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Clinical Trials/IRCT2017092317034N5
IRCT2017092317034N5
Completed
未知

Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women

Vice chancellor for research of Shiraz University of Medical Sciences0 sites120 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Vice chancellor for research of Shiraz University of Medical Sciences
Enrollment
120
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Vice chancellor for research of Shiraz University of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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