Elective Induction vs Spontaneous Labour in Patients With Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Conditions
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Heart; Disease,Complicating Pregnancy, Pre-existing

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: induction of labour<br>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 | Drug: Oxytocin<br>* Arm - Induction of labour<br>|
| No Intervention: Spontaneous Labour<br>patients were allowed to go into spontaneous labour | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labour |  | at the time of delivery | 
| Rate of caesarean section | mode of delivery and rate of caesarean section with indication | at the time of delivery | 
| Number of patients with delivery during workday hours |  | at the time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with maternal complications | maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths | day 5 | 
| number of patients with adverse neonatal outcome | apgar score number of admissions to neonatal intensive care unit number of neonatal deaths | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labour, heart disease patients