OligohydramniosPhase 3NCT00787163
Amnioinfusion Initiative
A Phase 3 study testing amnioinfusion in people with Oligohydramnios, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The aim of this study is to compare perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Oligohydramnios
- What is being tested?
- amnioinfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Dec 2013
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients above 18 years, who are able to consent, with
- Singleton pregnancy
- with a normal structural examination as much as possible;
- At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios
- Follow up ultrasound examinations weekly in the treatment group
- Acceptance of randomisation and to comply with the protocol
Who cannot join
- Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful;
- Preterm labour defined as contractions >6/hour associated with cervical changes, cervix shortened (<15 mm at randomization),
- Cervical cerclage in place
- Chorioamnionitis, defined as 2 or more of the following: maternal temperature>38 degrees, foul-smelling vaginal discharge, uterine tenderness, fetal tachycardia>170 bpm, white blood cell count >18,000
- Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes
- Previous invasive procedure in this index pregnancy
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- Fetal condition mandating immediate delivery
- Severe bleeding
- Maternal HIV and HCV infection
- Multiple gestation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Milano Bicocca, Ospedale san Gerardo Monza
Monza, Milano, 20052
Anna Locatelli, MD, +390392334720, anna.locatelli@unimib.it
About this study
Official title: Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios
The aim of this study is to compare perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.
Read the detailed description
Early spontaneous Preterm Premature Rupture of Membranes (PPROM) is associated with high perinatal mortality. Due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when PPROM occurs prior to 24 weeks. When oligohydramnios persists, it may raise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%.
We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Inclusion criteria: Single pregnancy, early spontaneous PPROM < 24.3 weeks, oligohydramnios (deepest vertical pocket < 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.
- Conditions
- Oligohydramnios
- Being tested
- amnioinfusion
- Keywords
- pPROM, oligohydramnios, amnioinfusion, prematurity, Early premature rupture of membranes in pregnancy
- Medical subject headings
- Oligohydramnios, Preterm Premature Rupture of the Membranes, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amnioinfusionProcedure or surgery
serial amnioinfusions aimed at restoring amniotic fluid volume
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | amnioinfusion Receives: Procedure: amnioinfusion |
| 2 | No intervention | expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management
Measured: discharge of every neonate from NICU
Secondary outcomes (1)
Gestational age of delivery (main secondary outcome)
Measured: time of delivery for every case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Milan, Catholic University, Italy
- Investigators
- Anna Locatelli, MD, Principal investigator, University of Milano BicoccaPatrizia Vergani, MD, Study chair, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787163
- Sponsor's protocol ID
- Amnioinfusion-001
- Status last verified
- Nov 2008
- First submitted
- 6 Nov 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios
- ClinicalTrials.gov ID
- NCT00787163
- Acronym / sponsor ID
- Amnioinfusion-001
- Conditions
- Oligohydramnios
- Keywords
- pPROM, oligohydramnios, amnioinfusion, prematurity, Early premature rupture of membranes in pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- KU Leuven, University of Milan, Catholic University, Italy
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Nov 2008 (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 perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.
Detailed description
Early spontaneous Preterm Premature Rupture of Membranes (PPROM) is associated with high perinatal mortality. Due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when PPROM occurs prior to 24 weeks. When oligohydramnios persists, it may raise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%.
We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Inclusion criteria: Single pregnancy, early spontaneous PPROM < 24.3 weeks, oligohydramnios (deepest vertical pocket < 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: amnioinfusionamnioinfusion |
| 2 | No intervention | –expectant management |
Who may qualify
- Ages
- 18 to 45 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, with
- Singleton pregnancy
- with a normal structural examination as much as possible;
- At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios
- Follow up ultrasound examinations weekly in the treatment group
Key exclusion criteria (10 listed)
- Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful;
- Preterm labour defined as contractions >6/hour associated with cervical changes, cervix shortened (<15 mm at randomization),
- Cervical cerclage in place
- Chorioamnionitis, defined as 2 or more of the following: maternal temperature>38 degrees, foul-smelling vaginal discharge, uterine tenderness, fetal tachycardia>170 bpm, white blood cell count >18,000
- Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes
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 |
|---|---|---|
| amnioinfusionserial amnioinfusions aimed at restoring amniotic fluid volume | Procedure or surgery | 1 |
Primary outcome
Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management
Time frame: discharge of every neonate from NICU
1 secondary outcome
Gestational age of delivery (main secondary outcome)
Time frame: time of delivery for every case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
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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.
Anna Locatelli, MD principal investigator
University of Milano Bicocca
Patrizia Vergani, MD study chair
University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amnioinfusion in people with Oligohydramnios, run by Università degli Studi di Brescia at 1 site in Italy.
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 10 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 22 Jan 2009. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Anna Locatelli, MD (+39 039 233 4720, anna.locatelli@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management (time frame: discharge of every neonate from NICU). 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 22 Jan 2009.