Condition category
Pregnancy and Childbirth
Date applied
23/10/2007
Date assigned
30/10/2007
Last edited
30/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudio Giorlandino

ORCID ID

Contact details

Viale Liegi 49
Rome
00198
Italy

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

http://www.cermet.it/

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

Publication citations

Additional files

Editorial Notes