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Elective Induction vs Spontaneous Labour in Patients With Heart Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01677364
Enrollment
50
Registered
2012-09-03
Start date
2009-07-31
Completion date
2010-12-31
Last updated
2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Disease,Complicating Pregnancy, Pre-existing

Keywords

induction of labour, heart disease patients

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.

Interventions

DRUGOxytocin

Arm - Induction of labour

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 37 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of labourat the time of delivery
Rate of caesarean sectionat the time of deliverymode of delivery and rate of caesarean section with indication
Number of patients with delivery during workday hoursat the time of delivery

Secondary

MeasureTime frameDescription
number of patients with adverse neonatal outcomeday 5apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
number of patients with maternal complicationsday 5maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026