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NCT06917157 | NOT YET RECRUITING | Preterm Prelabor Rupture of Membranes (PPROM)

Latency Antibiotics for Previable Rupture Of Membranes Trial
Sponsor:

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

Khalil want

Brief Summary:

The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.

Condition or disease

Preterm Prelabor Rupture of Membranes (PPROM)

Intervention/treatment

Administration of antibiotics prophylactically at the time of membrane rupture

Administration of antibiotics non-prophylactically at 22 weeks

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2027-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Preterm premature rupture of membranes at less than 22 weeks.
  • * Membrane rupture had occurred within 36 hours of randomization.
  • * Cervical dilatation is 3 cm or less (on visual or clinical examination).
  • * 4 or fewer contractions in the 60-minute monitoring period before randomization.
  • * Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
  • * Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.
Exclusion Criteria
  • * Nonreasoning fetal testing
  • * Vaginal bleeding
  • * Maternal or fetal indication for immediate delivery
  • * Cervical cerclage in place
  • * Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
  • * Allergy to Penicillins or Azithromycin
  • * Febrile illness requiring antibiotics
  • * Placenta previa
  • * Multifetal gestation
Latency Antibiotics for Previable Rupture Of Membranes Trial

Location Details

NCT06917157

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030