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Completed

NCT Number: NCT00187369

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

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)?

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Key information

Conditions

Twin Pregnancy

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Data Coordinating Centre/SHSC

Toronto, Ontario, M4N 3M5, Canada

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women at 32 0/7 - 38 6/7 weeks gestation
  • Estimated fetal weight of each fetus 1500 - 4000 g
  • Both twins alive at time of randomization
  • Twin A is in cephalic position

Exclusion criteria

  • Monoamniotic twins
  • Lethal fetal anomaly of either fetus
  • Contraindication to labour or vaginal delivery for either twin
  • Previous participation in the Twin Birth Study

Treatment and study plan

Method of Delivery

Procedure

CS or VB

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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