Pre-EclampsiaPhase 3NCT00197340
Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction
A Phase 3 study testing Epidural ropivacaine in people with Pre-Eclampsia and Fetal Growth Retardation, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Fetal Growth Retardation
- What is being tested?
- Epidural ropivacaine
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2003to Dec 2006
- 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
- 1. Reliable gestational age based upon an ultrasound crown-rump length performed between 7 to 14 completed weeks gestation. If the ultrasound date matches the date of the last menstrual period (LMP) within 7 days, the LMP date is used, otherwise the ultrasound date is used.
- 2. Gestational age at the time of enrollment between 28 to 32 weeks (based upon 1.) and need for in-hospital observation or treatment REGARDLESS of the study.
- 3. Presence of uterine artery notching in ultrasound scan. 4. EITHER 4a or 4b (if both, the patient is enrolled as for 4a): 4a. Pre-eclampsia: Women must have criteria #1 and #2 Criterion #1: Hypertension (> 140/90) at rest, measured twice, at least 6 hours apart.
- Criterion #2: Proteinuria:
- EITHER: At least 0.1 g/l in two random samples at least 6 hours apart. OR: At least 0.3g in a 24 hour collection.
- 4b Intrauterine growth retardation (IUGR): Women must have criteria #1 and #2. Criterion #1: Ultrasound abdominal circumference below 10th percentile. Criterion #2: Established IUGR for at least 2 weeks.
Who cannot join
- at the time of enrollment: active labor, severe pre-eclampsia, (resting blood pressure ≥ 160mmHg systolic or 110 diastolic, recorded on at least two occasions 6 hours apart), known fetal anomaly, intrauterine infection, placental anomalies (previa, abruption, circumvallate, infarction), twins, and refusal of consent.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Hebrew University Medical Center, POB 12000
Jerusalem, 91120
About this study
Official title: Antepartum Chronic Epidural Therapy (ACET) Using Ropivacaine to Improve Uteroplacental Blood Flow in Pre-Eclampsia and Intrauterine Growth Restriction
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.
Read the detailed description
Women with sonographic uterine artery flow abnormalities and either PE or IUGR (or both) were randomized to either ACET or non ACET control. Both groups were able to receive standard therapies (in-hospital monitoring, magnesium and anti-hypertensives as appropriate). The first five days of the therapeutic arm (ACET) consisted of a dose-finding trial, where epidural ropivacaine infusions (10ml/hr for 24 hours) of 0•04%, 0•06%, 0•08% and 0•1% and a saline placebo were each administered via tunneled epidural catheters in a randomized, double-blinded, cross-over design over five consecutive days; all three women received all doses. Doppler measurement of flow in the uterine artery was performed at baseline and at the end of each dose period. The ideal dose for an individual was determined to be lowest dose of drug giving maximal effect without side effects; in the second stage of the study, this dose was administered until delivery with the addition of a second placebo day to during this period.
- Conditions
- Pre-Eclampsia, Fetal Growth Retardation
- Being tested
- Epidural ropivacaine
- Keywords
- Pre-Eclampsia, Fetal Growth Retardation, Anesthesia, Epidural, Placental Circulation, Dose-Response Relationship, Drug
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural ropivacaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine artery blood flow
Gestational age at delivery.
Secondary outcomes (5)
Ductus venosus and MCA blood flow
Proprioceptive loss;
Maternal hemodynamic changes;
Fetal weight (throughout pregnancy and at delivery); amniotic fluid index;
obstetric outcome (maternal mortality, morbidity, neonatal mortality, morbidity, mode of delivery, obstetric complications).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- International Anesthesia Research Society (IARS)
- Investigators
- Yehuda Ginosar, BSc MBBS, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197340
- Sponsor's protocol ID
- ACET1-ginosar-HMO-CTIL
- Status last verified
- Feb 2006
- First submitted
- 13 Sep 2005
- Last updated
- 15 Jul 2008
- Results posted
- No
Publications
Ginosar Y, Nadjari M, Hoffman A, Firman N, Davidson EM, Weiniger CF, Rosen L, Weissman C, Elchalal U; ACET study group. Antepartum continuous epidural ropivacaine therapy reduces uterine artery vascular resistance in pre-eclampsia: a randomized, dose-ranging, placebo-controlled study. Br J Anaesth. 2009 Mar;102(3):369-78. doi: 10.1093/bja/aen402. Epub 2009 Jan 27.
PubMed 19176534
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antepartum Chronic Epidural Therapy (ACET) Using Ropivacaine to Improve Uteroplacental Blood Flow in Pre-Eclampsia and Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT00197340
- Acronym / sponsor ID
- ACET1-ginosar-HMO-CTIL
- Conditions
- Pre-Eclampsia, Fetal Growth Retardation
- Keywords
- Pre-Eclampsia, Fetal Growth Retardation, Anesthesia, Epidural, Placental Circulation, Dose-Response Relationship, Drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- International Anesthesia Research Society (IARS)
- Study start
- Aug 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (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.
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.
Detailed description
Women with sonographic uterine artery flow abnormalities and either PE or IUGR (or both) were randomized to either ACET or non ACET control. Both groups were able to receive standard therapies (in-hospital monitoring, magnesium and anti-hypertensives as appropriate). The first five days of the therapeutic arm (ACET) consisted of a dose-finding trial, where epidural ropivacaine infusions (10ml/hr for 24 hours) of 0•04%, 0•06%, 0•08% and 0•1% and a saline placebo were each administered via tunneled epidural catheters in a randomized, double-blinded, cross-over design over five consecutive days; all three women received all doses. Doppler measurement of flow in the uterine artery was performed at baseline and at the end of each dose period. The ideal dose for an individual was determined to be lowest dose of drug giving maximal effect without side effects; in the second stage of the study, this dose was administered until delivery with the addition of a second placebo day to during this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Reliable gestational age based upon an ultrasound crown-rump length performed between 7 to 14 completed weeks gestation. If the ultrasound date matches the date of the last menstrual period (LMP) within 7 days, the LMP date is used, otherwise the ultrasound date is used.
- 2. Gestational age at the time of enrollment between 28 to 32 weeks (based upon 1.) and need for in-hospital observation or treatment REGARDLESS of the study.
- 3. Presence of uterine artery notching in ultrasound scan. 4. EITHER 4a or 4b (if both, the patient is enrolled as for 4a): 4a. Pre-eclampsia: Women must have criteria #1 and #2 Criterion #1: Hypertension (> 140/90) at rest, measured twice, at least 6 hours apart.
- EITHER: At least 0.1 g/l in two random samples at least 6 hours apart. OR: At least 0.3g in a 24 hour collection.
- 4b Intrauterine growth retardation (IUGR): Women must have criteria #1 and #2. Criterion #1: Ultrasound abdominal circumference below 10th percentile. Criterion #2: Established IUGR for at least 2 weeks.
Key exclusion criteria (1 listed)
- at the time of enrollment: active labor, severe pre-eclampsia, (resting blood pressure ≥ 160mmHg systolic or 110 diastolic, recorded on at least two occasions 6 hours apart), known fetal anomaly, intrauterine infection, placental anomalies (previa, abruption, circumvallate, infarction), twins, and refusal of consent.
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 |
|---|---|---|
| Epidural ropivacaine | Drug | – |
Primary outcome
Uterine artery blood flow
Gestational age at delivery.
5 secondary outcomes
Ductus venosus and MCA blood flow
Proprioceptive loss;
Maternal hemodynamic changes;
Fetal weight (throughout pregnancy and at delivery); amniotic fluid index;
obstetric outcome (maternal mortality, morbidity, neonatal mortality, morbidity, mode of delivery, obstetric complications).
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 15 Jul 2008.
- Derived from this study: PubMed 19176534Ginosar Y, Nadjari M, Hoffman A, Firman N, Davidson EM, Weiniger CF, Rosen L, Weissman C, Elchalal U; ACET study group. Antepartum continuous epidural ropivacaine therapy reduces uterine artery vascular resistance in pre-eclampsia: a randomized, dose-ranging, placebo-controlled study. Br J Anaesth. 2009 Mar;102(3):369-78. doi: 10.1093/bja/aen402. Epub 2009 Jan 27.
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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.
Yehuda Ginosar, BSc MBBS principal investigator
Hadassah Medical Organization
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 Epidural ropivacaine in people with Pre-Eclampsia and Fetal Growth Retardation, run by Hadassah Medical Organization at 1 site in Israel.
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 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 15 Jul 2008. 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 Israel. 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?
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?
Uterine artery blood flow. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197340, which also lists 1 linked publication.
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 15 Jul 2008.