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Elective Induction vs Spontaneous Labour in Patients With Heart Disease

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ClinicalTrials.gov Identifier: NCT01677364
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Dr.Yogita Dogra, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Heart; Disease,Complicating Pregnancy, Pre-existing Drug: Oxytocin Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Duration of labour [ Time Frame: at the time of delivery ]
  2. Rate of caesarean section [ Time Frame: at the time of delivery ]
    mode of delivery and rate of caesarean section with indication

  3. Number of patients with delivery during workday hours [ Time Frame: at the time of delivery ]

Secondary Outcome Measures :
  1. number of patients with maternal complications [ Time Frame: day 5 ]
    maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths

  2. number of patients with adverse neonatal outcome [ Time Frame: day 5 ]
    apgar score number of admissions to neonatal intensive care unit number of neonatal deaths



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Ages Eligible for Study:   19 Years to 37 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677364


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

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
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Dr.Yogita Dogra, 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