Extended Azithromycin Treatment in Prelabor Rupture of Membranes
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Azithromycin (Azithro)
- Standard Azithromycin Dosing
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alexa Henderson
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov