OBJECTIVE: To evaluate whether for women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with reduced risk of death or serious outcomes for babies, without increasing harm.
DESIGN: Randomised controlled trial.
SETTING: Maternity hospitals across Australia, New Zealand and Italy.
POPULATION: A total of 235 women with an uncomplicated twin pregnancy at 36(+6) weeks of gestation, with no contraindication to continuing their pregnancy.
METHODS: Using a computer-generated, central telephone randomisation service, 235 women were randomised to Elective Birth (birth at 37 weeks; n=116) or Standard Care (continued expectant management, with birth planned from 38 weeks; n=119). Outcome assessors were masked to treatment allocation.
MAIN OUTCOME MEASURE: A composite of serious adverse outcome for the infant.
RESULTS: For women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with a significant reduction in risk of serious adverse outcome for the infant (Elective Birth 11/232 [4.7%] versus Standard Care 29/238 [12.2%]; risk ratio [RR] 0.39; 95% CI 0.20-0.75; P=0.005), reflecting a reduction in birthweight less than the third centile using singleton gestational age-specific charts (Elective Birth 7/232 [3.0%] versus Standard Care 24/238 [10.1%]; RR 0.30; 95% CI 0.13-0.67; P=0.004). In a post hoc analysis using twin gestational age-specific charts, there was evidence of a trend towards a reduction in the primary composite of serious adverse infant outcome (Elective Birth Group 4/232 [1.7%] versus Standard Care Group 12/238 [5.0%]; RR 0.34; 95% CI 0.11 to 1.05; P=0.06).
CONCLUSION: The findings of our study support recommendations for women with an uncomplicated twin pregnancy to birth at 37 weeks of gestation.
<b>BACKGROUND: </b>There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications.<b>Methods/design: </b><b>DESIGN: </b>Multicentred randomised trial.<b>Inclusion Criteria: </b>women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible). Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity.<b>Sample Size: </b>460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power).<b>DISCUSSION: </b>This is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation.
OBJECTIVE: The appropriate date of delivery in twin pregnancies is supposed to be earlier than that in singleton pregnancy. The aim of this study was to compare two strategies for managing twin pregnancies (i.e., immediate induction and expectant management).
METHODS: Seventeen patients underwent immediately induced labor by administration of oral prostaglandin E(2) at 37 weeks, while 19 patients underwent expectant management.
RESULTS: The average gestational age at delivery in the induction group was 37.5 +/- 0.4 weeks, significantly earlier than that in the expectant management group (39.0 +/- 1.1 weeks). However, there were no significant differences in the average birth weight between the two groups (2, 700 +/- 330 g in the induction group vs. 2,672 +/- 392 g in the expectant management group). The cesarean delivery rate in the induction group was 18%, not significantly different from that in the expectant management group (32%). The most common indication for cesarean section in the expectant management group was maternal infection, while there was no maternal infection in the induction group (p = 0.08).
CONCLUSION: It may be acceptable do intervene in twin pregnancies earlier than in singleton pregnancies during term.
To evaluate whether for women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with reduced risk of death or serious outcomes for babies, without increasing harm.
DESIGN:
Randomised controlled trial.
SETTING:
Maternity hospitals across Australia, New Zealand and Italy.
POPULATION:
A total of 235 women with an uncomplicated twin pregnancy at 36(+6) weeks of gestation, with no contraindication to continuing their pregnancy.
METHODS:
Using a computer-generated, central telephone randomisation service, 235 women were randomised to Elective Birth (birth at 37 weeks; n=116) or Standard Care (continued expectant management, with birth planned from 38 weeks; n=119). Outcome assessors were masked to treatment allocation.
MAIN OUTCOME MEASURE:
A composite of serious adverse outcome for the infant.
RESULTS:
For women with an uncomplicated twin pregnancy, elective birth at 37 weeks of gestation was associated with a significant reduction in risk of serious adverse outcome for the infant (Elective Birth 11/232 [4.7%] versus Standard Care 29/238 [12.2%]; risk ratio [RR] 0.39; 95% CI 0.20-0.75; P=0.005), reflecting a reduction in birthweight less than the third centile using singleton gestational age-specific charts (Elective Birth 7/232 [3.0%] versus Standard Care 24/238 [10.1%]; RR 0.30; 95% CI 0.13-0.67; P=0.004). In a post hoc analysis using twin gestational age-specific charts, there was evidence of a trend towards a reduction in the primary composite of serious adverse infant outcome (Elective Birth Group 4/232 [1.7%] versus Standard Care Group 12/238 [5.0%]; RR 0.34; 95% CI 0.11 to 1.05; P=0.06).
CONCLUSION:
The findings of our study support recommendations for women with an uncomplicated twin pregnancy to birth at 37 weeks of gestation.
