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Cervical Length in Cases of Placenta Previa

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451136
Recruitment Status : Unknown
Verified February 2018 by Marwa Mohamed Mahmoud Eid, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Marwa Mohamed Mahmoud Eid, Cairo University

Study Description
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Brief Summary:
This study establishes the relationship between cervical length and whether it can be used to predict haemorrhage and preterm delivery in cases of placenta previa.

Condition or disease
Placenta Previa

Detailed Description:

Some studies have reported an association between ultrasonographic decreased cervical length and the likelihood of complications as antepartum or post-partum haemorrhage requiring an emergency caesarean section (CS) .

The safety of trans-vaginal scanning is not in doubt, and the technique now has widespread acceptance. As a consequence, the clinical presentation of placenta previa has changed and most low lying placentas are diagnosed during the second trimester anomaly scan.

The objective of this study was to establish if there is a relation between transvaginal ultrasonographic measurement of cervical length in cases of placenta previa and whether it can be used as a predictor for antepartum haemorrhage or not.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of Third Trimester Cervical Length Measurement in Predicting Risk and Severity if Antepartum Haemorrhage in Cases of Placenta Previa
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cervical length measured in mm in relation to antepartum haemorrhage [ Time Frame: 4 months ]
    To find out the relationship between cervical length measured by transvaginal ultrasound and occurrence of antepartum hemorrhage in cases of placenta previa.


Secondary Outcome Measures :
  1. Need for blood transfusion [ Time Frame: 4 months ]
    Yes or no and no.of packed units

  2. Need for caesarean hysterectomy [ Time Frame: 4 months ]
    Yes or no

  3. Type of cesarean delivery [ Time Frame: 4 months ]
    Elective or emergency cesarean delivery

  4. Need for neonatal ICU [ Time Frame: 4 months ]
    Yes or no


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy pregnant females aged between 25-40 years
Criteria

Inclusion Criteria:

  1. Age: 20-45 years old
  2. Single Pregnancy
  3. Fetal gestational age 28 to < 36 weeks
  4. Normal amniotic fluid index (AFI)
  5. Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).

Exclusion Criteria:

  1. Threatened preterm labor and maternal use of vaginal progesterone.
  2. Preterm premature rupture of membranes;
  3. Polyhydramnios;
  4. Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
  5. Diagnosis of multiple fetal anomalies;
  6. Women with other risk factors for intra-partum hemorrhage
Contacts and Locations
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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): NCT03451136


Contacts
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Contact: Marwa Mohamed Eid, PhD 01001225079 Marwameid2014@gmail.com
Contact: Hisham Mamdouh Haggag, PhD 01224460134 Hmhaggag@kasralainy.edu.eg

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Marwa Mohamed Mahmoud Eid, Ass.prof obs&Gyn., Cairo University
ClinicalTrials.gov Identifier: NCT03451136    
Other Study ID Numbers: Cairo university obgyn 14534
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marwa Mohamed Mahmoud Eid, Cairo University:
Placenta previa
Cervical length
Antepartum haemorrhage
Additional relevant MeSH terms:
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Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases