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The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins

The Twin Birth Study: A Multicentre Randomised Controlled Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins More Than or Equal to 32 Weeks Gestation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00187369
Enrollment
2804
Registered
2005-09-16
Start date
2003-12-31
Completion date
2011-10-31
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin Pregnancy

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

PROCEDUREMethod of Delivery

CS or VB

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidityuntil 28 days after deliveryThe primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.

Secondary

MeasureTime frameDescription
Neonatal Morbidityuntil 28 days after deliveryNeonatal 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 yearsNeurodevelopmental 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 Postpartum2 years postpartumThe occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire

Other

MeasureTime frameDescription
Baseline Characteristics - Estimated Fetal WeightBasline
Other Maternal Outcomes2 years postpartumMaternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum
Baseline Characteristics - Gestational Age at RandomizationBasline

Countries

Canada

Participant flow

Participants by arm

ArmCount
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
Total2,786

Baseline characteristics

CharacteristicCaesarean SectionVaginal BirthTotal
Age, Customized
Maternal age >= 30 yr
632 Participants632 Participants1264 Participants
Chorionicity at birth
Dichorionic and diamnionic
961 Participants970 Participants1931 Participants
Chorionicity at birth
Monochorionic and diamnionic
334 Participants326 Participants660 Participants
Chorionicity at birth
Unknown
98 Participants97 Participants195 Participants
Gestational age at randomization
<32 wk 0 days
0 Participants1 Participants1 Participants
Gestational age at randomization
32 wk 0 days to 33 wk 6 days
475 Participants477 Participants952 Participants
Gestational age at randomization
34 wk 0 days to 36 wk 6 days
679 Participants665 Participants1344 Participants
Gestational age at randomization
37 wk 0 days to 38 wk 6 days
239 Participants250 Participants489 Participants
Membranes ruptured at randomization83 Participants76 Participants159 Participants
National perinatal mortality in mother's country of residence
15-20 deaths/1000 births
596 Participants591 Participants1187 Participants
National perinatal mortality in mother's country of residence
<15 deaths/1000 births
724 Participants730 Participants1454 Participants
National perinatal mortality in mother's country of residence
>20 deaths/1000 births
73 Participants72 Participants145 Participants
Not in labor at randomization1190 Participants1159 Participants2349 Participants
Parity >= 1857 Participants856 Participants1713 Participants
Previous cesarean section100 Participants97 Participants197 Participants
Sex/Gender, Customized
Female
1393 Participants1393 Participants2786 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1,3920 / 1,39224 / 2,78317 / 2,782
other
Total, other adverse events
0 / 1,3920 / 1,3920 / 2,7830 / 2,782
serious
Total, serious adverse events
0 / 1,3920 / 1,3920 / 2,7830 / 2,782

Outcome results

Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityDeath24 Participants
Planned Caesarean SectionPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityComposite primary outcome60 Participants
Planned Caesarean SectionPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityFetal death13 Participants
Planned Caesarean SectionPerinatal/Neonatal Mortality and/or Serious Neonatal MorbiditySerious neonatal morbidity36 Participants
Planned Caesarean SectionPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityNeonatal death11 Participants
Planned Vaginal BirthPerinatal/Neonatal Mortality and/or Serious Neonatal MorbiditySerious neonatal morbidity35 Participants
Planned Vaginal BirthPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityFetal death9 Participants
Planned Vaginal BirthPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityComposite primary outcome52 Participants
Planned Vaginal BirthPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityDeath17 Participants
Planned Vaginal BirthPerinatal/Neonatal Mortality and/or Serious Neonatal MorbidityNeonatal death8 Participants
Secondary

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).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Fetal or neonatal death24 Participants
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Death up to follow-up11 Participants
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Neurodevelopmental delay104 Participants
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Cerebral palsy2 Participants
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Motor delay62 Participants
Planned Caesarean SectionDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Cognitive delay95 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Motor delay78 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Fetal or neonatal death17 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Cerebral palsy1 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Death up to follow-up6 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Cognitive delay105 Participants
Planned Vaginal BirthDeath or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)Neurodevelopmental delay110 Participants
Secondary

Neonatal Morbidity

Neonatal morbidity, excluding death of either twin

Time frame: until 28 days after delivery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionNeonatal MorbidityLong bone fracture0 Participants
Planned Caesarean SectionNeonatal Morbidity≥2 seizures within 72 hr after birth3 Participants
Planned Caesarean SectionNeonatal MorbidityApgar score at 5 minutes less than 42 Participants
Planned Caesarean SectionNeonatal MorbidityAssisted ventilation for ≥24 hr by means of endotr27 Participants
Planned Caesarean SectionNeonatal MorbidityFacial-nerve injury at 72 hr of age or discharge0 Participants
Planned Caesarean SectionNeonatal MorbidityNeonatal sepsis within 72 hours after birth1 Participants
Planned Caesarean SectionNeonatal MorbidityComa0 Participants
Planned Caesarean SectionNeonatal MorbidityMeningitis within 72 hours after birth0 Participants
Planned Caesarean SectionNeonatal MorbidityOther bone fracture1 Participants
Planned Caesarean SectionNeonatal MorbidityNecrotizing enterocolitis1 Participants
Planned Caesarean SectionNeonatal MorbidityBroncho-pulmonary dysplasia (BPD)0 Participants
Planned Caesarean SectionNeonatal MorbidityStupor or decreased response to pain2 Participants
Planned Caesarean SectionNeonatal MorbidityGrade 3 or 4 intraventricular hemorrhage0 Participants
Planned Caesarean SectionNeonatal MorbidityIntracerebral hemmorrhage3 Participants
Planned Caesarean SectionNeonatal MorbidityCystic periventricular leukomalacia2 Participants
Planned Caesarean SectionNeonatal MorbidityHyperalert, drowsy, or lethargic9 Participants
Planned Vaginal BirthNeonatal MorbidityCystic periventricular leukomalacia0 Participants
Planned Vaginal BirthNeonatal MorbidityLong bone fracture4 Participants
Planned Vaginal BirthNeonatal MorbidityOther bone fracture1 Participants
Planned Vaginal BirthNeonatal MorbidityFacial-nerve injury at 72 hr of age or discharge1 Participants
Planned Vaginal BirthNeonatal MorbidityIntracerebral hemmorrhage1 Participants
Planned Vaginal BirthNeonatal MorbidityApgar score at 5 minutes less than 47 Participants
Planned Vaginal BirthNeonatal MorbidityComa1 Participants
Planned Vaginal BirthNeonatal MorbidityStupor or decreased response to pain0 Participants
Planned Vaginal BirthNeonatal MorbidityHyperalert, drowsy, or lethargic7 Participants
Planned Vaginal BirthNeonatal Morbidity≥2 seizures within 72 hr after birth3 Participants
Planned Vaginal BirthNeonatal MorbidityAssisted ventilation for ≥24 hr by means of endotr17 Participants
Planned Vaginal BirthNeonatal MorbidityNeonatal sepsis within 72 hours after birth2 Participants
Planned Vaginal BirthNeonatal MorbidityMeningitis within 72 hours after birth0 Participants
Planned Vaginal BirthNeonatal MorbidityBroncho-pulmonary dysplasia (BPD)0 Participants
Planned Vaginal BirthNeonatal MorbidityGrade 3 or 4 intraventricular hemorrhage0 Participants
Planned Vaginal BirthNeonatal MorbidityNecrotizing enterocolitis3 Participants
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumUrinary incontinence187 Participants
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic urinary incontinence93 Participants
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumFecal incontinence47 Participants
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic faecal incontinence21 Participants
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumFlatal incontinence180 Participants
Planned Caesarean SectionProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic flatal incontinence68 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumFlatal incontinence224 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumUrinary incontinence250 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic faecal incontinence29 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic urinary incontinence140 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumProblematic flatal incontinence82 Participants
Planned Vaginal BirthProblematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years PostpartumFecal incontinence68 Participants
Other Pre-specified

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)

ArmMeasureGroupValue (MEAN)Dispersion
Planned Caesarean SectionBaseline Characteristics - Estimated Fetal WeightFirst Twin2238 gramsStandard Deviation 424
Planned Caesarean SectionBaseline Characteristics - Estimated Fetal WeightSecond Twin2223 gramsStandard Deviation 413
Planned Vaginal BirthBaseline Characteristics - Estimated Fetal WeightFirst Twin2238 gramsStandard Deviation 419
Planned Vaginal BirthBaseline Characteristics - Estimated Fetal WeightSecond Twin2232 gramsStandard Deviation 422
Other Pre-specified

Baseline Characteristics - Gestational Age at Randomization

Time frame: Basline

ArmMeasureValue (MEAN)Dispersion
Planned Caesarean SectionBaseline Characteristics - Gestational Age at Randomization34.9 weeksStandard Deviation 1.8
Planned Vaginal BirthBaseline Characteristics - Gestational Age at Randomization34.9 weeksStandard Deviation 1.8
Other Pre-specified

Other Maternal Outcomes

Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum

Time frame: 2 years postpartum

Population: Available data

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionOther Maternal OutcomesDepression (EPDS >12)129 Participants
Planned Caesarean SectionOther Maternal OutcomesContinuing breast feeding110 Participants
Planned Vaginal BirthOther Maternal OutcomesDepression (EPDS >12)115 Participants
Planned Vaginal BirthOther Maternal OutcomesContinuing breast feeding144 Participants
Other Pre-specified

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.

ArmMeasureGroupValue (MEAN)Dispersion
Planned Caesarean SectionOther Maternal OutcomesMaternal quality of life (SF-36) Physical53.4 score on a scaleStandard Deviation 7
Planned Caesarean SectionOther Maternal OutcomesMaternal quality of life (SF-36) Mental47.9 score on a scaleStandard Deviation 10.4
Planned Vaginal BirthOther Maternal OutcomesMaternal quality of life (SF-36) Physical53.2 score on a scaleStandard Deviation 6.9
Planned Vaginal BirthOther Maternal OutcomesMaternal quality of life (SF-36) Mental48.1 score on a scaleStandard Deviation 10.8
Other Pre-specified

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Planned Caesarean SectionOther Maternal Outcomes≥10 (possible depression298 Participants
Planned Caesarean SectionOther Maternal OutcomesExperienced faecal incontinence49 Participants
Planned Caesarean SectionOther Maternal Outcomes>12 (probable depression)180 Participants
Planned Caesarean SectionOther Maternal OutcomesProblematic faecal incontinence18 Participants
Planned Caesarean SectionOther Maternal OutcomesExperienced any urinary incontinence145 Participants
Planned Caesarean SectionOther Maternal OutcomesExperienced incontinence of flatus205 Participants
Planned Caesarean SectionOther Maternal OutcomesBreastfed either baby at any time1084 Participants
Planned Caesarean SectionOther Maternal OutcomesProblematic urinary incontinence70 Participants
Planned Caesarean SectionOther Maternal OutcomesStopped breastfeeding at <15 days32 Participants
Planned Caesarean SectionOther Maternal OutcomesProblematic flatal incontinence62 Participants
Planned Vaginal BirthOther Maternal OutcomesStopped breastfeeding at <15 days45 Participants
Planned Vaginal BirthOther Maternal OutcomesProblematic flatal incontinence79 Participants
Planned Vaginal BirthOther Maternal Outcomes>12 (probable depression)190 Participants
Planned Vaginal BirthOther Maternal Outcomes≥10 (possible depression306 Participants
Planned Vaginal BirthOther Maternal OutcomesExperienced any urinary incontinence197 Participants
Planned Vaginal BirthOther Maternal OutcomesProblematic urinary incontinence82 Participants
Planned Vaginal BirthOther Maternal OutcomesExperienced faecal incontinence48 Participants
Planned Vaginal BirthOther Maternal OutcomesProblematic faecal incontinence17 Participants
Planned Vaginal BirthOther Maternal OutcomesExperienced incontinence of flatus145 Participants
Planned Vaginal BirthOther Maternal OutcomesBreastfed either baby at any time1110 Participants
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
Planned Caesarean SectionOther Maternal OutcomesMaternal quality of life (SF-36) Mental46.7 units on a scaleStandard Deviation 10.9
Planned Caesarean SectionOther Maternal OutcomesEdinburgh Postnatal Depression Scale5.7 units on a scaleStandard Deviation 5.6
Planned Caesarean SectionOther Maternal OutcomesGlobal Fatigue Index score20.3 units on a scaleStandard Deviation 8.8
Planned Caesarean SectionOther Maternal OutcomesIncontinence Impact Questionnaire-7 (IIQ-7)20.48 units on a scaleStandard Deviation 21.41
Planned Caesarean SectionOther Maternal OutcomesMaternal quality of life (SF-36) Physical51.8 units on a scaleStandard Deviation 7.1
Planned Vaginal BirthOther Maternal OutcomesIncontinence Impact Questionnaire-7 (IIQ-7)20.44 units on a scaleStandard Deviation 20.5
Planned Vaginal BirthOther Maternal OutcomesMaternal quality of life (SF-36) Physical51.6 units on a scaleStandard Deviation 7.6
Planned Vaginal BirthOther Maternal OutcomesMaternal quality of life (SF-36) Mental46.0 units on a scaleStandard Deviation 11.3
Planned Vaginal BirthOther Maternal OutcomesGlobal Fatigue Index score20.8 units on a scaleStandard Deviation 9.3
Planned Vaginal BirthOther Maternal OutcomesEdinburgh Postnatal Depression Scale5.9 units on a scaleStandard Deviation 5.7

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026