Extended Azithromycin Treatment in Prelabor Rupture of Membranes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAlexa Henderson
About this trial
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.
Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.
Participants will:
* Be randomly assigned to one of two groups: * The standard antibiotic treatment * The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day. * Participants will be asked to complete a survey regarding their experience and side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton gestation
Gestational age at time of PPROM between 22w0d and 28w0d
Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
Remain pregnant 48 hours after presentation.
Disqualifiers
Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
Lethal congenital defects
Multiple gestation
Ongoing alternative antibiotic treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Azithromycin (Azithro)
DrugAzithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
Standard Azithromycin Dosing
DrugOral Azithromycin 1g once.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Standard Antibiotic RegimenActive comparator 1 intervention
Group B: Extended Azithromycin RegimenExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recruitment Capability
Number of participants recruited per week/month
Time frame
From recruitment to enrollment, up to 3 days.2
Participant Eligibility
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
Time frame
From recruitment until enrollment, up to 3 days.3
Retention and Dropout Rates
Percentage of patients who complete study and reasons for withdrawal from study.
Time frame
From recruitment to completion of the study, up to 4 months.4
Intervention Delivery
Percentage of interventions delivered as intended
Time frame
From recruitment to completion of intervention, up to 15 days.Secondary outcomes
1
Pregnancy Latency
Number of days participants remain pregnant after PPROM until delivery
Time frame
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.2
Pregnancy Outcome
Intrauterine fetal demise, neonatal demise while in NICU, living infant to NICU discharge.
Time frame
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.3
NICU Admission
Requirement for NICU admission.
Time frame
From day of delivery through neonatal discharge, up to 4 months.4
Neonatal Ventilatory Support
Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
Time frame
From day of delivery through neonatal discharge, up to 4 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Alexa Henderson
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov