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

Twin Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187369
• Other study ID #: MCT-63164
• Secondary ID: ISRCTN74420086
• Status: Completed
• Phase: N/A
• Start date: December 2003
• Est. completion date: October 2011

Study information

• Verified date: May 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2804
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Twin Pregnancy

Intervention

Procedure:
• Method of Delivery
CS or VB

Locations

Country	Name	City	State
Canada	Data Coordinating Centre/SHSC	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline Characteristics - Gestational Age at Randomization		Basline
Other	Baseline Characteristics - Estimated Fetal Weight		Basline
Other	Other Maternal Outcomes	Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum	2 years postpartum
Other	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	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	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
Primary	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
Secondary	Neonatal Morbidity	Neonatal morbidity, excluding death of either twin	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.	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	2 years postpartum

External Links

•   Twin Birth Study website