Comparing antibiotic treatment with placebo for women with meconium-stained amniotic fluid
and Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Who Will be Treated With Prophylactic Antibiotics Zinacef vs. Placebo
This study is testing whether giving antibiotics to women with meconium-stained amniotic fluid during labor can reduce the risk of infections for both the mothers and their newborns compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya) |
| Trial ID | NCT06849037 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled double-blind study that aims to evaluate the effects of prophylactic antibiotics (zinacef) versus placebo on maternal and neonatal infectious morbidity in women with meconium-stained amniotic fluid at term. The study will assess the incidence of infections such as chorioamnionitis and neonatal sepsis, as well as the distribution of pathogens in swab cultures. By comparing outcomes between the two groups, the trial seeks to clarify the potential benefits of antibiotic treatment in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women with singleton pregnancies at term who present with meconium-stained amniotic fluid.
Not a fit: Patients who have intrauterine fetal death, are GBS carriers, have a zinacef allergy, or are receiving antibiotic treatment for other indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the rates of maternal and neonatal infections associated with meconium-stained amniotic fluid.
How similar studies have performed: Previous studies have indicated a relationship between meconium-stained amniotic fluid and increased infectious morbidity, but this specific approach comparing zinacef to placebo is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * singleton pregnancy at term * meconium-stained amniotic fluid Exclusion Criteria: * Intrauterine fetal death * GBS carriers * zinacef allergy * antibiotic treatment for other indication
Where this trial is running
Nahariya
- Galilee Medical center — Nahariya, Israel (Recruiting)
Study contacts
- Study coordinator: Maya Frank Wolf, prof.
- 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.