Two antibiotic approaches for women with prolonged rupture of membranes or preterm labor
Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
This trial will test whether ampicillin alone or ampicillin plus gentamicin better prevents infections in women over 18 with prolonged pre-labor rupture of membranes or preterm labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya) |
| Trial ID | NCT05469984 on ClinicalTrials.gov |
What this trial studies
This randomized prospective trial compares two prophylactic antibiotic regimens—ampicillin alone versus ampicillin plus gentamicin—in women with term prolonged pre-labor rupture of membranes (>18 hours) or preterm delivery. Eligible participants are adult women with a singleton, vertex pregnancy who are not GBS carriers and have no allergy to the study antibiotics. The study collects maternal and neonatal clinical outcomes, microbiologic cultures from placental, amnion, umbilical cord and uterine sites, maternal blood cultures, and placental histology. Primary outcome is peripartum infection (chorioamnionitis, endometritis, surgical site infection) and secondary outcomes include mode of delivery, Apgar scores, cord pH, maternal length of stay, postpartum antibiotic use, NICU admission, and early neonatal sepsis.
Who should consider this trial
Good fit: Ideal candidates are women aged over 18 with a singleton, vertex pregnancy experiencing term prolonged pre-labor rupture of membranes (>18 hours) or preterm labor who are not GBS carriers and have no allergy to the study antibiotics.
Not a fit: Patients who are GBS carriers, have major fetal anomalies or intrauterine fetal death, are receiving antibiotics for another infection, are managed conservatively for preterm PROM, or are allergic to the study drugs would not be eligible or likely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the combination regimen could reduce maternal and neonatal infections after prolonged rupture of membranes or preterm birth.
How similar studies have performed: Antibiotic prophylaxis for PROM and preterm rupture has been studied previously with mixed results, so comparing combination therapy to ampicillin alone builds on existing clinical evidence rather than being entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: maternal age \> 18 years singleton pregnancy vertex presentation prolonged \>18 h prom or preterm delivery \- Exclusion Criteria: * GBS carrier * preterm premature rupture of membrane for conservative treatment * intra-uterine fetal death fetal major anomaly * drug allergy for the antibiotic in use in this study * women receiving antibiotic treatment for other infection such as urinary tract infection
Where this trial is running
Nahariya
- Galil Medical Center — Nahariya, Israel (Recruiting)
Study contacts
- Study coordinator: Maya Wolf, MD
- Email: mayaw@gmc.gov.il
- Phone: 972-50-7887800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.