Antibiotics at home after early water break: study stopped early
NCT ID NCT05345457
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether giving pregnant people oral antibiotics at home could delay delivery after their water broke very early (between 18 and 23 weeks). The goal was to see if more people would stay pregnant for at least 28 days after the water broke. The study was stopped early after enrolling only one person, so no clear conclusions can be drawn.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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1 person
The number who actually took part.
- Started
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Jan 2023
- Finished
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Feb 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44111, United States
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MetroHealth
Cleveland, Ohio, 44109, United States
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University Hospitals
Cleveland, Ohio, 44106, United States
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