Cervical Length in Cases of Placenta Previa

February 28, 2018 updated by: Marwa Mohamed Mahmoud Eid, Cairo University

Value of Third Trimester Cervical Length Measurement in Predicting Risk and Severity if Antepartum Haemorrhage in Cases of Placenta Previa

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Healthy pregnant females aged between 25-40 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for blood transfusion
Time Frame: 4 months
Yes or no and no.of packed units
4 months
Need for caesarean hysterectomy
Time Frame: 4 months
Yes or no
4 months
Type of cesarean delivery
Time Frame: 4 months
Elective or emergency cesarean delivery
4 months
Need for neonatal ICU
Time Frame: 4 months
Yes or no
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 15, 2018

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo university obgyn 14534

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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