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NCT Number: NCT05469984

Comparing 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

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ampicillin Only Product

Drug

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

ampicillin plus gentamicin

Drug

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

Primary outcomes

  1. endometritis rate

    Time frame: up to 6 weeks postpartum

  2. chorioamnionitis rate

    Time frame: during labor (up to delivery of the newborn)

Secondary outcomes

  1. cord blood pH

    Time frame: immediately after delivery of the placenta

  2. maternal intrapartum fever

    Time frame: during labor (up to delivery of the newborn)

    body temperature,

  3. NICU (neonatal intensive care unit) hospitalization length,

    Time frame: up to 3 month from delivery

    days

  4. rate of neonatal early onset sepsis

    Time frame: up to one week from delivery

    positive blood culture

  5. Rate of participants treated with antibiotics during the postpartum period

    Time frame: 6 week postpartum

  6. maternal postpartum hospitalization length

    Time frame: up to 6 weeks post partum

  7. Number of neonate with ventilation support

    Time frame: one week from delivery

  8. Number of neonate treated with antibiotics

    Time frame: one week from delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Wolf, MD

CONTACT

[email protected]

972-50-7887800

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2022
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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