NCT04632017

Brief Summary

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

November 10, 2020

Last Update Submit

November 16, 2020

Conditions

CardiotocographyPremature Rupture of MembraneRupture of Membranes; PrematureSepsisPremature Birth

Keywords

cardiotocographyPremature Rupture of Membranecomputerized cardiotocographypremature birth

Outcome Measures

Primary Outcomes (1)

  • Preterm birth rate

    Less than 37 weeks gestation

Secondary Outcomes (8)

  • Gestational age at delivery

    Time of delivery

  • Preterm birth rates

    Less than 24, 28, 34 weeks gestation

  • Birth weight

    Time of delivery

  • Low birth weight rate

    Time of delivery

  • Neonatal death rate

    Between birth and 28 days of age

  • +3 more secondary outcomes

Study Arms (2)

pPROM

Singleton pregnancies admitted for pPROM to the Obstetrics ward

Diagnostic Test: Computerized cardiotocography

Control group

Healthy pregnant women matched for gestational age

Diagnostic Test: Computerized cardiotocography

Interventions

Computerized cardiotocographyDIAGNOSTIC_TEST

To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing

Control grouppPROM

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Singleton pregnancies admitted for pPROM to the Obstetrics ward of this Hospital will be recruited after informed consent.

You may qualify if:

  • pPROM between 24 and 34 weeks (w)

You may not qualify if:

  • multiple pregnancy, structural fetal anomalies, preexisting or gestational diabetes mellitus and\\or hypertension, intrauterine growth restriction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania "Luigi Vanvitelli"

Naples, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature RuptureSepsisPremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, Premature

Study Officials

  • Antonio Schiattarella, MD

    University of Campania Luigi Vanvitelli

    STUDY CHAIR

Central Study Contacts

Maddalena Morlando, MD

CONTACT

+39 333 426 3110madmorlando@gmail.com

Fabiana Savoia, MD

CONTACT

dott.fabianasavoia@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 17, 2020

Study Start

June 15, 2020

Primary Completion

March 30, 2021

Study Completion

July 30, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

IT(1)