NCT01722708

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

12.7 years

First QC Date

October 28, 2012

Last Update Submit

January 11, 2026

Conditions

Abnormal Vaginal FloraClindamycin Vs MetronidazoleHigh Risk Pregnancies for Preterm Labor

Keywords

Abnormal vaginal floraclindamycin Vs metronidazoleHigh risk pregnancies for preterm laborPreterm laborLate abortionbacterial vaginosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The prevalence of adverse effects

    During the antibacterial treatment which is 1 week of therapy

  • 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

Study Arms (2)

clindamycin

EXPERIMENTAL
Drug: Clindamycin

metronidazole

EXPERIMENTAL
Drug: Metronidazole

Interventions

ClindamycinDRUG

Oral clindamycin 300 Milligrams\*2/Day for a week

clindamycin
MetronidazoleDRUG

Oral metronidazole 500 Milligrams\*2/Day for a week

metronidazole

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departement of obstetric and gynecology, Poriya Medical Center

Tiberias, Israel, Israel

Location

Departement of obstetric and gynecology, HaEmek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Obstetric Labor, PrematureVaginosis, Bacterial

Interventions

ClindamycinMetronidazole

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydratesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzoles

Study Officials

  • Zohar Nachum, MD

    Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

July 2, 2025

Study Completion

December 30, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

IL(2)