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Completed

NCT Number: NCT01677364

Elective Induction vs Spontaneous Labour in Patients With Heart Disease

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.

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Key information

Conditions

Heart; Disease,Complicating Pregnancy, Pre-existing Disease Female Urogenital Diseases and Pregnancy Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

19 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

Arm - Induction of labour

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2012
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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