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

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00187369
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 2,804
• Location: 1
• Arms: 2
• Duration (Months): 94
• Patients Per Site Per Month: 29.8

Study Details

Study Description

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)?

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy	Procedure: Method of Delivery	N/A

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?

Study Design

• Study Type: Interventional
• Actual Enrollment: 2804 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Caesarean Section delivery by CS	Procedure: Method of Delivery; CS or VB
Other: Vaginal Birth delivery by VB	Procedure: Method of Delivery; CS or VB

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Neonatal Morbidity [until 28 days after delivery]

   Neonatal morbidity, excluding death of either twin

2. 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.

3. 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 Outcome Measures

1. Baseline Characteristics - Gestational Age at Randomization [Basline]

2. Baseline Characteristics - Estimated Fetal Weight [Basline]

3. Other Maternal Outcomes [2 years postpartum]

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

4. Other Maternal Outcomes [2 year 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);

5. Other Maternal Outcomes [3 months postpartum]

   Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months

6. Other Maternal Outcomes [3 months postpartum]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Data Coordinating Centre/SHSC	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Jon F Barrett, SHSC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Twin Birth Study website

Publications

• Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939. Erratum in: N Engl J Med. 2013 Dec 12;369(24):2364.

• Responsible Party: Dr Jon Barrett, Chief, Maternal-Fetal Medicine, Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT00187369
• Other Study ID Numbers: MCT-63164; ISRCTN74420086
• First Posted: Sep 16, 2005
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Keywords provided by Dr Jon Barrett, Chief, Maternal-Fetal Medicine, Sunnybrook Health Sciences Centre: twins; twin births; multiples

Study Results

Participant Flow

Arm/Group Title	Caesarean Section	Vaginal Birth
Arm/Group Description	delivery by caesarean section Method of Delivery: CS or VB	delivery by vaginal birth Method of Delivery: CS or VB
Period Title: Mothers
STARTED	1398	1406
Included in the Study	1393	1393
COMPLETED	1392	1392
NOT COMPLETED	6	14
Period Title: Mothers
STARTED	2795	2812
Included in the Study	2785	2786
COMPLETED	2783	2782
NOT COMPLETED	12	30

Baseline Characteristics

Arm/Group Title	Caesarean Section	Vaginal Birth	Total
Arm/Group Description	delivery by caesarean section Method of Delivery: CS or VB	delivery by vaginal birth Method of Delivery: CS or VB	Total of all reporting groups
Overall Participants	1393	1393	2786
Age, Customized (Count of Participants)
Maternal age >= 30 yr	632 45.4%	632 45.4%	1264 45.4%
Sex/Gender, Customized (Count of Participants)
Female	1393 100%	1393 100%	2786 100%
Parity >= 1 (Count of Participants)
Count of Participants [Participants]	857 61.5%	856 61.5%	1713 61.5%
Previous cesarean section (Count of Participants)
Count of Participants [Participants]	100 7.2%	97 7%	197 7.1%
Gestational age at randomization (Count of Participants)
<32 wk 0 days	0 0%	1 0.1%	1 0%
32 wk 0 days to 33 wk 6 days	475 34.1%	477 34.2%	952 34.2%
34 wk 0 days to 36 wk 6 days	679 48.7%	665 47.7%	1344 48.2%
37 wk 0 days to 38 wk 6 days	239 17.2%	250 17.9%	489 17.6%
Chorionicity at birth (Count of Participants)
Dichorionic and diamnionic	961 69%	970 69.6%	1931 69.3%
Monochorionic and diamnionic	334 24%	326 23.4%	660 23.7%
Unknown	98 7%	97 7%	195 7%
Not in labor at randomization (Count of Participants)
Count of Participants [Participants]	1190 85.4%	1159 83.2%	2349 84.3%
Membranes ruptured at randomization (Count of Participants)
Count of Participants [Participants]	83 6%	76 5.5%	159 5.7%
National perinatal mortality in mother's country of residence (Count of Participants)
<15 deaths/1000 births	724 52%	730 52.4%	1454 52.2%
15-20 deaths/1000 births	596 42.8%	591 42.4%	1187 42.6%
>20 deaths/1000 births	73 5.2%	72 5.2%	145 5.2%

Outcome Measures

1. Primary Outcome

Title	Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
Description	The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
Time Frame	until 28 days after delivery

Outcome Measure Data

Analysis Population Description

number of fetuses/infants

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	2783	2782
Composite primary outcome	60 4.3%	52 3.7%
Death	24 1.7%	17 1.2%
Fetal death	13 0.9%	9 0.6%
Neonatal death	11 0.8%	8 0.6%
Serious neonatal morbidity	36 2.6%	35 2.5%

2. Secondary Outcome

Title	Neonatal Morbidity
Description	Neonatal morbidity, excluding death of either twin
Time Frame	until 28 days after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by caesarean section Method of Delivery: CS or VB	delivery by vaginal birth Method of Delivery: CS or VB
Measure Participants	2759	2765
Long bone fracture	0 0%	4 0.3%
Other bone fracture	1 0.1%	1 0.1%
Facial-nerve injury at 72 hr of age or discharge	0 0%	1 0.1%
Intracerebral hemmorrhage	3 0.2%	1 0.1%
Apgar score at 5 minutes less than 4	2 0.1%	7 0.5%
Coma	0 0%	1 0.1%
Stupor or decreased response to pain	2 0.1%	0 0%
Hyperalert, drowsy, or lethargic	9 0.6%	7 0.5%
≥2 seizures within 72 hr after birth	3 0.2%	3 0.2%
Assisted ventilation for ≥24 hr by means of endotr	27 1.9%	17 1.2%
Neonatal sepsis within 72 hours after birth	1 0.1%	2 0.1%
Meningitis within 72 hours after birth	0 0%	0 0%
Necrotizing enterocolitis	1 0.1%	3 0.2%
Broncho-pulmonary dysplasia (BPD)	0 0%	0 0%
Grade 3 or 4 intraventricular hemorrhage	0 0%	0 0%
Cystic periventricular leukomalacia	2 0.1%	0 0%

3. Secondary Outcome

Title	Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
Description	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

Outcome Measure Data

Analysis Population Description

Neurodevelopmental outcomes of children at 2 years of age (based on available two year data of the children).

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by caesarean section Method of Delivery: CS or VB	delivery by vaginal birth Method of Delivery: CS or VB
Measure Participants	2320	2283
Fetal or neonatal death	24 1.7%	17 1.2%
Death up to follow-up	11 0.8%	6 0.4%
Neurodevelopmental delay	104 7.5%	110 7.9%
Cerebral palsy	2 0.1%	1 0.1%
Motor delay	62 4.5%	78 5.6%
Cognitive delay	95 6.8%	105 7.5%

4. Secondary Outcome

Title	Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS Method of Delivery: CS or VB	delivery by VB Method of Delivery: CS or VB
Measure Participants	1155	1150
Urinary incontinence	187 13.4%	250 17.9%
Problematic urinary incontinence	93 6.7%	140 10.1%
Fecal incontinence	47 3.4%	68 4.9%
Problematic faecal incontinence	21 1.5%	29 2.1%
Flatal incontinence	180 12.9%	224 16.1%
Problematic flatal incontinence	68 4.9%	82 5.9%

5. Other Pre-specified Outcome

Title	Baseline Characteristics - Gestational Age at Randomization
Time Frame	Basline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	1393	1393
Mean (Standard Deviation) [weeks]	34.9 (1.8)	34.9 (1.8)

6. Other Pre-specified Outcome

Title	Baseline Characteristics - Estimated Fetal Weight
Time Frame	Basline

Outcome Measure Data

Analysis Population Description

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/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	1393	1393
First Twin	2238 (424)	2238 (419)
Second Twin	2223 (413)	2232 (422)

7. Other Pre-specified Outcome

Title	Other Maternal Outcomes
Description	Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum
Time Frame	2 years postpartum

Outcome Measure Data

Analysis Population Description

Available data

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	1155	1150
Depression (EPDS >12)	129 9.3%	115 8.3%
Continuing breast feeding	110 7.9%	144 10.3%

8. Other Pre-specified Outcome

Title	Other Maternal Outcomes
Description	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

Outcome Measure Data

Analysis Population Description

Mean and standard deviation on available data. This is based on available maternal data at 2 years postpartum.

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	1141	1134
Maternal quality of life (SF-36) Physical	53.4 (7.0)	53.2 (6.9)
Maternal quality of life (SF-36) Mental	47.9 (10.4)	48.1 (10.8)

9. Other Pre-specified Outcome

Title	Other Maternal Outcomes
Description	Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months
Time Frame	3 months postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB	delivery by VB or Method of Delivery: CS or VB
Measure Participants	1285	1285
>12 (probable depression)	180 12.9%	190 13.6%
≥10 (possible depression	298 21.4%	306 22%
Experienced any urinary incontinence	145 10.4%	197 14.1%
Problematic urinary incontinence	70 5%	82 5.9%
Experienced faecal incontinence	49 3.5%	48 3.4%
Problematic faecal incontinence	18 1.3%	17 1.2%
Experienced incontinence of flatus	205 14.7%	145 10.4%
Problematic flatal incontinence	62 4.5%	79 5.7%
Breastfed either baby at any time	1084 77.8%	1110 79.7%
Stopped breastfeeding at <15 days	32 2.3%	45 3.2%

10. Other Pre-specified Outcome

Title	Other Maternal Outcomes
Description	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

Outcome Measure Data

Analysis Population Description

Mean and standard deviation on available data

Arm/Group Title	Planned Caesarean Section	Planned Vaginal Birth
Arm/Group Description	delivery by CS Method of Delivery: CS or VB	delivery by VB Method of Delivery: CS or VB
Measure Participants	1285	1285
Maternal quality of life (SF-36) Physical	51.8 (7.1)	51.6 (7.6)
Maternal quality of life (SF-36) Mental	46.7 (10.9)	46.0 (11.3)
Global Fatigue Index score	20.3 (8.8)	20.8 (9.3)
Edinburgh Postnatal Depression Scale	5.7 (5.6)	5.9 (5.7)
Incontinence Impact Questionnaire-7 (IIQ-7)	20.48 (21.41)	20.44 (20.50)

Adverse Events

Adverse Event Reporting Description	Fusion and adverse events were connected and baby. There were no serious adverse Maternal events.
Arm/Group Title	Planned Caesarean Section-Mother		Planned Vaginal Birth-Mother		Planned Caesarean Section-Infants/Fetuses		Planned Vaginal Birth-Infants/Fetuses
Arm/Group Description	delivery by CS or Method of Delivery: CS or VB		delivery by VB or Method of Delivery: CS or VB		delivery by CS or Method of Delivery: CS or VB		delivery by VB or Method of Delivery: CS or VB
All Cause Mortality
	Planned Caesarean Section-Mother		Planned Vaginal Birth-Mother		Planned Caesarean Section-Infants/Fetuses		Planned Vaginal Birth-Infants/Fetuses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1392 (0%)		0/1392 (0%)		24/2783 (0.9%)		17/2782 (0.6%)
Serious Adverse Events
	Planned Caesarean Section-Mother		Planned Vaginal Birth-Mother		Planned Caesarean Section-Infants/Fetuses		Planned Vaginal Birth-Infants/Fetuses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1392 (0%)		0/1392 (0%)		0/2783 (0%)		0/2782 (0%)
Other (Not Including Serious) Adverse Events
	Planned Caesarean Section-Mother		Planned Vaginal Birth-Mother		Planned Caesarean Section-Infants/Fetuses		Planned Vaginal Birth-Infants/Fetuses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1392 (0%)		0/1392 (0%)		0/2783 (0%)		0/2782 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.