Preterm labor and birth is associated with several neonatal complications including respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH). Differentiating true and false labor pain is a dilemma to obstetricians. We performed this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092317034N5
Registration date:2017-10-16, 1396/07/24
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Homeira Vafaei Cisakht
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
vafaeih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women
Public title
Cervical length measurement for preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age less than 34 weeks old, aged between 18-40 years old
Exclusion criteria: Women with cervix dilatation greater than 5 cm, polyhydramnios (amniotic fluid index (AFI) greater than 20 cm), oligohydramnios (AFI less than 10 cm), macrosomia (estimated fetal weight of 4 kg or more), suspected intrauterine infection (a temperature greater than 37.5°C) or growth restriction, major antepartum hemorrhage, rupture of membranes, maternal major medical disorders, diabetes mellitus, presence of a contraindication for vaginal delivery (e.g. major
placenta previa), one previous cesarean delivery, multiple pregnancy, hypertension in pregnancy, blood pressure less than 90/50mmHg, previous history of abruption placenta, signs of fetal distress, lethal fetal anomaly and contraindication for the use of beta-sympathomimetic drugs and previous
treatment with tocolytics in the present gestation were excluded from the trial.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Postal code
Approval date
2010-03-18, 1388/12/27
Ethics committee reference number
Ct-88-5026
Health conditions studied
1
Description of health condition studied
Threatened preterm labor
ICD-10 code
o60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
Transvaginal sonography
Timepoint
Before treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Betamethasone is given in two doses to patients with cervical length less than 15 mm.
Category
Treatment - Drugs
2
Description
Patients with cervical length greater than 15 mm are only under observation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Syedeh Marjan Hosseni
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Marjan Hosseni
Position
Rezedent of Obstetrics & GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، Zand street
City
Shiraz
Postal code
Phone
+32 332365
Fax
Email
marjanhosseini2410@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Homeira Vafaei
Position
Professor of Obstetrics & GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
vafaeih@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Seydeh Marjan Hosseni
Position
Professor of Obstetrics & GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)