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Detection of Preterm Labour by Cervical Length

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104984
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Shehab Alam Millad, Assiut University

Brief Summary:
Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .

Condition or disease Intervention/treatment Phase
Preterm Labour Device: transvaginal ultrasound Drug: Progesterone Vaginal Suppository Procedure: cervical cercalage Other: digital vaginal exam Device: abdominal ultrasound Drug: Tocolytic Agents Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 966 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : November 15, 2021

Arm Intervention/treatment
Experimental: control group not follow NICE guide lines
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.
Other: digital vaginal exam
vaginal examination to detect short cervix

Device: abdominal ultrasound
use abdominal ultrasound to measure cervical length

Drug: Tocolytic Agents
a medication is given to prevent uterine contraction

Experimental: study group follow NICE guide lines
- 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
Device: transvaginal ultrasound
a transvaginal ultrasound is done to patient to determine cervical length

Drug: Progesterone Vaginal Suppository
a progesterone vaginal suppository to prevent preterm labour

Procedure: cervical cercalage
Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour




Primary Outcome Measures :
  1. preterm birth, defined as delivery before 37 weeks 0 days of gestation [ Time Frame: baseline ]
    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 :
  1. Mean GA at delivery [ Time Frame: baseline ]
    detection of Mean gastational age at delivery

  2. Birth Wight less than 2500 grams. [ Time Frame: baseline ]
    determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.

  3. Birth Wight ( mean +SD) in grams [ Time Frame: baseline ]
    detection of Birth Wight ( mean +SD) in grams

  4. compliance to medication. [ Time Frame: baseline ]
    determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.

  5. side effect related to intervention either progesterone or cercalage [ Time Frame: baseline ]
    detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient

  6. Mode of delivery [ Time Frame: baseline ]
    recording which patients deliver normal vaginal delivery or by cesarean section

  7. perinatal mortality. [ Time Frame: baseline ]
    record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients

  8. Neonatal morbidity [ Time Frame: baseline ]
    record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .

  9. admission to Neonatal intensive care unit [ Time Frame: baseline ]
    determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .

  10. Maternal morbidity [ Time Frame: baseline ]
    record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.



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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104984


Contacts
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Contact: Shehab A Millad, MD +201206507003 shehab_yanni@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Alaa Eldeen M Ismail, MD Asssiut University
Principal Investigator: Ahmed M Alaa eldeen, MD Assiut University
Principal Investigator: Hany A Ali, MD Asssiut University
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Responsible Party: Shehab Alam Millad, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04104984    
Other Study ID Numbers: VUS cervical Length
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tocolytic Agents
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents