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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN74420086 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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)?
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caesarean Section | Other | delivery by CS |
|
| Vaginal Birth | Other | delivery by VB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Method of Delivery | Procedure | CS or VB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity. | until 28 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Morbidity | Neonatal morbidity, excluding death of either twin | until 28 days after delivery |
| Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics - Gestational Age at Randomization | Basline | |
| Baseline Characteristics - Estimated Fetal Weight | Basline | |
| Other Maternal Outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon F Barrett | SHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Data Coordinating Centre/SHSC | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24088091 | Background | 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. | |
| 35398584 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caesarean Section | delivery by caesarean section Method of Delivery: CS or VB |
| FG001 | Vaginal Birth | delivery by vaginal birth Method of Delivery: CS or VB |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mothers |
| ||||||||||||||||
| Fetuses or Infants |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caesarean Section | delivery by caesarean section Method of Delivery: CS or VB |
| BG001 | Vaginal Birth | delivery by vaginal birth Method of Delivery: CS or VB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity. | number of fetuses/infants | Posted | Count of Participants | Participants | until 28 days after delivery |
|
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Fusion and adverse events were connected and baby. There were no serious adverse Maternal events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Planned Caesarean Section-Mother | delivery by CS or Method of Delivery: CS or VB |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jon Barrett | Sunnybrook Health Sciences Center | jon.barrett@sunnybrook.ca |
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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.
| 2 years |
| 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 | 2 years postpartum |
Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum |
| 2 years postpartum |
| 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); | 2 year postpartum |
| Other Maternal Outcomes | Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months | 3 months postpartum |
| 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). | 3 months postpartum |
| Hochler H, Tevet A, Barg M, Suissa-Cohen Y, Lipschuetz M, Yagel S, Aviram A, Mei-Dan E, Melamed N, Barrett JFR, Fox NS, Walfisch A. Trial of labor of vertex-nonvertex twins following a previous cesarean delivery. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100640. doi: 10.1016/j.ajogmf.2022.100640. Epub 2022 Apr 8. |
| 33203367 | Derived | Dougan C, Gotha L, Melamed N, Aviram A, Asztalos EV, Anabusi S, Willan AR, Barrett J, Mei-Dan E. Cesarean delivery or induction of labor in pre-labor twin gestations: a secondary analysis of the twin birth study. BMC Pregnancy Childbirth. 2020 Nov 17;20(1):702. doi: 10.1186/s12884-020-03369-x. |
| 32592694 | Derived | Aviram A, Lipworth H, Asztalos EV, Mei-Dan E, Melamed N, Cao X, Zaltz A, Hvidman L, Barrett JFR. Delivery of monochorionic twins: lessons learned from the Twin Birth Study. Am J Obstet Gynecol. 2020 Dec;223(6):916.e1-916.e9. doi: 10.1016/j.ajog.2020.06.048. Epub 2020 Jun 24. |
| 31254526 | Derived | Aviram A, Lipworth H, Asztalos EV, Mei-Dan E, Cao X, Melamed N, Zaltz A, Anastasio HB, Berghella V, Barrett JFR. The worst of both worlds-combined deliveries in twin gestations: a subanalysis of the Twin Birth Study, a randomized, controlled, prospective study. Am J Obstet Gynecol. 2019 Oct;221(4):353.e1-353.e7. doi: 10.1016/j.ajog.2019.06.047. Epub 2019 Jun 27. |
| 28061767 | Derived | Mei-Dan E, Asztalos EV, Willan AR, Barrett JF. The effect of induction method in twin pregnancies: a secondary analysis for the twin birth study. BMC Pregnancy Childbirth. 2017 Jan 6;17(1):9. doi: 10.1186/s12884-016-1201-8. |
| 26551181 | Derived | Melamed N, Wong J, Asztalos E, Rosen H, Okby R, Barrett J. The Likelihood of Change in Fetal Presentation During the Third Trimester in Twin Pregnancies. Obstet Gynecol. 2015 Dec;126(6):1231-1236. doi: 10.1097/AOG.0000000000001128. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Parity >= 1 | Count of Participants | Participants |
|
| Previous cesarean section | Count of Participants | Participants |
|
| Gestational age at randomization | Count of Participants | Participants |
|
| Chorionicity at birth | Chorionicity was determined by means of ultrasonography | Count of Participants | Participants |
|
| Not in labor at randomization | Data was missing from one woman in the planned cesarean delivery | Count of Participants | Participants |
|
| Membranes ruptured at randomization | Count of Participants | Participants |
|
| National perinatal mortality in mother's country of residence | Countries included in the study that had fewer than 15 deaths per 1000 births were Australia, Belgium, Canada, Chile, Croatia, Estonia, Germany, Greece, Hungary, Israel, the Netherlands, Oman, Poland, Qatar, Romania, Serbia, Spain, the United Kingdom, the United States, and Uruguay; those with 15 to 20 deaths per 1000 births were Argentina, Brazil, and Jamaica; and those with more than 20 deaths per 1000 births were Egypt and Jordan. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Neonatal Morbidity | Neonatal morbidity, excluding death of either twin | Posted | Count of Participants | Participants | until 28 days after delivery |
|
|
|
| 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. | Neurodevelopmental outcomes of children at 2 years of age (based on available two year data of the children). | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 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 | Posted | Count of Participants | Participants | 2 years postpartum |
|
|
|
| Other Pre-specified | Baseline Characteristics - Gestational Age at Randomization | Posted | Mean | Standard Deviation | weeks | Basline |
|
|
|
| Other Pre-specified | Baseline Characteristics - Estimated Fetal Weight | 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) | Posted | Mean | Standard Deviation | grams | Basline |
|
|
|
| Other Pre-specified | Other Maternal Outcomes | Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum | Available data | Posted | Count of Participants | Participants | 2 years postpartum |
|
|
|
| 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); | Mean and standard deviation on available data. This is based on available maternal data at 2 years postpartum. | Posted | Mean | Standard Deviation | score on a scale | 2 year postpartum |
|
|
|
| Other Pre-specified | Other Maternal Outcomes | Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months | Posted | Count of Participants | Participants | 3 months postpartum |
|
|
|
| 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). | Mean and standard deviation on available data | Posted | Mean | Standard Deviation | units on a scale | 3 months postpartum |
|
|
|
| 0 |
| 1,392 |
| 0 |
| 1,392 |
| 0 |
| 1,392 |
| EG001 | Planned Vaginal Birth-Mother | delivery by VB or Method of Delivery: CS or VB | 0 | 1,392 | 0 | 1,392 | 0 | 1,392 |
| EG002 | Planned Caesarean Section-Infants/Fetuses | delivery by CS or Method of Delivery: CS or VB | 24 | 2,783 | 0 | 2,783 | 0 | 2,783 |
| EG003 | Planned Vaginal Birth-Infants/Fetuses | delivery by VB or Method of Delivery: CS or VB | 17 | 2,782 | 0 | 2,782 | 0 | 2,782 |
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| Facial-nerve injury at 72 hr of age or discharge |
|
| Intracerebral hemmorrhage |
|
| Apgar score at 5 minutes less than 4 |
|
| Coma |
|
| Stupor or decreased response to pain |
|
| Hyperalert, drowsy, or lethargic |
|
| ≥2 seizures within 72 hr after birth |
|
| Assisted ventilation for ≥24 hr by means of endotr |
|
| Neonatal sepsis within 72 hours after birth |
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| Meningitis within 72 hours after birth |
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| Necrotizing enterocolitis |
|
| Broncho-pulmonary dysplasia (BPD) |
|
| Grade 3 or 4 intraventricular hemorrhage |
|
| Cystic periventricular leukomalacia |
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| Death up to follow-up |
|
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| Neurodevelopmental delay |
|
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| Cerebral palsy |
|
|
| Motor delay |
|
|
| Cognitive delay |
|
|
| Fecal incontinence |
|
| Problematic faecal incontinence |
|
| Flatal incontinence |
|
| Problematic flatal incontinence |
|
| Second Twin |
|
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| Continuing breast feeding |
|
|
| Experienced any urinary incontinence |
|
| Problematic urinary incontinence |
|
| Experienced faecal incontinence |
|
| Problematic faecal incontinence |
|
| Experienced incontinence of flatus |
|
| Problematic flatal incontinence |
|
| Breastfed either baby at any time |
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| Stopped breastfeeding at <15 days |
|
| Maternal quality of life (SF-36) Mental |
|
|
| Global Fatigue Index score |
|
|
| Edinburgh Postnatal Depression Scale |
|
|
| Incontinence Impact Questionnaire-7 (IIQ-7) |
|
|