Maternal intra-partum fever.
O Apantaku, V Mulik
https://pubmed.ncbi.nlm.nih.gov/17365450Actively Recruiting
Phase Not Applicable
Age: 18Years - 48Years
FEMALE
Healthy Volunteers
ID05469984
Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Led by Western Galilee Hospital-Nahariya · Updated on 2025-08-06
600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different antibiotic treatments to prevent infections in women experiencing either prolonged pre-labor rupture of membranes at term or preterm labor. The study focuses on comparing the effects of using ampicillin alone versus a combination of ampicillin and gentamicin. The goal is to understand how these treatments impact obstetrical outcomes and the rates of infections during and after childbirth. Participants are randomly assigned to one of two groups: one group receives intravenous ampicillin every six hours until delivery, and the other group receives the same ampicillin regimen plus intravenous gentamicin once daily. This treatment occurs during labor for women with term prolonged rupture of membranes lasting more than 18 hours or those undergoing preterm delivery. Throughout the study, participants undergo monitoring for signs of infection including chorioamnionitis and endometritis, as well as assessments of obstetrical outcomes like mode of delivery and Apgar scores. The researchers also collect surface swab cultures and maternal blood cultures and evaluate neonatal outcomes such as NICU admission and early neonatal sepsis. Follow-up includes monitoring maternal and neonatal health up to six weeks postpartum and up to three months for some neonatal outcomes.
CONDITIONS
Brief Title
Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Who Can Participate
Age: 18Years - 48Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Maternal age over 18 years
- Singleton pregnancy with vertex (head-down) presentation
- Prolonged rupture of membranes over 18 hours or preterm delivery
You will not qualify if you...
- Group B Streptococcus (GBS) carrier status
- Preterm premature rupture of membranes under conservative treatment
- Intrauterine fetal death or major fetal anomaly
- Allergy to antibiotics used in the study
- Currently receiving antibiotic treatment for other infections such as urinary tract infection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to delivery
Participants receive intravenous antibiotics (either ampicillin alone or ampicillin plus gentamicin) until delivery to prevent infections associated with prolonged rupture of membranes or preterm labor.
Multiple visits during labor until delivery
Follow-up
Duration - Up to 6 weeks postpartum with some neonatal monitoring up to 3 months
Participants are monitored postpartum for infections, maternal and neonatal health outcomes including fever, antibiotic treatment, and neonatal intensive care unit admission.
Approximately 6 post-delivery visits
Trial Site Locations
Total: 1 location
1
Galil Medical Center
Nahariya, Israel
Actively Recruiting
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Research Team
M
Maya Wolf, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection.
https://pubmed.ncbi.nlm.nih.gov/28742677Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.
Alisa Kachikis, Linda O Eckert, Christie Walker...
https://pubmed.ncbi.nlm.nih.gov/31783982Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes.
B H Yoon, R Romero, J B Moon...
https://pubmed.ncbi.nlm.nih.gov/11717646Characterization and control of intraamniotic infection in an urban teaching hospital.
D E Soper, C G Mayhall, J W Froggatt
https://pubmed.ncbi.nlm.nih.gov/8765246