Cervical Stiffness Measurement in Cervical Insufficiency

Completed

• Conditions: Preterm Birth; Pregnancy Related; Cervical Insufficiency
• Interventions: Device: Pregnolia

• Registration Number: NCT04158401
• Lead Sponsor: Tufts Medical Center

Brief Summary

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.

The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.

In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Study Start: 2020-01-15
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

1. Pregnant women over 18 years of age.
2. Singleton gestation.
3. Gestational ages between 12w0d and 22w6d.
4. Candidates for cerclage
5. Normal controls, which will be matched to cerclage subjects by gestational age and parity

Exclusion Criteria

1. Multiple gestation pregnancy.
2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
3. Chorioamnionitis
4. Preterm contractions
5. History of cervical surgery (LEEP, trachelectomy, conization).
6. Mullarian anomaly
7. Known carrier or HIV or Hepatitis B/C
8. Active genital infection
9. Communication problems (cognitively impaired adults unable to give consent)
10. Cerclage placement already performed this pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Pregnolia	Pregnant patients between 12w0d and 22w0d who present for prenatal care.
Cerclage group B	Pregnolia	Patients who present for an ultrasound-indicated cerclage placement.
Cerclage group C	Pregnolia	Patients who present for an exam-indicated cerclage placement.
Cerclage group A	Pregnolia	Patients who present for a history-indicated cerclage placement.

Primary Outcome Measures

Name	Time	Method
Cervical stiffness (Pcl)	5 minutes	The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.

Secondary Outcome Measures

Name	Time	Method
Newborn outcomes	up to 10 months	Newborn outcomes including weight, APGARs and complications will be recorded
Delivery data	up to 10 months	Patient delivery data including gestational age, mode of delivery and complications will be recorded

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States