Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Not Applicable

Recruiting

• Conditions: High Risk Pregnancies for Preterm Labor; Abnormal Vaginal Flora; Clindamycin Vs Metronidazole
• Interventions: Drug: Clindamycin; Drug: Metronidazole

• Registration Number: NCT01722708
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated. Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal flora will be randomly treated either with clindamycin or metronidazole. Eradication of the abnormal flora and adverse effects will be monitored and compared

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-28
• Study Start: 2012-11-01
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

• Pregnant women at increased risk for preterm labor (preterm cervical effacement, preterm uterine contractions, twins pregnancy, vaginal bleeding, past preterm delivery)
• Age above 18 years

Exclusion Criteria

• Known allergy to the tested antibiotics
• Antibacterial treatment in the week before the vaginal culture was taken
• preterm premature rupture of membranes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clindamycin	Clindamycin	-
metronidazole	Metronidazole	-

Primary Outcome Measures

Name	Time	Method
To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora	Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment

Secondary Outcome Measures

Name	Time	Method
The prevalence of late abortions and preterm deliveries	From date of randomization until the date of delivery or abortion, assessed up to 28 weeks
Assessing the correlation between Nugent score , physical examination and Ph indicators	The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
The prevalence of adverse effects	During the antibacterial treatment which is 1 week of therapy

Trial Locations

Locations (2)

Departement of obstetric and gynecology, Poriya Medical Center; 🇮🇱 Tiberias, Israel

Departement of obstetric and gynecology, HaEmek medical center; 🇮🇱 Afula, Israel