Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
ID05345457

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

Led by University Hospitals Cleveland Medical Center · Updated on 2025-04-22

88

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Hospitals Cleveland Medical Center

Lead Sponsor

M

MetroHealth Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of outpatient oral antibiotics on delaying delivery after previable prelabor rupture of membranes (pPPROM) occurring between 18 weeks and 0 days and 22 weeks and 6 days of pregnancy. This randomized, controlled, non-placebo Phase 4 trial compares treatment with antibiotics versus standard care in pregnant women to see if antibiotics can prolong the time before delivery after membrane rupture. Participants are randomly assigned to one of two groups. The treatment group receives a seven-day oral antibiotic regimen including azithromycin and amoxicillin. Azithromycin is given as a single 500 mg dose before discharge, followed by 250 mg daily for 4 days. Amoxicillin is given as 500 mg three times daily for 7 days, starting before discharge. The control group receives standard care without antibiotics. The study focuses on outpatient management after membrane rupture. During the study, participants are monitored to assess delivery timing, with the main measure being whether delivery occurs within 28 days of membrane rupture. Researchers also track severe maternal and newborn health complications up to 6 weeks after delivery and until hospital discharge for newborns. The trial is led by University Hospitals Cleveland Medical Center and involves regular clinical assessments during the outpatient period. Participation continues until delivery and early postpartum follow-up, with the total study duration varying by individual pregnancy course.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • Pregnant
  • Live, singleton gestation
  • Able to provide informed consent
  • Gestational age between 18 weeks 0 days and 22 weeks 6 days at membrane rupture
  • Diagnosis of preterm, prelabor rupture of membranes by clinical exam or tests including amniotic fluid visualization, positive nitrazine test, ferning on microscopic exam, or low amniotic fluid index
Not Eligible

You will not qualify if you...

  • Gestational dating confirmed by ultrasound at 18 weeks or later
  • Desire for pregnancy interruption or labor induction
  • Known major fetal anomaly or aneuploidy
  • Amniocentesis within 7 days of membrane rupture diagnosis
  • Cervical cerclage placement within 7 days of membrane rupture diagnosis
  • Allergy or adverse reaction to macrolide or penicillin antibiotics
  • Current antibiotic use at diagnosis
  • Vaginal bleeding at or within 24 hours of membrane rupture diagnosis
  • Fever (temperature of 38°C or higher) at or within 24 hours of diagnosis
  • Active preterm labor or cervical change at or within 24 hours of diagnosis
  • Cervical dilation of 4 cm or more
  • Prolapse of fetal parts beyond internal cervical opening
  • Declining full 7-day outpatient monitoring prior to hospital readmission if rupture occurs during 22nd week of gestation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 days

Participants receive a 7-day course of antibiotics or standard care following previable rupture of membranes. Antibiotics include a single 500 mg azithromycin dose followed by 4 days of daily azithromycin tablets, and amoxicillin three times daily for 7 days.

1 treatment initiation visit prior to discharge and daily medication at home

Follow-up

Duration - Up to 6 months

Participants are monitored for delivery timing and health outcomes up to 6 weeks after delivery or hospital discharge.

Visits as needed up to 6 weeks postpartum and hospital stay follow-up

Trial Site Locations

Total: 3 locations

1

University Hospitals

Cleveland, Ohio, United States, 44106

Not Yet Recruiting

2

MetroHealth

Cleveland, Ohio, United States, 44109

Actively Recruiting

3

Cleveland Clinic

Cleveland, Ohio, United States, 44111

Not Yet Recruiting

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Research Team

F

Felicia LeMoine, MD

D

David Hackney, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

B M Mercer, M Miodovnik, G R Thurnau...

https://pubmed.ncbi.nlm.nih.gov/9307346