Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Preterm birth remains a major health concern affecting up to 12% of all live births prior to 37 weeks gestation. As preterm birth can often be associated with infection our proposal is to evaluate in a randomized fashion antibiotics for women with advanced cervical exams.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MetroHealth Medical Center
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Metronidazole

Criteria

Inclusion Criteria:

1. All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7 weeks gestation. Preterm labor will be defined by regular contractions and/or cervical change from last documented exam.

2. Cervical exam 4 cm or greater

3. Intact membranes

Exclusion Criteria:

1. Multiple gestation (>2)

2. Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia

3. Lethal fetal anomaly

4. Persistent vaginal bleeding, abruption, or placenta previa

5. Rupture of membranes

6. Maternal illness or fetal indication requiring delivery

7. Inability to give informed consent

8. Serious allergy to study medications. GI discomfort will not be considered a drug allergy