Using antibiotics to prolong pregnancy after premature rupture of membranes

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

This study is testing if giving antibiotics to women with a premature rupture of membranes can help them keep their pregnancy going longer.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Woman's (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT04047849 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of outpatient oral antibiotics, specifically amoxicillin and azithromycin, in extending the duration of pregnancy after a premature rupture of membranes (PPROM) in women between 18 and 22 weeks of gestation. Participants diagnosed with PPROM will undergo a 24-hour monitoring period before being randomly assigned to either receive antibiotics or not. The primary outcome measured will be the number of days the pregnancy continues after the rupture. This study aims to provide insights into the management of PPROM and its implications for preterm birth.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 or older, between 18 0/7 and 22 6/7 weeks of gestation, diagnosed with prelabor premature rupture of membranes without other complications.

Not a fit: Patients with fetal anomalies, diabetes, or other significant complications in their pregnancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help prolong pregnancies in women experiencing PPROM, potentially improving outcomes for both mothers and infants.

How similar studies have performed: Other studies have explored the use of antibiotics in similar contexts, showing promising results, but this specific approach in previable PPROM is less commonly tested.

Eligibility 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)

Where this trial is running

Baton Rouge, Louisiana

• Woman's Hospital — Baton Rouge, Louisiana, United States (RECRUITING)

Study contacts

• Principal investigator: Robert C Moore, MD — Woman's Hospital, Louisiana
• Study coordinator: Felicia LeMoine, MD

Conditions: Rupture of Membranes, Delayed Delivery, Premature, Premature, Affecting Fetus, Preterm Birth, Preterm PROM, Preterm Labor, Previable