NCT00517140

Brief Summary

The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

First QC Date

August 15, 2007

Last Update Submit

June 14, 2011

Conditions

Keywords

Pregnancy women with a scarred uterus due to previous caesarean section

Outcome Measures

Primary Outcomes (1)

  • pscyiatric morbidity

    after delivery

Secondary Outcomes (1)

  • Psychosocial function

    3 and 6 months after delivery

Interventions

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women who:
  • Have one prior caesarean section
  • No prior vaginal delivery and
  • Agree for either vaginal delivery or elective caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology, Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Uterine Rupture

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor ComplicationsPregnancy ComplicationsGenital DiseasesRuptureWounds and Injuries

Study Officials

  • Tze Kin Lau, Prof

    Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 16, 2007

Study Start

September 1, 2003

Study Completion

April 1, 2007

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations