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Antibiotics at home after early water break: study stopped early

NCT ID NCT05345457

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1 person

The number who actually took part.

Started

Jan 2023

Finished

Feb 2024

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Fetal Membranes, Premature Rupture Premature Birth preterm premature rupture of the membranes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44111, United States

  • MetroHealth

    Cleveland, Ohio, 44109, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

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