RecruitingNot Applicable

Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

Israel600 participantsStarted 2022-11-25

Plain-language summary

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity

Who can participate

Age range

18 Years – 48 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

endometritis rate

Timeframe: up to 6 weeks postpartum

chorioamnionitis rate

Timeframe: during labor (up to delivery of the newborn)

Trial details

NCT IDNCT05469984

SponsorWestern Galilee Hospital-Nahariya

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-25

Contact for this trial

Maya Wolf, MD

972-50-7887800 mayaw@gmc.gov.il

View on ClinicalTrials.gov More Preterm Labor With Preterm Delivery trials