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Search / Trial NCT01401179

Antibiotics Study in Preterm Premature Rupture of the Membranes

Launched by SAMSUNG MEDICAL CENTER · Jul 22, 2011

Trial Information

Current as of May 24, 2025

Completed

Keywords

Preterm Premature Rupture Of Fetal Membranes Antibiotic Therapy

ClinConnect Summary

Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv ...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • PPROM, PA 23+0\~33+0wks
  • ROM \<48 hrs before randomization
  • singleton
  • Cervical dilatation \<3cm
  • uterine contraction less than 4 times per 1 hr
  • Exclusion Criteria:
  • Major fetal malformation
  • Multifetal pregnancy
  • Rupture of the membrane \>8hrs before randomization
  • Prior antibiotics use at local clinic before referral
  • Vaginal bleeding
  • IIOC (incompetent internal os of cervix)
  • Placenta previa
  • Gestational diabetes or overt diabetes
  • Hypertensive disorders in pregnancy
  • Liver cirrhosis
  • Acute renal failure
  • IUGR(Intrauterine growth restriction)

About Samsung Medical Center

Samsung Medical Center (SMC) is a leading healthcare institution in South Korea, renowned for its commitment to advancing medical research and innovation. As a prominent clinical trial sponsor, SMC integrates cutting-edge technology and expert clinical practices to conduct rigorous studies aimed at improving patient outcomes. The center is dedicated to fostering collaborations with global research entities and adhering to the highest ethical standards, ensuring the integrity and reliability of its clinical trials. With a focus on diverse therapeutic areas, SMC plays a pivotal role in translating scientific discoveries into effective treatments, ultimately enhancing the quality of healthcare worldwide.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Soo-Young Oh, M.D., PhD

Principal Investigator

Samsung Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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