Back to resultsElective Induction vs Spontaneous Labour in Patients With Heart Disease
Primary Purpose
Heart; Disease,Complicating Pregnancy, Pre-existing
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Heart; Disease,Complicating Pregnancy, Pre-existing focused on measuring induction of labour, heart disease patients
Eligibility Criteria
Inclusion Criteria:
- NYHA class I-II
- cephalic presentation
- singleton gestation
Exclusion Criteria:
- previous cesarean section,
- Primary pulmonary hypertension,
- Eisenmenger syndrome,
- Marfan syndrome,
- Left heart obstruction,
- Prior cardiac event or arrhythmia,
- Malformed fetus,
- Severe anemia (<7g/dl),
- Intrauterine fetal death,
- other obstetrical indications for induction of labour
- patients on anticoagulation.
Sites / Locations
- Post Graduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
induction of labour
Spontaneous Labour
Arm Description
drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min
patients were allowed to go into spontaneous labour
Outcomes
Primary Outcome Measures
Duration of labour
Rate of caesarean section
mode of delivery and rate of caesarean section with indication
Number of patients with delivery during workday hours
Secondary Outcome Measures
number of patients with maternal complications
maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
number of patients with adverse neonatal outcome
apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
Full Information
NCT ID
NCT01677364
First Posted
August 26, 2012
Last Updated
August 29, 2012
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01677364
Brief Title
Elective Induction vs Spontaneous Labour in Patients With Heart Disease
Official Title
ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
5. Study Description
Brief Summary
Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were randomised into elective induction and spontaneous labour groups only after bishop score was equal to or more than 6.It was concluded that induction of labour with oxytocin is a relatively safe procedure in women with low risk heart disease with NYHA class I and II. It resulted in a similar caesarean delivery rate and was not associated with more maternal and neonatal complications.
Detailed Description
Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml normal saline was prepared and given through infusion pump at initial rate of 3mU/min. Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were established.
Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given intravenously for pain relief.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Disease,Complicating Pregnancy, Pre-existing
Keywords
induction of labour, heart disease patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
induction of labour
Arm Type
Active Comparator
Arm Description
drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min
Arm Title
Spontaneous Labour
Arm Type
No Intervention
Arm Description
patients were allowed to go into spontaneous labour
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Arm - Induction of labour
Primary Outcome Measure Information:
Title
Duration of labour
Time Frame
at the time of delivery
Title
Rate of caesarean section
Description
mode of delivery and rate of caesarean section with indication
Time Frame
at the time of delivery
Title
Number of patients with delivery during workday hours
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
number of patients with maternal complications
Description
maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
Time Frame
day 5
Title
number of patients with adverse neonatal outcome
Description
apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
Time Frame
day 5
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NYHA class I-II
cephalic presentation
singleton gestation
Exclusion Criteria:
previous cesarean section,
Primary pulmonary hypertension,
Eisenmenger syndrome,
Marfan syndrome,
Left heart obstruction,
Prior cardiac event or arrhythmia,
Malformed fetus,
Severe anemia (<7g/dl),
Intrauterine fetal death,
other obstetrical indications for induction of labour
patients on anticoagulation.
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
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Elective Induction vs Spontaneous Labour in Patients With Heart Disease
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