Recruiting

Latency Antibiotics

Sponsor:

Woman's

Code:

NCT04047849

Conditions

Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture)

Rupture of Membranes; Premature

Rupture of Membranes; Premature, Affecting Fetus

Preterm Birth

Preterm PROM (Pregnancy)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Antibiotics, oral Azithromycin and oral Amoxicillin

Study Details

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).

Conditions

Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture)

Rupture of Membranes; Premature

Rupture of Membranes; Premature, Affecting Fetus

Preterm Birth

Preterm PROM (Pregnancy)

Study ID

NCT04047849

Start date

Aug 28, 2019

Status verified date

Jan, 2021

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Felicia LeMoine, MD

2252768164fvenab@lsuhsc.edu

Robert C Moore, MD

2252153883robert.moore@womans.org

Locations

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Ericka Seidemann

225-231-5296ericka.seidemann@womans.org

Principal Investigator:

Robert C Moore, MD

More Information

Sponsor

Woman's

Last update posted

Jan 11, 2021

Last verified

Jan, 2021

Keywords

  • Previable
  • PPROM
  • Premature prelabor rupture of membranes
  • Preterm
  • Preterm birth
  • Latency antibiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Woman's on 2021-01-11.