Preterm Premature Rupture of Membranes (PPROM)NCT07148622
Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes
A study testing Antibiotic regimen 1: sulbactam + ampicillin + azithromycin and Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin in people with Preterm Premature Rupture of Membranes (PPROM) and Prophylaxis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membranes (PPROM), Prophylaxis, Perinatal Outcomes
- What is being tested?
- Antibiotic regimen 1: sulbactam + ampicillin + azithromycin and Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancies,
- PPROM after 34 weeks of gestation
Who cannot join
- Patients with fetal anomalies
- Preeclampsia, gestational or pregestational diabetes mellitus,
- Multiple pregnancies,
- Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies.
- Maternal immunodeficiency
- The presence of other infections requiring antibiotic therapy, antenatal corticosteroid use, chronic diseases,
- Unwillingness to participate and sign the detailed informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes After 34 Weeks
To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Read the detailed description
Background: To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.
- Being tested
- Antibiotic regimen 1: sulbactam + ampicillin + azithromycin, Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin
- Keywords
- Preterm premature rupture of membranes, prophylaxis, perinatal outcomes
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic regimen 1: sulbactam + ampicillin + azithromycinDrug
For the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin
Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillinDrug
For the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic regimen 1 | Active comparator | Not described Receives: Drug: Antibiotic regimen 1: sulbactam + ampicillin + azithromycin |
| Antibiotic regimen 2 | Active comparator | Not described Receives: Drug: Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mode of birth checklist
Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist
Measured: From enrollment to the end of treatment at 4 weeks"
neonatal birth weight
neonatal birth weight
Measured: From enrollment to the end of treatment at 4 weeks"
1st and 5th minute APGAR scores
1st and 5th minute APGAR scores
Measured: From enrollment to the end of treatment at 4 weeks"
need for NICU (neonatal intensive care unit) admission
need for NICU (neonatal intensive care unit) admission
Measured: From enrollment to the end of treatment at 4 weeks"
duration of NICU stay
duration of NICU stay.
Measured: From enrollment to the end of treatment at 4 weeks"
White blood cell (WBC) count
White blood cell (WBC) count was measured every 48 hours
Measured: From enrollment to the end of treatment at 4 weeks"
C-reactive protein (CRP) levels
C-reactive protein (CRP) level was measured every 48 hours
Measured: From enrollment to the end of treatment at 4 weeks"
Maternal complications
Maternal complications; chorioamnionitis, placental abruption
Measured: From enrollment to the end of treatment at 4 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Oct 2024
- Primary completion1 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of Membranes (PPROM)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Karaaslan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148622
- Sponsor's protocol ID
- VYYU-KHD-OK-11
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lee J, Romero R, Kim SM, Chaemsaithong P, Yoon BH. A new antibiotic regimen treats and prevents intra-amniotic inflammation/infection in patients with preterm PROM. J Matern Fetal Neonatal Med. 2016 Sep;29(17):2727-37. doi: 10.3109/14767058.2015.1103729. Epub 2015 Dec 2.
PubMed 26441216Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.
PubMed 36791845
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes After 34 Weeks
- ClinicalTrials.gov ID
- NCT07148622
- Acronym / sponsor ID
- VYYU-KHD-OK-11
- Keywords
- Preterm premature rupture of membranes, prophylaxis, perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Detailed description
Background: To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Antibiotic regimen 1 | Active comparator | Drug: Antibiotic regimen 1: sulbactam + ampicillin + azithromycin |
| Antibiotic regimen 2 | Active comparator | Drug: Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancies,
- PPROM after 34 weeks of gestation
Key exclusion criteria (7 listed)
- Patients with fetal anomalies
- Preeclampsia, gestational or pregestational diabetes mellitus,
- Multiple pregnancies,
- Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies.
- Maternal immunodeficiency
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 |
|---|---|---|
| Antibiotic regimen 1: sulbactam + ampicillin + azithromycinFor the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin | Drug | Antibiotic regimen 1 |
| Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillinFor the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin. | Drug | Antibiotic regimen 2 |
Primary outcome
mode of birth checklist
Time frame: From enrollment to the end of treatment at 4 weeks"
Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist
neonatal birth weight
Time frame: From enrollment to the end of treatment at 4 weeks"
neonatal birth weight
1st and 5th minute APGAR scores
Time frame: From enrollment to the end of treatment at 4 weeks"
1st and 5th minute APGAR scores
need for NICU (neonatal intensive care unit) admission
Time frame: From enrollment to the end of treatment at 4 weeks"
need for NICU (neonatal intensive care unit) admission
duration of NICU stay
Time frame: From enrollment to the end of treatment at 4 weeks"
duration of NICU stay.
White blood cell (WBC) count
Time frame: From enrollment to the end of treatment at 4 weeks"
White blood cell (WBC) count was measured every 48 hours
C-reactive protein (CRP) levels
Time frame: From enrollment to the end of treatment at 4 weeks"
C-reactive protein (CRP) level was measured every 48 hours
Maternal complications
Time frame: From enrollment to the end of treatment at 4 weeks"
Maternal complications; chorioamnionitis, placental abruption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Results publication: PubMed 26441216Lee J, Romero R, Kim SM, Chaemsaithong P, Yoon BH. A new antibiotic regimen treats and prevents intra-amniotic inflammation/infection in patients with preterm PROM. J Matern Fetal Neonatal Med. 2016 Sep;29(17):2727-37. doi: 10.3109/14767058.2015.1103729. Epub 2015 Dec 2.
- Results publication: PubMed 36791845Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.
- Individual participant dataSharing planned: Yes
Related trials for Preterm Premature Rupture of Membranes (PPROM)
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
Recruiting
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM)
RecruitingPhase 4
Extended Azithromycin Treatment in Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes, PPROM
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic regimen 1: sulbactam + ampicillin + azithromycin and Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin in people with Preterm Premature Rupture of Membranes (PPROM) and Prophylaxis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mode of birth checklist (time frame: From enrollment to the end of treatment at 4 weeks"). The study lists 8 primary outcomes in all. 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 NCT07148622, which also lists 2 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 29 Aug 2025.