Heart; Disease,Complicating Pregnancy, Pre-existingNCT01677364
Elective Induction vs Spontaneous Labour in Patients With Heart Disease
A study testing Oxytocin in people with Heart; Disease,Complicating Pregnancy, Pre-existing, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 19 to 37 years, women only
- Conditions the study is for
- Heart; Disease,Complicating Pregnancy, Pre-existing
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- NYHA class I-II
- cephalic presentation
- singleton gestation
Who cannot join
- previous cesarean section,
- Primary pulmonary hypertension,
- Eisenmenger syndrome,
- Marfan syndrome,
- Left heart obstruction,
- Prior cardiac event or arrhythmia,
Show all 11Show fewer
- Malformed fetus,
- Severe anemia (<7g/dl),
- Intrauterine fetal death,
- other obstetrical indications for induction of labour
- patients on anticoagulation.
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: 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.
Read the 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.
- Being tested
- Oxytocin
- Keywords
- induction of labour, heart disease patients
- Medical subject headings
- Disease, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Arm - Induction of labour
| Study group | Role | What they receive |
|---|---|---|
| induction of labour | Active comparator | 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 Receives: Drug: Oxytocin |
| Spontaneous Labour | No intervention | patients were allowed to go into spontaneous labour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labour
Measured: at the time of delivery
Rate of caesarean section
mode of delivery and rate of caesarean section with indication
Measured: at the time of delivery
Number of patients with delivery during workday hours
Measured: at the time of delivery
Secondary outcomes (2)
number of patients with maternal complications
maternal complications include postpartum hemorrhage, infection, cardiac complications and number of maternal deaths
Measured: day 5
number of patients with adverse neonatal outcome
apgar score number of admissions to neonatal intensive care unit number of neonatal deaths
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Disease,Complicating Pregnancy, Pre-existingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Yogita Dogra, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677364
- Sponsor's protocol ID
- 7862/PG/2Trg/08
- Status last verified
- Aug 2012
- First submitted
- 26 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01677364
- Acronym / sponsor ID
- 7862/PG/2Trg/08
- Keywords
- induction of labour, heart disease patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| induction of labour | Active comparator | Drug: Oxytocindrug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min |
| Spontaneous Labour | No intervention | –patients were allowed to go into spontaneous labour |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- NYHA class I-II
- cephalic presentation
- singleton gestation
Key exclusion criteria (11 listed)
- previous cesarean section,
- Primary pulmonary hypertension,
- Eisenmenger syndrome,
- Marfan syndrome,
- Left heart obstruction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinArm - Induction of labour | Drug | induction of labour |
Primary outcome
Duration of labour
Time frame: 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
Number of patients with delivery during workday hours
Time frame: at the time of delivery
2 secondary outcomes
number of patients with maternal complications
Time frame: day 5
number of patients with adverse neonatal outcome
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Heart; Disease,Complicating Pregnancy, Pre-existing, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of labour (time frame: at the time of delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.