Twin Pregnancy
Conditions
Keywords
twins, twin births, multiples
Brief summary
For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of planned caesarean section (CS) lower the likelihood of death or serious illness, during the first 28 days after birth, compared to a plan for vaginal birth (VB)?
Detailed description
For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB?
Interventions
CS or VB
Sponsors
Study design
Eligibility
Inclusion criteria
1. Women at 32 0/7 - 38 6/7 weeks gestation 2. Estimated fetal weight of each fetus 1500 - 4000 g 3. Both twins alive at time of randomization 4. Twin A is in cephalic position
Exclusion criteria
1. Monoamniotic twins 2. Lethal fetal anomaly of either fetus 3. Contraindication to labour or vaginal delivery for either twin 4. Previous participation in the Twin Birth Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | until 28 days after delivery | The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Morbidity | until 28 days after delivery | Neonatal morbidity, excluding death of either twin |
| Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | 2 years | Neurodevelopmental outcome will be assessed by the Ages and Stages Questionnaire (ASQ). The ASQ is a parent/parental caregiver-administered structured questionnaire that includes questions on 5 domains of development: communication, gross motor skills, fine motor skills, problem-solving skills, and personal-social skills. If the score for any 1 of the 5 domains is below the specific cutoff for the domain, the ASQ was considered abnormal. |
| Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | 2 years postpartum | The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics - Estimated Fetal Weight | Basline | — |
| Other Maternal Outcomes | 2 years postpartum | Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum |
| Baseline Characteristics - Gestational Age at Randomization | Basline | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caesarean Section delivery by caesarean section
Method of Delivery: CS or VB | 1,393 |
| Vaginal Birth delivery by vaginal birth
Method of Delivery: CS or VB | 1,393 |
| Total | 2,786 |
Baseline characteristics
| Characteristic | Caesarean Section | Vaginal Birth | Total |
|---|---|---|---|
| Age, Customized Maternal age >= 30 yr | 632 Participants | 632 Participants | 1264 Participants |
| Chorionicity at birth Dichorionic and diamnionic | 961 Participants | 970 Participants | 1931 Participants |
| Chorionicity at birth Monochorionic and diamnionic | 334 Participants | 326 Participants | 660 Participants |
| Chorionicity at birth Unknown | 98 Participants | 97 Participants | 195 Participants |
| Gestational age at randomization <32 wk 0 days | 0 Participants | 1 Participants | 1 Participants |
| Gestational age at randomization 32 wk 0 days to 33 wk 6 days | 475 Participants | 477 Participants | 952 Participants |
| Gestational age at randomization 34 wk 0 days to 36 wk 6 days | 679 Participants | 665 Participants | 1344 Participants |
| Gestational age at randomization 37 wk 0 days to 38 wk 6 days | 239 Participants | 250 Participants | 489 Participants |
| Membranes ruptured at randomization | 83 Participants | 76 Participants | 159 Participants |
| National perinatal mortality in mother's country of residence 15-20 deaths/1000 births | 596 Participants | 591 Participants | 1187 Participants |
| National perinatal mortality in mother's country of residence <15 deaths/1000 births | 724 Participants | 730 Participants | 1454 Participants |
| National perinatal mortality in mother's country of residence >20 deaths/1000 births | 73 Participants | 72 Participants | 145 Participants |
| Not in labor at randomization | 1190 Participants | 1159 Participants | 2349 Participants |
| Parity >= 1 | 857 Participants | 856 Participants | 1713 Participants |
| Previous cesarean section | 100 Participants | 97 Participants | 197 Participants |
| Sex/Gender, Customized Female | 1393 Participants | 1393 Participants | 2786 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,392 | 0 / 1,392 | 24 / 2,783 | 17 / 2,782 |
| other Total, other adverse events | 0 / 1,392 | 0 / 1,392 | 0 / 2,783 | 0 / 2,782 |
| serious Total, serious adverse events | 0 / 1,392 | 0 / 1,392 | 0 / 2,783 | 0 / 2,782 |
Outcome results
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
Time frame: until 28 days after delivery
Population: number of fetuses/infants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Death | 24 Participants |
| Planned Caesarean Section | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Composite primary outcome | 60 Participants |
| Planned Caesarean Section | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Fetal death | 13 Participants |
| Planned Caesarean Section | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Serious neonatal morbidity | 36 Participants |
| Planned Caesarean Section | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Neonatal death | 11 Participants |
| Planned Vaginal Birth | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Serious neonatal morbidity | 35 Participants |
| Planned Vaginal Birth | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Fetal death | 9 Participants |
| Planned Vaginal Birth | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Composite primary outcome | 52 Participants |
| Planned Vaginal Birth | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Death | 17 Participants |
| Planned Vaginal Birth | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | Neonatal death | 8 Participants |
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Neurodevelopmental outcome will be assessed by the Ages and Stages Questionnaire (ASQ). The ASQ is a parent/parental caregiver-administered structured questionnaire that includes questions on 5 domains of development: communication, gross motor skills, fine motor skills, problem-solving skills, and personal-social skills. If the score for any 1 of the 5 domains is below the specific cutoff for the domain, the ASQ was considered abnormal.
Time frame: 2 years
Population: Neurodevelopmental outcomes of children at 2 years of age (based on available two year data of the children).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Fetal or neonatal death | 24 Participants |
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Death up to follow-up | 11 Participants |
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Neurodevelopmental delay | 104 Participants |
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Cerebral palsy | 2 Participants |
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Motor delay | 62 Participants |
| Planned Caesarean Section | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Cognitive delay | 95 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Motor delay | 78 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Fetal or neonatal death | 17 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Cerebral palsy | 1 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Death up to follow-up | 6 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Cognitive delay | 105 Participants |
| Planned Vaginal Birth | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | Neurodevelopmental delay | 110 Participants |
Neonatal Morbidity
Neonatal morbidity, excluding death of either twin
Time frame: until 28 days after delivery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Neonatal Morbidity | Long bone fracture | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | ≥2 seizures within 72 hr after birth | 3 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Apgar score at 5 minutes less than 4 | 2 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Assisted ventilation for ≥24 hr by means of endotr | 27 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Facial-nerve injury at 72 hr of age or discharge | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Neonatal sepsis within 72 hours after birth | 1 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Coma | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Meningitis within 72 hours after birth | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Other bone fracture | 1 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Necrotizing enterocolitis | 1 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Broncho-pulmonary dysplasia (BPD) | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Stupor or decreased response to pain | 2 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Grade 3 or 4 intraventricular hemorrhage | 0 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Intracerebral hemmorrhage | 3 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Cystic periventricular leukomalacia | 2 Participants |
| Planned Caesarean Section | Neonatal Morbidity | Hyperalert, drowsy, or lethargic | 9 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Cystic periventricular leukomalacia | 0 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Long bone fracture | 4 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Other bone fracture | 1 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Facial-nerve injury at 72 hr of age or discharge | 1 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Intracerebral hemmorrhage | 1 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Apgar score at 5 minutes less than 4 | 7 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Coma | 1 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Stupor or decreased response to pain | 0 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Hyperalert, drowsy, or lethargic | 7 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | ≥2 seizures within 72 hr after birth | 3 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Assisted ventilation for ≥24 hr by means of endotr | 17 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Neonatal sepsis within 72 hours after birth | 2 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Meningitis within 72 hours after birth | 0 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Broncho-pulmonary dysplasia (BPD) | 0 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Grade 3 or 4 intraventricular hemorrhage | 0 Participants |
| Planned Vaginal Birth | Neonatal Morbidity | Necrotizing enterocolitis | 3 Participants |
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire
Time frame: 2 years postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Urinary incontinence | 187 Participants |
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic urinary incontinence | 93 Participants |
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Fecal incontinence | 47 Participants |
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic faecal incontinence | 21 Participants |
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Flatal incontinence | 180 Participants |
| Planned Caesarean Section | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic flatal incontinence | 68 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Flatal incontinence | 224 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Urinary incontinence | 250 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic faecal incontinence | 29 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic urinary incontinence | 140 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Problematic flatal incontinence | 82 Participants |
| Planned Vaginal Birth | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | Fecal incontinence | 68 Participants |
Baseline Characteristics - Estimated Fetal Weight
Time frame: Basline
Population: Data were missing for the following characteristics: estimated fetal weight of the first twin (for two women in the planned-cesarean-delivery group and for two in the planned-vaginal-delivery group) and estimated fetal weight of the second twin (for two women in the planned-cesarean-delivery group and for one in the planned-vaginal-delivery group)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Planned Caesarean Section | Baseline Characteristics - Estimated Fetal Weight | First Twin | 2238 grams | Standard Deviation 424 |
| Planned Caesarean Section | Baseline Characteristics - Estimated Fetal Weight | Second Twin | 2223 grams | Standard Deviation 413 |
| Planned Vaginal Birth | Baseline Characteristics - Estimated Fetal Weight | First Twin | 2238 grams | Standard Deviation 419 |
| Planned Vaginal Birth | Baseline Characteristics - Estimated Fetal Weight | Second Twin | 2232 grams | Standard Deviation 422 |
Baseline Characteristics - Gestational Age at Randomization
Time frame: Basline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Planned Caesarean Section | Baseline Characteristics - Gestational Age at Randomization | 34.9 weeks | Standard Deviation 1.8 |
| Planned Vaginal Birth | Baseline Characteristics - Gestational Age at Randomization | 34.9 weeks | Standard Deviation 1.8 |
Other Maternal Outcomes
Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum
Time frame: 2 years postpartum
Population: Available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Other Maternal Outcomes | Depression (EPDS >12) | 129 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Continuing breast feeding | 110 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Depression (EPDS >12) | 115 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Continuing breast feeding | 144 Participants |
Other Maternal Outcomes
Maternal quality of life at 2 years postpartum (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability);
Time frame: 2 year postpartum
Population: Mean and standard deviation on available data. This is based on available maternal data at 2 years postpartum.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Planned Caesarean Section | Other Maternal Outcomes | Maternal quality of life (SF-36) Physical | 53.4 score on a scale | Standard Deviation 7 |
| Planned Caesarean Section | Other Maternal Outcomes | Maternal quality of life (SF-36) Mental | 47.9 score on a scale | Standard Deviation 10.4 |
| Planned Vaginal Birth | Other Maternal Outcomes | Maternal quality of life (SF-36) Physical | 53.2 score on a scale | Standard Deviation 6.9 |
| Planned Vaginal Birth | Other Maternal Outcomes | Maternal quality of life (SF-36) Mental | 48.1 score on a scale | Standard Deviation 10.8 |
Other Maternal Outcomes
Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months
Time frame: 3 months postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Planned Caesarean Section | Other Maternal Outcomes | ≥10 (possible depression | 298 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Experienced faecal incontinence | 49 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | >12 (probable depression) | 180 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Problematic faecal incontinence | 18 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Experienced any urinary incontinence | 145 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Experienced incontinence of flatus | 205 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Breastfed either baby at any time | 1084 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Problematic urinary incontinence | 70 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Stopped breastfeeding at <15 days | 32 Participants |
| Planned Caesarean Section | Other Maternal Outcomes | Problematic flatal incontinence | 62 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Stopped breastfeeding at <15 days | 45 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Problematic flatal incontinence | 79 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | >12 (probable depression) | 190 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | ≥10 (possible depression | 306 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Experienced any urinary incontinence | 197 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Problematic urinary incontinence | 82 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Experienced faecal incontinence | 48 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Problematic faecal incontinence | 17 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Experienced incontinence of flatus | 145 Participants |
| Planned Vaginal Birth | Other Maternal Outcomes | Breastfed either baby at any time | 1110 Participants |
Other Maternal Outcomes
Maternal quality of life at 3 months (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability); Maternal fatigue at 3 months (the scale combines 16 items to produce a Global Fatigue Index (GFI), which can range from 1 (no fatigue) to 50 (severe fatigue)); Maternal depression at 3 months was measured by the Edinburgh Postnatal Depression Scale, which measures how women have been feeling in the previous 7 days, with a score of \>12 indicating depression (each answer is given a score of 0 to 3 based on the seriousness of the symptom. The total possible maximum depression score is 30). IIQ-7 at 3 months are validated questions about the impact of the incontinence (scores were reported using a scale of 0-100, with '0' indicating no impact at all and '100' greatly impacted).
Time frame: 3 months postpartum
Population: Mean and standard deviation on available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Planned Caesarean Section | Other Maternal Outcomes | Maternal quality of life (SF-36) Mental | 46.7 units on a scale | Standard Deviation 10.9 |
| Planned Caesarean Section | Other Maternal Outcomes | Edinburgh Postnatal Depression Scale | 5.7 units on a scale | Standard Deviation 5.6 |
| Planned Caesarean Section | Other Maternal Outcomes | Global Fatigue Index score | 20.3 units on a scale | Standard Deviation 8.8 |
| Planned Caesarean Section | Other Maternal Outcomes | Incontinence Impact Questionnaire-7 (IIQ-7) | 20.48 units on a scale | Standard Deviation 21.41 |
| Planned Caesarean Section | Other Maternal Outcomes | Maternal quality of life (SF-36) Physical | 51.8 units on a scale | Standard Deviation 7.1 |
| Planned Vaginal Birth | Other Maternal Outcomes | Incontinence Impact Questionnaire-7 (IIQ-7) | 20.44 units on a scale | Standard Deviation 20.5 |
| Planned Vaginal Birth | Other Maternal Outcomes | Maternal quality of life (SF-36) Physical | 51.6 units on a scale | Standard Deviation 7.6 |
| Planned Vaginal Birth | Other Maternal Outcomes | Maternal quality of life (SF-36) Mental | 46.0 units on a scale | Standard Deviation 11.3 |
| Planned Vaginal Birth | Other Maternal Outcomes | Global Fatigue Index score | 20.8 units on a scale | Standard Deviation 9.3 |
| Planned Vaginal Birth | Other Maternal Outcomes | Edinburgh Postnatal Depression Scale | 5.9 units on a scale | Standard Deviation 5.7 |