Clinical trial NCT00187369: The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Twin Pregnancy
Keywords: twins
twin births
multiples
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 2804
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)?

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?

Eligibility 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

Primary outcomes:
measure: Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
timeFrame: until 28 days after delivery
Secondary outcomes:
measure: Neonatal Morbidity
timeFrame: until 28 days after delivery
measure: Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
timeFrame: 2 years
measure: Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
timeFrame: 2 years postpartum
Other outcomes:
measure: Baseline Characteristics - Gestational Age at Randomization
timeFrame: Basline
measure: Baseline Characteristics - Estimated Fetal Weight
timeFrame: Basline
measure: Other Maternal Outcomes
timeFrame: 2 years postpartum
measure: Other Maternal Outcomes
timeFrame: 2 year postpartum
measure: Other Maternal Outcomes
timeFrame: 3 months postpartum
measure: Other Maternal Outcomes
timeFrame: 3 months postpartum
Locations:
city: Toronto
country: Canada
facility: Data Coordinating Centre/SHSC
state: Ontario
Study officials:
affiliation: SHSC
name: Jon F Barrett
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.