Comparison of Efficacy and Safety of Cervical Pessary with Routine Management in Decreasing the Preterm Labor Rate in Nulliparous Symptomatic Pregnant Women with Short Cervix: A Randomized Clinical Trial
- Evaluation of the Efficacy of Cervical Pessary in Decreasing the rate of preterm labor in women with singleton pregnancy and shortened cervix
- Evaluation of Safety of Cervical Pessary in Decreasing the rate of preterm labor in women with singleton pregnancy and shortened cervix
Design
A two parallel arm group randomized clinical trial, without placebo, without blinding and concealment, with sample size of 100
Settings and conduct
Study was performed in a referral teaching hospital with annual census of 40,000.
Included women were randomly allocated to 2 groups after verifying that the cervical length is <25 mm yet. In first group (pessary group), a cervical pessary (Milex® Pessary, CooperSurgical co, NewYork, USA) with proper size was placed for patient in lithotomy position. In second group (control group), no pessary was inserted and patients received only the routine standard institutional treatments.
Participants/Inclusion and exclusion criteria
- We included patients with gestational age between 24 weeks and 0 days to 34 weeks and 0 days and shortened cervical length (≤25 mm measured by transvaginal ultrasound scan in second trimester)
-We excluded cases with major fetal abnormalities, fever or any other clinical findings in favor of chorioamnionitis, placenta previa; women with normal cervical length and women who had not responded to the routine standard treatments of preterm labor and were experiencing continued signs and symptoms of preterm labor after 48 hours of admission, vaginal bleeding, signs of ruptured membranes.
Intervention groups
Cervical Pessary Insertion
Main outcome variables
Primary outcome: giving birth after 37 weeks of gestation
Secondary outcome:
- possible side effects of pessary (including vaginal discharge, pessary descent, urinary tract infection, severe pelvic pain or discomfort)
- spontaneous preterm birth before 34 weeks
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180819040830N3
Registration date:2020-04-29, 1399/02/10
Registration timing:retrospective
Last update:2020-04-29, 1399/02/10
Update count:1
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Zahra Naeiji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
z.naeigi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Comparison of Efficacy and Safety of Cervical Pessary with Routine Management in Decreasing the Preterm Labor Rate in Nulliparous Symptomatic Pregnant Women with Short Cervix: A Randomized Clinical Trial
Public title
Role of Cervical Pessary in Prevention of Preterm Labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 24 weeks and 0 days to 34 weeks and 0 days
Shortened cervical length (defined as cervical length ≤25 mm measured by trans-vaginal ultrasound scan in second trimester)
Exclusion criteria:
Major fetal abnormalities
Fever or any other clinical findings in favor of chorioamnionitis and
Placenta previa
Women with normal cervical length
Women who had not responded to the routine standard treatments of preterm labor and were experiencing continued signs and symptoms of preterm labor after 48 hours of admission
Vaginal bleeding
Signs of ruptured membranes.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated blocks of 4 in block randomization method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
--
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Shahid Beheshti University of Medical Sciences