Placenta PreviaNCT03321435
The Placenta Previa and Fetal Weight
An observational study of Placenta Previa, run by Assiut University.
Trial summary
Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- placenta previa patient and normal women
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Oct 2017
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: placenta previa patients
Who may be able to join
- Women who are sure of her pregnancy.
- Women aged 20-35 years.
- Women with BMI 18-22 kg/m2.
- Estimated gestational age is ranging between 30- 32 weeks gestation.
- Singleton pregnancy.
- Placenta previa; either major or minor degrees as regard the cases.
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- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.
- Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
Who cannot join
- Women aged < 20 and >35 years.
- Smoker ≥ 11 cigarettes/day.
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non reassuring.
- Multiple gestations.
- Previous Intrauterine growth restricted fetus.
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- Intrauterine fetal death or major fetal anomalies.
- If associated with abruptio placentae.
- Patients with known bleeding disorders or on anticoagulant therapy
About this study
Official title: The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow
Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.
In spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .
So in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.
- Conditions
- Placenta Previa
- Being tested
- placenta previa patient, normal women
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placenta previa patientOther
women had placenta previa either major or minor degree
normal womenOther
those women had not placenta previa
| Study group | Role | What they receive |
|---|---|---|
| placenta previa group | Not described Receives: Other: placenta previa patient | |
| Normal control group | Not described Receives: Other: normal women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fetal wight (gram)
Measured: 4 weeks
Secondary outcomes (1)
The value of Doppler indices in uterine artery
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Oct 2016
- Primary completion1 Aug 2017
- Study completion1 Oct 2017
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 Assiut 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321435
- Sponsor's protocol ID
- PPIUGR
- Status last verified
- Nov 2017
- First submitted
- 21 Oct 2017
- Last updated
- 17 Nov 2017
- 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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow
- ClinicalTrials.gov ID
- NCT03321435
- Acronym / sponsor ID
- PPIUGR
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.
In spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .
So in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placenta previa group | – | Other: placenta previa patient |
| Normal control group | – | Other: normal women |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- placenta previa patients
Key inclusion criteria (9 listed)
- Women who are sure of her pregnancy.
- Women aged 20-35 years.
- Women with BMI 18-22 kg/m2.
- Estimated gestational age is ranging between 30- 32 weeks gestation.
- Singleton pregnancy.
Key exclusion criteria (9 listed)
- Women aged < 20 and >35 years.
- Smoker ≥ 11 cigarettes/day.
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non reassuring.
- Multiple gestations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placenta previa patientwomen had placenta previa either major or minor degree | Other | placenta previa group |
| normal womenthose women had not placenta previa | Other | Normal control group |
Primary outcome
Estimated fetal wight (gram)
Time frame: 4 weeks
1 secondary outcome
The value of Doppler indices in uterine artery
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa, run by Assiut 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 17 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated fetal wight (gram) (time frame: 4 weeks). 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 17 Nov 2017.