Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PROT-PRSV-98/0012
Study information
Scientific title
Acronym
APGA Trial
Study hypothesis
We hypothesise that:
1. There exists a risk factor for infection that could be responsible for rupture of the membranes (preterm Premature Rupture Of Membranes [pPROM]) and often for foetal death, and that this risk factor is present even before the amniocentesis procedure is undertaken
2. Antibiotic prophylaxis before amniocentesis can prevent pPROM and/or foetal death
Ethics approval
Ethics approval obtained from the Local Ethics Committee of the "Artemisia Medical Institute Network" (created according to the guidelines reported in the "Decreto Ministeriale (DM) 15/7/1997", Ministry of Health of Italy) on the 12th September 1998.
Study design
Prospective, randomised controlled single-centre study on prophylactic therapy strategy
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm Premature Rupture Of Membranes (pPROM), foetal death
Intervention
Intervention:
Oral azithromycin 500 mg daily for the three days prior to the amniocentesis procedure, in three doses taken at 24-hour intervals.
Control:
No therapy.
Both groups have a scan on the day of the amniocentesis. The women have to be discharged 30 minutes after completion of the procedure. The patients that present any complications, within 4 weeks, must to be checked into the Centre with a scan and PROM test. The coordinators, after 4 weeks, will check by phone that all women will not come back to the centre for prescribed control. All study personnel were blinded to treatment assignment for the duration of the study.
Intervention type
Drug
Phase
Not Specified
Drug names
Azithromycin
Primary outcome measures
To determine the efficacy of antibiotic prophylaxis in second-trimester amniocentesis in preventing the foetal death in both groups, assessed four weeks after the procedure.
Secondary outcome measures
1. To determine the incidence of pPROM in both groups, defined as a rupture of the membranes, assessed four weeks after the procedure
2. To evaluate the incidence of foetal death after the pPROM in both groups, assessed four weeks after the procedure
Overall trial start date
02/01/1999
Overall trial end date
20/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women aged greater than or equal to 18 years
2. All women requested a second trimester genetic amniocentesis with the same chosen operator
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30000
Participant exclusion criteria
1. Non-viable foetus (also found after the randomisation)
2. Major foetal abnormalities (also found after the randomisation)
3. Leakage of amniotic fluid
4. Bleeding in the past week
5. Fever
6. Use of any antibiotics within the past 14 days or of long-acting injectable penicillin
7. Known allergy to the specific antibiotic used
Recruitment start date
02/01/1999
Recruitment end date
20/12/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Viale Liegi 49
Rome
00198
Italy
Sponsor information
Organisation
CERMET (Certification and Research for Quality) and Total Quality Management (Italy)
Sponsor details
Via Velletri 10
Rome
00198
Italy
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Italian Society of Prenatal Diagnosis and Feto-Maternal Medicine (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary