A single-centre randomised controlled trial of Antibiotic Prophylaxis before second-trimester Genetic Amniocentesis in women: the APGA trial
| ISRCTN | ISRCTN30372886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30372886 |
| Secondary identifying numbers | PROT-PRSV-98/0012 |
- Submission date
- 23/10/2007
- Registration date
- 30/10/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudio Giorlandino
Scientific
Scientific
Viale Liegi 49
Rome
00198
Italy
Study information
| Study design | Prospective, randomised controlled single-centre study on prophylactic therapy strategy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A single-centre randomised controlled trial of Antibiotic Prophylaxis before second-trimester Genetic Amniocentesis in women: the APGA trial |
| Study acronym | APGA Trial |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure | 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 study start date | 02/01/1999 |
| Completion date | 20/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30000 |
| Total final enrolment | 34923 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/01/1999 |
| Date of final enrolment | 20/12/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Liegi 49
Rome
00198
Italy
00198
Italy
Sponsor information
CERMET (Certification and Research for Quality) and Total Quality Management (Italy)
Industry
Industry
Via Velletri 10
Rome
00198
Italy
| Website | http://www.cermet.it/ |
|---|
Funders
Funder type
Research organisation
Italian Society of Prenatal Diagnosis and Feto-Maternal Medicine (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2009 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment number added.
