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Elective Induction vs Spontaneous Labour in Patients With Heart Disease

NCT ID: NCT01677364

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart; Disease,Complicating Pregnancy, Pre-existing

Keywords

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induction of labour heart disease patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Arm - Induction of labour

Spontaneous Labour

patients were allowed to go into spontaneous labour

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxytocin

Arm - Induction of labour

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr.Yogita Dogra

Dr.Yogita Dogra

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status

Countries

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India

Other Identifiers

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7862/PG/2Trg/08

Identifier Type: -

Identifier Source: org_study_id