Preterm Labor With Preterm DeliveryNCT05469984
Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
A study testing Ampicillin Only Product and ampicillin plus gentamicin in people with Preterm Labor With Preterm Delivery and Premature Rupture of Membranes Prolonged, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged
- What is being tested?
- Ampicillin Only Product and ampicillin plus gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Nov 2022to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- GBS carrier
- preterm premature rupture of membrane for conservative treatment
- intra-uterine fetal death fetal major anomaly
- drug allergy for the antibiotic in use in this study
- women receiving antibiotic treatment for other infection such as urinary tract infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Galil Medical Center
Nahariya
Maya Wolf, MD, 972-507887800, homesickid@yahoo.com
About this study
Official title: Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity
Read the detailed description
Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.
Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis
- Being tested
- Ampicillin Only Product, ampicillin plus gentamicin
- Keywords
- prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampicillin Only ProductDrug
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
ampicillin plus gentamicinDrug
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
| Study group | Role | What they receive |
|---|---|---|
| women with term prolonged>18h rupture of membrane | Active comparator | women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery Receives: Drug: Ampicillin Only Product; Drug: ampicillin plus gentamicin |
| women with preterm labor | Active comparator | women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours Receives: Drug: Ampicillin Only Product; Drug: ampicillin plus gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometritis rate
Measured: up to 6 weeks postpartum
chorioamnionitis rate
Measured: during labor (up to delivery of the newborn)
Secondary outcomes (8)
cord blood pH
Measured: immediately after delivery of the placenta
maternal intrapartum fever
body temperature,
Measured: during labor (up to delivery of the newborn)
NICU (neonatal intensive care unit) hospitalization length,
days
Measured: up to 3 month from delivery
rate of neonatal early onset sepsis
positive blood culture
Measured: up to one week from delivery
Rate of participants treated with antibiotics during the postpartum period
Measured: 6 week postpartum
maternal postpartum hospitalization length
Measured: up to 6 weeks post partum
Number of neonate with ventilation support
Measured: one week from delivery
Number of neonate treated with antibiotics
Measured: one week from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start25 Nov 2022
- Primary completion25 Sep 2025 (estimated)
- Study completion26 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm Labor With Preterm DeliveryStudies 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
- women with prolonged premature rupture of membrane\>18 h or women in preterm delivery will be randomized to receive one of two prophylactic antibiotic treatment
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469984
- Sponsor's protocol ID
- 0103-22-NHR
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644.
PubMed 17365450Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
PubMed 28742677Kachikis A, Eckert LO, Walker C, Bardaji A, Varricchio F, Lipkind HS, Diouf K, Huang WT, Mataya R, Bittaye M, Cutland C, Boghossian NS, Mallett Moore T, McCall R, King J, Mundle S, Munoz FM, Rouse C, Gravett M, Katikaneni L, Ault K, Klein NP, Roberts DJ, Kochhar S, Chescheir N; Brighton Collaboration Chorioamnionitis Working Group. Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7610-7622. doi: 10.1016/j.vaccine.2019.05.030. No abstract available.
PubMed 31783982Yoon BH, Romero R, Moon JB, Shim SS, Kim M, Kim G, Jun JK. Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001 Nov;185(5):1130-6. doi: 10.1067/mob.2001.117680.
PubMed 11717646Soper DE, Mayhall CG, Froggatt JW. Characterization and control of intraamniotic infection in an urban teaching hospital. Am J Obstet Gynecol. 1996 Aug;175(2):304-9; discussion 309-10. doi: 10.1016/s0002-9378(96)70139-4.
PubMed 8765246
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
- ClinicalTrials.gov ID
- NCT05469984
- Acronym / sponsor ID
- 0103-22-NHR
- Keywords
- prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 22 Jul 2022 (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.
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity
Detailed description
Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.
Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- women with prolonged premature rupture of membrane>18 h or women in preterm delivery will be randomized to receive one of two prophylactic antibiotic treatment
| Arm | Type | Receives |
|---|---|---|
| women with term prolonged>18h rupture of membrane | Active comparator | Drug: Ampicillin Only Product, Drug: ampicillin plus gentamicinwomen with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery |
| women with preterm labor | Active comparator | Drug: Ampicillin Only Product, Drug: ampicillin plus gentamicinwomen with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- GBS carrier
- preterm premature rupture of membrane for conservative treatment
- intra-uterine fetal death fetal major anomaly
- drug allergy for the antibiotic in use in this study
- women receiving antibiotic treatment for other infection such as urinary tract infection
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 |
|---|---|---|
| Ampicillin Only Productwomen will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin | Drug | women with preterm labor, women with term prolonged>18h rupture of membrane |
| ampicillin plus gentamicinwomen will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin | Drug | women with preterm labor, women with term prolonged>18h rupture of membrane |
Primary outcome
endometritis rate
Time frame: up to 6 weeks postpartum
chorioamnionitis rate
Time frame: during labor (up to delivery of the newborn)
8 secondary outcomes
cord blood pH
Time frame: immediately after delivery of the placenta
maternal intrapartum fever
Time frame: during labor (up to delivery of the newborn)
NICU (neonatal intensive care unit) hospitalization length,
Time frame: up to 3 month from delivery
rate of neonatal early onset sepsis
Time frame: up to one week from delivery
Rate of participants treated with antibiotics during the postpartum period
Time frame: 6 week postpartum
maternal postpartum hospitalization length
Time frame: up to 6 weeks post partum
Number of neonate with ventilation support
Time frame: one week from delivery
Number of neonate treated with antibiotics
Time frame: one week from delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 17365450Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644.
- Background: PubMed 28742677Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
- Background: PubMed 31783982Kachikis A, Eckert LO, Walker C, Bardaji A, Varricchio F, Lipkind HS, Diouf K, Huang WT, Mataya R, Bittaye M, Cutland C, Boghossian NS, Mallett Moore T, McCall R, King J, Mundle S, Munoz FM, Rouse C, Gravett M, Katikaneni L, Ault K, Klein NP, Roberts DJ, Kochhar S, Chescheir N; Brighton Collaboration Chorioamnionitis Working Group. Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7610-7622. doi: 10.1016/j.vaccine.2019.05.030. No abstract available.
- Background: PubMed 11717646Yoon BH, Romero R, Moon JB, Shim SS, Kim M, Kim G, Jun JK. Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001 Nov;185(5):1130-6. doi: 10.1067/mob.2001.117680.
- Background: PubMed 8765246Soper DE, Mayhall CG, Froggatt JW. Characterization and control of intraamniotic infection in an urban teaching hospital. Am J Obstet Gynecol. 1996 Aug;175(2):304-9; discussion 309-10. doi: 10.1016/s0002-9378(96)70139-4.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ampicillin Only Product and ampicillin plus gentamicin in people with Preterm Labor With Preterm Delivery and Premature Rupture of Membranes Prolonged, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Wolf, MD (972-50-7887800, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometritis rate (time frame: up to 6 weeks postpartum). The study lists 2 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 NCT05469984, which also lists 5 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 6 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.