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
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Protocol summary
A two parallel arm group randomized clinical trial, without placebo, without blinding and concealment, with sample size of 100
A two parallel arm groups randomized clinical trial, without placebo, without blinding and concealment, with sample size of 100
A two parallel arm groupgroups randomized clinical trial, without placebo, without blinding and concealment, with sample size of 100
General information
100
empty
100
2019-03-21, 1398/01/01
2020-05-01, 1399/02/12
20192020-0305-2101 00:00:00
2019-12-22, 1398/10/01
2020-10-01, 1399/07/10
20192020-1210-2201 00:00:00
2019-03-21, 1398/01/01
empty
2019-03-21 00:00:00
2019-12-22, 1398/10/01
empty
2019-12-22 00:00:00
2019-12-22, 1398/10/01
empty
2019-12-22 00:00:00
empty
Due to a miscalculation in conversion of Hijri to Gregorian date, the recruitment dates were entered wrongly so they are updated.
Due to a miscalculation in conversion of Hijri to Gregorian date, the recruitment dates were entered wrongly so they are updated.
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با توجه به اشتباه وارد کردن تاریخ جمع آوری نمونه ها، تاریخ تصحیح شد.
با توجه به اشتباه وارد کردن تاریخ جمع آوری نمونه ها، تاریخ تصحیح شد.
Recruitment centers
#1
Name of recruitment center - English:
Name of recruitment center - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Country:
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Mahdieh Hospital
Name of recruitment center - Persian: بیمارستان مهدیه
Full name of responsible person - English: Dr Zahra Naeigi
Full name of responsible person - Persian: دکتر زهرا نایئجی
Street address - English: Mahdieh Hospital, Shoosh Sq.
Street address - Persian: میدان شوش، بیمارستان مهدیه
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1185817311
Phone: +98 21 5506 2628
Fax: +98 21 5506 2628
Email: mahdieh_hospital@sbmu.ac.ir
Web page address: https://mmc.sbmu.ac.ir/
Name of recruitment center - English: Mahdieh Hospital Name of recruitment center - Persian: بیمارستان مهدیه Full name of responsible person - English: Dr Zahra Naeigi Full name of responsible person - Persian: دکتر زهرا نایئجی Street address - English: Mahdieh Hospital, Shoosh Sq. Street address - Persian: میدان شوش، بیمارستان مهدیه City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1185817311 Phone: +98 21 5506 2628 Fax: +98 21 5506 2628 Email: mahdieh_hospital@sbmu.ac.ir Web page address: https://mmc.sbmu.ac.ir/
#2
Name of recruitment center - English: Mahdiye hospital
Name of recruitment center - Persian: بیمارستان مهدیه
Full name of responsible person - English: Zahra Naeiji
Full name of responsible person - Persian: تهران
Street address - English: Mahdiyeh hospital, Shishegar Khaneh St., Fadayian Eslam Blv., Shoos Sq.
Street address - Persian: میدان شوش، بلواز فداییان اسلام، خیابان شیشه گر خانه، بیمارستان مهدیه
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445763693
Phone: +98 21 5506 2628
Fax:
Email: mahdiyeh_hospital@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Mahdiye hospital Name of recruitment center - Persian: بیمارستان مهدیه Full name of responsible person - English: Zahra Naeiji Full name of responsible person - Persian: تهران Street address - English: Mahdiyeh hospital, Shishegar Khaneh St., Fadayian Eslam Blv., Shoos Sq. Street address - Persian: میدان شوش، بلواز فداییان اسلام، خیابان شیشه گر خانه، بیمارستان مهدیه City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445763693 Phone: +98 21 5506 2628 Fax: Email: mahdiyeh_hospital@sbmu.ac.ir Web page address:
Protocol summary
Study aim
- 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 groups 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
Due to a miscalculation in conversion of Hijri to Gregorian date, the recruitment dates were entered wrongly so they are updated.
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180819040830N3
Registration date:2020-04-29, 1399/02/10
Registration timing:prospective
Last update:2020-11-20, 1399/08/30
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
2020-05-01, 1399/02/12
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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