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

Abnormal Vaginal Flora Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01722708
• Other study ID #: 0012-12-EMC
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: HaEmek Medical Center, Israel
• Contact: Zohar Nachum, MD
• Phone: 972-46495483
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Vaginal Flora
• Clindamycin Vs Metronidazole
• High Risk Pregnancies for Preterm Labor
• Obstetric Labor, Premature

Intervention

Drug:
• Clindamycin
Oral clindamycin 300 Milligrams*2/Day for a week
• Metronidazole
Oral metronidazole 500 Milligrams*2/Day for a week

Locations

Country	Name	City	State
Israel	Departement of obstetric and gynecology, HaEmek medical center	Afula
Israel	Departement of obstetric and gynecology, Poriya Medical Center	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The prevalence of adverse effects		During the antibacterial treatment which is 1 week of therapy
Secondary	The prevalence of late abortions and preterm deliveries		From date of randomization until the date of delivery or abortion, assessed up to 28 weeks
Secondary	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