Protocol summary
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Study aim
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This study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Women with cervical dilatation >5 cm, polyhydramnios, macrosomia, multiple pregnancy, suspected intrauterine infection, rupture of membranes, vaginal bleeding were excluded.
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Intervention groups
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65 patients undergoing cervical length measurement by transvaginal
ultrasonography for further management (case group) and 55 patients who received tocolytic and corticosteroid therapy (control group)
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Main outcome variables
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cervical length, Delivery within 7 days
General information
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Reason for update
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Add results and modify some items
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017092317034N5
Registration date:
2017-10-16, 1396/07/24
Registration timing:
retrospective
Last update:
2023-12-06, 1402/09/15
Update count:
1
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Registration date
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2017-10-16, 1396/07/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shiraz University of Medical Sciences
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Expected recruitment start date
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2010-10-01, 1389/07/09
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Expected recruitment end date
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2015-02-01, 1393/11/12
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Actual recruitment start date
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2010-10-01, 1389/07/09
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Actual recruitment end date
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2015-02-01, 1393/11/12
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Trial completion date
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2015-02-01, 1393/11/12
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Scientific title
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Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women
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Public title
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Cervical length measurement for preterm labor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
At least 4 contractions in 20 min interval
Single pregnancy
Gestational age before 34 weeks
Maternal age 18-40 y
Exclusion criteria:
Polyhydramnios (amniotic fluid index greater than 24 cm)
Macrosomia(estimated fetal weight >90th centile)
Rupture of membranes
Cervical dilatation >5 cm
Multiple pregnancy
Suspected intrauterine infection
Vaginal bleeding (more than bloody show)
Major medical disorders in mother
Contraindicated for vaginal delivery(e.g. placenta previa)
Non-reassuring fetal heart monitoring
Fetal anomaly
Any contraindication for administer of beta-sympathomimetic drugs and previous treatment with tocolytics/corticosteroid in this pregnancy
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
120
Actual sample size reached:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients will receive A medication based on computerized random digit number in double blind method and a code will be allocated to each patient (1 to 120) that will be encoded at the end of the study. The patients and the designer and drug distributors are not aware of the drug pack. This study is the second phase of trial.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2010-03-18, 1388/12/27
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Ethics committee reference number
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Ct-88-5026
Health conditions studied
1
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Description of health condition studied
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Threatened preterm labor
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ICD-10 code
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o60
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ICD-10 code description
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Preterm labour and delivery
Primary outcomes
1
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Description
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Transvaginal sonography
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Timepoint
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At the beginning of the enrollment and after persistent uterine contractions more than 4 hours
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Method of measurement
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Sonography
2
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Description
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Preterm birth
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Timepoint
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7 days after enrollment
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Method of measurement
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Delivery
Intervention groups
1
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Description
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Those who were assigned to the case group underwent transvaginal ultrasonography for measuring the cervical length by one expert obstetrician. Neither residents nor sonographers were not aware of this clinical trial. Those with cervical length <15 mm were received tocolytic ( Nifedipne (tablet 10 mg manufactured by toliddaru Pharmaceutical Company ) 20 to 30 mg orally initial loading dose, then followed 10 mg every 6 hours up to 48 hours with a maximum dose of 180 mg/day) and corticosteroid therapy according to the hospital protocol. Expectantly management was performed when cervical length was ≥15 mm, but with persistent uterine contractions more than 4 hr, another cervical measurement was performed by the same operator. If the cervical length was become <15 mm tocolytic and antenatal corticosteroids were given.
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Category
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Treatment - Drugs
2
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Description
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In 55 patients that were diagnosed with preterm labor pain without check cervical length, tocolytic and antenatal corticosteroids were given.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research of Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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Participant data file:2023Ethic form: 2023
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To whom data/document is available
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Participant data file: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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Participant data file: participant's or legal guardian's are permitted for awareness of the results. Ethic form: participant's or legal guardian's are permitted for awareness of the results.
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From where data/document is obtainable
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Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information. Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information.
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2023-12-06, 1402/09/15
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2017-11-01, 1396/08/10
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Abstract of published paper
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Background:
Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians.
Objective:
To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor.
Materials and Methods:
In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome.
Results:
This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001).
Conclusion:
“Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.