Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Apr 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether taking oral antibiotics, specifically azithromycin and amoxicillin, can help prolong the time a pregnant woman can carry her baby after her water breaks early, between 18 and 23 weeks of pregnancy. The goal is to see if these antibiotics can help delay delivery for at least 28 days in women who experience a preterm rupture of membranes, which means that the protective fluid around the baby leaks out before labor starts.

To participate in this study, women must be English-speaking, pregnant with a single baby, and at the right stage of pregnancy when their water breaks. They should also be able to provide consent to participate. However, there are certain conditions that would prevent someone from joining, such as a recent major health issue or if they have a known allergy to the antibiotics being tested. Participants will take the antibiotics at home and will be monitored for a week to see how things progress. This study aims to gather important information about managing early water breaks, which can be critical for the health of both the mother and baby.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • English-speaking
• • Pregnant
• • Live, singleton gestation
• • Patient able to provide informed consent
• • Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture
• • Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm
• Exclusion Criteria:
• • Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age
• • Patient desires pregnancy interruption or induction of labor
• • Known major fetal anomaly or aneuploidy
• • Amniocentesis ≤ 7 days of diagnosis of rupture of membranes
• • Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes
• • Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics
• • Current antibiotic use at the time of membrane rupture diagnosis
• • Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis
• • Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis
• • Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis
• • Cervical dilation of ≥ 4 cm
• • Prolapse of fetal parts beyond the level of the internal cervical os
• • Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation