complications and mode of delivery
ISSHP 16th WORLD CONGRESS

                              - Expectant management group -
                                                          Caesarean section   Vaginal delivery
                                                               (n= 72)            (n=306)
                            Maternal death                        0                  0
                            Systolic BP ≥170 mmHg              29 (41)            56 (19)
                            Diastolic BP ≥ 110 mmHg            30 (43)            69 (23)
                            Proteinuria ≥ 5 g/ 24 hours         3 (7)              1 (1)
                            HELLP -syndrome                     2 (3)              5 (2)
                            Eclampsia                             0                  0
                            Pulmonary edema                       0                2 (3)
                            Postpartum hemorrhage > 1 L         7 (10)            33 (11)
                            Thromboembolic disease                0                  0
                            Placental abruption                   0                  0
                            Composite adverse                  44 (61)            115 (38)
                            maternal outcome
                            Values expressed in n(%)
                               Relation between maternal
                            complications and mode of delivery
ISSHP 16th WORLD CONGRESS

                                - Induction of labour group-
                                                          Caesarean section   Vaginal delivery
                                                               (n=54)             (n=323)
                            Maternal death                       0                   0
                            Systolic BP ≥170 mmHg              13 (24)            42 (13)
                            Diastolic BP ≥ 110 mmHg            16 (30)            45 (14)
                            Proteinuria ≥ 5 g/ 24 hours         2 (8)              1 (1)
                            HELLP -syndrome                     1 (2)              2 (1)
                            Eclampsia                            0                   0
                            Pulmonary edema                      0                   0
                            Postpartum hemorrhage > 1 L        9 (17)              26 (8)
                            Thromboembolic disease               0                   1
                            Placental abruption                  0                   0
                            Composite adverse                  27 (50)            89 (28)
                            maternal outcome
                            Values expressed in n(%)
                                   Baseline Characteristics
ISSHP 16th WORLD CONGRESS


                                                                    Randomization         Non-randomization
                                                             Induction      Expectant   Induction    Expectant
                                                              (n=377)      Management     (n=73)    management
                                                                             (n=378)                  (n=324)
                            Gestational age                   38 ± 1.2       39 ± 1.2   39 ± 1.3      38 ± 1.3
                            (wkn)
                            High level of                      71 (30)        68 (30)    20 (51)      82 (49)
                            eduction
                            Smoking                            52 (13)        49 (14)    7 (10)        23 (8)
                            Body mass index                   27 ± 5.7       27 ± 5.1   25 ± 4.1      26 ± 5.0
                            at booking (kg/m2)
                            Systolic BP                       144 ± 12       144 ± 12   143 ± 10     142 ± 16
                            (mmHg)
                            Diastolic BP                      97 ± 6.4       97 ± 5.5   98 ± 5.6      96 ± 7.2
                            (mmHg)

                            Values expressed in n(%) or mean ± SD
                                             Primary and secondary
                                                   Outcomes
ISSHP 16th WORLD CONGRESS



                                                           Randomization          Non-randomization
                                                       Induction    Expectant   Induction    Expectant
                                                        (n=377)    management     (n=73)    management
                                                                     (n=378)                  (n=324)

                            Composite adverse          116 (31)      159 (42)    29 (40)      123 (38)
                            maternal outcome

                            Composite adverse           24 (9)       31 (13)     5 (10)        15 (7)
                            neonatal outcome

                            Caesarean section           54 (14)      72 (19)      3 (4)       53 (16)


                            Values expressed in n(%)
                                 Expectant management
                                                   Primary outcome
ISSHP 16th WORLD CONGRESS


                                                         Onset of labour:   Onset of labour:         RR
                                                         spontaneously      Induction or SC        (95%CI)
                                                             (n=197)            (n=172)              of P
                            Maternal death                      0                  0
                            Systolic BP ≥170mmHg             32 (17)            51 (32)        0.55 (0.37 to 0.81)

                            Diastolic BP ≥110mmHg            39 (21)            56 (35)        0.61 (0.43 to 0.87)

                            Proteinuria ≥5 g/24h               1 (1)              3 (3)        0.33 (0.04 to 3.2)
                            HELLP -syndrome                    1 (1)              3 (2)        0.29 (0.03 to 2.8)
                            Eclampsia                           0                  0
                            Pulmonary edema                     0                  0
                            Hemorrhage postpartum > 1L       20 (10)            18 (11)        0.97 (0.53 to 1.8)
                            Trombo-embolic disease              0                  0
                            Placental abruption                 0                  0
                            Composite adverse                67 (34)            88 (51)              0.001
                            maternal oucome


                            Values expressed in n(%)
                                     Expectant management
                                        Mode of delivery
ISSHP 16th WORLD CONGRESS



                                                             Onset of labour:   Onset of labour:          RR
                                                             spontaneously      Induction or SC         (95%CI)
                                                                (n=197)             (n=172)               of P
                            Time between                            7.6 ± 6.3      7.9 ± 5.7              0.69
                            randomization and
                            start of delivery
                            (days)
                            Mode of delivery
                            •Spontaneously                          151 (77)        98 (57)          1.3 (1.1 to 1.6)
                            •Vaginal instrumental                   29 (15)         22 (13)         1.2 (0.69 to 1.9)
                            delivery                                 17 (9)         52 (30)        0.29 (0.17 to 0.40)
                            •Caesarean section


                            Values expressed in n(%) or mean ± SD
                            Quality of life: SF-36
                            Physical Component
ISSHP 16th WORLD CONGRESS




                                                     Baseline   p= .897
                                                     6 Weeks PP p= .088
                                                     6 Months PP p= .349
                            Quality of life: SF-36
                            Mental Component
ISSHP 16th WORLD CONGRESS




                                                     Baseline    p= .968
                                                     6 Weeks PP p= .438
                                                     6 Months PP p= .478
                                     Conclusion
                                      Quality of life
ISSHP 16th WORLD CONGRESS



                            • In women with PIH or mild PE at
                              term, maternal QoL on the
                              physical plane is slightly better
                              after induction of labour than
                              after expectant management.
ISSHP 16th WORLD CONGRESS
                        Costs per patient
ISSHP 16th WORLD CONGRESS
                        Mean costs per patient
                                    Conclusion
                                        Costs
ISSHP 16th WORLD CONGRESS



                            • Induction of labour results in a
                              considerable cost saving
                              compared to expectant
                              management.
                            • Mainly due to differences in the
                              ante partum period.

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:12
posted:6/16/2011
language:English
pages:43