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NCT Number: NCT04158401

Cervical Stiffness Measurement in Cervical Insufficiency

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.

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Key information

Conditions

Pregnancy Related Abortion, Habitual Abortion, Spontaneous Cervical Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 02122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pregnolia

Device

The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.

Primary outcomes

  1. Cervical stiffness (Pcl)

    Time frame: 5 minutes

    The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.

Secondary outcomes

  1. Delivery data

    Time frame: up to 10 months

    Patient delivery data including gestational age, mode of delivery and complications will be recorded

  2. Newborn outcomes

    Time frame: up to 10 months

    Newborn outcomes including weight, APGARs and complications will be recorded

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Pregnolia AG

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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