Uterine artery Doppler plus uterocervical angle to predict preterm labor

Role of Uterine Artery Doppler Indices and Sonographic Measurement of Uterocervical Angle in Predicting Preterm Labor

This study will try adding a cervix-angle measurement to routine uterine artery Doppler in pregnant people at 24–34 weeks who present with threatened preterm labor to see if the two together better predict early birth.

Quick facts

• Study type: Observational
• Enrollment: 47 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Kafrelsheikh University (Academic / other)
• Locations: 1 site (Kafr ash Shaykh)
• Trial ID: NCT07336173 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort in which pregnant people with threatened preterm labor will have routine mid‑trimester uterine artery Doppler (resistance index, pulsatility index, and notching) measured transabdominally and an anterior uterocervical angle measured transvaginally between 24 and 34 weeks. The investigators will compare the sensitivity and specificity of each measurement alone versus the combination for predicting subsequent preterm birth. Eligible participants are singleton pregnancies dated by first‑trimester ultrasound, aged 18–40, and meeting criteria for threatened preterm labor; key exclusions include ruptured membranes, chorioamnionitis, multiple gestation, major fetal anomalies, and major maternal disease. All imaging is added to routine antenatal care and performed at a single center.

Who should consider this trial

Good fit: Pregnant people aged 18–40 with a singleton pregnancy dated by first‑trimester ultrasound who are 24–34 weeks' gestation and present with threatened preterm labor are the intended candidates.

Not a fit: People with ruptured membranes, clinical chorioamnionitis, multiple pregnancy, prior cervical surgery, major fetal anomalies, severe obstetric complications, or significant maternal medical disorders are excluded and unlikely to benefit from this specific prediction approach.

Why it matters

Potential benefit: If successful, combining these ultrasound measures could improve early identification of people at high risk of preterm birth so care can be targeted earlier.

How similar studies have performed: Prior research shows the uterocervical angle is associated with spontaneous preterm birth and uterine artery Doppler predicts placental problems that can lead to iatrogenic preterm birth, but combining both measurements for prediction is relatively novel with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Patient who will give verbal \& written will informed consent.
2. Pregnant women between 18 and 40 years old of age
3. Singleton pregnancy
4. Gestational age will be confirmed by first trimester ultrasound scan (\<14 weeks).
5. Gestational age between 24 and 34 weeks .
6. Threatened preterm labor which is defined as:

Presence of at least one uterine contraction every 10 minutes lasting ≥30 seconds . Cervical dilatation ≤3 cm . Cervical effacement \<80%.

Exclusion Criteria:

Obstetric:

1. Ruptured membranes
2. Clinical evidence of Chorioamnionitis.
3. Fetal compromise on evaluation.
4. Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
5. Diagnosed intrauterine growth restriction (IUGR).
6. Congenital fetal anomalies.
7. Multiple pregnancies.
8. Prior cervical surgery (e.g., cone biopsy, cerclage).

Non-Obstetric:

1. Significant maternal medical disorders (e.g., chronic hypertension, diabetes mellitus, liver dysfunction).
2. Severe non-obstetric complications (e.g., acute abdomen).

Where this trial is running

Kafr ash Shaykh

• Kafr elsheikh university hospital — Kafr ash Shaykh, Egypt (Recruiting)

Study contacts

• Study coordinator: Nourhan M Shalaby, Master

Conditions Preterm Labor