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New treatment option for Pregnancy Complications, Infectious
Official title Azithromycin and Ampicillin for Late PPROM
ClinicalTrials.gov ID: NCT07183462
What this study is testing
What is Intravenous Ampicillin followed by Oral Amoxicillin?
Intravenous Ampicillin followed by Oral Amoxicillin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pregnancy complications, infectious.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main question it aims to answer is: Does the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Maternal age 18-50
- Premature rupture of membranes
- Gestational age 34.0 and 36.4 weeks
- Singleton pregnancy
You likely can't join if
- Multiple gestations
- Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)
- Meconium stain amniotic fluid
- Non-reassuring fetal heart rate or status
- Maternal or fetal indication for labor:
- Suspected Chorioamnionitis
See the full eligibility criteria
- Maternal age 18-50
- Premature rupture of membranes
- Gestational age 34.0 and 36.4 weeks
- Singleton pregnancy
- Multiple gestations
- Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)
- Meconium stain amniotic fluid
- Non-reassuring fetal heart rate or status
- Maternal or fetal indication for labor:
- Suspected Chorioamnionitis
- Suspected placental abruption
- Any maternal morbidity requiring labor
- Cervical cerclage in place.
- Major fetal malformation or known chromosomal abnormalities.
- Stillbirth.
- Sensitivity to Macrolides Antibiotics
The study team makes the final eligibility decision.
Where it's taking place
- Ramat Gan, Israel, Israel
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ramat Gan, Israel, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.