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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047849
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Woman's

Brief 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).

Condition or disease Intervention/treatment Phase
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 Drug: Antibiotics, oral Azithromycin and oral Amoxicillin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The treatment group will include those subjects randomized to the antibiotic arm versus the control arm, no antibiotics. The antibiotic arm will receive a single, 500mg dose of Azithromycin given prior to discharge to home, followed by 250mg daily for 4 more days, and Amoxicillin 500mg orally TID for 7 days (first dose also being given prior to discharge home). Both arms will receive patient pamphlets with study contacts, precautions, and graphs for daily temperature/symptom tracking. Weekly follow up with Maternal-Fetal Medicine, for both arms, will include history and physical exam, vital signs, and ultrasound for fetal well-being and measurement of AFI. Both arms will be re-admitted to the hospital either at 1) viability (23 0/7 weeks) or 2) clinical signs of placental abruption, preterm labor, chorioamnionitis or fetal demise. Re-admission of both arms at viability will include latency antibiotics, neuroprotective magnesium sulfate, and corticosteroids for fetal lung maturity.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Antibiotics on Latency in Previable Prelabor Rupture of Membranes Between 18 0/7 and 22 6/7 Weeks Gestational Age
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears

Arm Intervention/treatment
Experimental: Antibiotics
This will include those subjects randomized into the treatment arm, receiving the outpatient antibiotic course of azithromycin and amoxicillin prior to re-admission at viability (23 0/7 weeks gestation). They will receive a single, 500mg dose of Azithromycin given prior to discharge to home, followed by 250mg daily for 4 more days, and Amoxicillin 500mg orally TID for 7 days (first dose also being given prior to discharge home).
Drug: Antibiotics, oral Azithromycin and oral Amoxicillin
Azithromycin (500mg day one followed by 250mg per day for 4 more days) and amoxicillin (500mg orally three times daily for 7 days) for a total course of seven days of antibiotic therapy
Other Name: Z-pack

No Intervention: No antibiotics
This will include those subjects randomized into the control arm and will not receive outpatient antibiotics prior to re-admission at viability (23 0/7 weeks gestation).



Primary Outcome Measures :
  1. Latency period [ Time Frame: Patient will be monitored from the date of diagnosis of previable prelabor rupture of membranes until date of delivery. This could vary from a duration of less than 1 day to 112 days. ]
    The number of days from diagnosis of previable prelabor rupture of membranes to the date of delivery


Secondary Outcome Measures :
  1. Viability [ Time Frame: Number of days from the time of rupture of membranes (earliest 18 0/7 weeks) to viability (23 0/7 weeks), max 35 days. ]
    The number of subjects in each arm that are able to reach 23 0/7 weeks gestational age following previable prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Singleton gestation
  2. Gestational age of greater than 18 0/7 but less than or equal to 22 6/7
  3. 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
  4. Greater than or equal to 18 years of age
  5. Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
  6. Afebrile at the time of presentation and throughout 24-hour observation period
  7. Patient must be able to provide informed consent

Exclusion Criteria:

  1. Fetal anomalies in current pregnancy
  2. Diabetes mellitus, including both pre-gestational and gestational
  3. Abnormal placentation
  4. Poor dating with dating ultrasound performed later than or equal to 20 0/7 weeks
  5. Current subchorionic hemorrhage or current vaginal bleeding on presentation
  6. Hypertensive disease, including pre-gestational chronic hypertension, gestational hypertension and pre-eclampsia/eclampsia
  7. History of amniocentesis during this pregnancy
  8. History of cervical incompetence, history of cerclage in previous pregnancy or current cerclage in place
  9. Current documented urinary tract infection or bacteriuria
  10. Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
  11. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047849


Contacts
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Contact: Felicia LeMoine, MD 2252768164 fvenab@lsuhsc.edu
Contact: Robert C Moore, MD 2252153883 robert.moore@womans.org

Locations
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United States, Louisiana
Woman's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70817
Contact: Ericka Seidemann    225-231-5296    ericka.seidemann@womans.org   
Sub-Investigator: Felicia V LeMoine, MD         
Principal Investigator: Robert C Moore, MD         
Sponsors and Collaborators
Woman's
Investigators
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Principal Investigator: Robert C Moore, MD Woman's Hospital, Louisiana
  Study Documents (Full-Text)

Documents provided by Woman's:
Study Protocol  [PDF] April 23, 2019
Informed Consent Form  [PDF] April 23, 2019

Additional Information:
Publications:
Cunningham, F. G., MD, Leveno, K. J., MD, Dashe, J. S., MD, Hoffman, B. L., MD, Bloom, S. L., MD, Casey, B. M., MD, Spong, C. Y., MD (Eds.). (2014). Preterm Labor. In Williams Obstetrics(24th ed., pp. 848-849). New York, NY: McGraw Hill Education.
Svigos, John M, et al. "Chapter 63: Prelabor Rupture of Membranes." High Risk Pregnancy: Management Options - Expert Consult, by David K. James et al., Saunders, 2010, pp. 1321-132.

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Responsible Party: Woman's
ClinicalTrials.gov Identifier: NCT04047849    
Other Study ID Numbers: RP-19-001
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: IPD will become available beginning 6 months after study publication and will be available indefinitely.
Access Criteria: Requests for data are available to all researchers; however, approval for access to data will be granted by primary investigator.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Woman's:
Previable
PPROM
Premature prelabor rupture of membranes
Preterm
Preterm birth
Latency antibiotics
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Fetal Membranes, Premature Rupture
Rupture, Spontaneous
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Amoxicillin
Azithromycin
Anti-Infective Agents