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Amnioinfusion Initiative

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Università degli Studi di Brescia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00787163
First Posted: November 7, 2008
Last Update Posted: January 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Katholieke Universiteit Leuven
University of Milan
Catholic University, Italy
Information provided by:
Università degli Studi di Brescia
  Purpose
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.

Condition Intervention Phase
Oligohydramnios Procedure: amnioinfusion Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios

Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management [ Time Frame: discharge of every neonate from NICU ]

Secondary Outcome Measures:
  • Gestational age of delivery (main secondary outcome) [ Time Frame: time of delivery for every case ]

Estimated Enrollment: 82
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
amnioinfusion
Procedure: amnioinfusion
serial amnioinfusions aimed at restoring amniotic fluid volume
No Intervention: 2
expectant management

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients above 18 years, who are able to consent, with
  2. Singleton pregnancy
  3. with a normal structural examination as much as possible;
  4. At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios
  5. Follow up ultrasound examinations weekly in the treatment group
  6. Acceptance of randomisation and to comply with the protocol

Exclusion Criteria:

  1. Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful;
  2. Preterm labour defined as contractions >6/hour associated with cervical changes, cervix shortened (<15 mm at randomization),
  3. Cervical cerclage in place
  4. 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
  5. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes
  6. Previous invasive procedure in this index pregnancy
  7. Fetal condition mandating immediate delivery
  8. Severe bleeding
  9. Maternal HIV and HCV infection
  10. Multiple gestation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787163


Contacts
Contact: Anna Locatelli, MD +39 039 233 4720 anna.locatelli@unimib.it

Locations
Italy
University of Milano Bicocca, Ospedale san Gerardo Monza Recruiting
Monza, Milano, Italy, 20052
Contact: Anna Locatelli, MD    +390392334720    anna.locatelli@unimib.it   
Sponsors and Collaborators
Università degli Studi di Brescia
Katholieke Universiteit Leuven
University of Milan
Catholic University, Italy
Investigators
Principal Investigator: Anna Locatelli, MD University of Milano Bicocca
Study Chair: Patrizia Vergani, MD University of Milano Bicocca
  More Information

Responsible Party: Anna Locatelli, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT00787163     History of Changes
Other Study ID Numbers: Amnioinfusion-001
First Submitted: November 6, 2008
First Posted: November 7, 2008
Last Update Posted: January 22, 2009
Last Verified: November 2008

Keywords provided by Università degli Studi di Brescia:
pPROM
oligohydramnios
amnioinfusion
prematurity
Early premature rupture of membranes in pregnancy

Additional relevant MeSH terms:
Oligohydramnios
Pregnancy Complications