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Detection of Preterm Labour by Cervical Length

Primary Purpose

Preterm Labour

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
transvaginal ultrasound
Progesterone Vaginal Suppository
cervical cercalage
digital vaginal exam
abdominal ultrasound
Tocolytic Agents
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labour

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus

Exclusion Criteria:

.Current Cervical cercalage.

  • Major Fetal malformation .
  • Prenatal infection (bacterial vaginosis ) .Medical comorbidities . .Currently receiving Progesterone treatment. .Pregnancy from assisted reproductive technique . .Threatened miscarriage . .Rupture membrane. .Painful uterine contraction. .Low implanted placenta.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    control group not follow NICE guide lines

    study group follow NICE guide lines

    Arm Description

    All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.

    - All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study . and will be managed according NICE guide lines

    Outcomes

    Primary Outcome Measures

    preterm birth, defined as delivery before 37 weeks 0 days of gestation
    determine number of patients with preterm birth under 37 week gastational age and trying to prevent early diagnosed conditions from 922 patient diagnosed with short cervix

    Secondary Outcome Measures

    Mean GA at delivery
    detection of Mean gastational age at delivery
    Birth Wight less than 2500 grams.
    determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.
    Birth Wight ( mean +SD) in grams
    detection of Birth Wight ( mean +SD) in grams
    compliance to medication.
    determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
    side effect related to intervention either progesterone or cercalage
    detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient
    Mode of delivery
    recording which patients deliver normal vaginal delivery or by cesarean section
    perinatal mortality.
    record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
    Neonatal morbidity
    record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .
    admission to Neonatal intensive care unit
    determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .
    Maternal morbidity
    record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.

    Full Information

    First Posted
    September 17, 2019
    Last Updated
    January 10, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04104984
    Brief Title
    Detection of Preterm Labour by Cervical Length
    Official Title
    Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2020 (Anticipated)
    Primary Completion Date
    September 15, 2021 (Anticipated)
    Study Completion Date
    November 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .
    Detailed Description
    All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study . History taking .Obstetric history will be obtained from the patient includes gravidity and parity , last menstrual period , duration of gestation at birth time , mode of delivery , gender, birth Wight, any complication in each pregnancy, miscarriage and causes of miscarriage . Past history will be obtained from the patient for any medical disease like ( severe anaemia, hypertensive disease, heart disease, antiretroviral therapy in pregnancy and genitourinary infection) and History of cervical cercalage . Family history will be obtained to determine any history of family preterm birth. Socioeconomic status will be obtained include occupation and financial status. Special Habits for both couples. Gynaecological history will be taken from the patient include any vaginal bleeding, history of vaginal infection, operations like D and C with cervical dilatation. Examination Examination of the patient include vital signs, general examination ( head, neck ,chest ,heart ) obstetric examination include inspection, palpation, auscultation and speculum vaginal examination. -Investigation Investigation includes antenatal care laboratory tests like urine analysis ,CBC, RH factor and random blood sugar . Transvaginal ultrasound: Study group : Cervical length will be measured using transvaginal ultrasonography with the standard longitudinal view of cervix while patient's bladder is empty. TVS probe will be used to measure cervical length. It will be measured by keeping the probe 3cm away from the posterior fornix. The cervical length is defined as the length between the internal OS and external OS Those with short cervix less than 25 mm will be managed According to NICE guide lines : Offer a choice of either prophylactic vaginal progesterone or prophylactic cervical cerclage to women: with a history of spontaneous preterm birth or mid-trimester loss between 16+0 and 34+0 weeks of pregnancy and in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm. Discuss the benefits and risks of prophylactic progesterone and cervical cerclage with the woman and take her preferences into account. Offer prophylactic vaginal progesterone to women with no history of spontaneous preterm birth or mid-trimester loss in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm. Consider prophylactic cervical cerclage for women in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm and who have either: had preterm prelabour rupture of membranes (P-PROM) in a previous pregnancy or a history of cervical trauma (17) . progesterone will be given in form of vaginal suppository 200 mg once daily . Start receiving it once diagnoses is established till 34 week gestation. A McDonald cerclage will be be preformed for women once diagnoses is established and removed at 36 week gestational or when labour pain start. Control group : All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix by digital vaginal exam or trans abdominal ultrasound or not specified and do not undergo transvaginal ultrasound assessment , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group. • Then all patients will be followed up every 4 weeks by taking history , any complaint of new symptoms , compliance to treatment, obstetric exam and investigation if indicated till delivery and record the time of delivery or termination of pregnancy. After delivery, record maternal and fetal outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Labour

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    966 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group not follow NICE guide lines
    Arm Type
    Experimental
    Arm Description
    All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.
    Arm Title
    study group follow NICE guide lines
    Arm Type
    Experimental
    Arm Description
    - All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study . and will be managed according NICE guide lines
    Intervention Type
    Device
    Intervention Name(s)
    transvaginal ultrasound
    Intervention Description
    a transvaginal ultrasound is done to patient to determine cervical length
    Intervention Type
    Drug
    Intervention Name(s)
    Progesterone Vaginal Suppository
    Intervention Description
    a progesterone vaginal suppository to prevent preterm labour
    Intervention Type
    Procedure
    Intervention Name(s)
    cervical cercalage
    Intervention Description
    Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
    Intervention Type
    Other
    Intervention Name(s)
    digital vaginal exam
    Intervention Description
    vaginal examination to detect short cervix
    Intervention Type
    Device
    Intervention Name(s)
    abdominal ultrasound
    Intervention Description
    use abdominal ultrasound to measure cervical length
    Intervention Type
    Drug
    Intervention Name(s)
    Tocolytic Agents
    Intervention Description
    a medication is given to prevent uterine contraction
    Primary Outcome Measure Information:
    Title
    preterm birth, defined as delivery before 37 weeks 0 days of gestation
    Description
    determine number of patients with preterm birth under 37 week gastational age and trying to prevent early diagnosed conditions from 922 patient diagnosed with short cervix
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Mean GA at delivery
    Description
    detection of Mean gastational age at delivery
    Time Frame
    baseline
    Title
    Birth Wight less than 2500 grams.
    Description
    determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.
    Time Frame
    baseline
    Title
    Birth Wight ( mean +SD) in grams
    Description
    detection of Birth Wight ( mean +SD) in grams
    Time Frame
    baseline
    Title
    compliance to medication.
    Description
    determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
    Time Frame
    baseline
    Title
    side effect related to intervention either progesterone or cercalage
    Description
    detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient
    Time Frame
    baseline
    Title
    Mode of delivery
    Description
    recording which patients deliver normal vaginal delivery or by cesarean section
    Time Frame
    baseline
    Title
    perinatal mortality.
    Description
    record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
    Time Frame
    baseline
    Title
    Neonatal morbidity
    Description
    record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .
    Time Frame
    baseline
    Title
    admission to Neonatal intensive care unit
    Description
    determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .
    Time Frame
    baseline
    Title
    Maternal morbidity
    Description
    record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
    Time Frame
    baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus Exclusion Criteria: .Current Cervical cercalage. Major Fetal malformation . Prenatal infection (bacterial vaginosis ) .Medical comorbidities . .Currently receiving Progesterone treatment. .Pregnancy from assisted reproductive technique . .Threatened miscarriage . .Rupture membrane. .Painful uterine contraction. .Low implanted placenta.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shehab A Millad, MD
    Phone
    +201206507003
    Email
    shehab_yanni@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alaa Eldeen M Ismail, MD
    Organizational Affiliation
    Asssiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ahmed M Alaa eldeen, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hany A Ali, MD
    Organizational Affiliation
    Asssiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Detection of Preterm Labour by Cervical Length

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