Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
This study is a non-blinded, prospective, randomized controlled trial designed to compare the
effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of
time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If
a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7
weeks and there are no other associated complications with the pregnancy, the patient is
eligible for initial consideration for this study. Patients will be admitted to the hospital
for a 24-hour monitoring period. If the patient remains without further complications during
this monitoring period, the patient will be eligible for enrollment. If enrollment is
desired, the patient will be randomly assigned to receive either antibiotics (treatment arm
of the study) or no antibiotics (control arm of the study). The treatment arm will receive an
outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first
dose given in the hospital to ensure no side effects. The control arm will not receive
outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk
pregnancy specialists to ensure no further complications. Both groups will be admitted to the
hospital if the patients reach 23 0/7 weeks without complications. At this time the patients
will receive all medications and therapies recommended by the governing board of OBGYNs.
Subjects of both groups will also be admitted before 23 0/7 weeks if further complications
noted either at their clinic follow up visits or anytime outside of the hospital. The
duration of time that the patient remains pregnant after breaking of the water bag will be
compared in each group. The investigators will also see if there is a difference in the
number of patients able to reach 23 0/7 weeks between each group (treatment versus control).