Elective Induction vs Spontaneous Labour in Patients With Heart Disease

Not Applicable

Completed

• Conditions: Heart; Disease,Complicating Pregnancy, Pre-existing
• Interventions: Drug: Oxytocin

• Registration Number: NCT01677364
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-26
• Study First Submitted QC: 2012-08-29
• Last Update Submitted: 2012-08-29
• Study First Posted: 2012-09-03
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
induction of labour	Oxytocin	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

Primary Outcome Measures

Name	Time	Method
Duration of labour	at the time of delivery
Rate of caesarean section	at the time of delivery	mode of delivery and rate of caesarean section with indication
Number of patients with delivery during workday hours	at the time of delivery

Secondary Outcome Measures

Name	Time	Method
number of patients with maternal complications	day 5	maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
number of patients with adverse neonatal outcome	day 5	apgar score number of admissions to neonatal intensive care unit number of neonatal deaths

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India