Rheumatic; Heart Disease, Maternal, Affecting FetusNCT03029117
Effect of Rheumatic Heart Disease on Maternal and Fetal Outcomes
An observational study of Rheumatic; Heart Disease, Maternal, Affecting Fetus, run by Assiut University.
Trial summary
It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females between corrected and uncorrected rheumatic valve lesions Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rheumatic; Heart Disease, Maternal, Affecting Fetus
- What is being tested?
- correction of rheumatic valve lesions
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Dec 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: pregnant females with rheumatic heart disease come for antenatal care at out patient clinic at tertiary obstetric center
Who may be able to join
- pregnant females with rheumatic heart disease
Who cannot join
- other heart diseases ( cardiomyopathy , myocardial infarction ...etc.
About this study
Official title: Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes
It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females between corrected and uncorrected rheumatic valve lesions
Read the detailed description
Heart disease is one of the most important medical complications during pregnancy as it is one of the common, indirect obstetric causes of maternal death. Approximately 1% of pregnancies are complicated by cardiac disease .
Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a chronic acquired heart disorder resulting from acute rheumatic fever. In developing countries, RHD continues to be a major cause of cardiac morbidity and mortality especially among young adult females In pregnancies complicated with cardiac disorders, maternal and perinatal mortality and morbidity depend on the type of disorder, the functional status of the patient and the complications associated with the pregnancy.
Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease, remains the most common acquired valvular lesion in pregnant women and the most common cause of maternal death from cardiac causes .
Although mortality is not high in women, the rate of fetal morbidity rises with the severity of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area <1.5 CM2).
In the second and third trimesters, when maternal blood volume and cardiac output peak, heart failure may occur in pregnant women with moderate or severe mitral stenosis, even in previously asymptomatic women .
The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%, fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).
The advancement in cardiology and obstetrics has provided major improvements in the management of pregnant patients with cardiac disorders. Now we are facing more women with previous history of surgical correction of rheumatic heart disease.
Vaginal delivery is considered In women with mild mitral stenosis, and in patients with moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class III-IV symptoms, or who have pulmonary hypertension despite medical therapy.
Therapeutic options for in women with rheumatic heart disease include both medical and surgical alternatives, as well as catheter-based interventions The choice dependent on the degree of valvular affection and patient symptoms. There are few studies that compare the Maternal and fetal outcomes in women with rheumatic heart disease between patient with corrected and uncorrected valve lesions
- Being tested
- correction of rheumatic valve lesions
- Keywords
- rheumatic pregnancy
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correction of rheumatic valve lesionsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| corrected and uncorrected rheumatic valve lesions | Not described Receives: Procedure: correction of rheumatic valve lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal morbidity
compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women
Measured: 40 days after delivery
Secondary outcomes (1)
Fetal outcome
compare birth weight and need for admission at neonatal intensive care unit (NICU) between corrected and uncorrected valve lesions in pregnant women
Measured: first 1 day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Feb 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic; Heart Disease, Maternal, Affecting FetusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armia Michael, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029117
- Sponsor's protocol ID
- 12345
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT03029117
- Acronym / sponsor ID
- 12345
- Keywords
- rheumatic pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 24 Jan 2017 (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.
It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females between corrected and uncorrected rheumatic valve lesions
Detailed description
Heart disease is one of the most important medical complications during pregnancy as it is one of the common, indirect obstetric causes of maternal death. Approximately 1% of pregnancies are complicated by cardiac disease .
Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a chronic acquired heart disorder resulting from acute rheumatic fever. In developing countries, RHD continues to be a major cause of cardiac morbidity and mortality especially among young adult females In pregnancies complicated with cardiac disorders, maternal and perinatal mortality and morbidity depend on the type of disorder, the functional status of the patient and the complications associated with the pregnancy.
Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease, remains the most common acquired valvular lesion in pregnant women and the most common cause of maternal death from cardiac causes .
Although mortality is not high in women, the rate of fetal morbidity rises with the severity of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area <1.5 CM2).
In the second and third trimesters, when maternal blood volume and cardiac output peak, heart failure may occur in pregnant women with moderate or severe mitral stenosis, even in previously asymptomatic women .
The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%, fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).
The advancement in cardiology and obstetrics has provided major improvements in the management of pregnant patients with cardiac disorders. Now we are facing more women with previous history of surgical correction of rheumatic heart disease.
Vaginal delivery is considered In women with mild mitral stenosis, and in patients with moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class III-IV symptoms, or who have pulmonary hypertension despite medical therapy.
Therapeutic options for in women with rheumatic heart disease include both medical and surgical alternatives, as well as catheter-based interventions The choice dependent on the degree of valvular affection and patient symptoms. There are few studies that compare the Maternal and fetal outcomes in women with rheumatic heart disease between patient with corrected and uncorrected valve lesions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| corrected and uncorrected rheumatic valve lesions | – | Procedure: correction of rheumatic valve lesions |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant females with rheumatic heart disease come for antenatal care at out patient clinic at tertiary obstetric center
Key inclusion criteria (1 listed)
- pregnant females with rheumatic heart disease
Key exclusion criteria (1 listed)
- other heart diseases ( cardiomyopathy , myocardial infarction ...etc.
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 |
|---|---|---|
| correction of rheumatic valve lesions | Procedure or surgery | corrected and uncorrected rheumatic valve lesions |
Primary outcome
maternal morbidity
Time frame: 40 days after delivery
compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women
1 secondary outcome
Fetal outcome
Time frame: first 1 day after delivery
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 26 Jan 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic; Heart Disease, Maternal, Affecting Fetus, run by Assiut University.
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 1 inclusion and 1 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
maternal morbidity (time frame: 40 days after delivery). 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 26 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.