Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Premature Birth Clinical Trial

Official title:

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345457
• Other study ID #: STUDY20220251
• Status: Recruiting
• Phase: Phase 4
• Start date: January 13, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Felicia LeMoine, MD
• Phone: (216) 983-6606
• Email: felicia.lemoine[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking
• Pregnant
• Live, singleton gestation
• Patient able to provide informed consent
• Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture
• Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm

Exclusion Criteria:

• Gestational dating performed or confirmed by ultrasound at = 18 weeks and 0 days gestational age
• Patient desires pregnancy interruption or induction of labor
• Known major fetal anomaly or aneuploidy
• Amniocentesis = 7 days of diagnosis of rupture of membranes
• Cervical cerclage placement = 7 days of diagnosis of rupture of membranes
• Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics
• Current antibiotic use at the time of membrane rupture diagnosis
• Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis
• Febrile at the time of membrane rupture diagnosis (i.e., temperature = 38 degrees Celsius) and/or within first 24 hours of diagnosis
• Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis
• Cervical dilation of = 4 cm
• Prolapse of fetal parts beyond the level of the internal cervical os
• Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Pregnancy Preterm
• Premature Birth
• PROM (Pregnancy)
• Rupture

Intervention

Drug:
• Azithromycin Pill
Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days).
• Amoxicillin Pill
Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	MetroHealth Medical Center, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery within 28 days	The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)	28 days from date of rupture
Secondary	Severe maternal morbidity composite	The proportion of patient's "positive" for severe maternal morbidity composite. A patient will be termed "positive" for severe maternal morbidity composite if any one of the following is diagnosed: maternal sepsis, postpartum hemorrhage, maternal ICU admission, maternal death.	From diagnosis of membrane rupture to 6 weeks following delivery
Secondary	Severe neonatal morbidity composite	The proportion of patient's "positive" for severe neonatal morbidity composite. A neonate will be termed "positive" for severe neonatal morbidity composite if any one of the following is diagnosis: bronchopulmonary dysplasia (BPD), pulmonary hypoplasia, intraventricular hemorrhage (IVH) grade III/IV, necrotizing enterocolitis (NEC) Bell's Stage II or greater, neonatal sepsis with positive blood cultures, neonatal pneumonia with positive blood cultures, neonatal death.	From date of delivery to date of hospital discharge (up to 6 months)