PolyhydramniosNCT00236340
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.
A study testing Syringe aspiration and Wall suction in people with Polyhydramnios, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to - 250 mmHg Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polyhydramnios
- What is being tested?
- Syringe aspiration and Wall suction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Feb 2005
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI>25cm)
- Single or twin pregnancies
Who cannot join
- Multiple pregnancy (more than 3 fetuses)
- Maternal history of placental abruptio
- Fetus with IUGR
- Pregnancy complicated with pre-eclampsia
- Unability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DRAINAGE AMNIOTIQUE A LA SERINGUE OU PAR ASPIRATION CONTINUE DANS LES HYDRAMNIOS SYMPTOMATIQUES. ETUDE PROSPECTIVE RANDOMISEE.
To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to - 250 mmHg
Read the detailed description
Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are preterm labor, premature rupture of membranes, altered utero-placental perfusion, and maternal discomfort.
Amniodrainage has become an established technique to improve maternal comfort and reduce the risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine contractility, as well as over-stretching of membranes and uterus. It also acts on the pathological processes of twin to twin transfusion syndrome.
Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous maternal and fetal monitoring is difficult. The standard syringe technique is often a source of discomfort for both the patient and the operator. Continuous aspiration is faster and limits patient's discomfort.
The aim of this study was to compare the efficiency and maternal and fetal tolerance of these two latter techniques of amnioreduction.
A preliminary study permitted to assess the depression value created at the tip of the needle during amniodrainage: the syringe aspiration technique showed large depression variations from 0 to - 300 millimeters of mercury (mmHg). The continuous wall suction was thus chosen to be set to - 250 mmHg: depression at the needle's tip didn't vary during the procedure.
- Conditions
- Polyhydramnios
- Being tested
- Syringe aspiration, Wall suction
- Keywords
- Amniodrainage, Pregnancy, Amniocentesis
- Medical subject headings
- Polyhydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syringe aspirationDevice
It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.
Wall suctionDevice
The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Other | 47 single foetal pregnancies and 33 twin pregnancies Receives: Device: Syringe aspiration; Device: Wall suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal pain (Analogic visual scale)
Measured: After drainage
Secondary outcomes (6)
Volume of amniotic fluid drained
Measured: After drainage
Duration of the drainage
Measured: After drainage
Uterine activity
Measured: After drainage
Recording of Foetal Heart Rate
Measured: After drainage
Clinical Retroplacental Haematome
Measured: After drainage
Histological analysis of the placentas
Measured: After drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJan 2002
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PolyhydramniosStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Franck Perrotin, MD PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceAndrea Wagner, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceGilles Body, MD PhD, Study chair, CHU Bretonneau TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236340
- Sponsor's protocol ID
- AMNIO-2000
- Status last verified
- Oct 2005
- First submitted
- 11 Oct 2005
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leung WC, Jouannic JM, Hyett J, Rodeck C, Jauniaux E. Procedure-related complications of rapid amniodrainage in the treatment of polyhydramnios. Ultrasound Obstet Gynecol. 2004 Feb;23(2):154-8. doi: 10.1002/uog.972.
PubMed 14770396Jauniaux E, Holmes A, Hyett J, Yates R, Rodeck C. Rapid and radical amniodrainage in the treatment of severe twin-twin transfusion syndrome. Prenat Diagn. 2001 Jun;21(6):471-6. doi: 10.1002/pd.96.
PubMed 11438952Elliott JP, Sawyer AT, Radin TG, Strong RE. Large-volume therapeutic amniocentesis in the treatment of hydramnios. Obstet Gynecol. 1994 Dec;84(6):1025-7.
PubMed 7970458Dolinger MB, Donnenfeld AE. Therapeutic amniocentesis using a vacuum bottle aspiration system. Obstet Gynecol. 1998 Jan;91(1):143-4. doi: 10.1016/s0029-7844(97)00584-x.
PubMed 9464739
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRAINAGE AMNIOTIQUE A LA SERINGUE OU PAR ASPIRATION CONTINUE DANS LES HYDRAMNIOS SYMPTOMATIQUES. ETUDE PROSPECTIVE RANDOMISEE.
- ClinicalTrials.gov ID
- NCT00236340
- Acronym / sponsor ID
- AMNIO-2000
- Conditions
- Polyhydramnios
- Keywords
- Amniodrainage, Pregnancy, Amniocentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jan 2002 (actual)
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 12 Oct 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.
To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to - 250 mmHg
Detailed description
Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are preterm labor, premature rupture of membranes, altered utero-placental perfusion, and maternal discomfort.
Amniodrainage has become an established technique to improve maternal comfort and reduce the risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine contractility, as well as over-stretching of membranes and uterus. It also acts on the pathological processes of twin to twin transfusion syndrome.
Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous maternal and fetal monitoring is difficult. The standard syringe technique is often a source of discomfort for both the patient and the operator. Continuous aspiration is faster and limits patient's discomfort.
The aim of this study was to compare the efficiency and maternal and fetal tolerance of these two latter techniques of amnioreduction.
A preliminary study permitted to assess the depression value created at the tip of the needle during amniodrainage: the syringe aspiration technique showed large depression variations from 0 to - 300 millimeters of mercury (mmHg). The continuous wall suction was thus chosen to be set to - 250 mmHg: depression at the needle's tip didn't vary during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | Other | Device: Syringe aspiration, Device: Wall suction47 single foetal pregnancies and 33 twin pregnancies |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI>25cm)
- Single or twin pregnancies
Key exclusion criteria (5 listed)
- Multiple pregnancy (more than 3 fetuses)
- Maternal history of placental abruptio
- Fetus with IUGR
- Pregnancy complicated with pre-eclampsia
- Unability to give informed 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 |
|---|---|---|
| Syringe aspirationIt consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube. | Device | Pregnant Women |
| Wall suctionThe tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg | Device | Pregnant Women |
Primary outcome
maternal pain (Analogic visual scale)
Time frame: After drainage
6 secondary outcomes
Volume of amniotic fluid drained
Time frame: After drainage
Duration of the drainage
Time frame: After drainage
Uterine activity
Time frame: After drainage
Recording of Foetal Heart Rate
Time frame: After drainage
Clinical Retroplacental Haematome
Time frame: After drainage
Histological analysis of the placentas
Time frame: After drainage
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 19 Sep 2025.
- Background: PubMed 14770396Leung WC, Jouannic JM, Hyett J, Rodeck C, Jauniaux E. Procedure-related complications of rapid amniodrainage in the treatment of polyhydramnios. Ultrasound Obstet Gynecol. 2004 Feb;23(2):154-8. doi: 10.1002/uog.972.
- Background: PubMed 11438952Jauniaux E, Holmes A, Hyett J, Yates R, Rodeck C. Rapid and radical amniodrainage in the treatment of severe twin-twin transfusion syndrome. Prenat Diagn. 2001 Jun;21(6):471-6. doi: 10.1002/pd.96.
- Background: PubMed 7970458Elliott JP, Sawyer AT, Radin TG, Strong RE. Large-volume therapeutic amniocentesis in the treatment of hydramnios. Obstet Gynecol. 1994 Dec;84(6):1025-7.
- Background: PubMed 9464739Dolinger MB, Donnenfeld AE. Therapeutic amniocentesis using a vacuum bottle aspiration system. Obstet Gynecol. 1998 Jan;91(1):143-4. doi: 10.1016/s0029-7844(97)00584-x.
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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.
Franck Perrotin, MD PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
Andrea Wagner, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Gilles Body, MD PhD study chair
CHU Bretonneau TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syringe aspiration and Wall suction in people with Polyhydramnios, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 2 inclusion and 5 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 19 Sep 2025. 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 France. 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?
maternal pain (Analogic visual scale) (time frame: After drainage). 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 NCT00236340, which also lists 4 linked publications.
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 19 Sep 2025.