Comparing antibiotic treatment with placebo for women with meconium-stained amniotic fluid
Official title: and Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Who Will be Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Run by Western Galilee Hospital-Nahariya · NCT06849037 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 182 (estimated) |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya) |
| Status | Recruiting |
| Started | February 18, 2025 |
| Main results expected | February 13, 2027 |
| Study ends | February 13, 2028 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT06849037 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women with singleton pregnancies at term who present with meconium-stained amniotic fluid.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Galilee Medical center
Nahariya, Israel Recruiting
Study contacts
- Study coordinator: Maya Frank Wolf, prof.
- Email: mayaw@gmc.gov.il
- Phone: 972-50-7887800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Amniotic fluid and the extremely preterm baby's gut
We will see if amniotic fluid from extremely preterm births (24+0 to 27+6 weeks) shows changes that relate to gut problems such as necrotizing enterocolitis or sepsis in very preterm infants.
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Amnioinfusion during labor to protect neonatal brain in chorioamnionitis
This trial tests whether giving fluid into the uterus during labor for pregnancies affected by chorioamnionitis can help protect the baby’s brain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.