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

Preterm Labor With Preterm Delivery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469984
• Other study ID #: 0103-22-NHR
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2025

Study information

• Verified date: July 2022
• Source: Western Galilee Hospital-Nahariya
• Contact: Maya Wolf, MD
• Phone: 972-50-7887800
• Email: mayaw[@]gmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery -

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor With Preterm Delivery
• Rupture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

References & Publications (5)

Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. Review. — View Citation

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

Kachikis A, Eckert LO, Walker C, Bardají 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometritis rate		up to 6 weeks postpartum
Primary	chorioamnionitis rate		during labor (up to delivery of the newborn)
Secondary	cord blood pH		immediately after delivery of the placenta
Secondary	maternal intrapartum fever	body temperature,	during labor (up to delivery of the newborn)
Secondary	NICU (neonatal intensive care unit) hospitalization length,	days	up to 3 month from delivery
Secondary	rate of neonatal early onset sepsis	positive blood culture	up to one week from delivery
Secondary	neonatal APGAR score		at 1 and 5 minute post-delivery
Secondary	Rate of participants treated with antibiotics during the postpartum period		6 week postpartum
Secondary	maternal postpartum hospitalization length		up to 6 weeks post partum
Secondary	Number of neonate with ventilation support		one week from delivery
Secondary	Number of neonate treated with antibiotics		one week from delivery