Preterm Premature Rupture Of Membranes (pPROM), foetal death Pregnancy and Childbirth Premature rupture of membranes
Conditions
Interventions
Intervention:
Oral azithromycin 500 mg daily for the three days prior to the amniocentesis procedure, in three doses taken at 24-hour intervals.
Control:
Sponsors
CERMET (Certification and Research for Quality) and Total Quality Management (Italy)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed