Status:
UNKNOWN
The Impact of Cervical Cerclage or Vaginal Progesterone on Vaginal Microbiome Distribution
Lead Sponsor:
Western Galilee Hospital-Nahariya
Conditions:
Preterm Labor
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal progesterone and maternal vaginal microbiome distribution during pregnancy
Detailed Description
Cervical insufficiency is primarily a clinical diagnosis, characterized by painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Ad...
Eligibility Criteria
Inclusion
- G- roup 1 - Pregnant women with a singleton gestation and cervical cerclage at 12-14 weeks of gestation due to obstetrical history characteristic of cervical insufficiency G- roup 2 - Pregnant women with a singleton gestation at 12-14 weeks of gestation without a history of cervical insufficiency
- Group 3 - Pregnant women treated with progesterone due to previous preterm labor without cerclage
Exclusion
- A- cute cervical insufficiency P- roven or suspected chorioamnionitis P- remature rupture of membranes F- etal structural abnormality G- estation beyond 15 weeks A- ntibiotic usage in the past month P- robiotic use in the past month R- eported autoimmune disease or immunosuppressive disorder
Key Trial Info
Start Date :
March 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03253016
Start Date
March 26 2017
End Date
January 1 2021
Last Update
August 17 2017
Active Locations (1)
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1
Galil Medical Center
Nahariya, Israel, Israel