Health TrialsbyHealthPanel

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

ConditionsPreterm Labor With Preterm DeliveryPremature Rupture of Membranes Prolonged
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorWestern Galilee Hospital-Nahariya

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ampicillin Only Product

    Drug

    women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

  • ampicillin plus gentamicin

    Drug

    women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: women with term prolonged>18h rupture of membraneActive comparator 2 interventions
Group B: women with preterm laborActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

endometritis rate

Time frame
up to 6 weeks postpartum
2

chorioamnionitis rate

Time frame
during labor (up to delivery of the newborn)

Secondary outcomes

1

cord blood pH

Time frame
immediately after delivery of the placenta
2

maternal intrapartum fever

body temperature,

Time frame
during labor (up to delivery of the newborn)
3

NICU (neonatal intensive care unit) hospitalization length,

days

Time frame
up to 3 month from delivery
4

rate of neonatal early onset sepsis

positive blood culture

Time frame
up to one week from delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western Galilee Hospital-Nahariya

Lead sponsor

Source ClinicalTrials.gov
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