The effectiveness of the combined treatment with vaginal progesterone plus cervical pessary compared to vaginal progesterone monotherapy for the prevention of preterm birth: a randomized clinical trial.
This study prospective, open-label, randomized clinical trial aimed to evaluate the effectiveness of the combined strategy of cervical pessary plus vaginal progesterone to vaginal progesterone alone in decreasing the rate of preterm birth in women with short cervical length detected by vaginal sonography in mid-pregnancy. Women were considered eligible if they had a singleton pregnancy with short cervix at 18-22 gestational weeks without any cervical dilation or medical illness. The women were randomly allocated in two groups: group A to receive 400mg of daily vaginal progesterone until 37 weeks of pregnancy, and group B to receive cervical pessary plus 400mg of daily vaginal progesterone until 37 weeks of pregnancy. Participants were visited every 4 weeks for routine assessment and detection of adverse effects of each treatment. The primary outcome measure was preterm birth before 37 weeks of gestation. The secondary outcome measures were the rate of low birth weight (LBW) delivery (defined as birth weight less than 2500 grams), premature rupture of membranes (PROM), chorioamnionitis (diagnosed based on placental pathology after delivery), requirement for NICU admission, and fetal or neonatal deaths.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603109568N15
Registration date:2016-03-22, 1395/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-22, 1395/01/03
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tehran University of Medical Scienses
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the combined treatment with vaginal progesterone plus cervical pessary compared to vaginal progesterone monotherapy for the prevention of preterm birth: a randomized clinical trial.
Public title
Vaginal progesterone plus cervical pessary for preventing preterm birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-40 years of age; singleton gestation; 18-22 gestational weeks; cervical length of less than 25 millimeters by transvaginal ultrasound; no cervical dilation; no history of any medical illness.
Exclusion criteria: : any medical illness upon enrollment; having urogenital infection; major fetal abnormalities; painful regular uterine contractions; placenta previa; ruptured membranes; active vaginal bleeding; history of cone biopsy; refusing to provide informed consent to participate in the study.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
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 of the Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street.
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
10010544
Health conditions studied
1
Description of health condition studied
Preterm delivery
ICD-10 code
O60.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery
Primary outcomes
1
Description
preterm birth before 37 weeks of gestation
Timepoint
monthly, after the intervention, untill 37th week of gestational
Method of measurement
clinical delivery and the time is assessed based on ultrasound imaging
Secondary outcomes
1
Description
Low birth weight (LBW) delivery
Timepoint
After birth
Method of measurement
weighing scale
2
Description
premature rupture of membranes
Timepoint
after the intervention
Method of measurement
clinical examination
3
Description
chorioamnionitis
Timepoint
after the intervention
Method of measurement
diagnosed based on placental pathology after delivery
4
Description
requirement for NICU admission
Timepoint
after the intervention
Method of measurement
clinical examination
5
Description
fetal or neonatal death rate
Timepoint
after the intervention
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention Group:
Cervical pessary inserted by an obstetrician, between 18-20 weeks of gestation, in an outpatient setting.A vaginal speculum examination was done to determine the appropriate size. The site with the smallest diameter was placed upwards to surround the cervix. The patients were asked to report any vaginal or pelvic discomfort. The pessary was removed by a simple vaginal examination in the 37th week of gestation, or earlier if the patient presented with rupture of membranes, vaginal bleeding, or painful uterine contractions despite tocolytics. These patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.
Category
Treatment - Devices
2
Description
Control Group:
Patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.