NCT02526459

Brief Summary

The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Oct 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

July 31, 2015

Last Update Submit

September 26, 2019

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Caesarean sections (yes/no variable)

    Was a Caesarean section used to deliver the baby? (yes/no variable abstracted from medical chart)

    4 weeks

Secondary Outcomes (3)

  • neonatal outcome: APGAR<7

    4 weeks

  • neonatal outcome: low birth weight

    4 weeks

  • Childbirth Satisfaction (questionnaire)

    4 weeks

Study Arms (2)

birth plan

EXPERIMENTAL

Use of birth plan

Behavioral: Birth plan

no birth plan

NO INTERVENTION

No use of birth plan

Interventions

Birth planBEHAVIORAL

Patient will receive a birth plan

birth plan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has singleton pregnancy
  • Patient has baby with cephalic presentation
  • Patient is at less than 34 weeks gestation

You may not qualify if:

  • Patient has planned Caesarean section
  • Patient has planned pre-existing birth plan
  • Patient has intrauterine fetal demise
  • Patient having a fetus with congenital anomalies
  • Existence of intrauterine growth restriction
  • Existence of oligohydramnios

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Rashmi Bhargava

Regina, Saskatchewan, S4P 0L9, Canada

Location

Study Officials

  • Rashmi Bhargava, MD

    RQHR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 18, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)