Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
ID04047849

The Effect of Antibiotics on Latency in Previable Prelabor Rupture of Membranes Between 18 0/7 and 22 6/7 Weeks Gestational Age

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

34

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effect of outpatient oral antibiotics on the length of pregnancy after premature rupture of membranes (water bag rupture) between 18 0/7 weeks and 22 6/7 weeks gestation. This trial compares how long pregnancy continues with or without antibiotic treatment, focusing on patients without other pregnancy complications. The study aims to see if antibiotics influence the time until delivery and the number of patients reaching 23 0/7 weeks gestation. Participants are admitted for a 24-hour hospital observation to ensure no infections or labor signs. Then, they are randomly assigned to receive either a 7-day course of oral antibiotics (azithromycin and amoxicillin) or no antibiotics. The first antibiotic dose is given in the hospital to monitor side effects. Both groups have weekly outpatient follow-up visits with specialists and will be admitted to the hospital at 23 weeks or earlier if complications arise. Upon readmission at 23 weeks, all receive standard medications and care for fetal and maternal health. During the study, participants have regular exams including ultrasounds, blood tests, and vital sign monitoring. They track symptoms and temperature daily, and adherence to antibiotics is checked by pill counts. The main outcome measured is the latency period, or how long pregnancy continues after membrane rupture, which can range from less than one day up to 112 days. Researchers also monitor how many patients reach 23 weeks. Safety is closely observed, and the study lasts until delivery or complications occur.

CONDITIONS

Brief 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 greater than 18 0/7 weeks but less than or equal to 22 6/7 weeks
  • Diagnosis of prelabor premature rupture of membranes confirmed by clinical examination (visualization of amniotic fluid, positive vaginal pH test, ferning of vaginal fluid, or low amniotic fluid index)
  • Age 18 years or older
  • No known allergies or significant reactions to azithromycin or amoxicillin
  • Afebrile at presentation and during 24-hour observation
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Fetal anomalies in the current pregnancy
  • Diabetes mellitus, including pre-gestational and gestational
  • Abnormal placentation
  • Poor dating with ultrasound performed at or after 20 0/7 weeks
  • Current subchorionic hemorrhage or vaginal bleeding at presentation
  • Hypertensive disease including chronic hypertension, gestational hypertension, or pre-eclampsia/eclampsia
  • History of amniocentesis during this pregnancy
  • History of cervical incompetence, previous cerclage, or current cerclage in place
  • Current documented urinary tract infection or bacteriuria
  • Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
  • Immunocompromised state (HIV positive, daily steroid use, or autoimmune disease under immunotherapy)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

24-hour Observation

Duration - 24 hours

Participants are admitted for a 24-hour hospital observation period to monitor for signs of infection, preterm labor, or other complications before enrollment and randomization.

Continuous in-hospital monitoring during observation period

Treatment

Duration - Up to 5 to 7 days of outpatient antibiotic therapy before 23 weeks gestation (for antibiotic arm)

Participants are randomized to receive either antibiotics (azithromycin and amoxicillin) or no antibiotics prior to discharge. Those in the antibiotic arm receive the first dose in the hospital and continue outpatient antibiotic therapy. Both groups receive counseling and a patient information pamphlet.

1 hospital visit for initial dose and discharge, then weekly outpatient visits until 23 weeks gestation

Monitoring

Duration - Up to 5 weeks (from enrollment to 23 0/7 weeks gestation)

Participants attend weekly outpatient follow-up visits with Maternal-Fetal Medicine specialists to monitor maternal and fetal well-being until 23 0/7 weeks gestation or clinical change.

Weekly outpatient visits including vital signs, physical exams, ultrasounds, and lab tests

Inpatient Management

Duration - From 23 0/7 weeks gestation until delivery (variable duration)

At 23 0/7 weeks gestation, participants are readmitted for inpatient management including fetal neuroprotective treatment, corticosteroids, antibiotics, and close monitoring until delivery.

Continuous inpatient care with regular ultrasounds and fetal monitoring

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

R

Robert C Moore, MD

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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Published Research Related To This Trial

Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

B M Mercer, M Miodovnik, G R Thurnau...

https://pubmed.ncbi.nlm.nih.gov/9307346

What we have learned regarding antibiotic therapy for the reduction of infant morbidity after preterm premature rupture of the membranes.

Brian M Mercer, Robert L Goldenberg, Anita F Das...

https://pubmed.ncbi.nlm.nih.gov/12889589

Induction versus expectant management in premature rupture of the membranes with mature amniotic fluid at 32 to 36 weeks: a randomized trial.

B M Mercer, L G Crocker, N M Boe...

https://pubmed.ncbi.nlm.nih.gov/8238131