Detection of Preterm Labour by Cervical Length
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|ClinicalTrials.gov Identifier: NCT04104984|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : January 14, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||966 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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
- Mean GA at delivery [ Time Frame: baseline ]detection of Mean gastational age at delivery
- 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.
- Birth Wight ( mean +SD) in grams [ Time Frame: baseline ]detection of Birth Wight ( mean +SD) in grams
- 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.
- 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
- Mode of delivery [ Time Frame: baseline ]recording which patients deliver normal vaginal delivery or by cesarean section
- perinatal mortality. [ Time Frame: baseline ]record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
- 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 .
- 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 .
- Maternal morbidity [ Time Frame: baseline ]record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
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
|Contact: Shehab A Millad, MDfirstname.lastname@example.org|
|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|