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

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ClinicalTrials.gov Identifier: NCT00187369
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 4, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr Jon Barrett, Sunnybrook Health Sciences Centre

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 Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
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 : December 2003
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Caesarean Section
delivery by CS
Procedure: Method of Delivery
CS or VB

Vaginal Birth
delivery by VB
Procedure: Method of Delivery
CS or VB




Primary Outcome Measures :
  1. Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Basline ]
  2. Baseline Characteristics - Estimated Fetal Weight [ Time Frame: Basline ]
  3. Other Maternal Outcomes [ Time Frame: 2 years postpartum ]
    Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum

  4. Other Maternal Outcomes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187369


Locations
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Canada, Ontario
Data Coordinating Centre/SHSC
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Jon F Barrett SHSC
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 16, 2005    Key Record Dates
Results First Posted: May 4, 2020
Last Update Posted: May 13, 2020
Last Verified: May 2020
Keywords provided by Dr Jon Barrett, Sunnybrook Health Sciences Centre:
twins
twin births
multiples