Placenta PreviaNCT03451136
Cervical Length in Cases of Placenta Previa
An observational study of Placenta Previa, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 15 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant females aged between 25-40 years
Who may be able to join
- Age: 20-45 years old
- Single Pregnancy
- Fetal gestational age 28 to < 36 weeks
- Normal amniotic fluid index (AFI)
- Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).
Who cannot join
- Threatened preterm labor and maternal use of vaginal progesterone.
- Preterm premature rupture of membranes;
- Polyhydramnios;
- Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
- Diagnosis of multiple fetal anomalies;
- Women with other risk factors for intra-partum hemorrhage
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Placenta Previa
- Keywords
- Placenta previa, Cervical length, Antepartum haemorrhage
- Medical subject headings
- Placenta Previa
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (4)
Need for blood transfusion
Yes or no and no.of packed units
Measured: 4 months
Need for caesarean hysterectomy
Yes or no
Measured: 4 months
Type of cesarean delivery
Elective or emergency cesarean delivery
Measured: 4 months
Need for neonatal ICU
Yes or no
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion15 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Mahmoud Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451136
- Sponsor's protocol ID
- Cairo university obgyn 14534
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Third Trimester Cervical Length Measurement in Predicting Risk and Severity if Antepartum Haemorrhage in Cases of Placenta Previa
- ClinicalTrials.gov ID
- NCT03451136
- Acronym / sponsor ID
- Cairo university obgyn 14534
- Conditions
- Placenta Previa
- Keywords
- Placenta previa, Cervical length, Antepartum haemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 15 Jul 2018 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant females aged between 25-40 years
Key inclusion criteria (5 listed)
- Age: 20-45 years old
- Single Pregnancy
- Fetal gestational age 28 to < 36 weeks
- Normal amniotic fluid index (AFI)
- Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).
Key exclusion criteria (6 listed)
- Threatened preterm labor and maternal use of vaginal progesterone.
- Preterm premature rupture of membranes;
- Polyhydramnios;
- Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
- Diagnosis of multiple fetal anomalies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Need for blood transfusion
Time frame: 4 months
Need for caesarean hysterectomy
Time frame: 4 months
Type of cesarean delivery
Time frame: 4 months
Need for neonatal ICU
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Mohamed Eid, PhD (01001225079, Marwameid2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical length measured in mm in relation to antepartum haemorrhage (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.