Elective Induction vs Spontaneous Labour in Patients With Heart Disease

This study has been completed.
Information provided by (Responsible Party):
Dr.Yogita Dogra, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
First received: August 26, 2012
Last updated: August 29, 2012
Last verified: August 2012

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.

Condition Intervention
Heart; Disease,Complicating Pregnancy, Pre-existing
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Duration of labour [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]
  • Rate of caesarean section [ Time Frame: at the time of delivery ] [ Designated as safety issue: Yes ]
    mode of delivery and rate of caesarean section with indication

  • Number of patients with delivery during workday hours [ Time Frame: at the time of delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of patients with maternal complications [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]
    maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths

  • number of patients with adverse neonatal outcome [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]
    apgar score number of admissions to neonatal intensive care unit number of neonatal deaths

Enrollment: 50
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: induction of labour
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
Arm - Induction of labour
No Intervention: Spontaneous Labour
patients were allowed to go into spontaneous labour

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.


Ages Eligible for Study:   19 Years to 37 Years
Genders Eligible for Study:   Female
Accepts 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677364

Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
  More Information

No publications provided

Responsible Party: Dr.Yogita Dogra, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01677364     History of Changes
Other Study ID Numbers: 7862/PG/2Trg/08
Study First Received: August 26, 2012
Last Updated: August 29, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
induction of labour
heart disease patients

Additional relevant MeSH terms:
Heart Diseases
Pregnancy Complications
Cardiovascular Diseases
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014