Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
NCT04047849

Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA

Led by Woman's · Updated on 2021-01-11

34

Participants Needed

1

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy
  • Gestational age between 18 0/7 and 22 6/7 weeks
  • Diagnosis of prelabor premature rupture of membranes by clinical exam or ultrasound
  • Age 18 years or older
  • No known allergies to azithromycin or amoxicillin
  • No fever at presentation and during 24-hour hospital observation
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Fetal abnormalities in current pregnancy
  • Diabetes mellitus (pre-gestational or gestational)
  • Abnormal placentation
  • Poor pregnancy dating if ultrasound done at or after 20 0/7 weeks
  • Current vaginal bleeding or subchorionic hemorrhage
  • Hypertensive disorders including chronic or gestational hypertension and pre-eclampsia/eclampsia
  • History of amniocentesis during this pregnancy
  • History of cervical incompetence or cerclage (current or previous pregnancy)
  • Current urinary tract infection or bacteriuria
  • Current genital tract infection (Chlamydia, gonorrhea, or trichomonas)
  • Immunocompromised conditions such as HIV, daily steroids, or autoimmune disease under immunotherapy treatment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Woman's Hospital

Baton Rouge, Louisiana, United States, 70817

Actively Recruiting

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Research Team

F

Felicia LeMoine, MD

CONTACT

R

Robert C Moore, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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