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

Woman's · NCT04047849

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
34
US sites recruiting
1
Study start
August 28, 2019
Record last updated
January 11, 2021

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Antibiotics, oral Azithromycin and oral Amoxicillin

Conditions: Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture); Rupture of Membranes; Premature; Rupture of Membranes; Premature, Affecting Fetus; Preterm Birth; Preterm PROM (Pregnancy); Preterm Labor

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Singleton gestation
  • Gestational age of greater than 18 0/7 but less than or equal to 22 6/7
  • Diagnosis of prelabor premature rupture of membranes as determined by clinical examination noting either/or 1) visualization of amniotic fluid passing from the cervical canal and pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (ferning) of dried vaginal fluid identified via microscopic examination, or 4) an amniotic fluid index (AFI) of less than 4cm
  • Greater than or equal to 18 years of age
  • Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
  • Afebrile at the time of presentation and throughout 24-hour observation period
  • Patient must be able to provide informed consent

Exclusion Criteria

  • Fetal anomalies in current pregnancy
  • Diabetes mellitus, including both pre-gestational and gestational
  • Abnormal placentation
  • Poor dating with dating ultrasound performed later than or equal to 20 0/7 weeks
  • Current subchorionic hemorrhage or current vaginal bleeding on presentation
  • Hypertensive disease, including pre-gestational chronic hypertension, gestational hypertension and pre-eclampsia/eclampsia
  • History of amniocentesis during this pregnancy
  • History of cervical incompetence, history of cerclage in previous pregnancy or current cerclage in place
  • Current documented urinary tract infection or bacteriuria
  • Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
  • Immunocompromised (i.e., HIV positive, daily steroid use, or a history of autoimmune disease for which the patient is currently undergoing treatment with immunotherapy medication)

Recruiting US locations

  • Woman's Hospital

    Baton Rouge, LA 70817

    Site contact: Ericka Seidemann · 225-231-5296 · ericka.seidemann@womans.org

Study contacts (from the official record)

  • Felicia LeMoine, MD · 2252768164 · fvenab@lsuhsc.edu
  • Robert C Moore, MD · 2252153883 · robert.moore@womans.org
All pregnancy studies in Louisiana →
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA (NCT04047849) | Bored Studies