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