Trial Outcomes & Findings for Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam (NCT NCT00589329)

NCT ID: NCT00589329

Last Updated: 2019-09-04

Results Overview

The length of time (in hours) from initiation of therapy to delivery will establish the latency

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Measured from randomization to delivery in hours
• Results posted on: 2019-09-04

Participant Flow

Participant milestones

Measure	Group A Group A will be assigned to receive antibiotics: * Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. * Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days. erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days	Group B Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen. placebo: IV and pill placebo
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group A n=10 Participants Antibiotic group	Group B n=10 Participants Non antibiotic group	Total n=20 Participants Total of all reporting groups
Age, Customized	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured from randomization to delivery in hours

The length of time (in hours) from initiation of therapy to delivery will establish the latency

Outcome measures

Measure	Group A n=10 Participants Group A will be assigned to receive antibiotics: * Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. * Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days. erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days	Group B n=10 Participants Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen. placebo: IV and pill placebo
Length of Pregnancy Prolongation	4 hours Interval 0.0 to 36.0	4 hours Interval 1.0 to 38.0

SECONDARY outcome

Timeframe: newborn nursery

Respiratory distress will be defined by the clinical record documentation of the neonatal team.

Outcome measures

Measure	Group A n=10 Participants Group A will be assigned to receive antibiotics: * Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. * Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days. erythromycin and metronidazole (antibiotics): Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days	Group B n=10 Participants Group B will not receive antibiotics for pregnancy prolongation, but will receive a matching masked placebo (IV saline and pill) regimen. placebo: IV and pill placebo
Respiratory Distress	2 Participants	1 Participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larraine Presley

MetroHealth Medical CEnter

Phone: 216-778-8927

Email: lpresley@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place