Severe OligohydramniosPhase 1NCT01258725
Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion
A Phase 1 study testing amnioinfusion procedure in people with Severe Oligohydramnios, run by Szeged University at 1 site in Hungary.
Trial summary
The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Severe Oligohydramnios
- What is being tested?
- amnioinfusion procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients above 18 years, who are able to consent;
- Singleton pregnancy;
- Normal structural examination between 16 and 20 weeks of gestation;
- Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week);
- At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios;
- Follow up ultrasound examinations weekly in both groups.
Who cannot join
- 1. pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38°C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation.
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Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Szeged, Department of Obstetrics and Gynecology
Szeged, H-6725
János Sikovanyecz, M.D., Ph.D., +3662545757, sikovanyecz@freemail.hu
About this study
Official title: Alterations of the Uteroplacental and Fetal Pulmonary Circulation in Patients With Severe Idiopathic Oligohydramnios Following Amnioinfusion Therapy in a Longitudinal Study
The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.
Read the detailed description
Severe oligohydramnios (AFI<5) is an uncommon complication of pregnancy and it is often associated with Preterm Premature Rupture of the Membranes (pPROM) or with the lethal congenital abnormality. However, in very few cases it is idiopathic (with no obvious etiopathology) and in the prevention of fetal complication (e.g. pulmonary hypoplasia) the amnioinfusion is a treatment option for the persisting oligohydramnios.
Severe oligohydramnios for >14 days had a predicted mortality rate >90%. Although severe oligohydramnios and pPROM may lead to pulmonary hypoplasia, all of these three factors are independent predictors of pulmonary hypertension. It is obvious that there are some alterations in the fetal pulmonary circulation in cases of severe oligohydramnios.
The preliminary study shows that single/serial amnioinfusion has some beneficial effects on the outcome of the pregnancies complicated with severe idiopathic oligohydramnios: to prolong the gestation, to reduce the number of premature labor and to prevent the adverse neonatal outcome.
The investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions and in matched controls (matched in gestational age, parity and gravidity, AFI>8). The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again.
Inclusion criteria: Single pregnancy, severe (AFI<4 cm), idiopathic oligohydramnios between the 18 and 34 weeks of gestation. The study is open and will be run by a single ultrasonographer to avoid interobserver bias, and with a set of minimal number of outcome measures recorded. Primary outcome: Doppler waveforms of the uteroplacental and fetal pulmonary circulation.
Alterations in Doppler indices of the Ductus venosus, arteria umbilicalis, arteria uterina, left and right arterial pulmonary branches: (1) systolic/diastolic ratio (S/D), (2) peak systolic velocity; (3) time-averaged velocity; (4) maximum forward velocity during atrial contraction; (5) pulsatility index (PI); (6) Pourcelot's resistance index (RI).
The pulsed Doppler measurements of the arterial pulmonary branches will be carried out from a transverse cross-section of the fetal chest at the level of the cardiac 4-chamber view after visualization with color Doppler. Depending on fetal position, the right or left lung will be examined. Doppler waveforms (sample volume: 0.1-0.3 cm) will be first obtained from the most proximal branch of the pulmonary artery, then in the middle lung region at equal distance from the outer border of the heart and the inner thoracic wall and subsequently in the distal lung region as close as possible to the fetal inner thoracic wall.
Secondary outcomes: Alterations of the Doppler waveforms during the progress of the pregnancy.
- Conditions
- Severe Oligohydramnios
- Being tested
- amnioinfusion procedure
- Keywords
- amnioinfusion, severe idiopahic oligohydramnios
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amnioinfusion procedureProcedure or surgery
Also called restoring amniotic fluid volume with intraamniotic transfusion of saline infusion
Single/serial amnioinfusions aimed at restoring amniotic fluid volume until a normal amount (AFI≥8cm).(Every pregnant women presenting with severe (AFI<5) idiopathic (with unknown origin) oligohydramnios is treated with amnioinfusion at our Dept.)
| Study group | Role | What they receive |
|---|---|---|
| amnioinfusion | Experimental | The investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions. The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again Receives: Procedure: amnioinfusion procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler waveforms of the uteroplacental and fetal pulmonary circulation following amnioinfusion
Measured: reaching 34 weeks of gestation
Secondary outcomes (1)
Alterations of the Doppler waveforms during the progress of the pregnancy following amnioinfusion
Measured: reaching 34 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe OligohydramniosStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Investigators
- János Sikovanyecz, M.D., Ph.D., Principal investigator, University of Szeged, Department of Obstetrics and GynecologyZoltan Kozinszky, M.D., Ph.D., Study director, Department of Obstetrics and Gynecology, University of Szeged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258725
- Sponsor's protocol ID
- Amnioinfusioncirculation
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of the Uteroplacental and Fetal Pulmonary Circulation in Patients With Severe Idiopathic Oligohydramnios Following Amnioinfusion Therapy in a Longitudinal Study
- ClinicalTrials.gov ID
- NCT01258725
- Acronym / sponsor ID
- Amnioinfusioncirculation
- Conditions
- Severe Oligohydramnios
- Keywords
- amnioinfusion, severe idiopahic oligohydramnios
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Dec 2010 (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.
The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.
Detailed description
Severe oligohydramnios (AFI<5) is an uncommon complication of pregnancy and it is often associated with Preterm Premature Rupture of the Membranes (pPROM) or with the lethal congenital abnormality. However, in very few cases it is idiopathic (with no obvious etiopathology) and in the prevention of fetal complication (e.g. pulmonary hypoplasia) the amnioinfusion is a treatment option for the persisting oligohydramnios.
Severe oligohydramnios for >14 days had a predicted mortality rate >90%. Although severe oligohydramnios and pPROM may lead to pulmonary hypoplasia, all of these three factors are independent predictors of pulmonary hypertension. It is obvious that there are some alterations in the fetal pulmonary circulation in cases of severe oligohydramnios.
The preliminary study shows that single/serial amnioinfusion has some beneficial effects on the outcome of the pregnancies complicated with severe idiopathic oligohydramnios: to prolong the gestation, to reduce the number of premature labor and to prevent the adverse neonatal outcome.
The investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions and in matched controls (matched in gestational age, parity and gravidity, AFI>8). The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again.
Inclusion criteria: Single pregnancy, severe (AFI<4 cm), idiopathic oligohydramnios between the 18 and 34 weeks of gestation. The study is open and will be run by a single ultrasonographer to avoid interobserver bias, and with a set of minimal number of outcome measures recorded. Primary outcome: Doppler waveforms of the uteroplacental and fetal pulmonary circulation.
Alterations in Doppler indices of the Ductus venosus, arteria umbilicalis, arteria uterina, left and right arterial pulmonary branches: (1) systolic/diastolic ratio (S/D), (2) peak systolic velocity; (3) time-averaged velocity; (4) maximum forward velocity during atrial contraction; (5) pulsatility index (PI); (6) Pourcelot's resistance index (RI).
The pulsed Doppler measurements of the arterial pulmonary branches will be carried out from a transverse cross-section of the fetal chest at the level of the cardiac 4-chamber view after visualization with color Doppler. Depending on fetal position, the right or left lung will be examined. Doppler waveforms (sample volume: 0.1-0.3 cm) will be first obtained from the most proximal branch of the pulmonary artery, then in the middle lung region at equal distance from the outer border of the heart and the inner thoracic wall and subsequently in the distal lung region as close as possible to the fetal inner thoracic wall.
Secondary outcomes: Alterations of the Doppler waveforms during the progress of the pregnancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amnioinfusion | Experimental | Procedure: amnioinfusion procedureThe investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions. The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients above 18 years, who are able to consent;
- Singleton pregnancy;
- Normal structural examination between 16 and 20 weeks of gestation;
- Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week);
- At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios;
Key exclusion criteria (2 listed)
- 1. pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38°C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation.
- -
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 |
|---|---|---|
| amnioinfusion procedureAlso: restoring amniotic fluid volume with intraamniotic transfusion of saline infusionSingle/serial amnioinfusions aimed at restoring amniotic fluid volume until a normal amount (AFI≥8cm).(Every pregnant women presenting with severe (AFI<5) idiopathic (with unknown origin) oligohydramnios is treated with amnioinfusion at our Dept.) | Procedure or surgery | amnioinfusion |
Primary outcome
Doppler waveforms of the uteroplacental and fetal pulmonary circulation following amnioinfusion
Time frame: reaching 34 weeks of gestation
1 secondary outcome
Alterations of the Doppler waveforms during the progress of the pregnancy following amnioinfusion
Time frame: reaching 34 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
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.
University of Szeged, Department of Obstetrics and Gynecology
Szeged, Hungary
János Sikovanyecz, M.D., Ph.D. principal investigator
University of Szeged, Department of Obstetrics and Gynecology
Zoltan Kozinszky, M.D., Ph.D. study director
Department of Obstetrics and Gynecology, University of Szeged
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing amnioinfusion procedure in people with Severe Oligohydramnios, run by Szeged University at 1 site in Hungary.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2010. 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 Hungary. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler waveforms of the uteroplacental and fetal pulmonary circulation following amnioinfusion (time frame: reaching 34 weeks of gestation). 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 13 Dec 2010.