Elective Induction vs Spontaneous Labour in Patients With Heart Disease

August 29, 2012 updated by: Dr.Yogita Dogra, Postgraduate Institute of Medical Education and Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of labour
Time Frame: at the time of delivery
at the time of delivery
Rate of caesarean section
Time Frame: at the time of delivery
mode of delivery and rate of caesarean section with indication
at the time of delivery
Number of patients with delivery during workday hours
Time Frame: at the time of delivery
at the time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with maternal complications
Time Frame: day 5
maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
day 5
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
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 26, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7862/PG/2Trg/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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