Trial Outcomes & Findings for The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins (NCT NCT00187369)
NCT ID: NCT00187369
Last Updated: 2020-05-13
Results Overview
The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2804 participants
Primary outcome timeframe
until 28 days after delivery
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Caesarean Section
delivery by caesarean section
Method of Delivery: CS or VB
|
Vaginal Birth
delivery by vaginal birth
Method of Delivery: CS or VB
|
|---|---|---|
|
Mothers
STARTED
|
1398
|
1406
|
|
Mothers
Included in the Study
|
1393
|
1393
|
|
Mothers
COMPLETED
|
1392
|
1392
|
|
Mothers
NOT COMPLETED
|
6
|
14
|
|
Fetuses or Infants
STARTED
|
2795
|
2812
|
|
Fetuses or Infants
Included in the Study
|
2785
|
2786
|
|
Fetuses or Infants
COMPLETED
|
2783
|
2782
|
|
Fetuses or Infants
NOT COMPLETED
|
12
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was missing from one woman in the planned cesarean delivery
Baseline characteristics by cohort
| Measure |
Caesarean Section
n=1393 Participants
delivery by caesarean section
Method of Delivery: CS or VB
|
Vaginal Birth
n=1393 Participants
delivery by vaginal birth
Method of Delivery: CS or VB
|
Total
n=2786 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Maternal age >= 30 yr
|
632 Participants
n=1393 Participants
|
632 Participants
n=1393 Participants
|
1264 Participants
n=2786 Participants
|
|
Sex/Gender, Customized
Female
|
1393 Participants
n=1393 Participants
|
1393 Participants
n=1393 Participants
|
2786 Participants
n=2786 Participants
|
|
Parity >= 1
|
857 Participants
n=1393 Participants
|
856 Participants
n=1393 Participants
|
1713 Participants
n=2786 Participants
|
|
Previous cesarean section
|
100 Participants
n=1393 Participants
|
97 Participants
n=1393 Participants
|
197 Participants
n=2786 Participants
|
|
Gestational age at randomization
<32 wk 0 days
|
0 Participants
n=1393 Participants
|
1 Participants
n=1393 Participants
|
1 Participants
n=2786 Participants
|
|
Gestational age at randomization
32 wk 0 days to 33 wk 6 days
|
475 Participants
n=1393 Participants
|
477 Participants
n=1393 Participants
|
952 Participants
n=2786 Participants
|
|
Gestational age at randomization
34 wk 0 days to 36 wk 6 days
|
679 Participants
n=1393 Participants
|
665 Participants
n=1393 Participants
|
1344 Participants
n=2786 Participants
|
|
Gestational age at randomization
37 wk 0 days to 38 wk 6 days
|
239 Participants
n=1393 Participants
|
250 Participants
n=1393 Participants
|
489 Participants
n=2786 Participants
|
|
Chorionicity at birth
Dichorionic and diamnionic
|
961 Participants
n=1393 Participants
|
970 Participants
n=1393 Participants
|
1931 Participants
n=2786 Participants
|
|
Chorionicity at birth
Monochorionic and diamnionic
|
334 Participants
n=1393 Participants
|
326 Participants
n=1393 Participants
|
660 Participants
n=2786 Participants
|
|
Chorionicity at birth
Unknown
|
98 Participants
n=1393 Participants
|
97 Participants
n=1393 Participants
|
195 Participants
n=2786 Participants
|
|
Not in labor at randomization
|
1190 Participants
n=1392 Participants • Data was missing from one woman in the planned cesarean delivery
|
1159 Participants
n=1393 Participants • Data was missing from one woman in the planned cesarean delivery
|
2349 Participants
n=2785 Participants • Data was missing from one woman in the planned cesarean delivery
|
|
Membranes ruptured at randomization
|
83 Participants
n=1393 Participants
|
76 Participants
n=1393 Participants
|
159 Participants
n=2786 Participants
|
|
National perinatal mortality in mother's country of residence
<15 deaths/1000 births
|
724 Participants
n=1393 Participants
|
730 Participants
n=1393 Participants
|
1454 Participants
n=2786 Participants
|
|
National perinatal mortality in mother's country of residence
15-20 deaths/1000 births
|
596 Participants
n=1393 Participants
|
591 Participants
n=1393 Participants
|
1187 Participants
n=2786 Participants
|
|
National perinatal mortality in mother's country of residence
>20 deaths/1000 births
|
73 Participants
n=1393 Participants
|
72 Participants
n=1393 Participants
|
145 Participants
n=2786 Participants
|
PRIMARY outcome
Timeframe: until 28 days after deliveryPopulation: number of fetuses/infants
The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
Outcome measures
| Measure |
Planned Caesarean Section
n=2783 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=2782 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Composite primary outcome
|
60 Participants
|
52 Participants
|
|
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Death
|
24 Participants
|
17 Participants
|
|
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Fetal death
|
13 Participants
|
9 Participants
|
|
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Neonatal death
|
11 Participants
|
8 Participants
|
|
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Serious neonatal morbidity
|
36 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: until 28 days after deliveryNeonatal morbidity, excluding death of either twin
Outcome measures
| Measure |
Planned Caesarean Section
n=2759 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=2765 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Neonatal Morbidity
Hyperalert, drowsy, or lethargic
|
9 Participants
|
7 Participants
|
|
Neonatal Morbidity
Long bone fracture
|
0 Participants
|
4 Participants
|
|
Neonatal Morbidity
Other bone fracture
|
1 Participants
|
1 Participants
|
|
Neonatal Morbidity
Facial-nerve injury at 72 hr of age or discharge
|
0 Participants
|
1 Participants
|
|
Neonatal Morbidity
Intracerebral hemmorrhage
|
3 Participants
|
1 Participants
|
|
Neonatal Morbidity
Apgar score at 5 minutes less than 4
|
2 Participants
|
7 Participants
|
|
Neonatal Morbidity
Coma
|
0 Participants
|
1 Participants
|
|
Neonatal Morbidity
Stupor or decreased response to pain
|
2 Participants
|
0 Participants
|
|
Neonatal Morbidity
≥2 seizures within 72 hr after birth
|
3 Participants
|
3 Participants
|
|
Neonatal Morbidity
Assisted ventilation for ≥24 hr by means of endotr
|
27 Participants
|
17 Participants
|
|
Neonatal Morbidity
Neonatal sepsis within 72 hours after birth
|
1 Participants
|
2 Participants
|
|
Neonatal Morbidity
Meningitis within 72 hours after birth
|
0 Participants
|
0 Participants
|
|
Neonatal Morbidity
Necrotizing enterocolitis
|
1 Participants
|
3 Participants
|
|
Neonatal Morbidity
Broncho-pulmonary dysplasia (BPD)
|
0 Participants
|
0 Participants
|
|
Neonatal Morbidity
Grade 3 or 4 intraventricular hemorrhage
|
0 Participants
|
0 Participants
|
|
Neonatal Morbidity
Cystic periventricular leukomalacia
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Neurodevelopmental outcomes of children at 2 years of age (based on available two year data of the children).
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.
Outcome measures
| Measure |
Planned Caesarean Section
n=2320 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=2283 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
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
|
17 Participants
|
|
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
|
6 Participants
|
|
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Neurodevelopmental delay
|
104 Participants
|
110 Participants
|
|
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Cerebral palsy
|
2 Participants
|
1 Participants
|
|
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Motor delay
|
62 Participants
|
78 Participants
|
|
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Cognitive delay
|
95 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: 2 years postpartumThe occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire
Outcome measures
| Measure |
Planned Caesarean Section
n=1155 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1150 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Urinary incontinence
|
187 Participants
|
250 Participants
|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Problematic urinary incontinence
|
93 Participants
|
140 Participants
|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Fecal incontinence
|
47 Participants
|
68 Participants
|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Problematic faecal incontinence
|
21 Participants
|
29 Participants
|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Flatal incontinence
|
180 Participants
|
224 Participants
|
|
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Problematic flatal incontinence
|
68 Participants
|
82 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaslineOutcome measures
| Measure |
Planned Caesarean Section
n=1393 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1393 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Baseline Characteristics - Gestational Age at Randomization
|
34.9 weeks
Standard Deviation 1.8
|
34.9 weeks
Standard Deviation 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaslinePopulation: 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)
Outcome measures
| Measure |
Planned Caesarean Section
n=1393 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1393 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Baseline Characteristics - Estimated Fetal Weight
Second Twin
|
2223 grams
Standard Deviation 413
|
2232 grams
Standard Deviation 422
|
|
Baseline Characteristics - Estimated Fetal Weight
First Twin
|
2238 grams
Standard Deviation 424
|
2238 grams
Standard Deviation 419
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years postpartumPopulation: Available data
Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum
Outcome measures
| Measure |
Planned Caesarean Section
n=1155 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1150 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Other Maternal Outcomes
Depression (EPDS >12)
|
129 Participants
|
115 Participants
|
|
Other Maternal Outcomes
Continuing breast feeding
|
110 Participants
|
144 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 year postpartumPopulation: Mean and standard deviation on available data. This is based on available maternal data at 2 years postpartum.
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);
Outcome measures
| Measure |
Planned Caesarean Section
n=1141 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1134 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Other Maternal Outcomes
Maternal quality of life (SF-36) Physical
|
53.4 score on a scale
Standard Deviation 7.0
|
53.2 score on a scale
Standard Deviation 6.9
|
|
Other Maternal Outcomes
Maternal quality of life (SF-36) Mental
|
47.9 score on a scale
Standard Deviation 10.4
|
48.1 score on a scale
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postpartumMaternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months
Outcome measures
| Measure |
Planned Caesarean Section
n=1285 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1285 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Other Maternal Outcomes
>12 (probable depression)
|
180 Participants
|
190 Participants
|
|
Other Maternal Outcomes
≥10 (possible depression
|
298 Participants
|
306 Participants
|
|
Other Maternal Outcomes
Experienced any urinary incontinence
|
145 Participants
|
197 Participants
|
|
Other Maternal Outcomes
Problematic urinary incontinence
|
70 Participants
|
82 Participants
|
|
Other Maternal Outcomes
Experienced faecal incontinence
|
49 Participants
|
48 Participants
|
|
Other Maternal Outcomes
Problematic faecal incontinence
|
18 Participants
|
17 Participants
|
|
Other Maternal Outcomes
Experienced incontinence of flatus
|
205 Participants
|
145 Participants
|
|
Other Maternal Outcomes
Problematic flatal incontinence
|
62 Participants
|
79 Participants
|
|
Other Maternal Outcomes
Breastfed either baby at any time
|
1084 Participants
|
1110 Participants
|
|
Other Maternal Outcomes
Stopped breastfeeding at <15 days
|
32 Participants
|
45 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postpartumPopulation: Mean and standard deviation on available data
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).
Outcome measures
| Measure |
Planned Caesarean Section
n=1285 Participants
delivery by CS or Method of Delivery: CS or VB
|
Planned Vaginal Birth
n=1285 Participants
delivery by VB or Method of Delivery: CS or VB
|
|---|---|---|
|
Other Maternal Outcomes
Maternal quality of life (SF-36) Physical
|
51.8 units on a scale
Standard Deviation 7.1
|
51.6 units on a scale
Standard Deviation 7.6
|
|
Other Maternal Outcomes
Maternal quality of life (SF-36) Mental
|
46.7 units on a scale
Standard Deviation 10.9
|
46.0 units on a scale
Standard Deviation 11.3
|
|
Other Maternal Outcomes
Global Fatigue Index score
|
20.3 units on a scale
Standard Deviation 8.8
|
20.8 units on a scale
Standard Deviation 9.3
|
|
Other Maternal Outcomes
Edinburgh Postnatal Depression Scale
|
5.7 units on a scale
Standard Deviation 5.6
|
5.9 units on a scale
Standard Deviation 5.7
|
|
Other Maternal Outcomes
Incontinence Impact Questionnaire-7 (IIQ-7)
|
20.48 units on a scale
Standard Deviation 21.41
|
20.44 units on a scale
Standard Deviation 20.50
|
Adverse Events
Planned Caesarean Section-Mother
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Planned Vaginal Birth-Mother
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Planned Caesarean Section-Infants/Fetuses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 24 deaths
Planned Vaginal Birth-Infants/Fetuses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place