Elective Induction vs Spontaneous Labour in Patients With Heart Disease

Heart; Disease,Complicating Pregnancy, Pre-existing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677364
• Other study ID #: 7862/PG/2Trg/08
• Status: Completed
• Phase: N/A
• First received: August 26, 2012
• Last updated: August 29, 2012
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 37 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart; Disease,Complicating Pregnancy, Pre-existing
• Pregnancy Complications

Intervention

Drug:
• Oxytocin
Arm - Induction of labour

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of labour		at the time of delivery	No
Primary	Rate of caesarean section	mode of delivery and rate of caesarean section with indication	at the time of delivery	Yes
Primary	Number of patients with delivery during workday hours		at the time of delivery	Yes
Secondary	number of patients with maternal complications	maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths	day 5	Yes
Secondary	number of patients with adverse neonatal outcome	apgar score number of admissions to neonatal intensive care unit number of neonatal deaths	day 5	Yes