Pregnancy PretermPhase 4NCT05345457
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
A Phase 4 study testing Azithromycin Pill and Amoxicillin Pill in people with Pregnancy Preterm and Pregnancy Prom, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy)
- What is being tested?
- Azithromycin Pill and Amoxicillin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jan 2023to 26 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals
Cleveland, Ohio, 44106
MetroHealth
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44111
About this study
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.
- Conditions
- Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy), Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor, Premature Birth
- Being tested
- Azithromycin Pill, Amoxicillin Pill
- Medical subject headings
- Fetal Membranes, Premature Rupture, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin PillDrug
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 PillDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. 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 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. Receives: Drug: Azithromycin Pill; Drug: Amoxicillin Pill |
| No antibiotics | No intervention | Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days from date of rupture
Secondary outcomes (2)
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.
Measured: From diagnosis of membrane rupture to 6 weeks following delivery
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.
Measured: From date of delivery to date of hospital discharge (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start13 Jan 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PretermStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MetroHealth Medical Center, The Cleveland Clinic
- Responsible party
- Principal investigator, David Hackney MD, MS, University Hospitals Cleveland Medical Center
- Investigators
- David Hackney, MD, Principal investigator, University Hospitals Cleveland Medical CenterJustin Lappen, MD, Principal investigator, The Cleveland ClinicBrian Mercer, MD, Principal investigator, MetroHealth Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345457
- Sponsor's protocol ID
- STUDY20220251
- Status last verified
- May 2026
- First submitted
- 14 Apr 2022
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data collection and primary analysis has been completed. A de-identified data set will be provided.
Publications
Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.
PubMed 24974589Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period linked birth/infant death data set. Natl Vital Stat Rep. 2010 Apr 30;58(17):1-31.
PubMed 20815136Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
PubMed 21508700Kilbride HW, Thibeault DW. Neonatal complications of preterm premature rupture of membranes. Pathophysiology and management. Clin Perinatol. 2001 Dec;28(4):761-85. doi: 10.1016/s0095-5108(03)00076-9.
PubMed 11817188Yeast JD. Preterm premature rupture of the membranes before viability. Clin Perinatol. 2001 Dec;28(4):849-60. doi: 10.1016/s0095-5108(03)00082-4.
PubMed 11758532Muris C, Girard B, Creveuil C, Durin L, Herlicoviez M, Dreyfus M. Management of premature rupture of membranes before 25 weeks. Eur J Obstet Gynecol Reprod Biol. 2007 Apr;131(2):163-8. doi: 10.1016/j.ejogrb.2006.05.016. Epub 2006 Jul 17.
PubMed 16846673Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, Rabello YA, Meis PJ, Moawad AH, Iams JD, Van Dorsten JP, Paul RH, Bottoms SF, Merenstein G, Thom EA, Roberts JM, McNellis D. 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. JAMA. 1997 Sep 24;278(12):989-95.
PubMed 9307346American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care consensus No. 6: Periviable Birth. Obstet Gynecol. 2017 Oct;130(4):e187-e199. doi: 10.1097/AOG.0000000000002352.
PubMed 28937572Grisaru-Granovsky S, Eitan R, Kaplan M, Samueloff A. Expectant management of midtrimester premature rupture of membranes: a plea for limits. J Perinatol. 2003 Apr-May;23(3):235-9. doi: 10.1038/sj.jp.7210880.
PubMed 12732862Schucker JL, Mercer BM. Midtrimester premature rupture of the membranes. Semin Perinatol. 1996 Oct;20(5):389-400. doi: 10.1016/s0146-0005(96)80006-1.
PubMed 8912993Waters TP, Mercer BM. The management of preterm premature rupture of the membranes near the limit of fetal viability. Am J Obstet Gynecol. 2009 Sep;201(3):230-40. doi: 10.1016/j.ajog.2009.06.049.
PubMed 19733274Pristauz G, Bauer M, Maurer-Fellbaum U, Rotky-Fast C, Bader AA, Haas J, Lang U. Neonatal outcome and two-year follow-up after expectant management of second trimester rupture of membranes. Int J Gynaecol Obstet. 2008 Jun;101(3):264-8. doi: 10.1016/j.ijgo.2007.12.007. Epub 2008 Mar 4.
PubMed 18289539Dotters-Katz SK, Myrick O, Smid M, Manuck TA, Boggess KA, Goodnight W. Use of prophylactic antibiotics in women with previable prelabor rupture of membranes. J Neonatal Perinatal Med. 2017;10(4):431-437. doi: 10.3233/NPM-16165.
PubMed 29286934Manuck TA, Eller AG, Esplin MS, Stoddard GJ, Varner MW, Silver RM. Outcomes of expectantly managed preterm premature rupture of membranes occurring before 24 weeks of gestation. Obstet Gynecol. 2009 Jul;114(1):29-37. doi: 10.1097/AOG.0b013e3181ab6fd3.
PubMed 19546755Esteves JS, de Sa RA, de Carvalho PR, Coca Velarde LG. Neonatal outcome in women with preterm premature rupture of membranes (PPROM) between 18 and 26 weeks. J Matern Fetal Neonatal Med. 2016;29(7):1108-12. doi: 10.3109/14767058.2015.1035643. Epub 2015 Jul 3.
PubMed 26138545
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
- ClinicalTrials.gov ID
- NCT05345457
- Acronym / sponsor ID
- STUDY20220251
- Conditions
- Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy), Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor, Premature Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- MetroHealth Medical Center, The Cleveland Clinic
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Posted 18 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: Azithromycin Pill, Drug: Amoxicillin PillPatients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. 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 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. |
| No antibiotics | No intervention | –Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin PillAzithromycin 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). | Drug | Antibiotics |
| Amoxicillin PillAmoxicillin 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. | Drug | Antibiotics |
Primary outcome
Delivery Within 28 Days
Time frame: 28 days from date of rupture
The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)
2 secondary outcomes
Severe Maternal Morbidity Composite
Time frame: From diagnosis of membrane rupture to 6 weeks following delivery
Severe Neonatal Morbidity Composite
Time frame: From date of delivery to date of hospital discharge (up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24974589Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.
- Background: PubMed 20815136Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period linked birth/infant death data set. Natl Vital Stat Rep. 2010 Apr 30;58(17):1-31.
- Background: PubMed 21508700Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
- Background: PubMed 11817188Kilbride HW, Thibeault DW. Neonatal complications of preterm premature rupture of membranes. Pathophysiology and management. Clin Perinatol. 2001 Dec;28(4):761-85. doi: 10.1016/s0095-5108(03)00076-9.
- Background: PubMed 11758532Yeast JD. Preterm premature rupture of the membranes before viability. Clin Perinatol. 2001 Dec;28(4):849-60. doi: 10.1016/s0095-5108(03)00082-4.
- Background: PubMed 16846673Muris C, Girard B, Creveuil C, Durin L, Herlicoviez M, Dreyfus M. Management of premature rupture of membranes before 25 weeks. Eur J Obstet Gynecol Reprod Biol. 2007 Apr;131(2):163-8. doi: 10.1016/j.ejogrb.2006.05.016. Epub 2006 Jul 17.
- Background: PubMed 9307346Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, Rabello YA, Meis PJ, Moawad AH, Iams JD, Van Dorsten JP, Paul RH, Bottoms SF, Merenstein G, Thom EA, Roberts JM, McNellis D. 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. JAMA. 1997 Sep 24;278(12):989-95.
- Background: PubMed 28937572American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care consensus No. 6: Periviable Birth. Obstet Gynecol. 2017 Oct;130(4):e187-e199. doi: 10.1097/AOG.0000000000002352.
- Background: PubMed 12732862Grisaru-Granovsky S, Eitan R, Kaplan M, Samueloff A. Expectant management of midtrimester premature rupture of membranes: a plea for limits. J Perinatol. 2003 Apr-May;23(3):235-9. doi: 10.1038/sj.jp.7210880.
- Background: PubMed 8912993Schucker JL, Mercer BM. Midtrimester premature rupture of the membranes. Semin Perinatol. 1996 Oct;20(5):389-400. doi: 10.1016/s0146-0005(96)80006-1.
- Background: PubMed 19733274Waters TP, Mercer BM. The management of preterm premature rupture of the membranes near the limit of fetal viability. Am J Obstet Gynecol. 2009 Sep;201(3):230-40. doi: 10.1016/j.ajog.2009.06.049.
- Background: PubMed 18289539Pristauz G, Bauer M, Maurer-Fellbaum U, Rotky-Fast C, Bader AA, Haas J, Lang U. Neonatal outcome and two-year follow-up after expectant management of second trimester rupture of membranes. Int J Gynaecol Obstet. 2008 Jun;101(3):264-8. doi: 10.1016/j.ijgo.2007.12.007. Epub 2008 Mar 4.
- Individual participant dataSharing planned: Yes. Once data collection and primary analysis has been completed. A de-identified data set will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hackney, MD principal investigator
University Hospitals Cleveland Medical Center
Justin Lappen, MD principal investigator
The Cleveland Clinic
Brian Mercer, MD principal investigator
MetroHealth Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin Pill and Amoxicillin Pill in people with Pregnancy Preterm and Pregnancy Prom, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery Within 28 Days (time frame: 28 days from date of rupture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345457, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.