Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

NCT05469984 | Recruiting

• 1 other identifier: 0103-22-NHR
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Preterm Labor With Preterm Delivery; Premature Rupture of Membranes Prolonged

Keywords

prolonged term PROM; pre-term labor; prophylactic antibiotic; peripartum infection; bacterial distribution

Outcome Measures

Primary Outcomes (2)

• endometritis rate

  up to 6 weeks postpartum

• chorioamnionitis rate

  during labor (up to delivery of the newborn)

Secondary Outcomes (8)

• cord blood pH

  immediately after delivery of the placenta

• maternal intrapartum fever

  during labor (up to delivery of the newborn)

• NICU (neonatal intensive care unit) hospitalization length,

  up to 3 month from delivery

• rate of neonatal early onset sepsis

  up to one week from delivery

• Rate of participants treated with antibiotics during the postpartum period

  6 week postpartum

Study Arms (2)

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

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

Drug: Ampicillin Only Product; Drug: ampicillin plus gentamicin

Interventions

Ampicillin Only Product DRUG

women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

women with preterm labor; women with term prolonged>18h rupture of membrane

ampicillin plus gentamicin DRUG

women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

women with preterm labor; women with term prolonged>18h rupture of membrane

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: women 18 years or older with singleton pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel

RECRUITING

Related Publications (5)

• Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644.

  PMID: 17365450 BACKGROUND

• Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.

  PMID: 28742677 BACKGROUND

• Kachikis 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.

  PMID: 31783982 BACKGROUND

• Yoon 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.

  PMID: 11717646 BACKGROUND

• Soper 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.

  PMID: 8765246 BACKGROUND

MeSH Terms

Interventions

Ampicillin; Gentamicins

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Maya Wolf, MD

CONTACT

972-50-7887800; mayaw@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director- Fetal Maternal Medicine Unit

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 22, 2022
• Study Start: November 25, 2022
• Primary Completion: September 25, 2025
• Study Completion: September 26, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IL (1)