Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Antibiotics Study in Preterm Premature Rupture of the Membranes

NCT01401179

Preterm Premature Rupture of the Membranes

COMPLETED PHASE3

Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes

NCT02819570

Premature Rupture of Membrane

UNKNOWN PHASE4

Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes

NCT07148622

Preterm Premature Rupture of Membranes (PPROM) Prophylaxis Perinatal Outcomes

COMPLETED NA

Azithromycin and Ampicillin for Late PPROM

NCT07183462

Pregnancy Complications, Infectious Premature Birth Neonatal Diseases and Abnormalities +3 more

RECRUITING PHASE4

Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

NCT06349122

Bacterial Vaginosis Vaginal Dysbiosis Premature Delivery

NOT_YET_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Premature Rupture of Membrane

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

one-week treatment group

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Cefazolin 1.0gm IVs q 12 hours after randomization for one week

Clarithromycin

Intervention Type DRUG

clarithromycin 500mg po bid after randomization for one week

until-delivery treatment group

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Cefazolin 1.0gm IVs q 12 hours after randomization until delivery

Clarithromycin

Intervention Type DRUG

clarithromycin 500mg po bid after randomization until delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cefazolin

Cefazolin 1.0gm IVs q 12 hours after randomization for one week

Intervention Type DRUG

Clarithromycin

clarithromycin 500mg po bid after randomization for one week

Intervention Type DRUG

Cefazolin

Cefazolin 1.0gm IVs q 12 hours after randomization until delivery

Intervention Type DRUG

Clarithromycin

clarithromycin 500mg po bid after randomization until delivery

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* preterm premature rupture of membrane(PPROM), PA 22+0\~34+0wks
* ROM \<72 hrs before randomization
* cervical dilatation \<3cm
* uterine contraction less than 4 times per 1 hr

Exclusion Criteria

* Major fetal malformation
* Rupture of the membrane \>72hrs before randomization
* Vaginal bleeding
* IIOC (incompetent internal os of cervix)
* Placenta previa
* Gestational diabetes or overt diabetes
* Hypertensive disorders in pregnancy
* Liver cirrhosis
* Acute renal failure

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No