Elective Induction vs Spontaneous Labour in Patients With Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Yogita Dogra, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01677364
First received: August 26, 2012
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01677364

Locations
India
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
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014