Amnioinfusion Initiative

Oligohydramnios Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00787163
• Other study ID #: Amnioinfusion-001
• Status: Recruiting
• Phase: Phase 3
• First received: November 6, 2008
• Last updated: January 21, 2009
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: November 2008
• Source: Università degli Studi di Brescia
• Contact: Anna Locatelli, MD
• Phone: +39 039 233 4720
• Email: anna.locatelli[@]unimib.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oligohydramnios

Intervention

Procedure:
• amnioinfusion
serial amnioinfusions aimed at restoring amniotic fluid volume

Locations

Country	Name	City	State
Italy	University of Milano Bicocca, Ospedale san Gerardo Monza	Monza	Milano

Sponsors (4)

Lead Sponsor	Collaborator
Università degli Studi di Brescia	Catholic University, Italy, Katholieke Universiteit Leuven, University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management		discharge of every neonate from NICU	Yes
Secondary	Gestational age of delivery (main secondary outcome)		time of delivery for every case	Yes