NCT00236340

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

September 19, 2025

Status Verified

October 1, 2005

Enrollment Period

3.1 years

First QC Date

October 11, 2005

Last Update Submit

September 15, 2025

Conditions

Polyhydramnios

Keywords

AmniodrainagePregnancyAmniocentesis

Outcome Measures

Primary Outcomes (1)

  • maternal pain (Analogic visual scale)

    After drainage

Secondary Outcomes (6)

  • Volume of amniotic fluid drained

    After drainage

  • Duration of the drainage

    After drainage

  • Uterine activity

    After drainage

  • Recording of Foetal Heart Rate

    After drainage

  • Clinical Retroplacental Haematome

    After drainage

  • +1 more secondary outcomes

Study Arms (1)

Pregnant Women

OTHER

47 single foetal pregnancies and 33 twin pregnancies

Device: Syringe aspirationDevice: Wall suction

Interventions

Syringe aspirationDEVICE

It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.

Pregnant Women
Wall suctionDEVICE

The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg

Pregnant Women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI\>25cm)
  • Single or twin pregnancies

You may not qualify if:

  • Multiple pregnancy (more than 3 fetuses)
  • Maternal history of placental abruptio
  • Fetus with IUGR
  • Pregnancy complicated with pre-eclampsia
  • Unability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bretonneau

Tours, Centre-Val de Loire, 37000, France

Location

Related Publications (4)

  • 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.

    PMID: 14770396BACKGROUND

  • Jauniaux 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.

    PMID: 11438952BACKGROUND

  • Elliott JP, Sawyer AT, Radin TG, Strong RE. Large-volume therapeutic amniocentesis in the treatment of hydramnios. Obstet Gynecol. 1994 Dec;84(6):1025-7.

    PMID: 7970458BACKGROUND

  • Dolinger 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.

    PMID: 9464739BACKGROUND

MeSH Terms

Conditions

Polyhydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Franck Perrotin, MD PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

  • Andrea Wagner, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

  • Gilles Body, MD PhD

    CHU Bretonneau TOURS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 12, 2005

Study Start

January 1, 2002

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

September 19, 2025

Record last verified: 2005-10

Locations

FR(1)