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IRCT2017092317034N5 IRCT 2017-10-16 Vice chancellor for research of Shiraz University of Medical Sciences Cervical length measurement for preterm labor Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women 2010-10-01 anticipated 120 Complete https://irct.ir/trial/15770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator, Blinding description: 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. N/A Threatened preterm labor. Intervention 1: 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. Intervention 2: In 55 patients that were diagnosed with preterm labor pain without check cervical length, tocolytic and antenatal corticosteroids were given. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5780555/ 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. Yes - There is a plan to make this available What will be shared: Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient When: Participant data file:2023Ethic form: 2023 To whom: Participant data file: Researcher & Patient Ethic form: Patient Conditions: 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. Where to obtain: Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences How to obtain: 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. Comments:
public Dr. Seyedeh Marjan Hosseni
Shiraz University of Medical Sciences، Zand street
Shiraz Iran (Islamic Republic of) 34786-71946 +32 332365 marjanhosseini2410@yahoo.com Shiraz University of Medical Sciences scientific Dr. Homeira Vafaei
Shiraz University of Medical Science, Zand Street
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3233 2365 vafaeih@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) At least 4 contractions in 20 min interval Single pregnancy Gestational age before 34 weeks Maternal age 18-40 y 18 years 40 years Female 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 o60 Preterm labour and delivery Treatment - Drugs Other 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. In 55 patients that were diagnosed with preterm labor pain without check cervical length, tocolytic and antenatal corticosteroids were given. Transvaginal sonography. Timepoint: At the beginning of the enrollment and after persistent uterine contractions more than 4 hours. Method of measurement: Sonography. Preterm birth. Timepoint: 7 days after enrollment. Method of measurement: Delivery. Vice chancellor for research of Shiraz University of Medical Sciences Approved 2010-03-18 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences، Zand Street، Shiraz Shiraz Fars Iran (Islamic Republic of)