Elective Induction vs Spontaneous Labour in Patients With Heart Disease

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Heart; Disease,Complicating Pregnancy, Pre-existing

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01677364

7862/PG/2Trg/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 19 to 37 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

induction of labour

Active Comparator group

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

Treatment:

Drug: Oxytocin

Spontaneous Labour

No Intervention group

Description:

patients were allowed to go into spontaneous labour