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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03451136
Other study ID # Cairo university obgyn 14534
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 5, 2018
Last updated February 28, 2018
Start date March 1, 2018
Est. completion date July 15, 2018

Study information

Verified date February 2018
Source Cairo University
Contact Marwa Mohamed Eid, PhD
Phone 01001225079
Email Marwameid2014@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 15, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Cervical length measured in mm in relation to antepartum haemorrhage 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 Need for blood transfusion Yes or no and no.of packed units 4 months
Secondary Need for caesarean hysterectomy Yes or no 4 months
Secondary Type of cesarean delivery Elective or emergency cesarean delivery 4 months
Secondary Need for neonatal ICU Yes or no 4 months
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