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Amnioinfusion Initiative

Primary Purpose

Oligohydramnios

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

amnioinfusion

About this trial

This is an interventional treatment trial for Oligohydramnios focused on measuring pPROM, oligohydramnios, amnioinfusion, prematurity, Early premature rupture of membranes in pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Fetal condition mandating immediate delivery
Severe bleeding
Maternal HIV and HCV infection
Multiple gestation

Sites / Locations

University of Milano Bicocca, Ospedale san Gerardo MonzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

amnioinfusion

expectant management

Outcomes

Primary Outcome Measures

Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management

Secondary Outcome Measures

Gestational age of delivery (main secondary outcome)

Full Information

NCT ID

NCT00787163

First Posted

November 6, 2008

Last Updated

January 21, 2009

Sponsor

Università degli Studi di Brescia

Collaborators

KU Leuven, University of Milan, Catholic University, Italy

1. Study Identification

Unique Protocol Identification Number

NCT00787163

Brief Title

Amnioinfusion Initiative

Official Title

Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Università degli Studi di Brescia

Collaborators

KU Leuven, University of Milan, Catholic University, Italy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oligohydramnios

Keywords

pPROM, oligohydramnios, amnioinfusion, prematurity, Early premature rupture of membranes in pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

amnioinfusion

Arm Title

Arm Type

No Intervention

Arm Description

expectant management

Intervention Type

Procedure

Intervention Name(s)

amnioinfusion

Intervention Description

serial amnioinfusions aimed at restoring amniotic fluid volume

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Gestational age of delivery (main secondary outcome)

Time Frame

time of delivery for every case

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Fetal condition mandating immediate delivery Severe bleeding Maternal HIV and HCV infection Multiple gestation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Locatelli, MD

Phone

+39 039 233 4720

anna.locatelli@unimib.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Locatelli, MD

Organizational Affiliation

University of Milano Bicocca

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patrizia Vergani, MD

Organizational Affiliation

University of Milano Bicocca

Official's Role

Study Chair

Facility Information:

Facility Name

University of Milano Bicocca, Ospedale san Gerardo Monza

City

Monza

State/Province

Milano

ZIP/Postal Code

20052

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Locatelli, MD

Phone

+390392334720

anna.locatelli@unimib.it

12. IPD Sharing Statement

Learn more about this trial

Amnioinfusion Initiative

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