Cervical length measurement for preterm labor

Not Applicable

Conditions: Threatened preterm labor.
Preterm labour and delivery

Registration Number: IRCT2017092317034N5

Lead Sponsor: Vice chancellor for research of Shiraz University of Medical Sciences

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 120

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures